Quality management systems -- Guidance for documented information

Este documento proporciona orientación para el desarrollo y mantenimiento de la información documentada necesaria para apoyar un sistema de gestión de la calidad eficaz, adaptado a las necesidades específicas de la organización. Este documento también se puede utilizar para apoyar otros sistemas de gestión, por ejemplo, sistemas de gestión ambiental o de seguridad y salud en el trabajo.

Systèmes de management de la qualité -- Recommandations pour les informations documentées

Le présent document fournit des recommandations pour l'élaboration et la tenue à jour des informations documentées nécessaires pour soutenir un système de management de la qualité efficace, adapté aux besoins spécifiques de l'organisme. Le présent document peut également être utilisé pour soutenir d'autres systèmes de management, par exemple des systèmes de management environnemental ou des systèmes de management de la santé et de la sécurité au travail.

Sistemi vodenja kakovosti - Napotki za dokumentirane informacije

General Information

Status
Published
Publication Date
08-Mar-2021
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
01-Feb-2021
Completion Date
01-Feb-2021

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INTERNATIONAL ISO
STANDARD 10013
Redline version
compares ISO 10013:2021
to ISO/TR 10013:2001
Quality management systems —
Guidance for documented information
Systèmes de management de la qualité — Recommandations pour les
informations documentées
Reference number
ISO 10013:redline:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO 10013:redline:2021(E)
IMPORTANT
This marked-up version uses the following colour-coding in the marked-up text:
Text example 1 — Text has been added (in green)
— Text has been deleted (in red)
Text example 2
— Graphic figure has been added
— Graphic figure has been deleted
1.x ... — If there are changes in a clause/subclause, the corresponding clause/
subclause number is highlighted in yellow in the Table of contents
DISCLAIMER

This marked-up version highlights the main changes in this edition of the document

compared with the previous edition. It does not focus on details (e.g. changes in

punctuation).

This marked-up version does not constitute the official ISO document and is not intended to

be used for implementation purposes.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 10013:redline:2021(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative reference references ........................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Quality management system documentation Documented information ...................................................2

4.1 General ........................................................................................................................................................................................................... 2

4.1.1 Structure ................................................................................................................................................................................. 3

4.1.2 Definitions ............................................................................................................................................................................. 3

4.1.3 Content ..................................................................................................................................................................................... 4

4.1.4 Purpose .................................................................................................................................................................................... 4

4.1.5 Benefits .................................................................................................................................................................................... 5

4.2 Purposes and benefits ...................................................................................................................................................................... 5

4.3 Quality policy and its objectives .............................................................................................................................................. 6

4.4 4.2 Quality manual Documented information to be maintained ........................................................................... 6

4.2.1 Scope of the quality management system .................................................................................................. 6

4.2.2 Quality policy ...................................................................................................................................................................... 6

4.2.3 Quality objectives ............................................................................................................................................................ 6

4.4.1 4.2.4 ......................................................................................................................................................

Contents Information that the organization determined necessary to

support the operation of the quality management system and its processes ............ 6

4.4.2 Title and scope ................................................................................................................................................................11

4.4.3 Table of contents ...........................................................................................................................................................11

4.4.4 Review, approval and revision ..........................................................................................................................11

4.4.5 Quality policy and objectives .............................................................................................................................11

4.4.6 Organization, responsibility and authority ............................................................................................12

4.4.7 References ..........................................................................................................................................................................12

4.4.8 Quality management system description ................................................................................................12

4.4.9 Appendices .................. .................................................... ...................................................................................................12

4.5 Documented procedures .............................................................................................................................................................12

4.5.1 Structure and format .................................................................................................................................................12

4.5.2 Contents ...................................................................... ..........................................................................................................12

4.5.3 Review, approval and revision ..........................................................................................................................13

4.5.4 Identification of changes ........................................................................................................................................13

4.6 Work instructions ..............................................................................................................................................................................14

4.6.1 Structure and format .................................................................................................................................................14

4.6.2 Contents ...................................................................... ..........................................................................................................14

4.6.3 Types of work instructions ..................................................................................................................................14

4.6.4 Review, approval and revision ..........................................................................................................................14

4.6.5 Records ..................................................................................................................................................................................14

4.6.6 Identification of changes ........................................................................................................................................14

4.7 Forms ............................................................................................................................................................................................................14

4.8 Quality plans ..........................................................................................................................................................................................15

4.9 Specifications.........................................................................................................................................................................................15

4.10 External documents .........................................................................................................................................................................15

4.11 4.3 ..........................................................................................................................................................................

Records Documented information to be retained ..................................................................................................15

5 Process of preparing quality management system documentation ............................................................15

5.1 Responsibility for preparation ...............................................................................................................................................15

5.2 Method of preparation of quality management system documentation ...........................................16

5.3 Use of references ................................................................................................................................................................................16

© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 10013:redline:2021(E)
6 5 Process of approval, issue and control of quality management system

documents Creating and updating documented information .............................................................................17

6.1 5.1 Review and approval Implementation .............................................................................................................................17

5.1.1 General...................................................................................................................................................................................17

5.1.2 Use of references ...........................................................................................................................................................18

5.1.3 Responsibility for creation of documented information ............................................................18

5.1.4 Identification and description ...........................................................................................................................18

5.1.5 Format and media ........................................................................................................................................................18

5.1.6 Review and approval .................................................................................................................................................18

6.2 Distribution .............................................................................................................................................................................................18

6.3 Incorporation of changes ............................................................................................................................................................18

6.4 5.2 Issue and change control Control of documented information ..................................................................19

5.2.1 Availability..........................................................................................................................................................................19

5.2.2 Protection ............................................................................................................................................................................19

5.2.3 Distribution, access, retrieval and use .......................................................................................................19

5.2.4 Storage and preservation ......................................................................................................................................19

5.2.5 Updating documented information and control of changes ...................................................19

5.2.6 Retention and disposition .....................................................................................................................................20

6.5 Uncontrolled copies .........................................................................................................................................................................20

Annex A

Typical quality management system documentation hierarchy .....................................................................21

Annex B A
(informative)
Example of structured text work instructions Examples of documented information

structures ..................................................................................................................................................................................................................22

Bibliography .............................................................................................................................................................................................................................24

iv © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 10013:redline:2021(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for whomwhich a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

International Standards areThe procedures used to develop this document and those intended for its

further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval

criteria needed for the different types of ISO documents should be noted. This document was drafted in

accordance with the rules given ineditorial rules of the ISO/IEC Directives, Part 32 (see www .iso .org/

directives).

The main task of technical committees is to prepare International Standards. Draft International

Standards adopted by the technical committees are circulated to the member bodies for voting.

Publication as an International Standard requires approval by at least 75 % of the member bodies

casting a vote.

In exceptional circumstances, when a technical committee has collected data of a different kind from

that which is normally published as an International Standard (“state of the art”, for example), it may

decide by a simple majority vote of its participating members to publish a Technical Report. A Technical

Report is entirely informative in nature and does not have to be reviewed until the data it provides are

considered to be no longer valid or useful.

Attention is drawn to the possibility that some of the elements of this Technical Reportdocument may

be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent

rights. Details of any patent rights identified during the development of the document will be in the

Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

ISO/TR 10013This document was prepared by Technical Committee ISO/TC 176, Quality management

and quality assurance, Subcommittee SC 3, Supporting technologies.

This first edition of ISO/TR 10013 cancels and replaces ISO/TR 10013:19952001, Guidelines for

developing quality manuals.which has been technically revised. The main changes compared with ISO/

TR 10013:2001 are as follows:

— it has been aligned with the new structure and requirements of ISO 9001:2015, notably the

documentation requirements;

— the original hierarchy of documentation is no longer used but left open for the user.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2021 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO 10013:redline:2021(E)
Introduction

The ISO 90009001 family of International Standards requires the quality management system

ofrequires an organization to be documentedmaintain and retain documented information to support

the operation of its processes and to have confidence that the processes are being carried out as

planned.

Documented information is information required to be controlled and maintained by an organization

and the medium on which it is contained. Documented information can be used to communicate, to

provide objective evidence or for sharing knowledge.

Documented information enables the knowledge and experiences of the organization to be preserved

and can generate value to support the improvement of products or services.

This Technical Report promotes the adoption of the process approach when developing and

implementing the quality management system and improving its effectivenessdocument provides

guidance for the development and maintenance of documented information.

For an organization to function effectively, it has to identify and manage numerous linked activities.

An activity using resources, and managed in order to enable the transformation of inputs into outputs,

can be considered as a process. Often the output from one of the processes directly forms the input to

the nextThe adoption of a quality management system is a strategic decision for an organization that

can help to improve its overall performance and provide a sound basis for sustainable development

initiatives. It is applicable to all organizations, regardless of size, complexity or business model. Its

aim is to increase an organization’s awareness of its duties and commitment in fulfilling the needs and

expectations of its customers and interested parties, and in achieving satisfaction with its products

and services.

The application of a system of processes within an organization, together with the identification and

interactions of these processes, and their management, can be referred to as the 'process approach'.

An advantage of the process approach is the ongoing control that it provides over the linkage between

the individual processes within the system of processes, as well as over their combination and

interaction.

An organization has flexibility in the way it chooses to documentIt is important to consider the context

of the organization, including the legal and regulatory framework, needs and expectations of interested

parties, risks and opportunities, and strategic direction of the organization, when an organization

plans what documented information to maintain and retain for its quality management system. Each

individual organization should develop that amount of documentation needed to demonstrate the

effective planning, operation, control and continual improvement of itsWhile the adoption of a quality

management system and its processesis strategic, this also applies to its documented information.

Quality management system documentation mayDocumented information can relate to an

organization'sorganization’s total activities or to a selected part of those activities; for example,, e.g.

specified requirements depending upon the nature of products and services, processes, contractual

requirements, governing regulations or thestatutory and regulatory requirements, the context of the

organization itself.

It is important that the requirements and content of the quality management system documentation

address the qualitydocumented information also conforms to the requirements of the standards they

intend to satisfy., e.g. sector-specific requirements.

Organizations have been moving from paper-based systems to electronic media in the last two decades.

ISO 9001 has reflected this change, replacing terminology such as “documentation, quality manual,

documented procedures, and records” with “documented information.” This guidance document

uses the word “documented information” to refer to information that needs to be controlled by the

organization and “documents” to refer to information. It also uses the word “document” as a verb in a

few places.
vi © ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
ISO 10013:redline:2021(E)

The guidelines given in this Technical Report are intended to assist an organization with documenting

itsISO management system standards use a high-level structure to encourage the use of integrated

management systems. This guidance document by its design and scope is focused on the quality

management system and uses terminology from ISO 9000:2015. They are not intended to be used as

requirements for contractual, regulatory or certification/registration purposesHowever, nothing

prohibits its use in other management system standards.

One aspect of a quality management system is quality planning. Quality planning documents may

include managerial and operational planning, preparing the application ofIn the previous version of

this document, a hierarchy of documentation, such as a quality manual, procedures, work instructions

and forms/checklists, was suggested as a way of documenting the quality management system

including organizing and scheduling, and the approach by which quality objectives are to be achieved.

This document does not prescribe a particular hierarchy but reflects the ability of electronic media

to organize itself in a multitude of ways. It is important to realize that while a quality manual is not

required, it can still be useful, and many sector-specific standards still require “quality manuals and

documented procedures”.
© ISO 2021 – All rights reserved vii
---------------------- Page: 7 ----------------------
INTERNATIONAL STANDARD ISO 10013:redline:2021(E)
Quality management systems — Guidance for documented
information
1 Scope

This Technical Report provides guidelinesdocument gives guidance for the development and

maintenance of the documentationdocumented information necessary to ensuresupport an

effective quality management system, tailored to the specific needs of the organization. The use of

these guidelines will aid in establishing a documented system as required by the applicable quality

management system standard.

This Technical Report maydocument can also be used to document management systems other than that

of the support other management systemsISO 9000 family, for example environmental management

systems, e.g. environmental or occupational health and safety management systems.

NOTE When a procedure is documented, the term “written procedure ” or “documented procedure” is

frequently used.
2 Normative reference references

The following normative document contains provisions which, through reference in this text, constitute

provisions of this Technical Report. For dated references, subsequent amendments to, or revisions of,

any of these publications do not apply. However, parties to agreements based on this Technical Report

are encouraged to investigate the possibility of applying the most recent edition of the normative

document indicated belowdocuments are referred to in the text in such a way that some or all of their

content constitutes requirements of this document. For dated references, only the edition cited applies.

For undated references, the latest edition of the normative document refered to applies. Members of ISO

and IEC maintain registers of currently valid International Standards.referenced document (including

any amendments) applies.
 2015, Quality management systems — Fundamentals and vocabulary
ISO 9000:2000
3 Terms and definitions

For the purposes of this Technical Reportdocument, the terms and definitions given in ISO 9000:2015

and the following apply. An organization's quality management system may use different terminology

for the defined types of documentation.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
work instructions instruction
detailed descriptions description of how to perform and record  tasks

EXAMPLE Detailed written descriptions, flow charts, templates, models, technical notes incorporated into

drawings, specifications, equipment instruction manuals, pictures, audios and videos, checklists or combinations

thereof.
Note 1 to entry: Work instructions can be documented or not .
© ISO 2021 – All rights reserved 1
---------------------- Page: 8 ----------------------
ISO 10013:redline:2021(E)

Note 2 to entry: Work Instructions may be, for example, detailed written descriptions, flowcharts, templates,

models, technical notes incorporated into drawings, specifications, equipment instruction manuals, pictures,

videos, checklists, or combinations thereof. Work instructions should instructions describe any materials,

equipment and documentation documented information to be used. When relevant, work instructions include

acceptance criteria.
3.2
form

document documented information to be maintained and used to record data required by the quality

management system

Note 1 to entry: A form becomes a record documented information to be retained (i.e. a record) when data are

entered.
3.3
workflow
series of activities necessary to complete a task

Note 1 to entry: A workflow that is partially or completely carried out without manual interference can be

referred to as an “automated workflow”.
Note 2 to entry: Workflows can be documented.
4 Quality management system documentation Documented information
4.1 General

The arrangement of quality management system documentation typically follows either the processes

of the organization or the structure of the applicable quality standard, or a combination of both. Any

other arrangement that satisfies the organization's needs may also be used.

The structure of the documentation used in the quality management system may be described

as a hierarchy. This structure facilitates the distribution, maintenance and understanding of the

documentation. Annex A illustrates a typical hierarchy of quality management system documentation.

The development of a hierarchy depends on the circumstances of the organization.

The extent of the quality management system documentation can differ from one organization to

another due to
a) the size of the organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.

The quality management system documentation may include definitions. The vocabulary used should

be in accordance with standard definitions and terms, which are referenced in ISO 9000 or in general

dictionary usage.
The quality management system documentation usually includes the following:
a) quality policy and its objectives;
b) quality manual;
c) documented procedures;
d) work instructions;
e) forms;
f) quality plans;
2 © ISO 2021 – All rights reserved
---------------------- Page: 9 ----------------------
ISO 10013:redline:2021(E)
g) specifications;
h) external documents;
i) records.

Quality management system documentation may be in any type of media, such as hard copy or

electronic media.
NOTE Some advan
...

SLOVENSKI STANDARD
SIST ISO 10013:2021
01-junij-2021
Nadomešča:
SIST ISO/TR 10013:2002
Sistemi vodenja kakovosti - Napotki za dokumentirane informacije
Quality management systems - Guidance for documented information

Lignes directrices pour la documentation des systèmes de management de la qualité

Ta slovenski standard je istoveten z: ISO 10013:2021
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
SIST ISO 10013:2021 en,fr

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST ISO 10013:2021
---------------------- Page: 2 ----------------------
SIST ISO 10013:2021
INTERNATIONAL ISO
STANDARD 10013
First edition
2021-03
Quality management systems —
Guidance for documented information
Systèmes de management de la qualité — Recommandations pour les
informations documentées
Reference number
ISO 10013:2021(E)
ISO 2021
---------------------- Page: 3 ----------------------
SIST ISO 10013:2021
ISO 10013:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
SIST ISO 10013:2021
ISO 10013:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Documented information ............................................................................................................................................................................ 2

4.1 General ........................................................................................................................................................................................................... 2

4.1.1 Structure ................................................................................................................................................................................. 2

4.1.2 Definitions ............................................................................................................................................................................. 2

4.1.3 Content ..................................................................................................................................................................................... 2

4.1.4 Purpose .................................................................................................................................................................................... 3

4.1.5 Benefits .................................................................................................................................................................................... 3

4.2 Documented information to be maintained .................................................................................................................. 4

4.2.1 Scope of the quality management system .................................................................................................. 4

4.2.2 Quality policy ...................................................................................................................................................................... 4

4.2.3 Quality objectives ............................................................................................................................................................ 4

4.2.4 Information that the organization determined necessary to support the

operation of the quality management system and its processes ........................................... 5

4.3 Documented information to be retained .......................................................................................................................... 9

5 Creating and updating documented information .............................................................................................................. 9

5.1 Implementation ...................................................................................................................................................................................... 9

5.1.1 General...................................................................................................................................................................................... 9

5.1.2 Use of references ...........................................................................................................................................................10

5.1.3 Responsibility for creation of documented information ............................................................10

5.1.4 Identification and description ...........................................................................................................................10

5.1.5 Format and media ........................................................................................................................................................10

5.1.6 Review and approval .................................................................................................................................................11

5.2 Control of documented information ..................................................................................................................................11

5.2.1 Availability..........................................................................................................................................................................11

5.2.2 Protection ............................................................................................................................................................................11

5.2.3 Distribution, access, retrieval and use .......................................................................................................11

5.2.4 Storage and preservation ......................................................................................................................................11

5.2.5 Updating documented information and control of changes ...................................................11

5.2.6 Retention and disposition .....................................................................................................................................12

Annex A (informative) Examples of documented information structures .................................................................13

Bibliography .............................................................................................................................................................................................................................14

© ISO 2021 – All rights reserved iii
---------------------- Page: 5 ----------------------
SIST ISO 10013:2021
ISO 10013:2021(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 176, Quality management and quality

assurance, Subcommittee SC 3, Supporting technologies.

This first edition of ISO 10013 cancels and replaces ISO/TR 10013:2001, which has been technically

revised. The main changes compared with ISO/TR 10013:2001 are as follows:

— it has been aligned with the new structure and requirements of ISO 9001:2015, notably the

documentation requirements;

— the original hierarchy of documentation is no longer used but left open for the user.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
SIST ISO 10013:2021
ISO 10013:2021(E)
Introduction

ISO 9001 requires an organization to maintain and retain documented information to support the

operation of its processes and to have confidence that the processes are being carried out as planned.

Documented information is information required to be controlled and maintained by an organization

and the medium on which it is contained. Documented information can be used to communicate, to

provide objective evidence or for sharing knowledge.

Documented information enables the knowledge and experiences of the organization to be preserved

and can generate value to support the improvement of products or services.

This document provides guidance for the development and maintenance of documented information.

The adoption of a quality management system is a strategic decision for an organization that can help

to improve its overall performance and provide a sound basis for sustainable development initiatives. It

is applicable to all organizations, regardless of size, complexity or business model. Its aim is to increase

an organization’s awareness of its duties and commitment in fulfilling the needs and expectations of its

customers and interested parties, and in achieving satisfaction with its products and services.

It is important to consider the context of the organization, including the legal and regulatory framework,

needs and expectations of interested parties, risks and opportunities, and strategic direction of the

organization, when an organization plans what documented information to maintain and retain for its

quality management system. While the adoption of a quality management system is strategic, this also

applies to its documented information.

Documented information can relate to an organization’s total activities or to a selected part of those

activities, e.g. specified requirements depending upon the nature of products and services, processes,

contractual requirements, statutory and regulatory requirements, the context of the organization itself.

It is important that the content of the documented information also conforms to the requirements of

the standards they intend to satisfy, e.g. sector-specific requirements.

Organizations have been moving from paper-based systems to electronic media in the last two decades.

ISO 9001 has reflected this change, replacing terminology such as “documentation, quality manual,

documented procedures, and records” with “documented information.” This guidance document

uses the word “documented information” to refer to information that needs to be controlled by the

organization and “documents” to refer to information. It also uses the word “document” as a verb in a

few places.

ISO management system standards use a high-level structure to encourage the use of integrated

management systems. This guidance document by its design and scope is focused on the quality

management system and uses terminology from ISO 9000:2015. However, nothing prohibits its use in

other management system standards.

In the previous version of this document, a hierarchy of documentation, such as a quality manual,

procedures, work instructions and forms/checklists, was suggested as a way of documenting the

quality management system. This document does not prescribe a particular hierarchy but reflects the

ability of electronic media to organize itself in a multitude of ways. It is important to realize that while

a quality manual is not required, it can still be useful, and many sector-specific standards still require

“quality manuals and documented procedures”.
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SIST ISO 10013:2021
INTERNATIONAL STANDARD ISO 10013:2021(E)
Quality management systems — Guidance for documented
information
1 Scope

This document gives guidance for the development and maintenance of the documented information

necessary to support an effective quality management system, tailored to the specific needs of the

organization.

This document can also be used to support other management systems, e.g. environmental or

occupational health and safety management systems.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 9000:2015 and the

following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
work instruction
detailed description of how to perform tasks

EXAMPLE Detailed written descriptions, flow charts, templates, models, technical notes incorporated into

drawings, specifications, equipment instruction manuals, pictures, audios and videos, checklists or combinations

thereof.
Note 1 to entry: Work instructions can be documented.

Note 2 to entry: Work instructions describe any materials, equipment and documented information to be used.

When relevant, work instructions include acceptance criteria.
3.2
form

documented information to be maintained and used to record data required by the quality

management system

Note 1 to entry: A form becomes documented information to be retained (i.e. a record) when data are entered.

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3.3
workflow
series of activities necessary to complete a task

Note 1 to entry: A workflow that is partially or completely carried out without manual interference can be

referred to as an “automated workflow”.
Note 2 to entry: Workflows can be documented.
4 Documented information
4.1 General
4.1.1 Structure

Documented information can be structured and created in many ways based on the needs of the

organization and other factors such as leadership, intended results of the management system, context

(including statutory and regulatory requirements) and interested parties.

The structure of the documented information used in the quality management system can be described

in a hierarchy. This structure facilitates the distribution, maintenance and understanding of the

documented information. Electronic systems provide additional choices for structuring documented

information. Annex A illustrates examples of documented information structures. Smaller organizations

may choose a simplified documented information structure to meet their needs.

The type and extent of the documented information needed for the quality management system should

be based on an analysis of processes and can differ from one organization to another due to, for example:

a) the size of the organization and type of activities;
b) the complexity of processes and their interactions;
c) the maturity of the quality management system;
d) risks and opportunities;
e) the competence of persons;
f) statutory and regulatory requirements;
g) customer and other interested party requirements;
h) the need for evidence of results achieved;
i) the need to support accessibility and retrievability remotely.
4.1.2 Definitions

Documented information can include definitions. To enhance comprehension, the organization

should consider using vocabulary that is in accordance with standard terms and definitions which

are referenced in ISO 9000, in general dictionary usage or which can be specific to the organization.

An organization's quality management system may use different terminology for the defined types of

documented information.
4.1.3 Content
An organization’s documented information should include the following:
a) the scope of the quality management system (see 4.2.1);
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b) a quality policy (see 4.2.2);
c) quality objectives (see 4.2.3);

d) information that the organization determined necessary to support the operation of the quality

management system and its processes, including, as applicable:
1) a quality manual (see 4.2.4.2);
2) organizational charts (see 4.2.4.3);
3) process maps, process flow charts and/or process descriptions (see 4.2.4.4);
4) procedures and work instructions (see 4.2.4.5);
5) automated workflows (see 4.2.4.6);
6) product and service specifications (see 4.2.4.7);
7) internal and external communications (see 4.2.4.8);
8) plans, schedules and lists (see 4.2.4.9);
9) forms and checklists (see 4.2.4.10);
10) documented information of external origin (see 4.2.4.11);

e) documented information to be retained (i.e. records) for providing evidence of results achieved

(see 4.3).

Documented information can be in any type of media, such as paper, electronic, photograph or

physical sample.
NOTE The advantages of electronic media are, for example:
— easier access to relevant versions including access from remote locations;

— easier control of changes, including the withdrawal of obsolete documented information;

— immediate and controlled distribution;
— retrievability and retention versus paper or other physical media.
4.1.4 Purpose
The purpose of having documented information for an organization includes:
a) communication of information;
b) evidence of achieving results or activities performed;
c) knowledge sharing;
d) knowledge preservation;
e) describing the quality management system of the organization.
4.1.5 Benefits
The benefits of having documented information for an organization include:
a) demonstrating compliance with statutory and regulatory requirements:
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ISO 10013:2021(E)

b) providing information for cross-functional groups so that they can better understand

interrelationships;

c) communicating the organization’s commitment to quality to relevant interested parties;

d) helping persons to understand their role within the organization, thus providing a basis for

expectations of work performance;

e) facilitating mutual understanding between different levels in the organization;

f) providing objective evidence that specified requirements have been achieved;

g) addressing risks and opportunities to improve organizational performance, product or service

conformity, and customer satisfaction;

h) providing organizational knowledge, including the basis for competency and training for persons

and other relevant interested parties;

i) stating how things are to be done to consistently meet specified requirements, thus promoting

controlled conditions and providing a basis for continual improvement;

j) demonstrating to interested parties the capabilities within the organization, thus providing

confidence;
k) providing requirements for external providers;

l) providing a basis for auditing and evaluating the effectiveness and continuing suitability of the

quality management system.
4.2 Documented information to be maintained
4.2.1 Scope of the quality management system

The scope of the quality management system should be documented based on the organization’s

determination of the boundaries and applicability of the quality management system. The scope of

a management system can include the whole of the organization, specific and identified functions

of the organization, specific and identified sections of the organization, or one or more functions

across a group of organizations. The scope should state the types of products and services covered

and, if required, provide justification for any requirement of the relevant quality standard that the

organization determines is not applicable to the scope of its quality management system. The scope

of the quality management system should be based on the nature of the organization’s products and

services, their operational processes, issues raised in establishing the context of the organization

and relevant requirements from interested parties, the results of risk-based thinking, commercial

considerations, and contractual, statutory and regulatory requirements.
4.2.2 Quality policy

The quality policy helps an organization engage its people in the culture of quality of the organization. It

should be aligned with the organization’s strategic direction, mission and vision. It provides a verifiable

commitment to quality to relevant interested parties.

An organization can have other policies besides the quality policy relating to the quality

management system.
4.2.3 Quality objectives

Quality objectives should reflect the results to be achieved by the organization with respect to its

strategic direction, quality policy, risks and opportunities, and applicable requirements to the quality

management system.
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4.2.4 Information that the organization determined necessary to support the operation of the

quality management system and its processes
4.2.4.1 General

The organization should determine the type and extent of documented information necessary to

support the operation of its processes, the formats to be used and the media for communicating

with users. The organization may decide what terms it uses for its documented information. While

terms such as “procedures”, “work instructions” and “quality manual” are used in this document, the

organization is not obliged to adopt such terminology.
4.2.4.2 Quality manual

There are many ways in which an organization can document its quality management system.

Organizations can choose to use a quality manual, or a quality manual can be mandated by the

organization’s external requirements. A quality manual is unique to each organization. It can provide

the structure, format, content or method of presentation for documenting the quality management

system and its processes for all types of organizations.

A small organization can find it appropriate to include the description of its entire quality management

system within a single manual, including all the documented information it maintains. Large,

multinational organizations can need manuals at different levels (e.g. the global, national or regional

level) and a more complex hierarchy of documented information. If the organization chooses to

implement a quality manual, it may include documented procedures or a reference to them, and a

description of the processes of the quality management system and their interactions.

Information about the organization, such as name, location, context and means of communication

including relevant specific terms and definitions, should be included in the quality manual. Additional

information such as its line of business, a brief description of its background, history and size may also

be included.

The quality manual can provide a description of the quality management system and its implementation

in the organization. Descriptions of the processes and their interactions or a reference to them should

be included in the manual. The processes of the organization should be designed to meet the overall

objectives of the organization, its policies, context, and relevant expectations of interested parties. In

large organizations, the processes can link the functional areas of the organization (see Annex A). The

organization should document its specific quality management system following the sequence of the

flow of the processes or any sequencing appropriate to the organization. Cross-referencing between the

selected standard and the processes of the organization can be useful. The sequence and interaction of

the processes within the quality management system can be documented using a process map.

NOTE 1 Manuals are also referred to as “quality manual”, “policy manual”, “reference manual”, “procedure

manual” or any other suitable title.

NOTE 2 Although ISO 9001:2015 does not require a quality manual, some sector-specific standards do.

4.2.4.3 Organizational charts

Organizational charts are often graphical depictions of the roles, responsibilities and authorities

within an organization. They can illustrate how roles, responsibilities and authorities flow through the

organization and how different people or groups of people interact within the organization.

4.2.4.4 Process maps, process flow charts and/or process descriptions

A process map identifies the processes and visually describes the sequence and interaction of the

processes in the organization. The processes can be further described using flow charts.

A process flow chart is a visual description of the process or procedure. It shows the process steps an

organization performs, what triggers the process or procedure (i.e. start of the process and its input)

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SIST ISO 10013:2021
ISO 10013:2021(E)

and what is the final step of the process or its output. Some process flow chart formats document the

input and output for each process step, the control points and the related acceptance criteria.

A process description is a textual description of the process. It explains the process steps in words.

Process owners should be identified for quality management system processes. Process owners are

usually assigned by top management and given the authority and responsibility for a process from start

to finish, and therefore should understand their role and be competent in the process. This is especially

important since processes can cut across functional or departmental boundaries.
4.2.4.5 Procedures and work instructions

The structure and format of documented procedures should be defined by the organization either

through text, flow charts, automated workflows, tables, a combination of the above or any other

suitable method according to the needs of the organization. A procedure generally answers questions

such as who, what, when, where and with what resources. Documented procedures should contain the

information necessary to properly carry out the activities that comprise the process and reference any

requirements to retain documented information and should be uniquely identified.
The l
...

INTERNATIONAL ISO
STANDARD 10013
First edition
2021-03
Quality management systems —
Guidance for documented information
Systèmes de management de la qualité — Recommandations pour les
informations documentées
Reference number
ISO 10013:2021(E)
ISO 2021
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ISO 10013:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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ISO 10013:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Documented information ............................................................................................................................................................................ 2

4.1 General ........................................................................................................................................................................................................... 2

4.1.1 Structure ................................................................................................................................................................................. 2

4.1.2 Definitions ............................................................................................................................................................................. 2

4.1.3 Content ..................................................................................................................................................................................... 2

4.1.4 Purpose .................................................................................................................................................................................... 3

4.1.5 Benefits .................................................................................................................................................................................... 3

4.2 Documented information to be maintained .................................................................................................................. 4

4.2.1 Scope of the quality management system .................................................................................................. 4

4.2.2 Quality policy ...................................................................................................................................................................... 4

4.2.3 Quality objectives ............................................................................................................................................................ 4

4.2.4 Information that the organization determined necessary to support the

operation of the quality management system and its processes ........................................... 5

4.3 Documented information to be retained .......................................................................................................................... 9

5 Creating and updating documented information .............................................................................................................. 9

5.1 Implementation ...................................................................................................................................................................................... 9

5.1.1 General...................................................................................................................................................................................... 9

5.1.2 Use of references ...........................................................................................................................................................10

5.1.3 Responsibility for creation of documented information ............................................................10

5.1.4 Identification and description ...........................................................................................................................10

5.1.5 Format and media ........................................................................................................................................................10

5.1.6 Review and approval .................................................................................................................................................11

5.2 Control of documented information ..................................................................................................................................11

5.2.1 Availability..........................................................................................................................................................................11

5.2.2 Protection ............................................................................................................................................................................11

5.2.3 Distribution, access, retrieval and use .......................................................................................................11

5.2.4 Storage and preservation ......................................................................................................................................11

5.2.5 Updating documented information and control of changes ...................................................11

5.2.6 Retention and disposition .....................................................................................................................................12

Annex A (informative) Examples of documented information structures .................................................................13

Bibliography .............................................................................................................................................................................................................................14

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ISO 10013:2021(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 176, Quality management and quality

assurance, Subcommittee SC 3, Supporting technologies.

This first edition of ISO 10013 cancels and replaces ISO/TR 10013:2001, which has been technically

revised. The main changes compared with ISO/TR 10013:2001 are as follows:

— it has been aligned with the new structure and requirements of ISO 9001:2015, notably the

documentation requirements;

— the original hierarchy of documentation is no longer used but left open for the user.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
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ISO 10013:2021(E)
Introduction

ISO 9001 requires an organization to maintain and retain documented information to support the

operation of its processes and to have confidence that the processes are being carried out as planned.

Documented information is information required to be controlled and maintained by an organization

and the medium on which it is contained. Documented information can be used to communicate, to

provide objective evidence or for sharing knowledge.

Documented information enables the knowledge and experiences of the organization to be preserved

and can generate value to support the improvement of products or services.

This document provides guidance for the development and maintenance of documented information.

The adoption of a quality management system is a strategic decision for an organization that can help

to improve its overall performance and provide a sound basis for sustainable development initiatives. It

is applicable to all organizations, regardless of size, complexity or business model. Its aim is to increase

an organization’s awareness of its duties and commitment in fulfilling the needs and expectations of its

customers and interested parties, and in achieving satisfaction with its products and services.

It is important to consider the context of the organization, including the legal and regulatory framework,

needs and expectations of interested parties, risks and opportunities, and strategic direction of the

organization, when an organization plans what documented information to maintain and retain for its

quality management system. While the adoption of a quality management system is strategic, this also

applies to its documented information.

Documented information can relate to an organization’s total activities or to a selected part of those

activities, e.g. specified requirements depending upon the nature of products and services, processes,

contractual requirements, statutory and regulatory requirements, the context of the organization itself.

It is important that the content of the documented information also conforms to the requirements of

the standards they intend to satisfy, e.g. sector-specific requirements.

Organizations have been moving from paper-based systems to electronic media in the last two decades.

ISO 9001 has reflected this change, replacing terminology such as “documentation, quality manual,

documented procedures, and records” with “documented information.” This guidance document

uses the word “documented information” to refer to information that needs to be controlled by the

organization and “documents” to refer to information. It also uses the word “document” as a verb in a

few places.

ISO management system standards use a high-level structure to encourage the use of integrated

management systems. This guidance document by its design and scope is focused on the quality

management system and uses terminology from ISO 9000:2015. However, nothing prohibits its use in

other management system standards.

In the previous version of this document, a hierarchy of documentation, such as a quality manual,

procedures, work instructions and forms/checklists, was suggested as a way of documenting the

quality management system. This document does not prescribe a particular hierarchy but reflects the

ability of electronic media to organize itself in a multitude of ways. It is important to realize that while

a quality manual is not required, it can still be useful, and many sector-specific standards still require

“quality manuals and documented procedures”.
© ISO 2021 – All rights reserved v
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 10013:2021(E)
Quality management systems — Guidance for documented
information
1 Scope

This document gives guidance for the development and maintenance of the documented information

necessary to support an effective quality management system, tailored to the specific needs of the

organization.

This document can also be used to support other management systems, e.g. environmental or

occupational health and safety management systems.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 9000:2015 and the

following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
work instruction
detailed description of how to perform tasks

EXAMPLE Detailed written descriptions, flow charts, templates, models, technical notes incorporated into

drawings, specifications, equipment instruction manuals, pictures, audios and videos, checklists or combinations

thereof.
Note 1 to entry: Work instructions can be documented.

Note 2 to entry: Work instructions describe any materials, equipment and documented information to be used.

When relevant, work instructions include acceptance criteria.
3.2
form

documented information to be maintained and used to record data required by the quality

management system

Note 1 to entry: A form becomes documented information to be retained (i.e. a record) when data are entered.

© ISO 2021 – All rights reserved 1
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ISO 10013:2021(E)
3.3
workflow
series of activities necessary to complete a task

Note 1 to entry: A workflow that is partially or completely carried out without manual interference can be

referred to as an “automated workflow”.
Note 2 to entry: Workflows can be documented.
4 Documented information
4.1 General
4.1.1 Structure

Documented information can be structured and created in many ways based on the needs of the

organization and other factors such as leadership, intended results of the management system, context

(including statutory and regulatory requirements) and interested parties.

The structure of the documented information used in the quality management system can be described

in a hierarchy. This structure facilitates the distribution, maintenance and understanding of the

documented information. Electronic systems provide additional choices for structuring documented

information. Annex A illustrates examples of documented information structures. Smaller organizations

may choose a simplified documented information structure to meet their needs.

The type and extent of the documented information needed for the quality management system should

be based on an analysis of processes and can differ from one organization to another due to, for example:

a) the size of the organization and type of activities;
b) the complexity of processes and their interactions;
c) the maturity of the quality management system;
d) risks and opportunities;
e) the competence of persons;
f) statutory and regulatory requirements;
g) customer and other interested party requirements;
h) the need for evidence of results achieved;
i) the need to support accessibility and retrievability remotely.
4.1.2 Definitions

Documented information can include definitions. To enhance comprehension, the organization

should consider using vocabulary that is in accordance with standard terms and definitions which

are referenced in ISO 9000, in general dictionary usage or which can be specific to the organization.

An organization's quality management system may use different terminology for the defined types of

documented information.
4.1.3 Content
An organization’s documented information should include the following:
a) the scope of the quality management system (see 4.2.1);
2 © ISO 2021 – All rights reserved
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ISO 10013:2021(E)
b) a quality policy (see 4.2.2);
c) quality objectives (see 4.2.3);

d) information that the organization determined necessary to support the operation of the quality

management system and its processes, including, as applicable:
1) a quality manual (see 4.2.4.2);
2) organizational charts (see 4.2.4.3);
3) process maps, process flow charts and/or process descriptions (see 4.2.4.4);
4) procedures and work instructions (see 4.2.4.5);
5) automated workflows (see 4.2.4.6);
6) product and service specifications (see 4.2.4.7);
7) internal and external communications (see 4.2.4.8);
8) plans, schedules and lists (see 4.2.4.9);
9) forms and checklists (see 4.2.4.10);
10) documented information of external origin (see 4.2.4.11);

e) documented information to be retained (i.e. records) for providing evidence of results achieved

(see 4.3).

Documented information can be in any type of media, such as paper, electronic, photograph or

physical sample.
NOTE The advantages of electronic media are, for example:
— easier access to relevant versions including access from remote locations;

— easier control of changes, including the withdrawal of obsolete documented information;

— immediate and controlled distribution;
— retrievability and retention versus paper or other physical media.
4.1.4 Purpose
The purpose of having documented information for an organization includes:
a) communication of information;
b) evidence of achieving results or activities performed;
c) knowledge sharing;
d) knowledge preservation;
e) describing the quality management system of the organization.
4.1.5 Benefits
The benefits of having documented information for an organization include:
a) demonstrating compliance with statutory and regulatory requirements:
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ISO 10013:2021(E)

b) providing information for cross-functional groups so that they can better understand

interrelationships;

c) communicating the organization’s commitment to quality to relevant interested parties;

d) helping persons to understand their role within the organization, thus providing a basis for

expectations of work performance;

e) facilitating mutual understanding between different levels in the organization;

f) providing objective evidence that specified requirements have been achieved;

g) addressing risks and opportunities to improve organizational performance, product or service

conformity, and customer satisfaction;

h) providing organizational knowledge, including the basis for competency and training for persons

and other relevant interested parties;

i) stating how things are to be done to consistently meet specified requirements, thus promoting

controlled conditions and providing a basis for continual improvement;

j) demonstrating to interested parties the capabilities within the organization, thus providing

confidence;
k) providing requirements for external providers;

l) providing a basis for auditing and evaluating the effectiveness and continuing suitability of the

quality management system.
4.2 Documented information to be maintained
4.2.1 Scope of the quality management system

The scope of the quality management system should be documented based on the organization’s

determination of the boundaries and applicability of the quality management system. The scope of

a management system can include the whole of the organization, specific and identified functions

of the organization, specific and identified sections of the organization, or one or more functions

across a group of organizations. The scope should state the types of products and services covered

and, if required, provide justification for any requirement of the relevant quality standard that the

organization determines is not applicable to the scope of its quality management system. The scope

of the quality management system should be based on the nature of the organization’s products and

services, their operational processes, issues raised in establishing the context of the organization

and relevant requirements from interested parties, the results of risk-based thinking, commercial

considerations, and contractual, statutory and regulatory requirements.
4.2.2 Quality policy

The quality policy helps an organization engage its people in the culture of quality of the organization. It

should be aligned with the organization’s strategic direction, mission and vision. It provides a verifiable

commitment to quality to relevant interested parties.

An organization can have other policies besides the quality policy relating to the quality

management system.
4.2.3 Quality objectives

Quality objectives should reflect the results to be achieved by the organization with respect to its

strategic direction, quality policy, risks and opportunities, and applicable requirements to the quality

management system.
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ISO 10013:2021(E)

4.2.4 Information that the organization determined necessary to support the operation of the

quality management system and its processes
4.2.4.1 General

The organization should determine the type and extent of documented information necessary to

support the operation of its processes, the formats to be used and the media for communicating

with users. The organization may decide what terms it uses for its documented information. While

terms such as “procedures”, “work instructions” and “quality manual” are used in this document, the

organization is not obliged to adopt such terminology.
4.2.4.2 Quality manual

There are many ways in which an organization can document its quality management system.

Organizations can choose to use a quality manual, or a quality manual can be mandated by the

organization’s external requirements. A quality manual is unique to each organization. It can provide

the structure, format, content or method of presentation for documenting the quality management

system and its processes for all types of organizations.

A small organization can find it appropriate to include the description of its entire quality management

system within a single manual, including all the documented information it maintains. Large,

multinational organizations can need manuals at different levels (e.g. the global, national or regional

level) and a more complex hierarchy of documented information. If the organization chooses to

implement a quality manual, it may include documented procedures or a reference to them, and a

description of the processes of the quality management system and their interactions.

Information about the organization, such as name, location, context and means of communication

including relevant specific terms and definitions, should be included in the quality manual. Additional

information such as its line of business, a brief description of its background, history and size may also

be included.

The quality manual can provide a description of the quality management system and its implementation

in the organization. Descriptions of the processes and their interactions or a reference to them should

be included in the manual. The processes of the organization should be designed to meet the overall

objectives of the organization, its policies, context, and relevant expectations of interested parties. In

large organizations, the processes can link the functional areas of the organization (see Annex A). The

organization should document its specific quality management system following the sequence of the

flow of the processes or any sequencing appropriate to the organization. Cross-referencing between the

selected standard and the processes of the organization can be useful. The sequence and interaction of

the processes within the quality management system can be documented using a process map.

NOTE 1 Manuals are also referred to as “quality manual”, “policy manual”, “reference manual”, “procedure

manual” or any other suitable title.

NOTE 2 Although ISO 9001:2015 does not require a quality manual, some sector-specific standards do.

4.2.4.3 Organizational charts

Organizational charts are often graphical depictions of the roles, responsibilities and authorities

within an organization. They can illustrate how roles, responsibilities and authorities flow through the

organization and how different people or groups of people interact within the organization.

4.2.4.4 Process maps, process flow charts and/or process descriptions

A process map identifies the processes and visually describes the sequence and interaction of the

processes in the organization. The processes can be further described using flow charts.

A process flow chart is a visual description of the process or procedure. It shows the process steps an

organization performs, what triggers the process or procedure (i.e. start of the process and its input)

© ISO 2021 – All rights reserved 5
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ISO 10013:2021(E)

and what is the final step of the process or its output. Some process flow chart formats document the

input and output for each process step, the control points and the related acceptance criteria.

A process description is a textual description of the process. It explains the process steps in words.

Process owners should be identified for quality management system processes. Process owners are

usually assigned by top management and given the authority and responsibility for a process from start

to finish, and therefore should understand their role and be competent in the process. This is especially

important since processes can cut across functional or departmental boundaries.
4.2.4.5 Procedures and work instructions

The structure and format of documented procedures should be defined by the organization either

through text, flow charts, automated workflows, tables, a combination of the above or any other

suitable method according to the needs of the organization. A procedure generally answers questions

such as who, what, when, where and with what resources. Documented procedures should contain the

information necessary to properly carry out the activities that comprise the process and reference any

requirements to retain documented information and should be uniquely identified.

The level of detail can vary depending on the complexity of the activities, risks and opportunities,

the methods used, and the levels of competency of people that is necessary to perform the activities.

Irrespective of the level of detail, the following aspects should be considered, as applicable:

— defining the needs of the organization and its relevant interested parties;

— describing the process(es) in terms of text, or other methods (e.g. flow charts, photos, videos) related

to the required activities;

— describing what is to be done, by whom or by which organizational function, why, when and where;

— describing process controls and controls of the identified activities;

— addressing risks and opportunities in a process as it affects the overall objectives of the organization;

— defining the resources needed for the activities (e.g. in terms of people, infrastructure and materials);

— defining the appropriate internal and external documented information related to the required

activities;
— defining the inputs required and outputs expected of
...

NORME ISO
INTERNATIONALE 10013
Version Redline
compare ISO 10013:2021
à ISO/TR 10013:2001
Systèmes de management de la
qualité — Recommandations pour les
informations documentées
Quality management systems — Guidance for documented
information
Numéro de référence
ISO 10013:redline:2021(F)
ISO 2021
---------------------- Page: 1 ----------------------
ISO 10013:redline:2021(F)
IMPORTANT
Cette version avec marques de révision utilise les codes couleur suivants
Exemple de texte 1 — Texte ayant été ajouté (en vert)
Exemple de texte 2 — Texte ayant été supprimé (en rouge)
— Figure graphique ayant été ajoutée
— Figure graphique ayant été supprimée

1.x ... — Si des modifications ont été apportées à un article/paragraphe, l’arti-

cle/le paragraphe est mis en évidence en jaune dans le Sommaire
AVERTISSEMENT

Cette version marquée met en évidence les principales modifications dans la présente

édition du document comparée à l’édition précédente. Elle ne reflète pas les détails (par

exemple les changements de ponctuation).

Cette version marquée ne constitue pas le document ISO officiel et n’est pas destinée à être

utilisée à des fins de mise en œuvre.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en oeuvre, aucune partie de cette

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Tél.: +41 22 749 01 11
Fax: +41 22 749 09 47
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii © ISO 2021 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 10013:redline:2021(F)
Sommaire Page

Avant-propos ................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Domaine d'application d’application ............................................................................................................................................... 1

2 Références normatives ................................................................................................................................................................................... 1

3 Termes et définitions ....................................................................................................................................................................................... 1

4 Documentation d'un système de management de la qualité Informations documentées .......2

4.1 Généralités .................................................................................................................................................................................................. 2

4.1.1 Structures ............................................................................................................................................................................... 3

4.1.2 Définitions ............................................................................................................................................................................. 4

4.1.3 Contenu .................................................................................................................................................................................... 4

4.1.4 Finalité ...................................................................................................................................................................................... 5

4.1.5 Avantages ............................................................................................................................................................................... 5

4.2 Finalités et avantages ........................................................................................................................................................................ 5

4.3 Politique qualité et objectifs ........................................................................................................................................................ 6

4.4 4.2 Manuel qualité Informations documentées à tenir à jour .................................................................................. 6

4.2.1 Domaine d’application du système de management de la qualité ........................................ 6

4.2.2 Politique qualité ............................................................................................................................................................... 6

4.2.3 Objectifs qualité ................................................................................................................................................................ 7

4.4.1 4.2.4 ......................................................................................................................................................

Contenu Informations que l’organisme a jugées nécessaires pour soutenir
le fonctionnement du système de management de la qualité et de ses processus . 7

4.4.2 Titre et domaine d'application .........................................................................................................................12

4.4.3 Sommaire ............................................................................................................................................................................12

4.4.4 Revue, approbation et révision ........................................................................................................................12

4.4.5 Politique qualité et objectifs qualité ............................................................................................................12

4.4.6 Organisme, responsabilités et autorités ...................................................................................................12

4.4.7 Références ..........................................................................................................................................................................12

4.4.8 Description du système de management de la qualité ................................................................12

4.4.9 Annexes .................................................................................................................................................................................13

4.5 Procédures documentées ......... ...................................................................................................................................................13

4.5.1 Structure et format .....................................................................................................................................................13

4.5.2 Contenu .................................................................................................................................................................................13

4.5.3 Revue, approbation et révision ........................................................................................................................14

4.5.4 Identification des modifications ......................................................................................................................14

4.6 Instructions de travail ....................................................................................................................................................................14

4.6.1 Structure et format .....................................................................................................................................................14

4.6.2 Contenu .................................................................................................................................................................................15

4.6.3 Types d'instructions de travail .........................................................................................................................15

4.6.4 Revue, approbation et révision ........................................................................................................................15

4.6.5 Enregistrements ............................................................................................................................................................15

4.6.6 Identification de modifications ........................................................................................................................15

4.7 Formulaires .............................................................................................................................................................................................15

4.8 Plans qualité ...........................................................................................................................................................................................15

4.9 Spécifications.........................................................................................................................................................................................16

4.10 Documents externes ........................................................................................................................................................................16

4.11 4.3 ..........................................................................................................................................................................

Enregistrements Informations documentées à conserver ..............................................................................16

5 Processus de préparation de la documentation d'un système de management de la

qualité Création et mise à jour des informations documentées .......................................................................16

5.1 Responsabilité de la préparation .........................................................................................................................................16

5.2 5.1 Méthode de préparation de la documentation d'un système de management de la

qualité Mise en œuvre .....................................................................................................................................................................17

© ISO 2021 – Tous droits réservés iii
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ISO 10013:redline:2021(F)

5.1.1 Généralités .........................................................................................................................................................................18

5.1.2 Utilisation de références ........................................................................................................................................18

5.1.3 Responsabilité de la création des informations documentées .................. ............................19

5.1.4 Identification et description ...............................................................................................................................19

5.1.5 Format et supports .....................................................................................................................................................19

5.1.6 Revue et approbation ........................................................................................................................................... .....19

5.3 5.2 Utilisation de références Maîtrise des informations documentées .........................................................19

5.2.1 Disponibilité......................................................................................................................................................................19

5.2.2 Protection ............................................................................................................................................................................20

5.2.3 Diffusion, accès, récupération et utilisation ..........................................................................................20

5.2.4 Stockage et préservation ........................................................................................................................................20

5.2.5 Mise à jour des informations documentées et maîtrise des modifications ................20

5.2.6 Conservation et élimination ................................................................................................................................20

6 Processus d'approbation, de diffusion et de maîtrise des documents du système de

management de la qualité .......................................................................................................................................................................21

6.1 Revue et approbation .....................................................................................................................................................................21

6.2 Diffusion ....................................................................................................................................................................................................21

6.3 Introduction des modifications .............................................................................................................................................21

6.4 Maîtrise de la diffusion et des modifications .............................................................................................................21

6.5 Copies non contrôlées ....................................................................................................................................................................21

Annexe A (informative) Hiérarchie type de la documentation d'un système de management

de la qualité Exemples de structures d’informations documentées ............................................................22

Annexe B Exemple d'instructions de travail à texte structuré .............................................................................................24

Bibliographie ...........................................................................................................................................................................................................................26

iv © ISO 2021 – Tous droits réservés
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ISO 10013:redline:2021(F)
Avant-propos

L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes

nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est

en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.

L'ISO collabore étroitement avec la Commission électrotechnique internationale (CEIIEC) en ce qui

concerne la normalisation électrotechnique.

Les Normes internationales sont rédigéesprocédures utilisées pour élaborer le présent document

et celles destinées à sa mise à jour sont décrites dans les Directives ISO/IEC, Partie 1. Il convient, en

particulier, de prendre note des différents critères d'approbation requis pour les différents types de

documents ISO. Le présent document a été rédigé conformément aux règles de rédaction données dans

les Directives ISO/CEIIEC, Partie 2 (voir www .iso .org/ directives).

La tâche principale des comités techniques est d'élaborer les Normes internationales. Les projets de

Normes internationales adoptés par les comités techniques sont soumis aux comités membres pour

vote. Leur publication comme Normes internationales requiert l'approbation de 75 % au moins des

comités membres votants.

Exceptionnellement, lorsqu'un comité technique a réuni des données de nature différente de celles qui

sont normalement publiées comme Normes internationales (ceci pouvant comprendre des informations

sur l'état de la technique par exemple), il peut décider, à la majorité simple de ses membres, de publier

un Rapport technique. Les Rapports techniques sont de nature purement informative et ne doivent pas

nécessairement être révisés avant que les données fournies ne soient plus jugées valables ou utiles.

L'attention est appeléeattirée sur le fait que certains des éléments du présent document peuvent faire

l'objet de droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour

responsable de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails

concernant les références aux droits de propriété intellectuelle ou autres droits analogues identifiés

lors de l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations

de brevets reçues par l'ISO (voir www .iso .org/ brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion

de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir www .iso .org/ avant -propos.

L'ISO/TR 10013 a été élaboré par le comité technique ISOLe comité chargé de l’élaboration du présent

document est l’ISO/TC 176, Management et assurance de la qualité, sous-comité SC 3, Techniques de

soutien.

Cette première édition de l’ISO 10013 annule et remplace l’ISO/TR 10013:19952001 qui a fait l’objet

d’une révision technique. Par rapport à l’ISO/TR 10013:2001, Lignes directrices pour l'élaboration des

manuels qualité.les principales modifications sont les suivantes:

— il a été aligné sur la nouvelle structure et les nouvelles exigences de l’ISO 9001:2015, notamment les

exigences de documentation;

— la hiérarchie originale de la documentation n’est plus utilisée mais laissée au choix de l’utilisateur.

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l’adresse www .iso .org/ fr/ members .html.
© ISO 2021 – Tous droits réservés v
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ISO 10013:redline:2021(F)
Introduction

L’ISO 9001 exige qu’un organisme tienne à jour et conserve les informations documentées nécessaires

au fonctionnement de ses processus et pour avoir l’assurance que les processus sont mis en œuvre

comme planifié.

Une information documentée est une information devant être maîtrisée et tenue à jour par un organisme

ainsi que le support sur lequel elle figure. Les informations documentées peuvent être utilisées pour

communiquer, pour fournir des preuves objectives ou pour partager des connaissances.

Les Normes internationales de la familleinformations documentées permettent de ISO 9000 exigent que

le système de management de la qualité d'un organisme soit documentéconserver les connaissances et

les expériences de l’organisme et peuvent générer de la valeur pour soutenir l’amélioration des produits

ou des services.

Le présent document fournit des recommandations pour l’élaboration et la tenue à jour des informations

documentées.

Le présent Rapport technique encourage l'adoption de l'approche processus lors de l'élaboration et la

mise en œuvre du système de management de la qualité et de l'amélioration de son efficacitéL’adoption

d’un système de management de la qualité relève d’une décision stratégique de l’organisme qui peut

l’aider à améliorer ses performances globales et fournir une base solide à des initiatives permettant

d’assurer sa pérennité. Il s’applique à tous les organismes quels que soient leur taille, leur complexité

ou leur modèle d’entreprise. Il vise à accroître la sensibilisation de l’organisme sur ses obligations et

son engagement à répondre aux besoins et aux attentes de ses clients et des parties intéressées et à les

satisfaire avec ses produits et services.

Pour qu'un organisme fonctionne de manière efficace, il doit identifier et gérer de nombreuses activités

corrélées. Toute activité utilisant des ressources et gérée de manière à permettre la transformation

d'éléments d'entrée en éléments de sortie, peut être considérée comme un processus. L'élément de

sortie d'un processus constitue souvent l'élément d'entrée du processus suivant.

«L'approche processus» désigne l'application d'un système de processus au sein d'un organisme, ainsi

que l'identification, les interactions et le management de ces processus.

Entre autres avantages, l'approche processus confère la maîtrise permanente des liens entre les

processus individuels et de leurs interactions et associations, au sein du système de processus.

Un organisme jouit d'une certaine souplesse dans la manière qu'il choisit pour documenter son système

de management de la qualité. Il convient que chaque organisme individuel élabore la quantité de

documentation nécessaire pour démontrer le caractère efficace de la planification, du fonctionnement,

de la maîtrise et de l'amélioration continue deIl est important de prendre en compte le contexte

de l’organisme, y compris le cadre juridique et réglementaire, les besoins et attentes des parties

intéressées, les risques et opportunités, et l’orientation stratégique de l’organisme lorsque celui-ci

planifie les informations documentées à tenir à jour et à conserver pour son système de management de

la qualité et de ses processus. Si l’adoption d’un système de management de la qualité est stratégique,

cela s’applique également à ses informations documentées.

La documentation d'un système de management de la qualité peutLes informations documentées

peuvent se rapporter à l'ensemblel’ensemble des activités d'und’un organisme ou à une partie

déterminée de celles-cices activités; par exemple, des exigences spécifiées selon la nature des produits

et services, des processus, des exigences contractuelles, de règlements en vigueur, ou de l'organismedes

exigences légales et réglementaires, du contexte de l’organisme lui-même.

Il est important que le contenu des informations documentées soit également conforme aux exigences

des normes qu’elles sont censées satisfaire; par exemple, des exigences spécifiques à un secteur.

Au cours des deux dernières décennies, les organismes sont passés de systèmes sur papier à des

supports électroniques. L’ISO 9001 a tenu compte de ce changement en remplaçant des termes tels

que «documentation, manuel qualité, procédures documentées et enregistrements» par «informations

vi © ISO 2021 – Tous droits réservés
---------------------- Page: 6 ----------------------
ISO 10013:redline:2021(F)

documentées». Le présent document de recommandations utilise le terme «informations documentées»

pour désigner les informations qu’il est nécessaire pour l’organisme de maîtriser et le terme

«documents» pour désigner les informations. Le verbe «documenter» est également utilisé à quelques

endroits.

Il est important que les exigences et le contenu de la documentation d'unLes normes de systèmes de

management de l’ISO utilisent une structure-cadre (HLS) pour favoriser l’utilisation de systèmes de

management intégrés. Le présent document de recommandations, de par sa conception et son domaine

d’application, est axé sur le système de management de la qualité répondent aux et utilise la terminologie

de l’ISO 9000:2015normes qualité qu'ils sont censés satisfaire. Cependant, rien n’interdit son utilisation

dans le cadre d’autres normes de systèmes de management.

Les lignes directrices fournies dans le présent Rapport technique sont destinées à aider un organisme

à documenter sonDans la version précédente de ce document, une hiérarchie de la documentation,

telle qu’un manuel qualité, les procédures, les instructions de travail et les formulaires/check-lists,

était suggérée comme moyen de documenter le système de management de la qualité. Elles ne sont pas

destinées à être utilisées comme exigences à des fins contractuelles, réglementaires ou de certification.

Le présent document ne spécifié pas de hiérarchie particulière mais tient compte de la capacité des

supports électroniques à s’organiser de multiples façons. Il est important de noter que même si un

manuel qualité n’est pas exigé, il peut quand même être utile, et que de nombreuses normes spécifiques

à un secteur exigent encore des «manuels qualité et procédures documentées».

L'un des aspects d'un système de management de la qualité est la planification de la qualité. Les

documents de planification de la qualité peuvent porter sur le management de la planification et sur

la planification opérationnelle, la préparation de la mise en œuvre du système de management de la

qualité, y compris l'organisation et le calendrier, et la démarche permettant d'atteindre les objectifs

qualité.
© ISO 2021 – Tous droits réservés vii
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NORME INTERNATIONALE ISO 10013:redline:2021(F)
Systèmes de management de la qualité —
Recommandations pour les informations documentées
1 Domaine d'application d’application

Le présent Rapport techniquedocument fournit des lignes directrices pour l'élaborationrecommandations

pour l’élaboration et la tenue à jour de la documentation nécessaire pour assurer un système efficacedes

informations documentées nécessaires pour soutenir un système de management de la qualité efficace,

adaptéeadapté aux besoins spécifiques de l'organisme utilisateur. L'utilisation de ces lignes directrices

facilitera l'établissement d'un système documenté répondant aux exigences de la norme de système de

management de la qualité applicable.l’organisme.

Le présent Rapport technique peutdocument peut également être utilisé pour documenter dessoutenir

d’autres systèmes de management relevant d'autres normes que celles de la famille ISO 9000, par

exemple des systèmes de management environnemental etou des systèmes de management de la

sécuritésanté et de la sécurité au travail.

NOTE Lorsqu'une procédure est documentée, le terme «procédure écrite» ou «procédure documentée» est

souvent employé.
2 Références normatives

Les documents normatifs suivants contiennent des dispositions qui, par suite de la référence qui y

est faite, constituent des dispositions valables pour la présente partie des Directives ISO/CEIsuivants

sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur contenu, des exigences

du présent document. Pour les références datées, les amendements ultérieurs ou les révisions de ces

publications ne s'appliquent pas. Toutefois, les parties prenantes aux accords fondés sur la présente

partie des Directives ISO/CEI sont invitées à rechercher la possibilité d'appliquer les éditions les plus

récentes des documents normatifs indiqués ci-aprèsseule l’édition citée s’applique. Pour les références

non datées, la dernière édition du document normatif en référence s'applique. Les membres de l'ISO et

de la CEI possèdent le registre des Normes internationales en vigueurde référence s'applique (y compris

les éventuels amendements).

ISO 9000:2005 2015, Systèmes de management de la qualité — Principes essentiels et vocabulaire

3 Termes et définitions

Pour les besoins du présent Rapport techniquedocument, les termes et définitions donnés dans l'les

définitions de l’ISO 9000:2015 ainsi que les suivants s'appliquent. Le système de management de la

qualité d'un organisme peut employer une terminologie différente pour les types de documentation

définis.s’appliquent.

L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en

normalisation, consultables aux adresses suivantes:

— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp

— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/
© ISO 2021 – Tous droits réservés 1
---------------------- Page: 8 ----------------------
ISO 10013:redline:2021(F)
3.1
instruction de travail
description détaillée sur la manière de réaliser et d'enregistrer  des tâches

EXEMPLE Descriptions écrites détaillées, de logigrammes, de formulaires, de modèles, de notes techniques

incorporées dans un plan, de spécifications, de notices techniques d’équipements, d’images, de documents audio

et vidéo, de check-lists, ou de combinaisons de ces éléments.

Note 1 à l'article: Une instruction Les instructions de travail peut être documentée ou pas peuvent être

documentées.

Note 2 à l'article: Une instruction de travail peut, par exemple, prendre la forme de description écrite détaillée,

de logigramme, de gabarit, de modèle, de note technique incorporée dans un plan, de spécification, de notice

technique pour équipements, d'images, de vidéo, de listes de vérification (check-list), ou de combinaisons de ce

...

NORME ISO
INTERNATIONALE 10013
Première édition
2021-03
Systèmes de management de la
qualité — Recommandations pour les
informations documentées
Quality management systems — Guidance for documented
information
Numéro de référence
ISO 10013:2021(F)
ISO 2021
---------------------- Page: 1 ----------------------
ISO 10013:2021(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii © ISO 2021 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 10013:2021(F)
Sommaire Page

Avant-propos ..............................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Domaine d’application ................................................................................................................................................................................... 1

2 Références normatives ................................................................................................................................................................................... 1

3 Termes et définitions ....................................................................................................................................................................................... 1

4 Informations documentées ....................................................................................................................................................................... 2

4.1 Généralités .................................................................................................................................................................................................. 2

4.1.1 Structures ............................................................................................................................................................................... 2

4.1.2 Définitions ............................................................................................................................................................................. 2

4.1.3 Contenu .................................................................................................................................................................................... 3

4.1.4 Finalité ...................................................................................................................................................................................... 3

4.1.5 Avantages ............................................................................................................................................................................... 4

4.2 Informations documentées à tenir à jour ........................................................................................................................ 4

4.2.1 Domaine d’application du système de management de la qualité ........................................ 4

4.2.2 Politique qualité ............................................................................................................................................................... 4

4.2.3 Objectifs qualité ................................................................................................................................................................ 5

4.2.4 Informations que l’organisme a jugées nécessaires pour soutenir le

fonctionnement du système de management de la qualité et de ses processus ....... 5

4.3 Informations documentées à conserver ........................................................................................................................... 9

5 Création et mise à jour des informations documentées...........................................................................................10

5.1 Mise en œuvre.......................................................................................................................................................................................10

5.1.1 Généralités .........................................................................................................................................................................10

5.1.2 Utilisation de références ........................................................................................................................................11

5.1.3 Responsabilité de la création des informations documentées .................. ............................11

5.1.4 Identification et description ...............................................................................................................................11

5.1.5 Format et supports .....................................................................................................................................................11

5.1.6 Revue et approbation ........................................................................................................................................... .....11

5.2 Maîtrise des informations documentées .......................................................................................................................12

5.2.1 Disponibilité......................................................................................................................................................................12

5.2.2 Protection ............................................................................................................................................................................12

5.2.3 Diffusion, accès, récupération et utilisation ..........................................................................................12

5.2.4 Stockage et préservation ........................................................................................................................................12

5.2.5 Mise à jour des informations documentées et maîtrise des modifications ................12

5.2.6 Conservation et élimination ................................................................................................................................13

Annexe A (informative) Exemples de structures d’informations documentées ...................................................14

Bibliographie ...........................................................................................................................................................................................................................15

© ISO 2021 – Tous droits réservés iii
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ISO 10013:2021(F)
Avant-propos

L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes

nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est

en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.

L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents

critères d'approbation requis pour les différents types de documents ISO. Le présent document a été

rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www

.iso .org/ directives).

L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de

droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant

les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de

brevets reçues par l'ISO (voir www .iso .org/ brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion

de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir www .iso .org/ avant -propos.

Le comité chargé de l’élaboration du présent document est l’ISO/TC 176, Management et assurance de la

qualité, sous-comité SC 3, Techniques de soutien.

Cette première édition de l’ISO 10013 annule et remplace l’ISO/TR 10013:2001 qui a fait l’objet d’une

révision technique. Par rapport à l’ISO/TR 10013:2001, les principales modifications sont les suivantes:

— il a été aligné sur la nouvelle structure et les nouvelles exigences de l’ISO 9001:2015, notamment les

exigences de documentation;

— la hiérarchie originale de la documentation n’est plus utilisée mais laissée au choix de l’utilisateur.

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l’adresse www .iso .org/ fr/ members .html.
iv © ISO 2021 – Tous droits réservés
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ISO 10013:2021(F)
Introduction

L’ISO 9001 exige qu’un organisme tienne à jour et conserve les informations documentées nécessaires

au fonctionnement de ses processus et pour avoir l’assurance que les processus sont mis en œuvre

comme planifié.

Une information documentée est une information devant être maîtrisée et tenue à jour par un organisme

ainsi que le support sur lequel elle figure. Les informations documentées peuvent être utilisées pour

communiquer, pour fournir des preuves objectives ou pour partager des connaissances.

Les informations documentées permettent de conserver les connaissances et les expériences de

l’organisme et peuvent générer de la valeur pour soutenir l’amélioration des produits ou des services.

Le présent document fournit des recommandations pour l’élaboration et la tenue à jour des informations

documentées.

L’adoption d’un système de management de la qualité relève d’une décision stratégique de l’organisme

qui peut l’aider à améliorer ses performances globales et fournir une base solide à des initiatives

permettant d’assurer sa pérennité. Il s’applique à tous les organismes quels que soient leur taille,

leur complexité ou leur modèle d’entreprise. Il vise à accroître la sensibilisation de l’organisme sur

ses obligations et son engagement à répondre aux besoins et aux attentes de ses clients et des parties

intéressées et à les satisfaire avec ses produits et services.

Il est important de prendre en compte le contexte de l’organisme, y compris le cadre juridique et

réglementaire, les besoins et attentes des parties intéressées, les risques et opportunités, et l’orientation

stratégique de l’organisme lorsque celui-ci planifie les informations documentées à tenir à jour et à

conserver pour son système de management de la qualité. Si l’adoption d’un système de management de

la qualité est stratégique, cela s’applique également à ses informations documentées.

Les informations documentées peuvent se rapporter à l’ensemble des activités d’un organisme ou à une

partie déterminée de ces activités; par exemple, des exigences spécifiées selon la nature des produits

et services, des processus, des exigences contractuelles, des exigences légales et réglementaires, du

contexte de l’organisme lui-même.

Il est important que le contenu des informations documentées soit également conforme aux exigences

des normes qu’elles sont censées satisfaire; par exemple, des exigences spécifiques à un secteur.

Au cours des deux dernières décennies, les organismes sont passés de systèmes sur papier à des

supports électroniques. L’ISO 9001 a tenu compte de ce changement en remplaçant des termes tels

que «documentation, manuel qualité, procédures documentées et enregistrements» par «informations

documentées». Le présent document de recommandations utilise le terme «informations documentées»

pour désigner les informations qu’il est nécessaire pour l’organisme de maîtriser et le terme

«documents» pour désigner les informations. Le verbe «documenter» est également utilisé à quelques

endroits.

Les normes de systèmes de management de l’ISO utilisent une structure-cadre (HLS) pour favoriser

l’utilisation de systèmes de management intégrés. Le présent document de recommandations, de par sa

conception et son domaine d’application, est axé sur le système de management de la qualité et utilise

la terminologie de l’ISO 9000:2015. Cependant, rien n’interdit son utilisation dans le cadre d’autres

normes de systèmes de management.

Dans la version précédente de ce document, une hiérarchie de la documentation, telle qu’un manuel

qualité, les procédures, les instructions de travail et les formulaires/check-lists, était suggérée comme

moyen de documenter le système de management de la qualité. Le présent document ne spécifié pas

de hiérarchie particulière mais tient compte de la capacité des supports électroniques à s’organiser de

multiples façons. Il est important de noter que même si un manuel qualité n’est pas exigé, il peut quand

même être utile, et que de nombreuses normes spécifiques à un secteur exigent encore des «manuels

qualité et procédures documentées».
© ISO 2021 – Tous droits réservés v
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NORME INTERNATIONALE ISO 10013:2021(F)
Systèmes de management de la qualité —
Recommandations pour les informations documentées
1 Domaine d’application

Le présent document fournit des recommandations pour l’élaboration et la tenue à jour des informations

documentées nécessaires pour soutenir un système de management de la qualité efficace, adapté aux

besoins spécifiques de l’organisme.

Le présent document peut également être utilisé pour soutenir d’autres systèmes de management, par

exemple des systèmes de management environnemental ou des systèmes de management de la santé et

de la sécurité au travail.
2 Références normatives

Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur

contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.

Pour les références non datées, la dernière édition du document de référence s'applique (y compris les

éventuels amendements).

ISO 9000:2015, Systèmes de management de la qualité — Principes essentiels et vocabulaire

3 Termes et définitions

Pour les besoins du présent document, les termes et les définitions de l’ISO 9000:2015 ainsi que les

suivants s’appliquent.

L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en

normalisation, consultables aux adresses suivantes:

— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp

— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/
3.1
instruction de travail
description détaillée sur la manière de réaliser des tâches

EXEMPLE Descriptions écrites détaillées, de logigrammes, de formulaires, de modèles, de notes techniques

incorporées dans un plan, de spécifications, de notices techniques d’équipements, d’images, de documents audio

et vidéo, de check-lists, ou de combinaisons de ces éléments.
Note 1 à l'article: Les instructions de travail peuvent être documentées.

Note 2 à l'article: Les instructions de travail décrivent tout matériel, équipement et toute information documentée

à utiliser. Lorsque cela est approprié, les instructions de travail incluent des critères d’acceptation.

3.2
formulaire

information documentée à tenir à jour et à utiliser pour enregistrer les données exigées par le système

de management de la qualité

Note 1 à l'article: Un formulaire devient une information documentée à conserver (par exemple, un

enregistrement) lorsque des données y sont consignées.
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ISO 10013:2021(F)
3.3
flux de travail (workflow)
série d’activités nécessaires à la réalisation d’une tâche

Note 1 à l'article: Un flux de travail qui se déroule en partie ou en totalité sans intervention manuelle peut être

qualifié de «flux de travail automatisé».
Note 2 à l'article: Les flux de travail peuvent être documentés.
4 Informations documentées
4.1 Généralités
4.1.1 Structures

Les informations documentées peuvent être structurées et créées de différentes manières en fonction

des besoins de l’organisme et d’autres facteurs tels que le leadership, les résultats escomptés du

système de management, du contexte (y compris des exigences légales et réglementaires), et des parties

intéressées.

La structure des informations documentées utilisées dans le système de management de la qualité

peut être décrite sous la forme d’une hiérarchie. Cette structure facilite la diffusion, la tenue à jour

et la compréhension des informations documentées. Les systèmes électroniques offrent des choix

supplémentaires pour structurer les informations documentées. L’Annexe A présente des exemples de

structures d’informations documentées. Les PME/TPE peuvent choisir une structure d’informations

documentées simplifiée pour répondre à leurs besoins.

Il convient que le type et l’étendue des informations documentées nécessaires au système de

management de la qualité soient basés sur une analyse des processus. Ils peuvent varier d’un organisme

à l’autre en raison, par exemple:
a) de la taille de l’organisme et du type d’activités;
b) de la complexité des processus et de leurs interactions;
c) de la maturité du système de management de la qualité;
d) des risques et des opportunités;
e) de la compétence des personnes;
f) des exigences légales et réglementaires;
g) des exigences des clients et des autres parties intéressées;
h) de la nécessité de prouver les résultats obtenus;
i) de la nécessité de faciliter l’accessibilité et la récupération à distance.
4.1.2 Définitions

Les informations documentées peuvent comporter des définitions. Afin d’améliorer la compréhension,

il convient que l’organisme prévoit l’utilisation d’un vocabulaire qui soit conforme avec les termes et

définitions normalisés référencés dans l’ISO 9000, dans un dictionnaire d’usage général ou qui peuvent

être spécifiques à l’organisme. Le système de management de la qualité d’un organisme peut employer

une terminologie différente pour les types d’informations documentées définis.
2 © ISO 2021 – Tous droits réservés
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ISO 10013:2021(F)
4.1.3 Contenu

Il convient que les informations documentées d’un organisme incluent les éléments suivants:

a) le domaine d’application du système de management de la qualité (voir 4.2.1);
b) une politique qualité (voir 4.2.2);
c) les objectifs qualité (voir 4.2.3);

d) les informations que l’organisme a jugées nécessaires pour soutenir le fonctionnement du système

de management de la qualité et de ses processus, y compris, si applicable:
1) un manuel qualité (voir 4.2.4.2);
2) les organigrammes (voir 4.2.4.3);

3) la cartographie des processus, logigrammes de processus et/ou descriptions de processus (voir

4.2.4.4);
4) les procédures et instructions de travail (voir 4.2.4.5);
5) les flux de travail automatisés (voir 4.2.4.6);
6) les spécifications des produits et des services (voir 4.2.4.7);
7) les communications internes et externes (voir 4.2.4.8);
8) les plans d’actions, plannings et listes (voir 4.2.4.9);
9) les formulaires et check-lists (voir 4.2.4.10);
10) les informations documentées d’origine externe (voir 4.2.4.11);

e) les informations documentées à conserver (c’est-à-dire les enregistrements) pour apporter la

preuve des résultats obtenus (voir 4.3).

Les informations documentées peuvent être utilisées sous tout support tel que papier, électronique,

photographie ou échantillon physique.
NOTE Les avantages offerts par les supports électroniques sont par exemple:
— un accès plus facile aux versions pertinentes, y compris l’accès à distance;

— une maîtrise plus facile des modifications, y compris le retrait des informations documentées obsolètes;

— une diffusion immédiate et maîtrisée;

— la facilité de récupération et la conservation par rapport au papier ou à d’autres supports physiques.

4.1.4 Finalité

Pour un organisme, le fait de disposer d’informations documentées a notamment pour but:

a) la communication d’informations;
b) la preuve de l’obtention de résultats ou des activités réalisées;
c) le partage des connaissances;
d) la préservation des connaissances;
e) la description du système de management de la qualité de l’organisme.
© ISO 2021 – Tous droits réservés 3
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ISO 10013:2021(F)
4.1.5 Avantages

Pour un organisme, le fait de disposer d’informations documentées confère notamment les avantages

suivants:
a) démontrer la conformité aux exigences légales et réglementaires;

b) fournir des informations aux groupes pluridisciplinaires afin qu’ils puissent mieux comprendre

les interactions;

c) communiquer l’engagement de l’organisme en matière de qualité aux parties intéressées

pertinentes;

d) aider les personnes à comprendre leur rôle au sein de l’organisme, constituant ainsi une base pour

les attentes en matière de performances au travail;

e) faciliter la compréhension mutuelle entre les différents niveaux de l’organisme;

f) fournir des preuves objectives de la satisfaction aux exigences spécifiées;

g) traiter les risques et les opportunités afin d’améliorer les performances de l’organisme, la

conformité des produits ou services et la satisfaction des clients;

h) fournir les connaissances organisationnelles, y compris les bases de compétences et de formation

pour les personnes et autres parties intéressées pertinentes;

i) indiquer comment procéder pour satisfaire en permanence aux exigences spécifiées, ce qui favorise

des conditions maîtrisées et fournit une base pour l’amélioration continue;

j) démontrer aux parties intéressées les aptitudes présentes dans l’organisme, ce qui permet

d’instaurer la confiance;
k) fournir des exigences pour les prestataires externes;

l) fournir une base permettant d’auditer et d’évaluer l’efficacité et la pertinence continue du système

de management de la qualité.
4.2 Informations documentées à tenir à jour
4.2.1 Domaine d’application du système de management de la qualité

Il convient de documenter le domaine d’application du système de management de la qualité en se

basant sur la détermination par l’organisme des limites et de l’applicabilité du système de management

de la qualité. Le domaine d’application d’un système de management peut comprendre l’ensemble de

l’organisme, des fonctions ou des sections spécifiques et identifiées de l’organisme, ou une ou plusieurs

fonctions dans un groupe d’organismes. Il convient que le domaine d’application indique les types de

produits et services couverts et, si nécessaire, fournisse une justification pour toute exigence de la

norme qualité pertinente que l’organisme juge non applicable dans le cadre du domaine d’application

de son système de management de la qualité. Il convient que le domaine d’application du système

de management de la qualité soit fondé sur la nature des produits et services de l’organisme, leurs

processus opérationnels, les enjeux soulevés lors de l’établissement du contexte de l’organisme et

des exigences pertinentes des parties intéressées, les résultats de l’approche par les risques, les

considérations commerciales et les exigences contractuelles, légales et réglementaires.

4.2.2 Politique qualité

La politique qualité aide un organisme à ce que son personnel s’engage dans la culture qualité de

l’organisme. Il convient qu’elle soit harmonisée à l’orientation stratégique sur la mission et la vision

de l’organisme. Elle fournit un engagement démontrable en matière de qualité aux parties intéressées

pertinentes.
4 © ISO 2021 – Tous droits réservés
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ISO 10013:2021(F)

Un organisme peut avoir d’autres politiques outre la politique qualité relatives au système de

management de la qualité.
4.2.3 Objectifs qualité

Il convient que les objectifs qualité tiennent compte des résultats à atteindre par l’organisme en ce qui

concerne son orientation stratégique, sa politique qualité, les risques et opportunités et les exigences

applicables au système de management de la qualité.

4.2.4 Informations que l’organisme a jugées nécessaires pour soutenir le fonctionnement du

système de management de la qualité et de ses processus
4.2.4.1 Généralités

Il convient que l’organisme détermine le type et l’étendue des informations documentées nécessaires

pour soutenir le fonctionnement de ses processus, les formats à utiliser et les moyens de communication

avec les utilisateurs. L’organisme peut décider des termes qu’il utilise pour ses informations

documentées. Bien que des termes tels que «procédures», «instructions de travail» et «manuel qualité»

soient utilisés dans le présent document, l’organisme n’est pas obligé d’adopter cette terminologie.

4.2.4.2 Manuel qualité

Il existe de nombreuses façons pour un organisme de documenter son système de management de la

qualité. Les organismes peuvent choisir d’utiliser un manuel qualité, ou un manuel qualité peut être

imposé par les exigences externes de l’organisme. Un manuel qualité est unique à chaque organisme. Il

peut fournir la structure, le format, le contenu ou le mode de présentation pour documenter le système

de management de la qualité et de ses processus pour tous types d’organismes.

Il peut s’avérer approprié pour un petit organisme d’inclure la description de l’ensemble de son système

de management de la qualité dans un seul manuel, y compris toutes les informations documentées

qu’il tient à jour. Les grands organismes multinationaux peuvent avoir besoin de manuels à différents

niveaux (par exemple au niveau international, national ou régional), ainsi que d’une hiérarchie plus

complexe d’informations documentées. Si l’organisme choisit de mettre en œuvre un manuel qualité,

celui-ci peut inclure les procédures documentées ou une référence à celles-ci, ainsi qu’une description

des processus du système de management de la qualité et de leurs interactions.

Il convient d’inclure dans le manuel qualité les informations relatives à l’organisme, telles que le nom,

l’endroit où il se trouve, le contexte et les moyens de communication, y compris les termes et définitions

spécifiques pertinents. Des informations complémentaires telles que son type d’activité, une brève

description de ses antécédents, de son historique et de sa taille peuvent également être incluses.

Le manuel qualité peut fournir une description du système de management de la qualité et de sa mise

en œuvre au sein de l’organisme. Il convient d’inclure dans le manuel des descriptions des processus et

de leurs interactions, ou une référence à ceux-ci. Il convient de concevoir les processus de l’organisme

de manière qu’ils répondent aux objectifs généraux de l’organisme, à ses politiques, à son contexte et

aux attentes pertinentes des parties intéressées. Dans les grands organismes, les processus peuvent

relier les domaines fonctionnels de l’organisme (voir l’Annexe A). Il convient que l’organisme documente

son système spécifique de management de la qualité en suivant l’ordre du flux des processus ou toute

séquence adaptée à l’organisme. Des renvois entre la norme choisie et les processus de l’organisme

peuvent s’avérer utiles. La séquence et l’interaction des processus au sein du système de management

de la qualité peuvent être documentées à l’aide d’une cartographie des processus.

NOTE 1 Les manuels sont également appelés «manuel qualité», «manuel de politiques», «manuel de référence»,

«manuel de procédures» ou tout autre titre approprié.

NOTE 2 Bien que l’ISO 9001:2015 n’exige pas de manuel qualité, certaines normes sectorielles l’exigent.

© ISO 2021 – Tous droits réservés 5
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ISO 10013:2021(F)
4.2.4.3 Organigrammes

Les organigrammes sont souvent des représentations graphiques des rôles, des responsabilités et des

pouvoirs au sein d’un organisme. Ils peuvent illustrer
...

NORMA ISO
INTERNACIONAL 10013
Primera edición
Traducción oficial
2021-03
Official translation
Traduction officielle
Sistemas de gestión de la calidad —
Orientación para la información
documentada
Quality management systems — Guidance for documented
information
Systèmes de management de la qualité — Recommandations pour les
informations documentées
Publicado por la Secretaría Central de ISO en Ginebra, Suiza, como
traducción oficial en español avalada por el Grupo de Trabajo Spanish
Translation Task Force (STTF), que ha certificado la conformidad en
relación con las versiones inglesa y francesa.
Número de referencia
ISO 10013:2021 (traducción oficial)
---------------------- Page: 1 ----------------------
ISO 10013:2021 (traducción oficial)
DOCUMENTO PROTEGIDO POR COPYRIGHT
© ISO 2021

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ISO 10013:2021 (traducción oficial)
Índice Página

Prólogo .............................................................................................................................................................................................................................................iv

Prólogo de la versión en español ............................................................................................................................................................................v

Introducción ...............................................................................................................................................................................................................................vi

1 Objeto y campo de aplicación.................................................................................................................................................................. 1

2 Referencias normativas ................................................................................................................................................................................. 1

3 Términos y definiciones ................................................................................................................................................................................ 1

4 Información documentada ........................................................................................................................................................................ 2

4.1 Generalidades .......................................................................................................................................................................................... 2

4.1.1 Estructura .............................................................................................................................................................................. 2

4.1.2 Definiciones .......................................................................................................................................................................... 2

4.1.3 Contenido ............................................................................................................................................................................... 3

4.1.4 Propósitos .............................................................................................................................................................................. 3

4.1.5 Beneficios ............................................................................................................................................................................... 4

4.2 Información documentada para ser mantenida ......................................................................................................... 4

4.2.1 Alcance del sistema de gestión de la calidad ........................................................................................... 4

4.2.2 Política de la calidad ..................................................................................................................................................... 4

4.2.3 Objetivos de la calidad ................................................................................................................................................ 5

4.2.4 Información que la organización determina como necesaria para apoyar

la operación del sistema de gestión de la calidad y sus procesos ......................................... 5

4.3 Información documentada a ser conservada ................................................................................................................ 9

5 Creación y actualización de la información documentada ....................................................................................10

5.1 Implementación ..................................................................................................................................................................................10

5.1.1 Generalidades ..................................................................................................................................................................10

5.1.2 Uso de referencias .......................................................................................................................................................11

5.1.3 Responsabilidad para la creación de la información documentada .................................11

5.1.4 Identificación y descripción ................................................................................................................................11

5.1.5 Formato y medios ........................................................................................................................................................11

5.1.6 Revisión y aprobación ..............................................................................................................................................11

5.2 Control de la información documentada .......................................................................................................................11

5.2.1 Disponibilidad .................................................................................................................................................................11

5.2.2 Protección ...........................................................................................................................................................................12

5.2.3 Distribución, acceso, recuperación y uso .................................................................................................12

5.2.4 Almacenamiento y preservación.....................................................................................................................12

5.2.5 Actualización de la información documentada y control de cambios ............................12

5.2.6 Conservación y disposición .................................................................................................................................12

Anexo A (informativo) Ejemplos de estructura de la información documentada ..............................................13

Bibliografía ................................................................................................................................................................................................................................14

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ISO 10013:2021 (traducción oficial)
Prólogo

ISO (Organización Internacional de Normalización) es una federación mundial de organismos

nacionales de normalización (organismos miembros de ISO). El trabajo de elaboración de las Normas

Internacionales se lleva a cabo normalmente a través de los comités técnicos de ISO. Cada organismo

miembro interesado en una materia para la cual se haya establecido un comité técnico, tiene el derecho

de estar representado en dicho comité. Las organizaciones internacionales, gubernamentales y no

gubernamentales, vinculadas con ISO, también participan en el trabajo. ISO colabora estrechamente

con la Comisión Electrotécnica Internacional (IEC) en todos los temas de normalización electrotécnica.

En la Parte 1 de las Directivas ISO/IEC se describen los procedimientos utilizados para desarrollar este

documento y aquellos previstos para su mantenimiento posterior. En particular debería tomarse nota

de los diferentes criterios de aprobación necesarios para los distintos tipos de documentos ISO. Este

documento ha sido redactado de acuerdo con las reglas editoriales de la Parte 2 de las Directivas ISO/

IEC (véase www .iso .org/ directives).

Se llama la atención sobre la posibilidad de que algunos de los elementos de este documento puedan

estar sujetos a derechos de patente. ISO no asume la responsabilidad por la identificación de alguno

o todos los derechos de patente. Los detalles sobre cualquier derecho de patente identificado durante

el desarrollo de este documento se indicarán en la Introducción y/o en la lista ISO de declaraciones de

patente recibidas (véase www .iso .org/ patents).

Cualquier nombre comercial utilizado en este documento es información que se proporciona para

comodidad del usuario y no constituye una recomendación.

Para una explicación de la naturaleza voluntaria de las normas, el significado de los términos específicos

de ISO y las expresiones relacionadas con la evaluación de la conformidad, así como la información

acerca de la adhesión de ISO a los principios de la Organización Mundial del Comercio (OMC) respecto a

los Obstáculos Técnicos al Comercio (OTC), véase www .iso .org/ iso/ foreword .html.

Este documento ha sido elaborado por el Comité Técnico ISO/TC 176, Gestión y aseguramiento de la

calidad, Subcomité SC 3, Tecnologías de apoyo.

Esta primera edición de la Norma ISO 10013 anula y sustituye al Informe Técnico ISO/TR 10013:2001,

que ha sido revisado técnicamente. Los cambios principales en comparación con el Informe Técnico

ISO/TR 10013:2001 son los siguientes:

— este ha sido alineado con la nueva estructura y requisitos de la Norma ISO 9001:2015, y ahora refleja

los cambios relacionados con los requisitos de documentación;

— la jerarquía original de la documentación ya no se usa, sino que se deja abierta para el usuario.

Cualquier comentario o pregunta sobre este documento debería dirigirse al organismo nacional de

normalización del usuario. Puede encontrar una lista completa de estos organismos en www .iso .org/

members .html.
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ISO 10013:2021 (traducción oficial)
Prólogo de la versión en español

Este documento ha sido traducido por el Grupo de Trabajo Spanish Translation Task Force (STTF) del

Comité Técnico ISO/TC 176, Gestión y aseguramiento de la calidad, en el que participan representantes de

los organismos nacionales de normalización y representantes del sector empresarial de los siguientes

países:

Argentina, Bolivia, Brasil, Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, España, Estados

Unidos de América, México, Panamá, Perú y Uruguay.

Igualmente, en el citado Grupo de Trabajo participan representantes de COPANT (Comisión

Panamericana de Normas Técnicas) e INLAC (Instituto Latinoamericano de la Calidad).

Esta traducción es parte del resultado del trabajo que el Grupo ISO/TC 176/STTF viene desarrollando

desde su creación en el año 1999 para lograr la unificación de la terminología en lengua española en el

ámbito de la gestión de la calidad.
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ISO 10013:2021 (traducción oficial)
Introducción

La Norma ISO 9001 requiere que una organización mantenga y conserve información documentada

para apoyar la operación de sus procesos y tener confianza en que los procesos se están llevando a cabo

según lo planificado.

La información documentada es la información requerida a ser controlada y mantenida por una

organización y el medio en el que está contenida. La información documentada se puede utilizar para

comunicar, para proporcionar evidencia objetiva o para compartir conocimiento.

La información documentada permite preservar los conocimientos y las experiencias de la organización

y puede generar valor para apoyar la mejora de productos o servicios.

Este documento proporciona orientación para el desarrollo y mantenimiento de la información

documentada.

La adopción de un sistema de gestión de la calidad es una decisión estratégica para una organización

que puede ayudar a mejorar su desempeño global y proporcionar una base sólida para las iniciativas

de desarrollo sostenible. Es aplicable a todas las organizaciones, independientemente de su tamaño,

complejidad o modelo de negocio. Su objetivo es incrementar la toma de conciencia de la organización

sobre sus tareas y su compromiso para satisfacer las necesidades y expectativas de sus clientes y sus

partes interesadas y lograr la satisfacción con sus productos y servicios.

Es importante considerar el contexto de la organización, incluido el marco legal y regulatorio, las

necesidades y expectativas de las partes interesadas, los riesgos y las oportunidades, y la dirección

estratégica de la organización, cuando una organización planifica qué información documentada

mantener y conservar para su sistema de gestión de la calidad. Si bien la adopción de un sistema de

gestión de la calidad es estratégica, esto también aplica a su información documentada

La información documentada puede relacionarse con todas las actividades de la organización o

con una parte seleccionada de esas actividades; por ejemplo, requisitos especificados que dependen

de la naturaleza de los productos y servicios, procesos, requisitos contractuales, requisitos legales y

reglamentarios y el contexto de la propia organización.

Es importante que el contenido de la información documentada también cumpla los requisitos de las

normas que pretenden satisfacer; por ejemplo, requisitos específicos del sector.

Las organizaciones han pasado de los sistemas en papel a los medios electrónicos en las últimas

dos décadas. La Norma ISO 9001 ha reflejado este cambio, reemplazando la terminología como

"documentación, manual de la calidad, procedimientos documentados y registros" con "información

documentada". Este documento de orientación utiliza la palabra "información documentada" para

referirse a la información que necesita ser controlada por la organización y "documentos" para referirse

a la información. También utiliza la palabra "documentar" como verbo en algunos lugares.

Las normas de sistema de gestión ISO han adoptado la estructura de alto nivel e ISO ha alentado el uso

de sistemas integrados de gestión. Este documento de orientación, por su diseño y alcance, se centra en

el sistema de gestión de la calidad y utiliza la terminología de la Norma ISO 9000:2015. Sin embargo,

nada prohíbe su uso en otras normas de sistemas de gestión.

En la versión anterior de esta norma de orientación se sugirió una jerarquía de documentación tal como:

manual de la calidad, procedimientos, instrucciones de trabajo y formularios/listas de verificación

como una forma de documentar el sistema de gestión de la calidad. Este documento no prescribe una

jerarquía en particular, sino que refleja la capacidad de los medios electrónicos para organizarse de

muchas maneras. Es importante darse cuenta que, aunque no se requiere un manual de la calidad,

éste aún puede ser de utilidad, y varias normas de sectores específicos aún requieren "manuales de la

calidad y procedimientos documentados".
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NORMA INTERNACIONAL ISO 10013:2021 (traducción oficial)
Sistemas de gestión de la calidad — Orientación para la
información documentada
1 Objeto y campo de aplicación

Este documento proporciona orientación para el desarrollo y mantenimiento de la información

documentada necesaria para apoyar un sistema de gestión de la calidad eficaz, adaptado a las

necesidades específicas de la organización.

Este documento también se puede utilizar para apoyar otros sistemas de gestión, por ejemplo, sistemas

de gestión ambiental o de seguridad y salud en el trabajo.
2 Referencias normativas

En el texto se hace referencia a los siguientes documentos de manera que parte o la totalidad de su

contenido constituyen requisitos de este documento. Para las referencias con fecha, solo se aplica la

edición citada. Para las referencias sin fecha se aplica la última edición (incluida cualquier modificación

de esta).
ISO 9000:2015, Sistemas de gestión de la calidad — Fundamentos y vocabulario
3 Términos y definiciones

Para los fines de este documento, se aplican los términos y definiciones incluidos en la Norma

ISO 9000:2015 y los siguientes.

ISO e IEC mantienen bases de datos terminológicas para su utilización en normalización en las siguientes

direcciones:

— Plataforma de búsqueda en línea de ISO: disponible en https:// www .iso .org/ obp

— Electropedia de IEC: disponible en https:// www .electropedia .org/
3.1
instrucciones de trabajo
descripciones detalladas de cómo realizar tareas

EJEMPLO Descripciones escritas detalladas, diagramas de flujo, plantillas, modelos, notas técnicas

incorporadas en dibujos, especificaciones, manuales de instrucción de equipo, imágenes, audios y videos, listas

de verificación o combinaciones de los mismos.
Nota 1 a la entrada: Las instrucciones de trabajo pueden estar documentadas.

Nota 2 a la entrada: Las instrucciones de trabajo describen cualquier material, equipo e información documentada

a utilizar. Cuando sea pertinente, las instrucciones de trabajo incluyen criterios de aceptación.

3.2
formulario

información documentada que se mantiene y se usa para registrar los datos requeridos por el sistema

de gestión de la calidad

Nota 1 a la entrada: Un formulario se convierte en información documentada a conservar (por ejemplo, un

registro) cuando se ingresan los datos.
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ISO 10013:2021 (traducción oficial)
3.3
flujo de trabajo
serie de actividades necesarias para completar una tarea

Nota 1 a la entrada: Un flujo de trabajo que se realiza de forma parcial o completa sin interferencia manual puede

denominarse “flujo de trabajo automatizado”.
Nota 2 a la entrada: Los flujos de trabajo pueden estar documentados.
4 Información documentada
4.1 Generalidades
4.1.1 Estructura

La información documentada puede estructurarse y crearse de muchas maneras en función de las

necesidades de la organización, y otros factores tales como el liderazgo, los resultados previstos

del sistema de gestión, el contexto (incluidos los requisitos legales y reglamentarios) y las partes

interesadas.

La estructura de la información documentada utilizada en el sistema de gestión de la calidad puede

describirse en una jerarquía. Esta estructura facilita la distribución, el mantenimiento y la comprensión

de la información documentada. Los sistemas electrónicos proporcionan opciones adicionales para

estructurar la información documentada. El Anexo A ilustra ejemplos de estructuras de información

documentada. Las organizaciones más pequeñas pueden elegir una estructura de información

documentada simplificada para satisfacer sus necesidades.

El tipo y la extensión de la información documentada necesaria para el sistema de gestión de la calidad

debería basarse en un análisis de procesos y pueden diferir de una organización a otra debido a, por

ejemplo:
a) el tamaño de la organización y el tipo de actividades;
b) la complejidad de los procesos y sus interacciones;
c) la madurez del sistema de gestión de la calidad;
d) los riesgos y las oportunidades;
e) la competencia de las personas;
f) los requisitos legales y reglamentarios;
g) los requisitos del cliente y otras partes interesadas;
h) la necesidad de evidencia de los resultados alcanzados;

i) la necesidad de apoyar la accesibilidad y la recuperabilidad de manera remota.

4.1.2 Definiciones

La información documentada puede incluir definiciones. Para mejorar la comprensión, la organización

debería considerar el uso del vocabulario que está de acuerdo con los términos y definiciones

normalizados a los que se hace referencia en la Norma ISO 9000, en el uso general del diccionario o que

puede ser específico de la organización. El sistema de gestión de la calidad de una organización puede

usar una terminología diferente para los tipos definidos de información documentada.

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ISO 10013:2021 (traducción oficial)
4.1.3 Contenido
La información documentada de una organización debería incluir lo siguiente:
a) el alcance del sistema de gestión de la calidad (véase 4.2.1);
b) una política de la calidad (véase 4.2.2);
c) los objetivos de la calidad (véase 4.2.3);

d) la información que la organización ha determinado como necesaria para apoyar la operación del

sistema de gestión de la calidad y sus procesos, incluyendo, según corresponda:
1) el manual de la calidad (véase 4.2.4.2);
2) los diagramas organizacionales (véase 4.2.4.3);

3) los mapas de procesos, los diagramas de flujo de procesos y/o las descripciones de procesos

(véase 4.2.4.4);
4) los procedimientos e instrucciones de trabajo (véase 4.2.4.5);
5) los flujos de trabajo automatizados (véase 4.2.4.6);
6) las especificaciones de productos y servicios (véase 4.2.4.7);
7) las comunicaciones internas y externas (véase 4.2.4.8);
8) los planes, los cronogramas y las listas (véase 4.2.4.9);
9) los formularios y las listas de verificación (véase 4.2.4.10);
10) la información documentada de origen externo (véase 4.2.4.11);

e) la información documentada a conservar (es decir, registros) para proporcionar evidencia de los

resultados alcanzados (véase 4.3).

La información documentada puede estar en cualquier tipo de medio, tales como papel, electrónico,

fotografía o muestra física.
NOTA Las ventajas de los medios electrónicos, son por ejemplo:

— facilitar el acceso a las versiones pertinentes, incluido el acceso desde ubicaciones remotas;

— facilitar el control de los cambios; incluyendo el retiro de información documentada obsoleta;

— la distribución inmediata y controlada;
— la recuperabilidad y la conservación frente al papel u otros medios físicos.
4.1.4 Propósitos
Los propósitos de tener información documentada para una organización incluyen:
a) la comunicación de la información;
b) la evidencia del logro de resultados o actividades realizadas;
c) el intercambio de conocimientos;
d) la preservación del conocimiento;
e) la descripción del sistema de gestión de la calidad de la organización.
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ISO 10013:2021 (traducción oficial)
4.1.5 Beneficios
Los beneficios de tener información documentada para una organización incluyen:
a) demostrar el cumplimiento de los requisitos legales y reglamentarios;

b) proporcionar información a los grupos interfuncionales para que puedan comprender mejor las

interrelaciones;

c) comunicar el compromiso de la organización con la calidad a las partes interesadas pertinentes;

d) ayudar a las personas a comprender su rol dentro de la organización, proporcionando así una base

para las expectativas de desempeño laboral;

e) facilitar la comprensión mutua entre los diferentes niveles de la organización;

f) proporcionar evidencia objetiva de que se han cumplido los requisitos especificados;

g) abordar los riesgos y las oportunidades para mejorar el desempeño organizacional, la conformidad

del producto o servicio y la satisfacción del cliente;

h) proporcionar conocimiento organizacional, incluyendo la base para la competencia y la formación

de personas y otras partes interesadas pertinentes;

i) establecer cómo se hacen las cosas para cumplir de manera coherente los requisitos especificados,

promoviendo así condiciones controladas y proporcionando una base para la mejora continua;

j) demostrar a las partes interesadas las capacidades dentro de la organización, proporcionando así

confianza;
k) proporcionar requisitos para proveedores externos;

l) proporcionar una base para auditar y evaluar la eficacia y la idoneidad continua del sistema de

gestión de la calidad.
4.2 Información documentada para ser mantenida
4.2.1 Alcance del sistema de gestión de la calidad

El alcance del sistema de gestión de la calidad se debería documentar con base en la determinación de los

límites y la aplicabilidad del sistema de gestión de la calidad. El alcance de un sistema de gestión puede

incluir la totalidad de la organización, funciones específicas e identificadas de la organización, secciones

específicas e identificadas de la organización, o una o más funciones en un grupo de organizaciones.

El alcance debería indicar los tipos de productos y servicios cubiertos y, si es necesario, proporcionar

justificación para cualquier requisito de la norma de la calidad pertinente que la organización

determine que no es aplicable al alcance de su sistema de gestión de la calidad. El alcance del sistema de

gestión de la calidad se debería basar en la naturaleza de los productos y servicios de la organización,

sus procesos operativos, las cuestiones que surjan al establecer el contexto de la organización y los

requisitos pertinentes de las partes interesadas, los resultados del pensamiento basado en el riesgo, las

consideraciones comerciales y los requisitos contractuales, legales y reglamentarios.

4.2.2 Política de la calidad

La política de la calidad ayuda a que las personas de una organización se comprometan con la cultura

de la calidad de su organización. Ésta debería estar alineada con la dirección estratégica, la misión y la

visión de la organización. Proporciona un compromiso verificable con la calidad a las partes interesadas

pertinentes.

Una organización puede tener otras políticas, además de la política de la calidad, relacionadas con el

sistema de gestión de la calidad.
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ISO 10013:2021 (traducción oficial)
4.2.3 Objetivos de la calidad

Los objetivos de la calidad deberían reflejar los resultados que logrará la organización con respecto a su

dirección estratégica, la política de la calidad, los riesgos y oportunidades y los requisitos aplicables al

sistema de gestión de la calidad.

4.2.4 Información que la organización determina como necesaria para apoyar la operación del

sistema de gestión de la calidad y sus procesos
4.2.4.1 Generalidades

La organización debería determinar el tipo y la extensión de la información documentada necesaria

para apoyar la operación de sus procesos, los formatos que se utilizarán y los medios para comunicarse

con los usuarios. La organización puede decidir qué términos usa para su información documentada. Si

bien a continuación se utilizan términos como “procedimientos”, “instrucciones de trabajo” y “manual

de la calidad”, la organización no está obligada a adoptar dicha terminología.
4.2.4.2 Manual de la calidad

Hay muchas formas en que una organización puede documentar su sistema de gestión de la calidad.

Las organizaciones pueden optar por utilizar un manual de la calidad, o los requisitos externos

de la organización pueden exigir un manual de la calidad. Un manual de la calidad es exclusivo de

cada organización. Este puede proporcionar la estructura, el formato, el contenido o el método de

presentación para documentar el sistema de gestión de la calidad y sus procesos para todo tipo de

organizaciones.

Una organización pequeña puede considerar apropiado incluir la descripción de todo su sistema de

gestión de la calidad en un solo manual, incluida toda la información documentada que mantiene. Las

grandes organizaciones multinacionales pueden necesitar manuales a diferentes niveles (por ejemplo,

a nivel global, nacional o regional) y una jerarquía más compleja de información documentada. Si la

organización elige implementar un manual de la calidad, puede incluir procedimientos documentados

o una referencia a ellos, y una descripción de los procesos del sistema de gestión de la calidad y sus

interacciones.

La información sobre la organización, como el nombre, la ubicación, el contexto y los medios de

comunicación, incluido
...

INTERNATIONAL ISO
STANDARD 10013
Second edition
Quality management systems —
Guidance for documented information
Systèmes de management de la qualité — Recommandations pour les
informations documentées
PROOF/ÉPREUVE
Reference number
ISO 10013:2021(E)
ISO 2021
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ISO 10013:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2021 – All rights reserved
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ISO 10013:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Documented information ............................................................................................................................................................................ 2

4.1 General ........................................................................................................................................................................................................... 2

4.1.1 Structure ................................................................................................................................................................................. 2

4.1.2 Definitions ............................................................................................................................................................................. 2

4.1.3 Content ..................................................................................................................................................................................... 2

4.1.4 Purpose .................................................................................................................................................................................... 3

4.1.5 Benefits .................................................................................................................................................................................... 3

4.2 Documented information to be maintained .................................................................................................................. 4

4.2.1 Scope of the quality management system .................................................................................................. 4

4.2.2 Quality policy ...................................................................................................................................................................... 4

4.2.3 Quality objectives ............................................................................................................................................................ 4

4.2.4 Information that the organization determined necessary to support the

operation of the quality management system and its processes ........................................... 5

4.3 Documented information to be retained .......................................................................................................................... 9

5 Creating and updating documented information .............................................................................................................. 9

5.1 Implementation ...................................................................................................................................................................................... 9

5.1.1 General...................................................................................................................................................................................... 9

5.1.2 Use of references ...........................................................................................................................................................10

5.1.3 Responsibility for creation of documented information ............................................................10

5.1.4 Identification and description ...........................................................................................................................10

5.1.5 Format and media ........................................................................................................................................................10

5.1.6 Review and approval .................................................................................................................................................11

5.2 Control of documented information ..................................................................................................................................11

5.2.1 Availability..........................................................................................................................................................................11

5.2.2 Protection ............................................................................................................................................................................11

5.2.3 Distribution, access, retrieval and use .......................................................................................................11

5.2.4 Storage and preservation ......................................................................................................................................11

5.2.5 Updating documented information and control of changes ...................................................11

5.2.6 Retention and disposition .....................................................................................................................................12

Annex A (informative) Examples of documented information structures .................................................................13

Bibliography .............................................................................................................................................................................................................................14

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ISO 10013:2021(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 176, Quality management and quality

assurance, Subcommittee SC 3, Supporting technologies.

This second edition of ISO 10013 cancels and replaces ISO/TR 10013:2001, which has been technically

revised. The main changes compared with ISO/TR 10013:2001 are as follows:

— it has been aligned with the new structure and requirements of ISO 9001:2015, notably the

documentation requirements;

— the original hierarchy of documentation is no longer used but left open for the user.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
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ISO 10013:2021(E)
Introduction

ISO 9001 requires an organization to maintain and retain documented information to support the

operation of its processes and to have confidence that the processes are being carried out as planned.

Documented information is information required to be controlled and maintained by an organization

and the medium on which it is contained. Documented information can be used to communicate, to

provide objective evidence or for sharing knowledge.

Documented information enables the knowledge and experiences of the organization to be preserved

and can generate value to support the improvement of products or services.

This document provides guidance for the development and maintenance of documented information.

The adoption of a quality management system is a strategic decision for an organization that can help

to improve its overall performance and provide a sound basis for sustainable development initiatives. It

is applicable to all organizations, regardless of size, complexity or business model. Its aim is to increase

an organization’s awareness of its duties and commitment in fulfilling the needs and expectations of its

customers and interested parties, and in achieving satisfaction with its products and services.

It is important to consider the context of the organization, including the legal and regulatory framework,

needs and expectations of interested parties, risks and opportunities, and strategic direction of the

organization, when an organization plans what documented information to maintain and retain for its

quality management system. While the adoption of a quality management system is strategic, this also

applies to its documented information.

Documented information can relate to an organization’s total activities or to a selected part of those

activities, e.g. specified requirements depending upon the nature of products and services, processes,

contractual requirements, statutory and regulatory requirements, the context of the organization itself.

It is important that the content of the documented information also conforms to the requirements of

the standards they intend to satisfy, e.g. sector-specific requirements.

Organizations have been moving from paper-based systems to electronic media in the last two decades.

ISO 9001 has reflected this change, replacing terminology such as “documentation, quality manual,

documented procedures, and records” with “documented information.” This guidance document

uses the word “documented information” to refer to information that needs to be controlled by the

organization and “documents” to refer to information. It also uses the word “document” as a verb in a

few places.

ISO management system standards use a high-level structure to encourage the use of integrated

management systems. This guidance document by its design and scope is focused on the quality

management system and uses terminology from ISO 9000:2015. However, nothing prohibits its use in

other management system standards.

In the previous version of this document, a hierarchy of documentation, such as a quality manual,

procedures, work instructions and forms/checklists, was suggested as a way of documenting the

quality management system. This document does not prescribe a particular hierarchy but reflects the

ability of electronic media to organize itself in a multitude of ways. It is important to realize that while

a quality manual is not required, it can still be useful, and many sector-specific standards still require

“quality manuals and documented procedures”.
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INTERNATIONAL STANDARD ISO 10013:2021(E)
Quality management systems — Guidance for documented
information
1 Scope

This document gives guidance for the development and maintenance of the documented information

necessary to support an effective quality management system, tailored to the specific needs of the

organization.

This document can also be used to support other management systems, e.g. environmental or

occupational health and safety management systems.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 9000:2015 and the

following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
work instruction
detailed description of how to perform tasks

EXAMPLE Detailed written descriptions, flow charts, templates, models, technical notes incorporated into

drawings, specifications, equipment instruction manuals, pictures, audios and videos, checklists or combinations

thereof.
Note 1 to entry: Work instructions can be documented.

Note 2 to entry: Work instructions describe any materials, equipment and documented information to be used.

When relevant, work instructions include acceptance criteria.
3.2
form

documented information to be maintained and used to record data required by the quality

management system

Note 1 to entry: A form becomes documented information to be retained (i.e. a record) when data are entered.

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3.3
workflow
series of activities necessary to complete a task

Note 1 to entry: A workflow that is partially or completely carried out without manual interference can be

referred to as an “automated workflow”.
Note 2 to entry: Workflows can be documented.
4 Documented information
4.1 General
4.1.1 Structure

Documented information can be structured and created in many ways based on the needs of the

organization and other factors such as leadership, intended results of the management system, context

(including statutory and regulatory requirements) and interested parties.

The structure of the documented information used in the quality management system can be described

in a hierarchy. This structure facilitates the distribution, maintenance and understanding of the

documented information. Electronic systems provide additional choices for structuring documented

information. Annex A illustrates examples of documented information structures. Smaller organizations

may choose a simplified documented information structure to meet their needs.

The type and extent of the documented information needed for the quality management system should

be based on an analysis of processes and can differ from one organization to another due to, for example:

a) the size of the organization and type of activities;
b) the complexity of processes and their interactions;
c) the maturity of the quality management system;
d) risks and opportunities;
e) the competence of persons;
f) statutory and regulatory requirements;
g) customer and other interested party requirements;
h) the need for evidence of results achieved;
i) the need to support accessibility and retrievability remotely.
4.1.2 Definitions

Documented information can include definitions. To enhance comprehension, the organization

should consider using vocabulary that is in accordance with standard terms and definitions which

are referenced in ISO 9000, in general dictionary usage or which can be specific to the organization.

An organization's quality management system may use different terminology for the defined types of

documented information.
4.1.3 Content
An organization’s documented information should include the following:
a) the scope of the quality management system (see 4.2.1);
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ISO 10013:2021(E)
b) a quality policy (see 4.2.2);
c) quality objectives (see 4.2.3);

d) information that the organization determined necessary to support the operation of the quality

management system and its processes, including, as applicable:
1) a quality manual (see 4.2.4.2);
2) organizational charts (see 4.2.4.3);
3) process maps, process flow charts and/or process descriptions (see 4.2.4.4);
4) procedures and work instructions (see 4.2.4.5);
5) automated workflows (see 4.2.4.6);
6) product and service specifications (see 4.2.4.7);
7) internal and external communications (see 4.2.4.8);
8) plans, schedules and lists (see 4.2.4.9);
9) forms and checklists (see 4.2.4.10);
10) documented information of external origin (see 4.2.4.11);

e) documented information to be retained (i.e. records) for providing evidence of results achieved

(see 4.3).

Documented information can be in any type of media, such as paper, electronic, photograph or

physical sample.
NOTE The advantages of electronic media are, for example:
— easier access to relevant versions including access from remote locations;

— easier control of changes, including the withdrawal of obsolete documented information;

— immediate and controlled distribution;
— retrievability and retention versus paper or other physical media.
4.1.4 Purpose
The purpose of having documented information for an organization includes:
a) communication of information;
b) evidence of achieving results or activities performed;
c) knowledge sharing;
d) knowledge preservation;
e) describing the quality management system of the organization.
4.1.5 Benefits
The benefits of having documented information for an organization include:
a) demonstrating compliance with statutory and regulatory requirements:
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ISO 10013:2021(E)

b) providing information for cross-functional groups so that they can better understand

interrelationships;

c) communicating the organization’s commitment to quality to relevant interested parties;

d) helping persons to understand their role within the organization, thus providing a basis for

expectations of work performance;

e) facilitating mutual understanding between different levels in the organization;

f) providing objective evidence that specified requirements have been achieved;

g) addressing risks and opportunities to improve organizational performance, product or service

conformity, and customer satisfaction;

h) providing organizational knowledge, including the basis for competency and training for persons

and other relevant interested parties;

i) stating how things are to be done to consistently meet specified requirements, thus promoting

controlled conditions and providing a basis for continual improvement;

j) demonstrating to interested parties the capabilities within the organization, thus providing

confidence;
k) providing requirements for external providers;

l) providing a basis for auditing and evaluating the effectiveness and continuing suitability of the

quality management system.
4.2 Documented information to be maintained
4.2.1 Scope of the quality management system

The scope of the quality management system should be documented based on the organization’s

determination of the boundaries and applicability of the quality management system. The scope of

a management system can include the whole of the organization, specific and identified functions

of the organization, specific and identified sections of the organization, or one or more functions

across a group of organizations. The scope should state the types of products and services covered

and, if required, provide justification for any requirement of the relevant quality standard that the

organization determines is not applicable to the scope of its quality management system. The scope

of the quality management system should be based on the nature of the organization’s products and

services, their operational processes, issues raised in establishing the context of the organization

and relevant requirements from interested parties, the results of risk-based thinking, commercial

considerations, and contractual, statutory and regulatory requirements.
4.2.2 Quality policy

The quality policy helps an organization engage its people in the culture of quality of the organization. It

should be aligned with the organization’s strategic direction, mission and vision. It provides a verifiable

commitment to quality to relevant interested parties.

An organization can have other policies besides the quality policy relating to the quality

management system.
4.2.3 Quality objectives

Quality objectives should reflect the results to be achieved by the organization with respect to its

strategic direction, quality policy, risks and opportunities, and applicable requirements to the quality

management system.
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4.2.4 Information that the organization determined necessary to support the operation of the

quality management system and its processes
4.2.4.1 General

The organization should determine the type and extent of documented information necessary to

support the operation of its processes, the formats to be used and the media for communicating

with users. The organization may decide what terms it uses for its documented information. While

terms such as “procedures”, “work instructions” and “quality manual” are used in this document, the

organization is not obliged to adopt such terminology.
4.2.4.2 Quality manual

There are many ways in which an organization can document its quality management system.

Organizations can choose to use a quality manual, or a quality manual can be mandated by the

organization’s external requirements. A quality manual is unique to each organization. It can provide

the structure, format, content or method of presentation for documenting the quality management

system and its processes for all types of organizations.

A small organization can find it appropriate to include the description of its entire quality management

system within a single manual, including all the documented information it maintains. Large,

multinational organizations can need manuals at different levels (e.g. the global, national or regional

level) and a more complex hierarchy of documented information. If the organization chooses to

implement a quality manual, it may include documented procedures or a reference to them, and a

description of the processes of the quality management system and their interactions.

Information about the organization, such as name, location, context and means of communication

including relevant specific terms and definitions, should be included in the quality manual. Additional

information such as its line of business, a brief description of its background, history and size may also

be included.

The quality manual can provide a description of the quality management system and its implementation

in the organization. Descriptions of the processes and their interactions or a reference to them should

be included in the manual. The processes of the organization should be designed to meet the overall

objectives of the organization, its policies, context, and relevant expectations of interested parties. In

large organizations, the processes can link the functional areas of the organization (see Annex A). The

organization should document its specific quality management system following the sequence of the

flow of the processes or any sequencing appropriate to the organization. Cross-referencing between the

selected standard and the processes of the organization can be useful. The sequence and interaction of

the processes within the quality management system can be documented using a process map.

NOTE 1 Manuals are also referred to as “quality manual”, “policy manual”, “reference manual”, “procedure

manual” or any other suitable title.

NOTE 2 Although ISO 9001:2015 does not require a quality manual, some sector-specific standards do.

4.2.4.3 Organizational charts

Organizational charts are often graphical depictions of the roles, responsibilities and authorities

within an organization. They can illustrate how roles, responsibilities and authorities flow through the

organization and how different people or groups of people interact within the organization.

4.2.4.4 Process maps, process flow charts and/or process descriptions

A process map identifies the processes and visually describes the sequence and interaction of the

processes in the organization. The processes can be further described using flow charts.

A process flow chart is a visual description of the process or procedure. It shows the process steps an

organization performs, what triggers the process or procedure (i.e. start of the process and its input)

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and what is the final step of the process or its output. Some process flow chart formats document the

input and output for each process step, the control points and the related acceptance criteria.

A process description is a textual description of the process. It explains the process steps in words.

Process owners should be identified for quality management system processes. Process owners are

usually assigned by top management and given the authority and responsibility for a process from start

to finish, and therefore should understand their role and be competent in the process. This is especially

important since processes can cut across functional or departmental boundaries.
4.2.4.5 Procedures and work instructions

The structure and format of documented procedures should be defined by the organization either

through text, flow charts, automated workflows, tables, a combination of the above or any other

suitable method according to the needs of the organization. A procedure generally answers questions

such as who, what, when, where and with what resources. Documented procedures should contain the

information necessary to properly carry out the activities that comprise the process and reference any

requirements to retain documented information. and should be uniquely identified.

The level of detail can vary depending on the complexity of the activities, risks and opportunities,

the methods used, and the levels of competency of people that is necessary to perform the activities.

Irrespective of the level of detail, the following aspects should be considered, as applicable:

— defining the needs of the organization and its relevant interested parties;

— describing the process(es) in terms of text, or other methods (e.g. flow charts, photos, videos) related

to the required activities;

— describing what is to be done, by whom or by which organizational function, why, when and where;

— describing process controls and controls of the identified activities;

— addressing risks and opportunities in a process as it affects the overall objectives of the organization;

— defining the resources needed for the activities (e.g. in terms of people, infrastructure and materials);

— defining the appropriate internal a
...

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