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Quality management systems - Guidance for documented information

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.

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

Sistemi vodenja kakovosti - Napotki za dokumentirane informacije

General Information

Status

Not Published

Public Enquiry End Date

29-Sep-2020

ICS

03.100.70 - Management systems

03.120.10 - Quality management and quality assurance

Technical Committee

VZK - Quality management and quality assurance

Current Stage

5020 - Formal vote (FV) (Adopted Project)

Start Date

13-Jan-2021

Due Date

03-Mar-2021

Completion Date

15-Feb-2021

Ref Project

ISO 10013:2021 - Quality management systems -- Guidance for documented information

RELATIONS

Revised

SIST ISO/TR 10013:2002 - Guidelines for quality management system documentation

Effective Date

01-Sep-2020

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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

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
...

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: 1 ----------------------
ISO 10013:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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: 2 ----------------------
ISO 10013:2021(E)
Contents Page

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

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

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: 4 ----------------------
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
---------------------- Page: 6 ----------------------
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);
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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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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)

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
...

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)
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ISO 10013:2021(E)
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