ISO/PRF 10013

Quality management systems -- Guidance for documented information

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

Sistemi vodenja kakovosti - Napotki za dokumentirane informacije

Standards Content (sample)

DRAFT INTERNATIONAL STANDARD
ISO/DIS 10013
ISO/TC 176/SC 3 Secretariat: NEN
Voting begins on: Voting terminates on:
2020-04-13 2020-07-06
Quality management systems — Guidance for documented
information
ICS: 03.120.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
This document is circulated as received from the committee secretariat.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10013:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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ISO/DIS 10013:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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ISO/DIS 10013:2020(E)
Contents Page

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

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

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

2 Normative reference ......................................................................................................................................................................................... 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 and 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 ........................................... 4

4.2.5 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 .................................................................................................................................................10

5.2 Control of documented information ..................................................................................................................................10

5.2.1 Availability..........................................................................................................................................................................10

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 .....................................................................................................................................11

Annex A (informative) Examples of documented information structure ....................................................................12

Bibliography .............................................................................................................................................................................................................................13

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ISO/DIS 10013:2020(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 whom 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 are drafted in accordance with the rules given in the ISO/IEC Directives, Part

2 (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.

Attention is drawn to the possibility that some of the elements of this International Standard may be the

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

ISO 10013 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance,

Subcommittee SC 3, Supporting technologies.

This edition of ISO 10013 cancels and replaces ISO/TR 10013:2001, Guidelines for quality management

system documentation.
[1]

This document is aligned with the new structure and requirements of ISO 9001:2015, and now

reflects the changes as related to the documentation requirements specifically stated in section 7.5

(Documented Information), section 4.4.2, and throughout that standard. In addition, the original

hierarchy of documentation is no longer used but left open for the user. Next, ideas from within the

[4,5]
ISO/TC 176 community have been included ( ).
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ISO/DIS 10013:2020(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 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 all 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 adoption of a quality management system is strategic, so also is its

documented information.

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

activities; for example, specified requirements depending upon the nature of products and services,

processes, contractual requirements, statutory and regulatory requirements and the context of the

organization itself.

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

standards they intend to satisfy; for example, 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 standard

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 have adopted the high-level structure and ISO has encouraged the

use of Integrated Management Systems. This guidance standard by its design and scope is focused

[1]

on the quality management system and uses terminology from ISO 9001:2015. However, nothing

prohibits its use in other management system standards.

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

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

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

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

a quality manual is not required nothing prevents its continuing use and that many sector specific

standards still require “quality manuals and documented procedures.”
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DRAFT INTERNATIONAL STANDARD ISO/DIS 10013:2020(E)
Quality management systems — Guidance for documented
information
1 Scope

This document provides guidelines 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 may also be used to support other management systems for example environmental or

occupational health and safety management systems.

This document is not intended for contractual, regulatory, or certification/registration purposes or to

be used as requirements for any purpose.
2 Normative reference

The following document is referred to in the text in such a way that some or all their content constitutes

guidance 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, 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 instructions
detailed descriptions of how to perform tasks
Note 1 to entry: to entry: Work instructions may or may not be documented.

Note 2 to entry: to entry: Work instructions are, for example, detailed written descriptions, flowcharts,

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

pictures, audios and videos, checklists, or combinations thereof. 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: Note to entry: A form becomes documented information to be retained when data are entered.

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ISO/DIS 10013:2020(E)
3.3
workflow
series of activities necessary to complete a task.

Note 1 to entry: 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: to entry: Workflows may or may not be documented.
4 Documented information
4.1 General
4.1.1 Structure

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

organization, leadership, management system intended results, context, including statutory and

regulatory requirements and interested parties.

The structure of the documented information used in the quality management system may 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 documented information needed for the QMS should be based on an analysis of

processes and may 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) maturity of the quality management system;
d) risks, opportunities and risk-based thinking;
e) competence of persons;
f) statutory and regulatory requirements;
g) customer and other interested party requirements;
h) need for evidence of results achieved.
It should not be the documentation that drives the processes.
4.1.2 Definitions

Documented information may include definitions. The vocabulary used shall be in accordance with

standard terms and definitions, which are referenced in ISO 9000 or in general dictionary usage. 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;
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ISO/DIS 10013:2020(E)

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

management system and its processes, including, as applicable:
1) quality manual;
2) organizational charts;
3) process maps, process flowcharts, and/or process descriptions;
4) documented procedures and work instructions;
5) automated workflows;
6) product and service specifications;
7) internal and external communications;
8) plans, schedules, and lists;
9) forms and checklists;
10) documented information of external origin;
c) quality policy;
d) quality objectives;

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

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

master sample.
NOTE Advantages of electronic media are for instance:
a) easier access to relevant versions including access from remote locations;

b) easier control of changes; including withdrawal of obsolete documented information;

c) immediate and controlled distribution;
d) retrievability, and retention vs. paper or other physical media.
4.1.4 Purpose and benefits
The purposes of having documented information for an organization include:
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.
The benefits of having documented information for an organization include:

a) demonstrating compliance to statutory and regulatory requirements, providing information for

cross-functional groups so that they may better understand interrelationships;

b) communicating management’s commitment to quality to relevant interested parties;

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

expectations of work performance;
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ISO/DIS 10013:2020(E)

d) facilitating mutual understanding between the different levels in the organization (for example top

management, workers);
e) providing objective evidence that specified requirements have been achieved;

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

conformance and customer satisfaction;

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

other relevant interested parties;

h) stating how things are to be done to consistently achieve specified requirements, thus promoting

controlled conditions and providing a basis for continual improvement;

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

confidence;
j) providing requirements for external providers;

k) 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 product(s) and service(s) 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 result 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 can be used to align strategic direction with the organization’s mission and vision. It provides a

verifiable commitment to quality to relevant interested parties.

An organization may 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.

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

quality management system and its processes

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 can decide what terms it uses for its documented information. While terms like

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ISO/DIS 10013:2020(E)

procedures, work instructions and quality manual are used below, the organization is not obliged to

adopt such terminology.
a) Quality manual

There are many ways in which an organisation may document its quality management system.

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

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

flexibility in defining the structure, format, content, or method of presentation for documenting the

quality management system for all types of organizations.

A small organization may 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 may need manuals at different levels, for example, the global, national or

regional level, and a more complex hierarchy of documented information. If the organization chooses

to implement a quality manual, it can 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 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 interested party expectations. In large organizations, the

processes may 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 may 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.

b) Organizational charts

Organizational charts (for example, organograms) are often graphical depictions of roles,

responsibilities and authorities within an organization. They may illustrate how roles, responsibilities

and authorities flow through the organization from one level or group to the next and how different

people or groups of people interact within the organization.
c) Process maps, process flowcharts 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 visually 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

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

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ISO/DIS 10013:2020(E)

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.
d) Documented 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, reference any

requirements to retain documented information and should be uniquely identified.

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

methods used, and the levels of skills and training of people that is necessary for them to accomplish 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 and/or flow charts 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 risk 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 these interrelated or interacting activities;

— defining the
...

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: [phone]
Email: [e-mail]
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

© ISO 2021 – All rights reserved PROOF/ÉPREUVE iii
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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”.
© ISO 2021 – All rights reserved PROOF/ÉPREUVE v
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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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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
...

SLOVENSKI STANDARD
oSIST ISO/DIS 10013:2020
01-september-2020
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/DIS 10013
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
oSIST ISO/DIS 10013:2020 en,fr

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

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oSIST ISO/DIS 10013:2020
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oSIST ISO/DIS 10013:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10013
ISO/TC 176/SC 3 Secretariat: NEN
Voting begins on: Voting terminates on:
2020-04-13 2020-07-06
Quality management systems — Guidance for documented
information
ICS: 03.120.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
This document is circulated as received from the committee secretariat.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10013:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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oSIST ISO/DIS 10013:2020
ISO/DIS 10013:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST ISO/DIS 10013:2020
ISO/DIS 10013:2020(E)
Contents Page

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

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

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

2 Normative reference ......................................................................................................................................................................................... 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 and 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 ........................................... 4

4.2.5 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 .................................................................................................................................................10

5.2 Control of documented information ..................................................................................................................................10

5.2.1 Availability..........................................................................................................................................................................10

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 .....................................................................................................................................11

Annex A (informative) Examples of documented information structure ....................................................................12

Bibliography .............................................................................................................................................................................................................................13

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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 whom 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 are drafted in accordance with the rules given in the ISO/IEC Directives, Part

2 (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.

Attention is drawn to the possibility that some of the elements of this International Standard may be the

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

ISO 10013 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance,

Subcommittee SC 3, Supporting technologies.

This edition of ISO 10013 cancels and replaces ISO/TR 10013:2001, Guidelines for quality management

system documentation.
[1]

This document is aligned with the new structure and requirements of ISO 9001:2015, and now

reflects the changes as related to the documentation requirements specifically stated in section 7.5

(Documented Information), section 4.4.2, and throughout that standard. In addition, the original

hierarchy of documentation is no longer used but left open for the user. Next, ideas from within the

[4,5]
ISO/TC 176 community have been included ( ).
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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 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 all 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 adoption of a quality management system is strategic, so also is its

documented information.

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

activities; for example, specified requirements depending upon the nature of products and services,

processes, contractual requirements, statutory and regulatory requirements and the context of the

organization itself.

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

standards they intend to satisfy; for example, 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 standard

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 have adopted the high-level structure and ISO has encouraged the

use of Integrated Management Systems. This guidance standard by its design and scope is focused

[1]

on the quality management system and uses terminology from ISO 9001:2015. However, nothing

prohibits its use in other management system standards.

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

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

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

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

a quality manual is not required nothing prevents its continuing use and that many sector specific

standards still require “quality manuals and documented procedures.”
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oSIST ISO/DIS 10013:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 10013:2020(E)
Quality management systems — Guidance for documented
information
1 Scope

This document provides guidelines 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 may also be used to support other management systems for example environmental or

occupational health and safety management systems.

This document is not intended for contractual, regulatory, or certification/registration purposes or to

be used as requirements for any purpose.
2 Normative reference

The following document is referred to in the text in such a way that some or all their content constitutes

guidance 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, 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 instructions
detailed descriptions of how to perform tasks
Note 1 to entry: to entry: Work instructions may or may not be documented.

Note 2 to entry: to entry: Work instructions are, for example, detailed written descriptions, flowcharts,

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

pictures, audios and videos, checklists, or combinations thereof. 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: Note to entry: A form becomes documented information to be retained when data are entered.

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3.3
workflow
series of activities necessary to complete a task.

Note 1 to entry: 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: to entry: Workflows may or may not be documented.
4 Documented information
4.1 General
4.1.1 Structure

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

organization, leadership, management system intended results, context, including statutory and

regulatory requirements and interested parties.

The structure of the documented information used in the quality management system may 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 documented information needed for the QMS should be based on an analysis of

processes and may 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) maturity of the quality management system;
d) risks, opportunities and risk-based thinking;
e) competence of persons;
f) statutory and regulatory requirements;
g) customer and other interested party requirements;
h) need for evidence of results achieved.
It should not be the documentation that drives the processes.
4.1.2 Definitions

Documented information may include definitions. The vocabulary used shall be in accordance with

standard terms and definitions, which are referenced in ISO 9000 or in general dictionary usage. 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;
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b) information that the organization determined necessary to support the operation of the quality

management system and its processes, including, as applicable:
1) quality manual;
2) organizational charts;
3) process maps, process flowcharts, and/or process descriptions;
4) documented procedures and work instructions;
5) automated workflows;
6) product and service specifications;
7) internal and external communications;
8) plans, schedules, and lists;
9) forms and checklists;
10) documented information of external origin;
c) quality policy;
d) quality objectives;

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

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

master sample.
NOTE Advantages of electronic media are for instance:
a) easier access to relevant versions including access from remote locations;

b) easier control of changes; including withdrawal of obsolete documented information;

c) immediate and controlled distribution;
d) retrievability, and retention vs. paper or other physical media.
4.1.4 Purpose and benefits
The purposes of having documented information for an organization include:
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.
The benefits of having documented information for an organization include:

a) demonstrating compliance to statutory and regulatory requirements, providing information for

cross-functional groups so that they may better understand interrelationships;

b) communicating management’s commitment to quality to relevant interested parties;

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

expectations of work performance;
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d) facilitating mutual understanding between the different levels in the organization (for example top

management, workers);
e) providing objective evidence that specified requirements have been achieved;

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

conformance and customer satisfaction;

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

other relevant interested parties;

h) stating how things are to be done to consistently achieve specified requirements, thus promoting

controlled conditions and providing a basis for continual improvement;

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

confidence;
j) providing requirements for external providers;

k) 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 product(s) and service(s) 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 result 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 can be used to align strategic direction with the organization’s mission and vision. It provides a

verifiable commitment to quality to relevant interested parties.

An organization may 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.

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

quality management system and its processes

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 can decide what terms it uses for its documented information. While terms like

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oSIST ISO/DIS 10013:2020
ISO/DIS 10013:2020(E)

procedures, work instructions and quality manual are used below, the organization is not obliged to

adopt such terminology.
a) Quality manual

There are many ways in which an organisation may document its quality management system.

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

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

flexibility in defining the structure, format, content, or method of presentation for documenting the

quality management system for all types of organizations.

A small organization may 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 may need manuals at different levels, for example, the global, national or

regional level, and a more complex hierarchy of documented information. If the organization chooses

to implement a quality manual, it can 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 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 interested party expectations. In large organizations, the

processes may 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 may 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.

b) Organizational charts

Organizational charts (for example, organograms) are often graphical depictions of roles,

responsibilities and authorities within an organization. They may illustrate how roles, responsibilities

and authorities flow through the organization from one level or group to the next and how different

people or groups of people interact within the organization.
c) Process maps, process flowcharts 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 visually 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

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

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oSIST ISO/DIS 10013:2020
ISO/DIS 10013:2020(E)

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.
d) Documented 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, reference any

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

PROJET DE NORME INTERNATIONALE
ISO/DIS 10013
ISO/TC 176/SC 3 Secrétariat: NEN
Début de vote: Vote clos le:
2020-04-13 2020-07-06
Systèmes de management de la qualité —
Recommandations pour les informations documentées
Quality management systems — Guidance for documented information
ICS: 03.120.10
CE DOCUMENT EST UN PROJET DIFFUSÉ POUR
OBSERVATIONS ET APPROBATION. IL EST DONC
SUSCEPTIBLE DE MODIFICATION ET NE PEUT
ÊTRE CITÉ COMME NORME INTERNATIONALE
AVANT SA PUBLICATION EN TANT QUE TELLE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES
FINS INDUSTRIELLES, TECHNOLOGIQUES ET
COMMERCIALES, AINSI QUE DU POINT DE VUE

Le présent document est distribué tel qu’il est parvenu du secrétariat du comité.

DES UTILISATEURS, LES PROJETS DE NORMES
INTERNATIONALES DOIVENT PARFOIS ÊTRE
CONSIDÉRÉS DU POINT DE VUE DE LEUR
POSSIBILITÉ DE DEVENIR DES NORMES
POUVANT SERVIR DE RÉFÉRENCE DANS LA
RÉGLEMENTATION NATIONALE.
Numéro de référence
LES DESTINATAIRES DU PRÉSENT PROJET
ISO/DIS 10013:2020(F)
SONT INVITÉS À PRÉSENTER, AVEC LEURS
OBSERVATIONS, NOTIFICATION DES DROITS
DE PROPRIÉTÉ DONT ILS AURAIENT
ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE. ISO 2020
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ISO/DIS 10013:2020(F)
ISO/DIS 10013:2020(F)
Sommaire ƒ‰‡

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 ..................................................................................................................................................... 3

4.1.3 Contenu .......................................................................................................................................................... 3

4.1.4 Finalité et avantages .................................................................................................................................. 4

4.2 Informations documentées à tenir à jour ............................................................................................ 5

4.2.1 Domaine d’application du système de management de la qualité ............................................... 5

4.2.2 Politique qualité .......................................................................................................................................... 5

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

4.2.5 Informations documentées à conserver ........................................................................................... 11

5 Création et mise à jour des informations documentées............................................................... 11

5.1 Mise en œuvre ........................................................................................................................................... 11

5.1.1 Généralités ................................................................................................................................................. 11

5.1.2 Utilisation de références ........................................................................................................................ 12

5.1.3 Responsabilité de la création des informations documentées .................................................. 12

5.1.4 Identification et description ................................................................................................................. 12

5.1.5 Format et supports .................................................................................................................................. 13

5.1.6 Revue et approbation ............................................................................................................................. 13

5.2 Maîtrise des informations documentées .......................................................................................... 13

5.2.1 Disponibilité .............................................................................................................................................. 13

5.2.2 Protection ................................................................................................................................................... 13

5.2.3 Diffusion, accès, récupération et utilisation .................................................................................... 13

5.2.4 Stockage et préservation ....................................................................................................................... 14

5.2.5 Mise à jour des informations documentées et maîtrise des modifications ............................ 14

5.2.6 Conservation et élimination ................................................................................................................. 14

ȋ‹ˆ‘”ƒ–‹˜‡Ȍ Exemples de structures d’informations documentées.................................. 15

Bibliographie ........................................................................................................................................................... 16

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2020

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.: [phone]
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Website: www.iso.org ̹ʹͲʹͲ–‘—•†”‘‹–•”±•‡”˜±•
‹‹‹
Publié en Suisse
ii © ISO 2020 – Tous droits réservés
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ISO/DIS 10013:2020(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 ..................................................................................................................................................... 3

4.1.3 Contenu .......................................................................................................................................................... 3

4.1.4 Finalité et avantages .................................................................................................................................. 4

4.2 Informations documentées à tenir à jour ............................................................................................ 5

4.2.1 Domaine d’application du système de management de la qualité ............................................... 5

4.2.2 Politique qualité .......................................................................................................................................... 5

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

4.2.5 Informations documentées à conserver ........................................................................................... 11

5 Création et mise à jour des informations documentées............................................................... 11

5.1 Mise en œuvre ........................................................................................................................................... 11

5.1.1 Généralités ................................................................................................................................................. 11

5.1.2 Utilisation de références ........................................................................................................................ 12

5.1.3 Responsabilité de la création des informations documentées .................................................. 12

5.1.4 Identification et description ................................................................................................................. 12

5.1.5 Format et supports .................................................................................................................................. 13

5.1.6 Revue et approbation ............................................................................................................................. 13

5.2 Maîtrise des informations documentées .......................................................................................... 13

5.2.1 Disponibilité .............................................................................................................................................. 13

5.2.2 Protection ................................................................................................................................................... 13

5.2.3 Diffusion, accès, récupération et utilisation .................................................................................... 13

5.2.4 Stockage et préservation ....................................................................................................................... 14

5.2.5 Mise à jour des informations documentées et maîtrise des modifications ............................ 14

5.2.6 Conservation et élimination ................................................................................................................. 14

(informative) Exemples de structures d’informations documentées.................................. 15

Bibliographie ........................................................................................................................................................... 16

© ISO 2020 – Tous droits réservés
iii
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ISO/DIS 10013:2020(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 Normes internationales sont rédigées conformément aux règles données dans les Directives ISO/IEC,

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.

L’attention est appelée 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.

Le comité chargé de l’élaboration du présent document est ISO/TC 176, Management et assurance de la

qualité, sous-comité SC 3, Techniques de soutien.

Cette édition de l’ISO 10013 annule et remplace l’ISO/TR 10013:2001, Lignes directrices pour la

documentation des systèmes de management de la qualité.
[1]

Le présent document est aligné sur la nouvelle structure et les nouvelles exigences de l’ISO 9001:2015

et reflète désormais les changements relatifs aux exigences en matière de documentation spécifiquement

énoncées au paragraphe 7.5 (Informations documentées), au paragraphe 4.4.2 et dans l’ensemble de

cette norme. En outre, la hiérarchie originale de la documentation n’est plus utilisée mais laissée au choix

[4,5]

de l’utilisateur. Enfin, des idées provenant de la communauté de l’ISO/TC 176 ont été incluses ( ).

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ISO/DIS 10013:2020(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 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 de toutes les

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, il en va de même pour 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 et du

contexte de l’organisme lui-même.

Il est important que le contenu des informations documentées soit 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 ». La présente norme 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 ont adopté la structure-cadre (HLS) et l’ISO encourage

l’utilisation de systèmes de management intégrés. La présente norme de recommandations, de par sa

conception et son domaine d’application, est axée sur le système de management de la qualité et utilise

[1]

la terminologie de l’ISO 9001:2015 . Cependant, rien n’interdit son utilisation dans le cadre d’autres

normes de systèmes de management.
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ISO/DIS 10013:2020(F)

Dans la version précédente de la présente norme de recommandations, une hiérarchie de la

documentation, telle que le 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. La présente norme ne prescrit 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, rien n’empêche de continuer à l’utiliser, et que de nombreuses normes spécifiques

à un secteur exigent encore des « manuels qualité et procédures documentées ».
© ISO 2020 – Tous droits réservés
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PROJET DE NORME INTERNATIONALE ISO/DIS 10013:2020(F)
Systèmes de management de la qualité — Recommandations
pour les informations documentées
1 Domaine d’application

Le présent document fournit des lignes directrices 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.

Le présent document n’est pas destiné à être utilisé à des fins contractuelles, réglementaires ou de

certification, ni à servir d’exigences à quelque fin que ce soit.
2 Références normatives

Le document suivant est cité dans le texte de sorte qu’il constitue, pour tout ou partie de son contenu, des

recommandations 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, Systèmes de management de la qualité — Principes essentiels et vocabulaire.

3 Termes et définitions

Pour les besoins du présent document, les termes et 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
instructions de travail
descriptions détaillées sur la manière de réaliser des tâches

Note 1 à l’article : Les instructions de travail peuvent être documentées ou non.

Note 2 à l’article : Les instructions de travail prennent, par exemple, la forme de 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. 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.

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ISO/DIS 10013:2020(F)
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 lorsque des données y sont

consignées.
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 ou non.
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, du leadership, des 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 SMQ 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, des opportunités et de l’approche par les risques ;
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.
Il convient que ce ne soit pas la documentation qui dicte les processus.
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ISO/DIS 10013:2020(F)
4.1.2 Définitions

Les informations documentées peuvent comporter des définitions. Le vocabulaire utilisé doit être

cohérent avec les termes et définitions normalisés qui figurent dans l’ISO 9000 ou dans un dictionnaire

d’usage général. Le système de management de la qualité d’un organisme peut employer une

terminologie différente pour les types d’informations documentées définis.
4.1.3 Contenu

Il convient que les informations documentées d’un organisme incluent les éléments suivants :

a) le périmètre d’application du système de management de la qualité ;

b) 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) le manuel qualité ;
2) les organigrammes ;

3) la cartographie des processus, les logigrammes de processus et/ou les descriptions de

processus ;
4) les procédures documentées et les instructions de travail ;
5) les flux de travail automatisés ;
6) les spécifications des produits et des services ;
7) les communications internes et externes ;
8) les plans d’actions, les plannings et les listes ;
9) les formulaires et les check-lists ;
10) les informations documentées d’origine externe ;
c) la politique qualité ;
d) les objectifs qualité ;

e) les informations documentées à conserver (c’est-à-dire les enregistrements) pour apporter la preuve

des résultats obtenus.

Les informations documentées peuvent être utilisées sous tout support tel que papier, électronique,

photographie ou échantillon témoin.
NOTE Les avantages offerts par les supports électroniques sont par exemple :
a) un accès plus facile aux versions pertinentes, y compris l’accès à distance ;

b) une maîtrise plus facile des modifications, y compris le retrait des informations documentées obsolètes ;

c) une diffusion immédiate et maîtrisée ;

d) la facilité de récupération et la conservation par rapport au papier ou à d’autres supports physiques.

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ISO/DIS 10013:2020(F)
4.1.4 Finalité et avantages

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.

Pour un organisme, le fait de disposer d’informations documentées confère notamment les avantages

suivants :

a) démontrer la conformité aux exigences légales et réglementaires, fournir des informations aux

groupes pluridisciplinaires afin qu’ils puissent mieux comprendre les interactions ;

b) communiquer l’engagement du management en matière de qualité aux parties intéressées

pertinentes ;

c) 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 ;

d) faciliter la compréhension mutuelle entre les différents niveaux de l’organisme (par exemple la

direction, le personnel) ;
e) fournir des preuves objectives de la satisfaction aux exigences spécifiées ;

f) 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 ;

g) fournir les connaissances organisationnelles, y compris les bases de compétences et de formation

pour les personnes et autres parties intéressées pertinentes ;

h) indiquer comment procéder pour satisfaire en permanence aux exigences spécifiées, ce qui favorise

des conditions maîtrisées et fournit une base pour l’amélioration continue ;

i) démontrer aux parties intéressées les aptitudes présentes dans l’organisme, ce qui permet

d’instaurer la confiance ;
j) fournir des exigences pour les prestataires externes ;

k) fournir une base permettant d’auditer et d’évaluer l’efficacité et la pertinence continue du système

de management de la qualité.
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ISO/DIS 10013:2020(F)
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, le résultat de l’approche par les risques, les considérations

commerc
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