ISO 10013:2021
(Main)Quality management systems — Guidance for documented information
Quality management systems — Guidance for documented information
This document gives guidance for the development and maintenance of the documented information necessary to support an effective quality management system, tailored to the specific needs of the organization. This document can also be used to support other management systems, e.g. environmental or occupational health and safety management systems.
Systèmes de management de la qualité — Recommandations pour les informations documentées
Le présent document fournit des recommandations pour l'élaboration et la tenue à jour des informations documentées nécessaires pour soutenir un système de management de la qualité efficace, adapté aux besoins spécifiques de l'organisme. Le présent document peut également être utilisé pour soutenir d'autres systèmes de management, par exemple des systèmes de management environnemental ou des systèmes de management de la santé et de la sécurité au travail.
Sistemi vodenja kakovosti - Napotki za dokumentirane informacije
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INTERNATIONAL ISO
STANDARD 10013
Redline version
compares ISO 10013:2021
to ISO/TR 10013:2001
Quality management systems —
Guidance for documented information
Systèmes de management de la qualité — Recommandations pour les
informations documentées
Reference number
ISO 10013:redline:2021(E)
©
ISO 2021
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ISO 10013:redline:2021(E)
IMPORTANT
This marked-up version uses the following colour-coding in the marked-up text:
Text example 1 — Text has been added (in green)
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1.x . — If there are changes in a clause/subclause, the corresponding clause/
subclause number is highlighted in yellow in the Table of contents
DISCLAIMER
This marked-up version highlights the main changes in this edition of the document
compared with the previous edition. It does not focus on details (e.g. changes in
punctuation).
This marked-up version does not constitute the official ISO document and is not intended to
be used for implementation purposes.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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ISO 10013:redline:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative reference references . 1
3 Terms and definitions . 1
4 Quality management system documentation Documented information .2
4.1 General . 2
4.1.1 Structure . 3
4.1.2 Definitions . 3
4.1.3 Content . 4
4.1.4 Purpose . 4
4.1.5 Benefits . 5
4.2 Purposes and benefits . 5
4.3 Quality policy and its objectives . 6
4.4 4.2 Quality manual Documented information to be maintained . 6
4.2.1 Scope of the quality management system . 6
4.2.2 Quality policy . 6
4.2.3 Quality objectives . 6
4.4.1 4.2.4 .
Contents Information that the organization determined necessary to
support the operation of the quality management system and its processes . 6
4.4.2 Title and scope .11
4.4.3 Table of contents .11
4.4.4 Review, approval and revision .11
4.4.5 Quality policy and objectives .11
4.4.6 Organization, responsibility and authority .12
4.4.7 References .12
4.4.8 Quality management system description .12
4.4.9 Appendices . . .12
4.5 Documented procedures .12
4.5.1 Structure and format .12
4.5.2 Contents . .12
4.5.3 Review, approval and revision .13
4.5.4 Identification of changes .13
4.6 Work instructions .14
4.6.1 Structure and format .14
4.6.2 Contents . .14
4.6.3 Types of work instructions .14
4.6.4 Review, approval and revision .14
4.6.5 Records .14
4.6.6 Identification of changes .14
4.7 Forms .14
4.8 Quality plans .15
4.9 Specifications.15
4.10 External documents .15
4.11 4.3 .
Records Documented information to be retained .15
5 Process of preparing quality management system documentation .15
5.1 Responsibility for preparation .15
5.2 Method of preparation of quality management system documentation .16
5.3 Use of references .16
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ISO 10013:redline:2021(E)
6 5 Process of approval, issue and control of quality management system
documents Creating and updating documented information .17
6.1 5.1 Review and approval Implementation .17
5.1.1 General.17
5.1.2 Use of references .18
5.1.3 Responsibility for creation of documented information .18
5.1.4 Identification and description .18
5.1.5 Format and media .18
5.1.6 Review and approval .18
6.2 Distribution .18
6.3 Incorporation of changes .18
6.4 5.2 Issue and change control Control of documented information .19
5.2.1 Availability.19
5.2.2 Protection .19
5.2.3 Distribution, access, retrieval and use .19
5.2.4 Storage and preservation .19
5.2.5 Updating documented information and control of changes .19
5.2.6 Retention and disposition .20
6.5 Uncontrolled copies .20
Annex A
Typical quality management system documentation hierarchy .21
Annex B A
(informative)
Example of structured text work instructions Examples of documented information
structures .22
Bibliography .24
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ISO 10013:redline:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for whomwhich a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
International Standards areThe procedures used to develop this document and those intended for its
further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval
criteria needed for the different types of ISO documents should be noted. This document was drafted in
accordance with the rules given ineditorial rules of the ISO/IEC Directives, Part 32 (see www .iso .org/
directives).
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
In exceptional circumstances, when a technical committee has collected data of a different kind from
that which is normally published as an International Standard (“state of the art”, for example), it may
decide by a simple majority vote of its participating members to publish a Technical Report. A Technical
Report is entirely informative in nature and does not have to be reviewed until the data it provides are
considered to be no longer valid or useful.
Attention is drawn to the possibility that some of the elements of this Technical Reportdocument may
be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent
rights. Details of any patent rights identified during the development of the document will be in the
Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
ISO/TR 10013This document was prepared by Technical Committee ISO/TC 176, Quality management
and quality assurance, Subcommittee SC 3, Supporting technologies.
This first edition of ISO/TR 10013 cancels and replaces ISO/TR 10013:19952001, Guidelines for
developing quality manuals.which has been technically revised. The main changes compared with ISO/
TR 10013:2001 are as follows:
— it has been aligned with the new structure and requirements of ISO 9001:2015, notably the
documentation requirements;
— the original hierarchy of documentation is no longer used but left open for the user.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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ISO 10013:redline:2021(E)
Introduction
The ISO 90009001 family of International Standards requires the quality management system
ofrequires an organization to be documentedmaintain and retain documented information to support
the operation of its processes and to have confidence that the processes are being carried out as
planned.
Documented information is information required to be controlled and maintained by an organization
and the medium on which it is contained. Documented information can be used to communicate, to
provide objective evidence or for sharing knowledge.
Documented information enables the knowledge and experiences of the organization to be preserved
and can generate value to support the improvement of products or services.
This Technical Report promotes the adoption of the process approach when developing and
implementing the quality management system and improving its effectivenessdocument provides
guidance for the development and maintenance of documented information.
For an organization to function effectively, it has to identify and manage numerous linked activities.
An activity using resources, and managed in order to enable the transformation of inputs into outputs,
can be considered as a process. Often the output from one of the processes directly forms the input to
the nextThe adoption of a quality management system is a strategic decision for an organization that
can help to improve its overall performance and provide a sound basis for sustainable development
initiatives. It is applicable to all organizations, regardless of size, complexity or business model. Its
aim is to increase an organization’s awareness of its duties and commitment in fulfilling the needs and
expectations of its customers and interested parties, and in achieving satisfaction with its products
and services.
The application of a system of processes within an organization, together with the identification and
interactions of these processes, and their management, can be referred to as the 'process approach'.
An advantage of the process approach is the ongoing control that it provides over the linkage between
the individual processes within the system of processes, as well as over their combination and
interaction.
An organization has flexibility in the way it chooses to documentIt is important to consider the context
of the organization, including the legal and regulatory framework, needs and expectations of interested
parties, risks and opportunities, and strategic direction of the organization, when an organization
plans what documented information to maintain and retain for its quality management system. Each
individual organization should develop that amount of documentation needed to demonstrate the
effective planning, operation, control and continual improvement of itsWhile the adoption of a quality
management system and its processesis strategic, this also applies to its documented information.
Quality management system documentation mayDocumented information can relate to an
organization'sorganization’s total activities or to a selected part of those activities; for example,, e.g.
specified requirements depending upon the nature of products and services, processes, contractual
requirements, governing regulations or thestatutory and regulatory requirements, the context of the
organization itself.
It is important that the requirements and content of the quality management system documentation
address the qualitydocumented information also conforms to the requirements of the standards they
intend to satisfy., e.g. sector-specific requirements.
Organizations have been moving from paper-based systems to electronic media in the last two decades.
ISO 9001 has reflected this change, replacing terminology such as “documentation, quality manual,
documented procedures, and records” with “documented information.” This guidance document
uses the word “documented information” to refer to information that needs to be controlled by the
organization and “documents” to refer to information. It also uses the word “document” as a verb in a
few places.
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ISO 10013:redline:2021(E)
The guidelines given in this Technical Report are intended to assist an organization with documenting
itsISO management system standards use a high-level structure to encourage the use of integrated
management systems. This guidance document by its design and scope is focused on the quality
management system and uses terminology from ISO 9000:2015. They are not intended to be used as
requirements for contractual, regulatory or certification/registration purposesHowever, nothing
prohibits its use in other management system standards.
One aspect of a quality management system is quality planning. Quality planning documents may
include managerial and operational planning, preparing the application ofIn the previous version of
this document, a hierarchy of documentation, such as a quality manual, procedures, work instructions
and forms/checklists, was suggested as a way of documenting the quality management system
including organizing and scheduling, and the approach by which quality objectives are to be achieved.
This document does not prescribe a particular hierarchy but reflects the ability of electronic media
to organize itself in a multitude of ways. It is important to realize that while a quality manual is not
required, it can still be useful, and many sector-specific standards still require “quality manuals and
documented procedures”.
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INTERNATIONAL STANDARD ISO 10013:redline:2021(E)
Quality management systems — Guidance for documented
information
1 Scope
This Technical Report provides guidelinesdocument gives guidance for the development and
maintenance of the documentationdocumented information necessary to ensuresupport an
effective quality management system, tailored to the specific needs of the organization. The use of
these guidelines will aid in establishing a documented system as required by the applicable quality
management system standard.
This Technical Report maydocument can also be used to document management systems other than that
of the support other management systemsISO 9000 family, for example environmental management
systems, e.g. environmental or occupational health and safety management systems.
NOTE When a procedure is documented, the term “written procedure ” or “documented procedure” is
frequently used.
2 Normative reference references
The following normative document contains provisions which, through reference in this text, constitute
provisions of this Technical Report. For dated references, subsequent amendments to, or revisions of,
any of these publications do not apply. However, parties to agreements based on this Technical Report
are encouraged to investigate the possibility of applying the most recent edition of the normative
document indicated belowdocuments are referred to in the text in such a way that some or all of their
content constitutes requirements of this document. For dated references, only the edition cited applies.
For undated references, the latest edition of the normative document refered to applies. Members of ISO
and IEC maintain registers of currently valid International Standards.referenced document (including
any amendments) applies.
2015, Quality management systems — Fundamentals and vocabulary
ISO 9000:2000
3 Terms and definitions
For the purposes of this Technical Reportdocument, the terms and definitions given in ISO 9000:2015
and the following apply. An organization's quality management system may use different terminology
for the defined types of documentation.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
work instructions instruction
detailed descriptions description of how to perform and record tasks
EXAMPLE Detailed written descriptions, flow charts, templates, models, technical notes incorporated into
drawings, specifications, equipment instruction manuals, pictures, audios and videos, checklists or combinations
thereof.
Note 1 to entry: Work instructions can be documented or not .
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ISO 10013:redline:2021(E)
Note 2 to entry: Work Instructions may be, for example, detailed written descriptions, flowcharts, templates,
models, technical notes incorporated into drawings, specifications, equipment instruction manuals, pictures,
videos, checklists, or combinations thereof. Work instructions should instructions describe any materials,
equipment and documentation documented information to be used. When relevant, work instructions include
acceptance criteria.
3.2
form
document documented information to be maintained and used to record data required by the quality
management system
Note 1 to entry: A form becomes a record documented information to be retained (i.e. a record) when data are
entered.
3.3
workflow
series of activities necessary to complete a task
Note 1 to entry: A workflow that is partially or completely carried out without manual interference can be
referred to as an “automated workflow”.
Note 2 to entry: Workflows can be documented.
4 Quality management system documentation Documented information
4.1 General
The arrangement of quality management system documentation typically follows either the processes
of the organization or the structure of the applicable quality standard, or a combination of both. Any
other arrangement that satisfies the organization's needs may also be used.
The structure of the documentation used in the quality management system may be described
as a hierarchy. This structure facilitates the distribution, maintenance and understanding of the
documentation. Annex A illustrates a typical hierarchy of quality management system documentation.
The development of a hierarchy depends on the circumstances of the organization.
The extent of the quality management system documentation can differ from one organization to
another due to
a) the size of the organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
The quality management system documentation may include definitions. The vocabulary used should
be in accordance with standard definitions and terms, which are referenced in ISO 9000 or in general
dictionary usage.
The quality management system documentation usually includes the following:
a) quality policy and its objectives;
b) quality manual;
c) documented procedures;
d) work instructions;
e) forms;
f) quality plans;
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ISO 10013:redline:2021(E)
g) specifications;
h) external documents;
i) records.
Quality management system documentation may be in any type of media, such as hard copy or
electronic media.
NOTE Some advan
...
SLOVENSKI STANDARD
SIST ISO 10013:2021
01-junij-2021
Nadomešča:
SIST ISO/TR 10013:2002
Sistemi vodenja kakovosti - Napotki za dokumentirane informacije
Quality management systems - Guidance for documented information
Lignes directrices pour la documentation des systèmes de management de la qualité
Ta slovenski standard je istoveten z: ISO 10013:2021
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
SIST ISO 10013:2021 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST ISO 10013:2021
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SIST ISO 10013:2021
INTERNATIONAL ISO
STANDARD 10013
First edition
2021-03
Quality management systems —
Guidance for documented information
Systèmes de management de la qualité — Recommandations pour les
informations documentées
Reference number
ISO 10013:2021(E)
©
ISO 2021
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SIST ISO 10013:2021
ISO 10013:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
SIST ISO 10013:2021
ISO 10013:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Documented information . 2
4.1 General . 2
4.1.1 Structure . 2
4.1.2 Definitions . 2
4.1.3 Content . 2
4.1.4 Purpose . 3
4.1.5 Benefits . 3
4.2 Documented information to be maintained . 4
4.2.1 Scope of the quality management system . 4
4.2.2 Quality policy . 4
4.2.3 Quality objectives . 4
4.2.4 Information that the organization determined necessary to support the
operation of the quality management system and its processes . 5
4.3 Documented information to be retained . 9
5 Creating and updating documented information . 9
5.1 Implementation . 9
5.1.1 General. 9
5.1.2 Use of references .10
5.1.3 Responsibility for creation of documented information .10
5.1.4 Identification and description .10
5.1.5 Format and media .10
5.1.6 Review and approval .11
5.2 Control of documented information .11
5.2.1 Availability.11
5.2.2 Protection .11
5.2.3 Distribution, access, retrieval and use .11
5.2.4 Storage and preservation .11
5.2.5 Updating documented information and control of changes .11
5.2.6 Retention and disposition .12
Annex A (informative) Examples of documented information structures .13
Bibliography .14
© ISO 2021 – All rights reserved iii
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SIST ISO 10013:2021
ISO 10013:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 176, Quality management and quality
assurance, Subcommittee SC 3, Supporting technologies.
This first edition of ISO 10013 cancels and replaces ISO/TR 10013:2001, which has been technically
revised. The main changes compared with ISO/TR 10013:2001 are as follows:
— it has been aligned with the new structure and requirements of ISO 9001:2015, notably the
documentation requirements;
— the original hierarchy of documentation is no longer used but left open for the user.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
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SIST ISO 10013:2021
ISO 10013:2021(E)
Introduction
ISO 9001 requires an organization to maintain and retain documented information to support the
operation of its processes and to have confidence that the processes are being carried out as planned.
Documented information is information required to be controlled and maintained by an organization
and the medium on which it is contained. Documented information can be used to communicate, to
provide objective evidence or for sharing knowledge.
Documented information enables the knowledge and experiences of the organization to be preserved
and can generate value to support the improvement of products or services.
This document provides guidance for the development and maintenance of documented information.
The adoption of a quality management system is a strategic decision for an organization that can help
to improve its overall performance and provide a sound basis for sustainable development initiatives. It
is applicable to all organizations, regardless of size, complexity or business model. Its aim is to increase
an organization’s awareness of its duties and commitment in fulfilling the needs and expectations of its
customers and interested parties, and in achieving satisfaction with its products and services.
It is important to consider the context of the organization, including the legal and regulatory framework,
needs and expectations of interested parties, risks and opportunities, and strategic direction of the
organization, when an organization plans what documented information to maintain and retain for its
quality management system. While the adoption of a quality management system is strategic, this also
applies to its documented information.
Documented information can relate to an organization’s total activities or to a selected part of those
activities, e.g. specified requirements depending upon the nature of products and services, processes,
contractual requirements, statutory and regulatory requirements, the context of the organization itself.
It is important that the content of the documented information also conforms to the requirements of
the standards they intend to satisfy, e.g. sector-specific requirements.
Organizations have been moving from paper-based systems to electronic media in the last two decades.
ISO 9001 has reflected this change, replacing terminology such as “documentation, quality manual,
documented procedures, and records” with “documented information.” This guidance document
uses the word “documented information” to refer to information that needs to be controlled by the
organization and “documents” to refer to information. It also uses the word “document” as a verb in a
few places.
ISO management system standards use a high-level structure to encourage the use of integrated
management systems. This guidance document by its design and scope is focused on the quality
management system and uses terminology from ISO 9000:2015. However, nothing prohibits its use in
other management system standards.
In the previous version of this document, a hierarchy of documentation, such as a quality manual,
procedures, work instructions and forms/checklists, was suggested as a way of documenting the
quality management system. This document does not prescribe a particular hierarchy but reflects the
ability of electronic media to organize itself in a multitude of ways. It is important to realize that while
a quality manual is not required, it can still be useful, and many sector-specific standards still require
“quality manuals and documented procedures”.
© ISO 2021 – All rights reserved v
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SIST ISO 10013:2021
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SIST ISO 10013:2021
INTERNATIONAL STANDARD ISO 10013:2021(E)
Quality management systems — Guidance for documented
information
1 Scope
This document gives guidance for the development and maintenance of the documented information
necessary to support an effective quality management system, tailored to the specific needs of the
organization.
This document can also be used to support other management systems, e.g. environmental or
occupational health and safety management systems.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
work instruction
detailed description of how to perform tasks
EXAMPLE Detailed written descriptions, flow charts, templates, models, technical notes incorporated into
drawings, specifications, equipment instruction manuals, pictures, audios and videos, checklists or combinations
thereof.
Note 1 to entry: Work instructions can be documented.
Note 2 to entry: Work instructions describe any materials, equipment and documented information to be used.
When relevant, work instructions include acceptance criteria.
3.2
form
documented information to be maintained and used to record data required by the quality
management system
Note 1 to entry: A form becomes documented information to be retained (i.e. a record) when data are entered.
© ISO 2021 – All rights reserved 1
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SIST ISO 10013:2021
ISO 10013:2021(E)
3.3
workflow
series of activities necessary to complete a task
Note 1 to entry: A workflow that is partially or completely carried out without manual interference can be
referred to as an “automated workflow”.
Note 2 to entry: Workflows can be documented.
4 Documented information
4.1 General
4.1.1 Structure
Documented information can be structured and created in many ways based on the needs of the
organization and other factors such as leadership, intended results of the management system, context
(including statutory and regulatory requirements) and interested parties.
The structure of the documented information used in the quality management system can be described
in a hierarchy. This structure facilitates the distribution, maintenance and understanding of the
documented information. Electronic systems provide additional choices for structuring documented
information. Annex A illustrates examples of documented information structures. Smaller organizations
may choose a simplified documented information structure to meet their needs.
The type and extent of the documented information needed for the quality management system should
be based on an analysis of processes and can differ from one organization to another due to, for example:
a) the size of the organization and type of activities;
b) the complexity of processes and their interactions;
c) the maturity of the quality management system;
d) risks and opportunities;
e) the competence of persons;
f) statutory and regulatory requirements;
g) customer and other interested party requirements;
h) the need for evidence of results achieved;
i) the need to support accessibility and retrievability remotely.
4.1.2 Definitions
Documented information can include definitions. To enhance comprehension, the organization
should consider using vocabulary that is in accordance with standard terms and definitions which
are referenced in ISO 9000, in general dictionary usage or which can be specific to the organization.
An organization's quality management system may use different terminology for the defined types of
documented information.
4.1.3 Content
An organization’s documented information should include the following:
a) the scope of the quality management system (see 4.2.1);
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SIST ISO 10013:2021
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 l
...
INTERNATIONAL ISO
STANDARD 10013
First edition
2021-03
Quality management systems —
Guidance for documented information
Systèmes de management de la qualité — Recommandations pour les
informations documentées
Reference number
ISO 10013:2021(E)
©
ISO 2021
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ISO 10013:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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ISO 10013:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Documented information . 2
4.1 General . 2
4.1.1 Structure . 2
4.1.2 Definitions . 2
4.1.3 Content . 2
4.1.4 Purpose . 3
4.1.5 Benefits . 3
4.2 Documented information to be maintained . 4
4.2.1 Scope of the quality management system . 4
4.2.2 Quality policy . 4
4.2.3 Quality objectives . 4
4.2.4 Information that the organization determined necessary to support the
operation of the quality management system and its processes . 5
4.3 Documented information to be retained . 9
5 Creating and updating documented information . 9
5.1 Implementation . 9
5.1.1 General. 9
5.1.2 Use of references .10
5.1.3 Responsibility for creation of documented information .10
5.1.4 Identification and description .10
5.1.5 Format and media .10
5.1.6 Review and approval .11
5.2 Control of documented information .11
5.2.1 Availability.11
5.2.2 Protection .11
5.2.3 Distribution, access, retrieval and use .11
5.2.4 Storage and preservation .11
5.2.5 Updating documented information and control of changes .11
5.2.6 Retention and disposition .12
Annex A (informative) Examples of documented information structures .13
Bibliography .14
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ISO 10013:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 176, Quality management and quality
assurance, Subcommittee SC 3, Supporting technologies.
This first edition of ISO 10013 cancels and replaces ISO/TR 10013:2001, which has been technically
revised. The main changes compared with ISO/TR 10013:2001 are as follows:
— it has been aligned with the new structure and requirements of ISO 9001:2015, notably the
documentation requirements;
— the original hierarchy of documentation is no longer used but left open for the user.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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ISO 10013:2021(E)
Introduction
ISO 9001 requires an organization to maintain and retain documented information to support the
operation of its processes and to have confidence that the processes are being carried out as planned.
Documented information is information required to be controlled and maintained by an organization
and the medium on which it is contained. Documented information can be used to communicate, to
provide objective evidence or for sharing knowledge.
Documented information enables the knowledge and experiences of the organization to be preserved
and can generate value to support the improvement of products or services.
This document provides guidance for the development and maintenance of documented information.
The adoption of a quality management system is a strategic decision for an organization that can help
to improve its overall performance and provide a sound basis for sustainable development initiatives. It
is applicable to all organizations, regardless of size, complexity or business model. Its aim is to increase
an organization’s awareness of its duties and commitment in fulfilling the needs and expectations of its
customers and interested parties, and in achieving satisfaction with its products and services.
It is important to consider the context of the organization, including the legal and regulatory framework,
needs and expectations of interested parties, risks and opportunities, and strategic direction of the
organization, when an organization plans what documented information to maintain and retain for its
quality management system. While the adoption of a quality management system is strategic, this also
applies to its documented information.
Documented information can relate to an organization’s total activities or to a selected part of those
activities, e.g. specified requirements depending upon the nature of products and services, processes,
contractual requirements, statutory and regulatory requirements, the context of the organization itself.
It is important that the content of the documented information also conforms to the requirements of
the standards they intend to satisfy, e.g. sector-specific requirements.
Organizations have been moving from paper-based systems to electronic media in the last two decades.
ISO 9001 has reflected this change, replacing terminology such as “documentation, quality manual,
documented procedures, and records” with “documented information.” This guidance document
uses the word “documented information” to refer to information that needs to be controlled by the
organization and “documents” to refer to information. It also uses the word “document” as a verb in a
few places.
ISO management system standards use a high-level structure to encourage the use of integrated
management systems. This guidance document by its design and scope is focused on the quality
management system and uses terminology from ISO 9000:2015. However, nothing prohibits its use in
other management system standards.
In the previous version of this document, a hierarchy of documentation, such as a quality manual,
procedures, work instructions and forms/checklists, was suggested as a way of documenting the
quality management system. This document does not prescribe a particular hierarchy but reflects the
ability of electronic media to organize itself in a multitude of ways. It is important to realize that while
a quality manual is not required, it can still be useful, and many sector-specific standards still require
“quality manuals and documented procedures”.
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INTERNATIONAL STANDARD ISO 10013:2021(E)
Quality management systems — Guidance for documented
information
1 Scope
This document gives guidance for the development and maintenance of the documented information
necessary to support an effective quality management system, tailored to the specific needs of the
organization.
This document can also be used to support other management systems, e.g. environmental or
occupational health and safety management systems.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
work instruction
detailed description of how to perform tasks
EXAMPLE Detailed written descriptions, flow charts, templates, models, technical notes incorporated into
drawings, specifications, equipment instruction manuals, pictures, audios and videos, checklists or combinations
thereof.
Note 1 to entry: Work instructions can be documented.
Note 2 to entry: Work instructions describe any materials, equipment and documented information to be used.
When relevant, work instructions include acceptance criteria.
3.2
form
documented information to be maintained and used to record data required by the quality
management system
Note 1 to entry: A form becomes documented information to be retained (i.e. a record) when data are entered.
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ISO 10013:2021(E)
3.3
workflow
series of activities necessary to complete a task
Note 1 to entry: A workflow that is partially or completely carried out without manual interference can be
referred to as an “automated workflow”.
Note 2 to entry: Workflows can be documented.
4 Documented information
4.1 General
4.1.1 Structure
Documented information can be structured and created in many ways based on the needs of the
organization and other factors such as leadership, intended results of the management system, context
(including statutory and regulatory requirements) and interested parties.
The structure of the documented information used in the quality management system can be described
in a hierarchy. This structure facilitates the distribution, maintenance and understanding of the
documented information. Electronic systems provide additional choices for structuring documented
information. Annex A illustrates examples of documented information structures. Smaller organizations
may choose a simplified documented information structure to meet their needs.
The type and extent of the documented information needed for the quality management system should
be based on an analysis of processes and can differ from one organization to another due to, for example:
a) the size of the organization and type of activities;
b) the complexity of processes and their interactions;
c) the maturity of the quality management system;
d) risks and opportunities;
e) the competence of persons;
f) statutory and regulatory requirements;
g) customer and other interested party requirements;
h) the need for evidence of results achieved;
i) the need to support accessibility and retrievability remotely.
4.1.2 Definitions
Documented information can include definitions. To enhance comprehension, the organization
should consider using vocabulary that is in accordance with standard terms and definitions which
are referenced in ISO 9000, in general dictionary usage or which can be specific to the organization.
An organization's quality management system may use different terminology for the defined types of
documented information.
4.1.3 Content
An organization’s documented information should include the following:
a) the scope of the quality management system (see 4.2.1);
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ISO 10013:2021(E)
b) a quality policy (see 4.2.2);
c) quality objectives (see 4.2.3);
d) information that the organization determined necessary to support the operation of the quality
management system and its processes, including, as applicable:
1) a quality manual (see 4.2.4.2);
2) organizational charts (see 4.2.4.3);
3) process maps, process flow charts and/or process descriptions (see 4.2.4.4);
4) procedures and work instructions (see 4.2.4.5);
5) automated workflows (see 4.2.4.6);
6) product and service specifications (see 4.2.4.7);
7) internal and external communications (see 4.2.4.8);
8) plans, schedules and lists (see 4.2.4.9);
9) forms and checklists (see 4.2.4.10);
10) documented information of external origin (see 4.2.4.11);
e) documented information to be retained (i.e. records) for providing evidence of results achieved
(see 4.3).
Documented information can be in any type of media, such as paper, electronic, photograph or
physical sample.
NOTE The advantages of electronic media are, for example:
— easier access to relevant versions including access from remote locations;
— easier control of changes, including the withdrawal of obsolete documented information;
— immediate and controlled distribution;
— retrievability and retention versus paper or other physical media.
4.1.4 Purpose
The purpose of having documented information for an organization includes:
a) communication of information;
b) evidence of achieving results or activities performed;
c) knowledge sharing;
d) knowledge preservation;
e) describing the quality management system of the organization.
4.1.5 Benefits
The benefits of having documented information for an organization include:
a) demonstrating compliance with statutory and regulatory requirements:
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ISO 10013:2021(E)
b) providing information for cross-functional groups so that they can better understand
interrelationships;
c) communicating the organization’s commitment to quality to relevant interested parties;
d) helping persons to understand their role within the organization, thus providing a basis for
expectations of work performance;
e) facilitating mutual understanding between different levels in the organization;
f) providing objective evidence that specified requirements have been achieved;
g) addressing risks and opportunities to improve organizational performance, product or service
conformity, and customer satisfaction;
h) providing organizational knowledge, including the basis for competency and training for persons
and other relevant interested parties;
i) stating how things are to be done to consistently meet specified requirements, thus promoting
controlled conditions and providing a basis for continual improvement;
j) demonstrating to interested parties the capabilities within the organization, thus providing
confidence;
k) providing requirements for external providers;
l) providing a basis for auditing and evaluating the effectiveness and continuing suitability of the
quality management system.
4.2 Documented information to be maintained
4.2.1 Scope of the quality management system
The scope of the quality management system should be documented based on the organization’s
determination of the boundaries and applicability of the quality management system. The scope of
a management system can include the whole of the organization, specific and identified functions
of the organization, specific and identified sections of the organization, or one or more functions
across a group of organizations. The scope should state the types of products and services covered
and, if required, provide justification for any requirement of the relevant quality standard that the
organization determines is not applicable to the scope of its quality management system. The scope
of the quality management system should be based on the nature of the organization’s products and
services, their operational processes, issues raised in establishing the context of the organization
and relevant requirements from interested parties, the results of risk-based thinking, commercial
considerations, and contractual, statutory and regulatory requirements.
4.2.2 Quality policy
The quality policy helps an organization engage its people in the culture of quality of the organization. It
should be aligned with the organization’s strategic direction, mission and vision. It provides a verifiable
commitment to quality to relevant interested parties.
An organization can have other policies besides the quality policy relating to the quality
management system.
4.2.3 Quality objectives
Quality objectives should reflect the results to be achieved by the organization with respect to its
strategic direction, quality policy, risks and opportunities, and applicable requirements to the quality
management system.
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ISO 10013:2021(E)
4.2.4 Information that the organization determined necessary to support the operation of the
quality management system and its processes
4.2.4.1 General
The organization should determine the type and extent of documented information necessary to
support the operation of its processes, the formats to be used and the media for communicating
with users. The organization may decide what terms it uses for its documented information. While
terms such as “procedures”, “work instructions” and “quality manual” are used in this document, the
organization is not obliged to adopt such terminology.
4.2.4.2 Quality manual
There are many ways in which an organization can document its quality management system.
Organizations can choose to use a quality manual, or a quality manual can be mandated by the
organization’s external requirements. A quality manual is unique to each organization. It can provide
the structure, format, content or method of presentation for documenting the quality management
system and its processes for all types of organizations.
A small organization can find it appropriate to include the description of its entire quality management
system within a single manual, including all the documented information it maintains. Large,
multinational organizations can need manuals at different levels (e.g. the global, national or regional
level) and a more complex hierarchy of documented information. If the organization chooses to
implement a quality manual, it may include documented procedures or a reference to them, and a
description of the processes of the quality management system and their interactions.
Information about the organization, such as name, location, context and means of communication
including relevant specific terms and definitions, should be included in the quality manual. Additional
information such as its line of business, a brief description of its background, history and size may also
be included.
The quality manual can provide a description of the quality management system and its implementation
in the organization. Descriptions of the processes and their interactions or a reference to them should
be included in the manual. The processes of the organization should be designed to meet the overall
objectives of the organization, its policies, context, and relevant expectations of interested parties. In
large organizations, the processes can link the functional areas of the organization (see Annex A). The
organization should document its specific quality management system following the sequence of the
flow of the processes or any sequencing appropriate to the organization. Cross-referencing between the
selected standard and the processes of the organization can be useful. The sequence and interaction of
the processes within the quality management system can be documented using a process map.
NOTE 1 Manuals are also referred to as “quality manual”, “policy manual”, “reference manual”, “procedure
manual” or any other suitable title.
NOTE 2 Although ISO 9001:2015 does not require a quality manual, some sector-specific standards do.
4.2.4.3 Organizational charts
Organizational charts are often graphical depictions of the roles, responsibilities and authorities
within an organization. They can illustrate how roles, responsibilities and authorities flow through the
organization and how different people or groups of people interact within the organization.
4.2.4.4 Process maps, process flow charts and/or process descriptions
A process map identifies the processes and visually describes the sequence and interaction of the
processes in the organization. The processes can be further described using flow charts.
A process flow chart is a visual description of the process or procedure. It shows the process steps an
organization performs, what triggers the process or procedure (i.e. start of the process and its input)
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ISO 10013:2021(E)
and what is the final step of the process or its output. Some process flow chart formats document the
input and output for each process step, the control points and the related acceptance criteria.
A process description is a textual description of the process. It explains the process steps in words.
Process owners should be identified for quality management system processes. Process owners are
usually assigned by top management and given the authority and responsibility for a process from start
to finish, and therefore should understand their role and be competent in the process. This is especially
important since processes can cut across functional or departmental boundaries.
4.2.4.5 Procedures and work instructions
The structure and format of documented procedures should be defined by the organization either
through text, flow charts, automated workflows, tables, a combination of the above or any other
suitable method according to the needs of the organization. A procedure generally answers questions
such as who, what, when, where and with what resources. Documented procedures should contain the
information necessary to properly carry out the activities that comprise the process and reference any
requirements to retain documented information and should be uniquely identified.
The level of detail can vary depending on the complexity of the activities, risks and opportunities,
the methods used, and the levels of competency of people that is necessary to perform the activities.
Irrespective of the level of detail, the following aspects should be considered, as applicable:
— defining the needs of the organization and its relevant interested parties;
— describing the process(es) in terms of text, or other methods (e.g. flow charts, photos, videos) related
to the required activities;
— describing what is to be done, by whom or by which organizational function, why, when and where;
— describing process controls and controls of the identified activities;
— addressing risks and opportunities in a process as it affects the overall objectives of the organization;
— defining the resources needed for the activities (e.g. in terms of people, infrastructure and materials);
— defining the appropriate internal and external documented information related to the required
activities;
— defining the inputs required and outputs expected of
...
NORME ISO
INTERNATIONALE 10013
Version Redline
compare ISO 10013:2021
à ISO/TR 10013:2001
Systèmes de management de la
qualité — Recommandations pour les
informations documentées
Quality management systems — Guidance for documented
information
Numéro de référence
ISO 10013:redline:2021(F)
©
ISO 2021
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ISO 10013:redline:2021(F)
IMPORTANT
Cette version avec marques de révision utilise les codes couleur suivants
Exemple de texte 1 — Texte ayant été ajouté (en vert)
Exemple de texte 2 — Texte ayant été supprimé (en rouge)
— Figure graphique ayant été ajoutée
— Figure graphique ayant été supprimée
1.x . — Si des modifications ont été apportées à un article/paragraphe, l’arti-
cle/le paragraphe est mis en évidence en jaune dans le Sommaire
AVERTISSEMENT
Cette version marquée met en évidence les principales modifications dans la présente
édition du document comparée à l’édition précédente. Elle ne reflète pas les détails (par
exemple les changements de ponctuation).
Cette version marquée ne constitue pas le document ISO officiel et n’est pas destinée à être
utilisée à des fins de mise en œuvre.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en oeuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Tél.: +41 22 749 01 11
Fax: +41 22 749 09 47
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii © ISO 2021 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 10013:redline:2021(F)
Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d'application d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Documentation d'un système de management de la qualité Informations documentées .2
4.1 Généralités . 2
4.1.1 Structures . 3
4.1.2 Définitions . 4
4.1.3 Contenu . 4
4.1.4 Finalité . 5
4.1.5 Avantages . 5
4.2 Finalités et avantages . 5
4.3 Politique qualité et objectifs . 6
4.4 4.2 Manuel qualité Informations documentées à tenir à jour . 6
4.2.1 Domaine d’application du système de management de la qualité . 6
4.2.2 Politique qualité . 6
4.2.3 Objectifs qualité . 7
4.4.1 4.2.4 .
Contenu Informations que l’organisme a jugées nécessaires pour soutenir
le fonctionnement du système de management de la qualité et de ses processus . 7
4.4.2 Titre et domaine d'application .12
4.4.3 Sommaire .12
4.4.4 Revue, approbation et révision .12
4.4.5 Politique qualité et objectifs qualité .12
4.4.6 Organisme, responsabilités et autorités .12
4.4.7 Références .12
4.4.8 Description du système de management de la qualité .12
4.4.9 Annexes .13
4.5 Procédures documentées . .13
4.5.1 Structure et format .13
4.5.2 Contenu .13
4.5.3 Revue, approbation et révision .14
4.5.4 Identification des modifications .14
4.6 Instructions de travail .14
4.6.1 Structure et format .14
4.6.2 Contenu .15
4.6.3 Types d'instructions de travail .15
4.6.4 Revue, approbation et révision .15
4.6.5 Enregistrements .15
4.6.6 Identification de modifications .15
4.7 Formulaires .15
4.8 Plans qualité .15
4.9 Spécifications.16
4.10 Documents externes .16
4.11 4.3 .
Enregistrements Informations documentées à conserver .16
5 Processus de préparation de la documentation d'un système de management de la
qualité Création et mise à jour des informations documentées .16
5.1 Responsabilité de la préparation .16
5.2 5.1 Méthode de préparation de la documentation d'un système de management de la
qualité Mise en œuvre .17
© ISO 2021 – Tous droits réservés iii
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ISO 10013:redline:2021(F)
5.1.1 Généralités .18
5.1.2 Utilisation de références .18
5.1.3 Responsabilité de la création des informations documentées . .19
5.1.4 Identification et description .19
5.1.5 Format et supports .19
5.1.6 Revue et approbation . .19
5.3 5.2 Utilisation de références Maîtrise des informations documentées .19
5.2.1 Disponibilité.19
5.2.2 Protection .20
5.2.3 Diffusion, accès, récupération et utilisation .20
5.2.4 Stockage et préservation .20
5.2.5 Mise à jour des informations documentées et maîtrise des modifications .20
5.2.6 Conservation et élimination .20
6 Processus d'approbation, de diffusion et de maîtrise des documents du système de
management de la qualité .21
6.1 Revue et approbation .21
6.2 Diffusion .21
6.3 Introduction des modifications .21
6.4 Maîtrise de la diffusion et des modifications .21
6.5 Copies non contrôlées .21
Annexe A (informative) Hiérarchie type de la documentation d'un système de management
de la qualité Exemples de structures d’informations documentées .22
Annexe B Exemple d'instructions de travail à texte structuré .24
Bibliographie .26
iv © ISO 2021 – Tous droits réservés
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ISO 10013:redline:2021(F)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes
nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est
en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.
L'ISO collabore étroitement avec la Commission électrotechnique internationale (CEIIEC) en ce qui
concerne la normalisation électrotechnique.
Les Normes internationales sont rédigéesprocédures utilisées pour élaborer le présent document
et celles destinées à sa mise à jour sont décrites dans les Directives ISO/IEC, Partie 1. Il convient, en
particulier, de prendre note des différents critères d'approbation requis pour les différents types de
documents ISO. Le présent document a été rédigé conformément aux règles de rédaction données dans
les Directives ISO/CEIIEC, Partie 2 (voir www .iso .org/ directives).
La tâche principale des comités techniques est d'élaborer les Normes internationales. Les projets de
Normes internationales adoptés par les comités techniques sont soumis aux comités membres pour
vote. Leur publication comme Normes internationales requiert l'approbation de 75 % au moins des
comités membres votants.
Exceptionnellement, lorsqu'un comité technique a réuni des données de nature différente de celles qui
sont normalement publiées comme Normes internationales (ceci pouvant comprendre des informations
sur l'état de la technique par exemple), il peut décider, à la majorité simple de ses membres, de publier
un Rapport technique. Les Rapports techniques sont de nature purement informative et ne doivent pas
nécessairement être révisés avant que les données fournies ne soient plus jugées valables ou utiles.
L'attention est appeléeattirée sur le fait que certains des éléments du présent document peuvent faire
l'objet de droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour
responsable de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails
concernant les références aux droits de propriété intellectuelle ou autres droits analogues identifiés
lors de l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations
de brevets reçues par l'ISO (voir www .iso .org/ brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion
de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles
techniques au commerce (OTC), voir www .iso .org/ avant -propos.
L'ISO/TR 10013 a été élaboré par le comité technique ISOLe comité chargé de l’élaboration du présent
document est l’ISO/TC 176, Management et assurance de la qualité, sous-comité SC 3, Techniques de
soutien.
Cette première édition de l’ISO 10013 annule et remplace l’ISO/TR 10013:19952001 qui a fait l’objet
d’une révision technique. Par rapport à l’ISO/TR 10013:2001, Lignes directrices pour l'élaboration des
manuels qualité.les principales modifications sont les suivantes:
— il a été aligné sur la nouvelle structure et les nouvelles exigences de l’ISO 9001:2015, notamment les
exigences de documentation;
— la hiérarchie originale de la documentation n’est plus utilisée mais laissée au choix de l’utilisateur.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes
se trouve à l’adresse www .iso .org/ fr/ members .html.
© ISO 2021 – Tous droits réservés v
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ISO 10013:redline:2021(F)
Introduction
L’ISO 9001 exige qu’un organisme tienne à jour et conserve les informations documentées nécessaires
au fonctionnement de ses processus et pour avoir l’assurance que les processus sont mis en œuvre
comme planifié.
Une information documentée est une information devant être maîtrisée et tenue à jour par un organisme
ainsi que le support sur lequel elle figure. Les informations documentées peuvent être utilisées pour
communiquer, pour fournir des preuves objectives ou pour partager des connaissances.
Les Normes internationales de la familleinformations documentées permettent de ISO 9000 exigent que
le système de management de la qualité d'un organisme soit documentéconserver les connaissances et
les expériences de l’organisme et peuvent générer de la valeur pour soutenir l’amélioration des produits
ou des services.
Le présent document fournit des recommandations pour l’élaboration et la tenue à jour des informations
documentées.
Le présent Rapport technique encourage l'adoption de l'approche processus lors de l'élaboration et la
mise en œuvre du système de management de la qualité et de l'amélioration de son efficacitéL’adoption
d’un système de management de la qualité relève d’une décision stratégique de l’organisme qui peut
l’aider à améliorer ses performances globales et fournir une base solide à des initiatives permettant
d’assurer sa pérennité. Il s’applique à tous les organismes quels que soient leur taille, leur complexité
ou leur modèle d’entreprise. Il vise à accroître la sensibilisation de l’organisme sur ses obligations et
son engagement à répondre aux besoins et aux attentes de ses clients et des parties intéressées et à les
satisfaire avec ses produits et services.
Pour qu'un organisme fonctionne de manière efficace, il doit identifier et gérer de nombreuses activités
corrélées. Toute activité utilisant des ressources et gérée de manière à permettre la transformation
d'éléments d'entrée en éléments de sortie, peut être considérée comme un processus. L'élément de
sortie d'un processus constitue souvent l'élément d'entrée du processus suivant.
«L'approche processus» désigne l'application d'un système de processus au sein d'un organisme, ainsi
que l'identification, les interactions et le management de ces processus.
Entre autres avantages, l'approche processus confère la maîtrise permanente des liens entre les
processus individuels et de leurs interactions et associations, au sein du système de processus.
Un organisme jouit d'une certaine souplesse dans la manière qu'il choisit pour documenter son système
de management de la qualité. Il convient que chaque organisme individuel élabore la quantité de
documentation nécessaire pour démontrer le caractère efficace de la planification, du fonctionnement,
de la maîtrise et de l'amélioration continue deIl est important de prendre en compte le contexte
de l’organisme, y compris le cadre juridique et réglementaire, les besoins et attentes des parties
intéressées, les risques et opportunités, et l’orientation stratégique de l’organisme lorsque celui-ci
planifie les informations documentées à tenir à jour et à conserver pour son système de management de
la qualité et de ses processus. Si l’adoption d’un système de management de la qualité est stratégique,
cela s’applique également à ses informations documentées.
La documentation d'un système de management de la qualité peutLes informations documentées
peuvent se rapporter à l'ensemblel’ensemble des activités d'und’un organisme ou à une partie
déterminée de celles-cices activités; par exemple, des exigences spécifiées selon la nature des produits
et services, des processus, des exigences contractuelles, de règlements en vigueur, ou de l'organismedes
exigences légales et réglementaires, du contexte de l’organisme lui-même.
Il est important que le contenu des informations documentées soit également conforme aux exigences
des normes qu’elles sont censées satisfaire; par exemple, des exigences spécifiques à un secteur.
Au cours des deux dernières décennies, les organismes sont passés de systèmes sur papier à des
supports électroniques. L’ISO 9001 a tenu compte de ce changement en remplaçant des termes tels
que «documentation, manuel qualité, procédures documentées et enregistrements» par «informations
vi © ISO 2021 – Tous droits réservés
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ISO 10013:redline:2021(F)
documentées». Le présent document de recommandations utilise le terme «informations documentées»
pour désigner les informations qu’il est nécessaire pour l’organisme de maîtriser et le terme
«documents» pour désigner les informations. Le verbe «documenter» est également utilisé à quelques
endroits.
Il est important que les exigences et le contenu de la documentation d'unLes normes de systèmes de
management de l’ISO utilisent une structure-cadre (HLS) pour favoriser l’utilisation de systèmes de
management intégrés. Le présent document de recommandations, de par sa conception et son domaine
d’application, est axé sur le système de management de la qualité répondent aux et utilise la terminologie
de l’ISO 9000:2015normes qualité qu'ils sont censés satisfaire. Cependant, rien n’interdit son utilisation
dans le cadre d’autres normes de systèmes de management.
Les lignes directrices fournies dans le présent Rapport technique sont destinées à aider un organisme
à documenter sonDans la version précédente de ce document, une hiérarchie de la documentation,
telle qu’un manuel qualité, les procédures, les instructions de travail et les formulaires/check-lists,
était suggérée comme moyen de documenter le système de management de la qualité. Elles ne sont pas
destinées à être utilisées comme exigences à des fins contractuelles, réglementaires ou de certification.
Le présent document ne spécifié pas de hiérarchie particulière mais tient compte de la capacité des
supports électroniques à s’organiser de multiples façons. Il est important de noter que même si un
manuel qualité n’est pas exigé, il peut quand même être utile, et que de nombreuses normes spécifiques
à un secteur exigent encore des «manuels qualité et procédures documentées».
L'un des aspects d'un système de management de la qualité est la planification de la qualité. Les
documents de planification de la qualité peuvent porter sur le management de la planification et sur
la planification opérationnelle, la préparation de la mise en œuvre du système de management de la
qualité, y compris l'organisation et le calendrier, et la démarche permettant d'atteindre les objectifs
qualité.
© ISO 2021 – Tous droits réservés vii
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NORME INTERNATIONALE ISO 10013:redline:2021(F)
Systèmes de management de la qualité —
Recommandations pour les informations documentées
1 Domaine d'application d’application
Le présent Rapport techniquedocument fournit des lignes directrices pour l'élaborationrecommandations
pour l’élaboration et la tenue à jour de la documentation nécessaire pour assurer un système efficacedes
informations documentées nécessaires pour soutenir un système de management de la qualité efficace,
adaptéeadapté aux besoins spécifiques de l'organisme utilisateur. L'utilisation de ces lignes directrices
facilitera l'établissement d'un système documenté répondant aux exigences de la norme de système de
management de la qualité applicable.l’organisme.
Le présent Rapport technique peutdocument peut également être utilisé pour documenter dessoutenir
d’autres systèmes de management relevant d'autres normes que celles de la famille ISO 9000, par
exemple des systèmes de management environnemental etou des systèmes de management de la
sécuritésanté et de la sécurité au travail.
NOTE Lorsqu'une procédure est documentée, le terme «procédure écrite» ou «procédure documentée» est
souvent employé.
2 Références normatives
Les documents normatifs suivants contiennent des dispositions qui, par suite de la référence qui y
est faite, constituent des dispositions valables pour la présente partie des Directives ISO/CEIsuivants
sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur contenu, des exigences
du présent document. Pour les références datées, les amendements ultérieurs ou les révisions de ces
publications ne s'appliquent pas. Toutefois, les parties prenantes aux accords fondés sur la présente
partie des Directives ISO/CEI sont invitées à rechercher la possibilité d'appliquer les éditions les plus
récentes des documents normatifs indiqués ci-aprèsseule l’édition citée s’applique. Pour les références
non datées, la dernière édition du document normatif en référence s'applique. Les membres de l'ISO et
de la CEI possèdent le registre des Normes internationales en vigueurde référence s'applique (y compris
les éventuels amendements).
ISO 9000:2005 2015, Systèmes de management de la qualité — Principes essentiels et vocabulaire
3 Termes et définitions
Pour les besoins du présent Rapport techniquedocument, les termes et définitions donnés dans l'les
définitions de l’ISO 9000:2015 ainsi que les suivants s'appliquent. Le système de management de la
qualité d'un organisme peut employer une terminologie différente pour les types de documentation
définis.s’appliquent.
L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en
normalisation, consultables aux adresses suivantes:
— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp
— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/
© ISO 2021 – Tous droits réservés 1
---------------------- Page: 8 ----------------------
ISO 10013:redline:2021(F)
3.1
instruction de travail
description détaillée sur la manière de réaliser et d'enregistrer des tâches
EXEMPLE Descriptions écrites détaillées, de logigrammes, de formulaires, de modèles, de notes techniques
incorporées dans un plan, de spécifications, de notices techniques d’équipements, d’images, de documents audio
et vidéo, de check-lists, ou de combinaisons de ces éléments.
Note 1 à l'article: Une instruction Les instructions de travail peut être documentée ou pas peuvent être
documentées.
Note 2 à l'article: Une instruction de travail peut, par exemple, prendre la forme de description écrite détaillée,
de logigramme, de gabarit, de modèle, de note technique incorporée dans un plan, de spécification, de notice
technique pour équipements, d'images, de vidéo, de listes de vérification (check-list), ou de combinaisons de ce
...
NORME ISO
INTERNATIONALE 10013
Première édition
2021-03
Systèmes de management de la
qualité — Recommandations pour les
informations documentées
Quality management systems — Guidance for documented
information
Numéro de référence
ISO 10013:2021(F)
©
ISO 2021
---------------------- Page: 1 ----------------------
ISO 10013:2021(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii © ISO 2021 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 10013:2021(F)
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Informations documentées . 2
4.1 Généralités . 2
4.1.1 Structures . 2
4.1.2 Définitions . 2
4.1.3 Contenu . 3
4.1.4 Finalité . 3
4.1.5 Avantages . 4
4.2 Informations documentées à tenir à jour . 4
4.2.1 Domaine d’application du système de management de la qualité . 4
4.2.2 Politique qualité . 4
4.2.3 Objectifs qualité . 5
4.2.4 Informations que l’organisme a jugées nécessaires pour soutenir le
fonctionnement du système de management de la qualité et de ses processus . 5
4.3 Informations documentées à conserver . 9
5 Création et mise à jour des informations documentées.10
5.1 Mise en œuvre.10
5.1.1 Généralités .10
5.1.2 Utilisation de références .11
5.1.3 Responsabilité de la création des informations documentées . .11
5.1.4 Identification et description .11
5.1.5 Format et supports .11
5.1.6 Revue et approbation . .11
5.2 Maîtrise des informations documentées .12
5.2.1 Disponibilité.12
5.2.2 Protection .12
5.2.3 Diffusion, accès, récupération et utilisation .12
5.2.4 Stockage et préservation .12
5.2.5 Mise à jour des informations documentées et maîtrise des modifications .12
5.2.6 Conservation et élimination .13
Annexe A (informative) Exemples de structures d’informations documentées .14
Bibliographie .15
© ISO 2021 – Tous droits réservés iii
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ISO 10013:2021(F)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes
nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est
en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.
L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d'approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www
.iso .org/ directives).
L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de
brevets reçues par l'ISO (voir www .iso .org/ brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion
de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles
techniques au commerce (OTC), voir www .iso .org/ avant -propos.
Le comité chargé de l’élaboration du présent document est l’ISO/TC 176, Management et assurance de la
qualité, sous-comité SC 3, Techniques de soutien.
Cette première édition de l’ISO 10013 annule et remplace l’ISO/TR 10013:2001 qui a fait l’objet d’une
révision technique. Par rapport à l’ISO/TR 10013:2001, les principales modifications sont les suivantes:
— il a été aligné sur la nouvelle structure et les nouvelles exigences de l’ISO 9001:2015, notamment les
exigences de documentation;
— la hiérarchie originale de la documentation n’est plus utilisée mais laissée au choix de l’utilisateur.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes
se trouve à l’adresse www .iso .org/ fr/ members .html.
iv © ISO 2021 – Tous droits réservés
---------------------- Page: 4 ----------------------
ISO 10013:2021(F)
Introduction
L’ISO 9001 exige qu’un organisme tienne à jour et conserve les informations documentées nécessaires
au fonctionnement de ses processus et pour avoir l’assurance que les processus sont mis en œuvre
comme planifié.
Une information documentée est une information devant être maîtrisée et tenue à jour par un organisme
ainsi que le support sur lequel elle figure. Les informations documentées peuvent être utilisées pour
communiquer, pour fournir des preuves objectives ou pour partager des connaissances.
Les informations documentées permettent de conserver les connaissances et les expériences de
l’organisme et peuvent générer de la valeur pour soutenir l’amélioration des produits ou des services.
Le présent document fournit des recommandations pour l’élaboration et la tenue à jour des informations
documentées.
L’adoption d’un système de management de la qualité relève d’une décision stratégique de l’organisme
qui peut l’aider à améliorer ses performances globales et fournir une base solide à des initiatives
permettant d’assurer sa pérennité. Il s’applique à tous les organismes quels que soient leur taille,
leur complexité ou leur modèle d’entreprise. Il vise à accroître la sensibilisation de l’organisme sur
ses obligations et son engagement à répondre aux besoins et aux attentes de ses clients et des parties
intéressées et à les satisfaire avec ses produits et services.
Il est important de prendre en compte le contexte de l’organisme, y compris le cadre juridique et
réglementaire, les besoins et attentes des parties intéressées, les risques et opportunités, et l’orientation
stratégique de l’organisme lorsque celui-ci planifie les informations documentées à tenir à jour et à
conserver pour son système de management de la qualité. Si l’adoption d’un système de management de
la qualité est stratégique, cela s’applique également à ses informations documentées.
Les informations documentées peuvent se rapporter à l’ensemble des activités d’un organisme ou à une
partie déterminée de ces activités; par exemple, des exigences spécifiées selon la nature des produits
et services, des processus, des exigences contractuelles, des exigences légales et réglementaires, du
contexte de l’organisme lui-même.
Il est important que le contenu des informations documentées soit également conforme aux exigences
des normes qu’elles sont censées satisfaire; par exemple, des exigences spécifiques à un secteur.
Au cours des deux dernières décennies, les organismes sont passés de systèmes sur papier à des
supports électroniques. L’ISO 9001 a tenu compte de ce changement en remplaçant des termes tels
que «documentation, manuel qualité, procédures documentées et enregistrements» par «informations
documentées». Le présent document de recommandations utilise le terme «informations documentées»
pour désigner les informations qu’il est nécessaire pour l’organisme de maîtriser et le terme
«documents» pour désigner les informations. Le verbe «documenter» est également utilisé à quelques
endroits.
Les normes de systèmes de management de l’ISO utilisent une structure-cadre (HLS) pour favoriser
l’utilisation de systèmes de management intégrés. Le présent document de recommandations, de par sa
conception et son domaine d’application, est axé sur le système de management de la qualité et utilise
la terminologie de l’ISO 9000:2015. Cependant, rien n’interdit son utilisation dans le cadre d’autres
normes de systèmes de management.
Dans la version précédente de ce document, une hiérarchie de la documentation, telle qu’un manuel
qualité, les procédures, les instructions de travail et les formulaires/check-lists, était suggérée comme
moyen de documenter le système de management de la qualité. Le présent document ne spécifié pas
de hiérarchie particulière mais tient compte de la capacité des supports électroniques à s’organiser de
multiples façons. Il est important de noter que même si un manuel qualité n’est pas exigé, il peut quand
même être utile, et que de nombreuses normes spécifiques à un secteur exigent encore des «manuels
qualité et procédures documentées».
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NORME INTERNATIONALE ISO 10013:2021(F)
Systèmes de management de la qualité —
Recommandations pour les informations documentées
1 Domaine d’application
Le présent document fournit des recommandations pour l’élaboration et la tenue à jour des informations
documentées nécessaires pour soutenir un système de management de la qualité efficace, adapté aux
besoins spécifiques de l’organisme.
Le présent document peut également être utilisé pour soutenir d’autres systèmes de management, par
exemple des systèmes de management environnemental ou des systèmes de management de la santé et
de la sécurité au travail.
2 Références normatives
Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur
contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.
Pour les références non datées, la dernière édition du document de référence s'applique (y compris les
éventuels amendements).
ISO 9000:2015, Systèmes de management de la qualité — Principes essentiels et vocabulaire
3 Termes et définitions
Pour les besoins du présent document, les termes et les définitions de l’ISO 9000:2015 ainsi que les
suivants s’appliquent.
L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en
normalisation, consultables aux adresses suivantes:
— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp
— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/
3.1
instruction de travail
description détaillée sur la manière de réaliser des tâches
EXEMPLE Descriptions écrites détaillées, de logigrammes, de formulaires, de modèles, de notes techniques
incorporées dans un plan, de spécifications, de notices techniques d’équipements, d’images, de documents audio
et vidéo, de check-lists, ou de combinaisons de ces éléments.
Note 1 à l'article: Les instructions de travail peuvent être documentées.
Note 2 à l'article: Les instructions de travail décrivent tout matériel, équipement et toute information documentée
à utiliser. Lorsque cela est approprié, les instructions de travail incluent des critères d’acceptation.
3.2
formulaire
information documentée à tenir à jour et à utiliser pour enregistrer les données exigées par le système
de management de la qualité
Note 1 à l'article: Un formulaire devient une information documentée à conserver (par exemple, un
enregistrement) lorsque des données y sont consignées.
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ISO 10013:2021(F)
3.3
flux de travail (workflow)
série d’activités nécessaires à la réalisation d’une tâche
Note 1 à l'article: Un flux de travail qui se déroule en partie ou en totalité sans intervention manuelle peut être
qualifié de «flux de travail automatisé».
Note 2 à l'article: Les flux de travail peuvent être documentés.
4 Informations documentées
4.1 Généralités
4.1.1 Structures
Les informations documentées peuvent être structurées et créées de différentes manières en fonction
des besoins de l’organisme et d’autres facteurs tels que le leadership, les résultats escomptés du
système de management, du contexte (y compris des exigences légales et réglementaires), et des parties
intéressées.
La structure des informations documentées utilisées dans le système de management de la qualité
peut être décrite sous la forme d’une hiérarchie. Cette structure facilite la diffusion, la tenue à jour
et la compréhension des informations documentées. Les systèmes électroniques offrent des choix
supplémentaires pour structurer les informations documentées. L’Annexe A présente des exemples de
structures d’informations documentées. Les PME/TPE peuvent choisir une structure d’informations
documentées simplifiée pour répondre à leurs besoins.
Il convient que le type et l’étendue des informations documentées nécessaires au système de
management de la qualité soient basés sur une analyse des processus. Ils peuvent varier d’un organisme
à l’autre en raison, par exemple:
a) de la taille de l’organisme et du type d’activités;
b) de la complexité des processus et de leurs interactions;
c) de la maturité du système de management de la qualité;
d) des risques et des opportunités;
e) de la compétence des personnes;
f) des exigences légales et réglementaires;
g) des exigences des clients et des autres parties intéressées;
h) de la nécessité de prouver les résultats obtenus;
i) de la nécessité de faciliter l’accessibilité et la récupération à distance.
4.1.2 Définitions
Les informations documentées peuvent comporter des définitions. Afin d’améliorer la compréhension,
il convient que l’organisme prévoit l’utilisation d’un vocabulaire qui soit conforme avec les termes et
définitions normalisés référencés dans l’ISO 9000, dans un dictionnaire d’usage général ou qui peuvent
être spécifiques à l’organisme. Le système de management de la qualité d’un organisme peut employer
une terminologie différente pour les types d’informations documentées définis.
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ISO 10013:2021(F)
4.1.3 Contenu
Il convient que les informations documentées d’un organisme incluent les éléments suivants:
a) le domaine d’application du système de management de la qualité (voir 4.2.1);
b) une politique qualité (voir 4.2.2);
c) les objectifs qualité (voir 4.2.3);
d) les informations que l’organisme a jugées nécessaires pour soutenir le fonctionnement du système
de management de la qualité et de ses processus, y compris, si applicable:
1) un manuel qualité (voir 4.2.4.2);
2) les organigrammes (voir 4.2.4.3);
3) la cartographie des processus, logigrammes de processus et/ou descriptions de processus (voir
4.2.4.4);
4) les procédures et instructions de travail (voir 4.2.4.5);
5) les flux de travail automatisés (voir 4.2.4.6);
6) les spécifications des produits et des services (voir 4.2.4.7);
7) les communications internes et externes (voir 4.2.4.8);
8) les plans d’actions, plannings et listes (voir 4.2.4.9);
9) les formulaires et check-lists (voir 4.2.4.10);
10) les informations documentées d’origine externe (voir 4.2.4.11);
e) les informations documentées à conserver (c’est-à-dire les enregistrements) pour apporter la
preuve des résultats obtenus (voir 4.3).
Les informations documentées peuvent être utilisées sous tout support tel que papier, électronique,
photographie ou échantillon physique.
NOTE Les avantages offerts par les supports électroniques sont par exemple:
— un accès plus facile aux versions pertinentes, y compris l’accès à distance;
— une maîtrise plus facile des modifications, y compris le retrait des informations documentées obsolètes;
— une diffusion immédiate et maîtrisée;
— la facilité de récupération et la conservation par rapport au papier ou à d’autres supports physiques.
4.1.4 Finalité
Pour un organisme, le fait de disposer d’informations documentées a notamment pour but:
a) la communication d’informations;
b) la preuve de l’obtention de résultats ou des activités réalisées;
c) le partage des connaissances;
d) la préservation des connaissances;
e) la description du système de management de la qualité de l’organisme.
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ISO 10013:2021(F)
4.1.5 Avantages
Pour un organisme, le fait de disposer d’informations documentées confère notamment les avantages
suivants:
a) démontrer la conformité aux exigences légales et réglementaires;
b) fournir des informations aux groupes pluridisciplinaires afin qu’ils puissent mieux comprendre
les interactions;
c) communiquer l’engagement de l’organisme en matière de qualité aux parties intéressées
pertinentes;
d) aider les personnes à comprendre leur rôle au sein de l’organisme, constituant ainsi une base pour
les attentes en matière de performances au travail;
e) faciliter la compréhension mutuelle entre les différents niveaux de l’organisme;
f) fournir des preuves objectives de la satisfaction aux exigences spécifiées;
g) traiter les risques et les opportunités afin d’améliorer les performances de l’organisme, la
conformité des produits ou services et la satisfaction des clients;
h) fournir les connaissances organisationnelles, y compris les bases de compétences et de formation
pour les personnes et autres parties intéressées pertinentes;
i) indiquer comment procéder pour satisfaire en permanence aux exigences spécifiées, ce qui favorise
des conditions maîtrisées et fournit une base pour l’amélioration continue;
j) démontrer aux parties intéressées les aptitudes présentes dans l’organisme, ce qui permet
d’instaurer la confiance;
k) fournir des exigences pour les prestataires externes;
l) fournir une base permettant d’auditer et d’évaluer l’efficacité et la pertinence continue du système
de management de la qualité.
4.2 Informations documentées à tenir à jour
4.2.1 Domaine d’application du système de management de la qualité
Il convient de documenter le domaine d’application du système de management de la qualité en se
basant sur la détermination par l’organisme des limites et de l’applicabilité du système de management
de la qualité. Le domaine d’application d’un système de management peut comprendre l’ensemble de
l’organisme, des fonctions ou des sections spécifiques et identifiées de l’organisme, ou une ou plusieurs
fonctions dans un groupe d’organismes. Il convient que le domaine d’application indique les types de
produits et services couverts et, si nécessaire, fournisse une justification pour toute exigence de la
norme qualité pertinente que l’organisme juge non applicable dans le cadre du domaine d’application
de son système de management de la qualité. Il convient que le domaine d’application du système
de management de la qualité soit fondé sur la nature des produits et services de l’organisme, leurs
processus opérationnels, les enjeux soulevés lors de l’établissement du contexte de l’organisme et
des exigences pertinentes des parties intéressées, les résultats de l’approche par les risques, les
considérations commerciales et les exigences contractuelles, légales et réglementaires.
4.2.2 Politique qualité
La politique qualité aide un organisme à ce que son personnel s’engage dans la culture qualité de
l’organisme. Il convient qu’elle soit harmonisée à l’orientation stratégique sur la mission et la vision
de l’organisme. Elle fournit un engagement démontrable en matière de qualité aux parties intéressées
pertinentes.
4 © ISO 2021 – Tous droits réservés
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ISO 10013:2021(F)
Un organisme peut avoir d’autres politiques outre la politique qualité relatives au système de
management de la qualité.
4.2.3 Objectifs qualité
Il convient que les objectifs qualité tiennent compte des résultats à atteindre par l’organisme en ce qui
concerne son orientation stratégique, sa politique qualité, les risques et opportunités et les exigences
applicables au système de management de la qualité.
4.2.4 Informations que l’organisme a jugées nécessaires pour soutenir le fonctionnement du
système de management de la qualité et de ses processus
4.2.4.1 Généralités
Il convient que l’organisme détermine le type et l’étendue des informations documentées nécessaires
pour soutenir le fonctionnement de ses processus, les formats à utiliser et les moyens de communication
avec les utilisateurs. L’organisme peut décider des termes qu’il utilise pour ses informations
documentées. Bien que des termes tels que «procédures», «instructions de travail» et «manuel qualité»
soient utilisés dans le présent document, l’organisme n’est pas obligé d’adopter cette terminologie.
4.2.4.2 Manuel qualité
Il existe de nombreuses façons pour un organisme de documenter son système de management de la
qualité. Les organismes peuvent choisir d’utiliser un manuel qualité, ou un manuel qualité peut être
imposé par les exigences externes de l’organisme. Un manuel qualité est unique à chaque organisme. Il
peut fournir la structure, le format, le contenu ou le mode de présentation pour documenter le système
de management de la qualité et de ses processus pour tous types d’organismes.
Il peut s’avérer approprié pour un petit organisme d’inclure la description de l’ensemble de son système
de management de la qualité dans un seul manuel, y compris toutes les informations documentées
qu’il tient à jour. Les grands organismes multinationaux peuvent avoir besoin de manuels à différents
niveaux (par exemple au niveau international, national ou régional), ainsi que d’une hiérarchie plus
complexe d’informations documentées. Si l’organisme choisit de mettre en œuvre un manuel qualité,
celui-ci peut inclure les procédures documentées ou une référence à celles-ci, ainsi qu’une description
des processus du système de management de la qualité et de leurs interactions.
Il convient d’inclure dans le manuel qualité les informations relatives à l’organisme, telles que le nom,
l’endroit où il se trouve, le contexte et les moyens de communication, y compris les termes et définitions
spécifiques pertinents. Des informations complémentaires telles que son type d’activité, une brève
description de ses antécédents, de son historique et de sa taille peuvent également être incluses.
Le manuel qualité peut fournir une description du système de management de la qualité et de sa mise
en œuvre au sein de l’organisme. Il convient d’inclure dans le manuel des descriptions des processus et
de leurs interactions, ou une référence à ceux-ci. Il convient de concevoir les processus de l’organisme
de manière qu’ils répondent aux objectifs généraux de l’organisme, à ses politiques, à son contexte et
aux attentes pertinentes des parties intéressées. Dans les grands organismes, les processus peuvent
relier les domaines fonctionnels de l’organisme (voir l’Annexe A). Il convient que l’organisme documente
son système spécifique de management de la qualité en suivant l’ordre du flux des processus ou toute
séquence adaptée à l’organisme. Des renvois entre la norme choisie et les processus de l’organisme
peuvent s’avérer utiles. La séquence et l’interaction des processus au sein du système de management
de la qualité peuvent être documentées à l’aide d’une cartographie des processus.
NOTE 1 Les manuels sont également appelés «manuel qualité», «manuel de politiques», «manuel de référence»,
«manuel de procédures» ou tout autre titre approprié.
NOTE 2 Bien que l’ISO 9001:2015 n’exige pas de manuel qualité, certaines normes sectorielles l’exigent.
© ISO 2021 – Tous droits réservés 5
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ISO 10013:2021(F)
4.2.4.3 Organigrammes
Les organigrammes sont souvent des représentations graphiques des rôles, des responsabilités et des
pouvoirs au sein d’un organisme. Ils peuvent illustrer
...
NORMA ISO
INTERNACIONAL 10013
Primera edición
Traducción oficial
2021-03
Official translation
Traduction officielle
Sistemas de gestión de la calidad —
Orientación para la información
documentada
Quality management systems — Guidance for documented
information
Systèmes de management de la qualité — Recommandations pour les
informations documentées
Publicado por la Secretaría Central de ISO en Ginebra, Suiza, como
traducción oficial en español avalada por el Grupo de Trabajo Spanish
Translation Task Force (STTF), que ha certificado la conformidad en
relación con las versiones inglesa y francesa.
Número de referencia
ISO 10013:2021 (traducción oficial)
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ISO 10013:2021 (traducción oficial)
DOCUMENTO PROTEGIDO POR COPYRIGHT
© ISO 2021
Reservados los derechos de reproducción. Salvo prescripción diferente, o requerido en el contexto de su implementación, no podrá
reproducirse ni utilizarse ninguna parte de esta publicación bajo ninguna forma y por ningún medio, electrónico o mecánico,
incluidos el fotocopiado, o la publicación en Internet o una Intranet, sin la autorización previa por escrito. La autorización puede
solicitarse a ISO en la siguiente dirección o al organismo miembro de ISO en el país solicitante.
ISO copyright office
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Phone: +41 22 749 01 11
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Email: copyright@iso.org
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Publicada en Suiza
Versión española publicada en 2021
Traducción oficial/Official translation/Traduction officielle
ii © ISO 2021 – Todos los derechos reservados
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ISO 10013:2021 (traducción oficial)
Índice Página
Prólogo .iv
Prólogo de la versión en español .v
Introducción .vi
1 Objeto y campo de aplicación. 1
2 Referencias normativas . 1
3 Términos y definiciones . 1
4 Información documentada . 2
4.1 Generalidades . 2
4.1.1 Estructura . 2
4.1.2 Definiciones . 2
4.1.3 Contenido . 3
4.1.4 Propósitos . 3
4.1.5 Beneficios . 4
4.2 Información documentada para ser mantenida . 4
4.2.1 Alcance del sistema de gestión de la calidad . 4
4.2.2 Política de la calidad . 4
4.2.3 Objetivos de la calidad . 5
4.2.4 Información que la organización determina como necesaria para apoyar
la operación del sistema de gestión de la calidad y sus procesos . 5
4.3 Información documentada a ser conservada . 9
5 Creación y actualización de la información documentada .10
5.1 Implementación .10
5.1.1 Generalidades .10
5.1.2 Uso de referencias .11
5.1.3 Responsabilidad para la creación de la información documentada .11
5.1.4 Identificación y descripción .11
5.1.5 Formato y medios .11
5.1.6 Revisión y aprobación .11
5.2 Control de la información documentada .11
5.2.1 Disponibilidad .11
5.2.2 Protección .12
5.2.3 Distribución, acceso, recuperación y uso .12
5.2.4 Almacenamiento y preservación.12
5.2.5 Actualización de la información documentada y control de cambios .12
5.2.6 Conservación y disposición .12
Anexo A (informativo) Ejemplos de estructura de la información documentada .13
Bibliografía .14
Traducción oficial/Official translation/Traduction officielle
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ISO 10013:2021 (traducción oficial)
Prólogo
ISO (Organización Internacional de Normalización) es una federación mundial de organismos
nacionales de normalización (organismos miembros de ISO). El trabajo de elaboración de las Normas
Internacionales se lleva a cabo normalmente a través de los comités técnicos de ISO. Cada organismo
miembro interesado en una materia para la cual se haya establecido un comité técnico, tiene el derecho
de estar representado en dicho comité. Las organizaciones internacionales, gubernamentales y no
gubernamentales, vinculadas con ISO, también participan en el trabajo. ISO colabora estrechamente
con la Comisión Electrotécnica Internacional (IEC) en todos los temas de normalización electrotécnica.
En la Parte 1 de las Directivas ISO/IEC se describen los procedimientos utilizados para desarrollar este
documento y aquellos previstos para su mantenimiento posterior. En particular debería tomarse nota
de los diferentes criterios de aprobación necesarios para los distintos tipos de documentos ISO. Este
documento ha sido redactado de acuerdo con las reglas editoriales de la Parte 2 de las Directivas ISO/
IEC (véase www .iso .org/ directives).
Se llama la atención sobre la posibilidad de que algunos de los elementos de este documento puedan
estar sujetos a derechos de patente. ISO no asume la responsabilidad por la identificación de alguno
o todos los derechos de patente. Los detalles sobre cualquier derecho de patente identificado durante
el desarrollo de este documento se indicarán en la Introducción y/o en la lista ISO de declaraciones de
patente recibidas (véase www .iso .org/ patents).
Cualquier nombre comercial utilizado en este documento es información que se proporciona para
comodidad del usuario y no constituye una recomendación.
Para una explicación de la naturaleza voluntaria de las normas, el significado de los términos específicos
de ISO y las expresiones relacionadas con la evaluación de la conformidad, así como la información
acerca de la adhesión de ISO a los principios de la Organización Mundial del Comercio (OMC) respecto a
los Obstáculos Técnicos al Comercio (OTC), véase www .iso .org/ iso/ foreword .html.
Este documento ha sido elaborado por el Comité Técnico ISO/TC 176, Gestión y aseguramiento de la
calidad, Subcomité SC 3, Tecnologías de apoyo.
Esta primera edición de la Norma ISO 10013 anula y sustituye al Informe Técnico ISO/TR 10013:2001,
que ha sido revisado técnicamente. Los cambios principales en comparación con el Informe Técnico
ISO/TR 10013:2001 son los siguientes:
— este ha sido alineado con la nueva estructura y requisitos de la Norma ISO 9001:2015, y ahora refleja
los cambios relacionados con los requisitos de documentación;
— la jerarquía original de la documentación ya no se usa, sino que se deja abierta para el usuario.
Cualquier comentario o pregunta sobre este documento debería dirigirse al organismo nacional de
normalización del usuario. Puede encontrar una lista completa de estos organismos en www .iso .org/
members .html.
Traducción oficial/Official translation/Traduction officielle
iv © ISO 2021 – Todos los derechos reservados
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ISO 10013:2021 (traducción oficial)
Prólogo de la versión en español
Este documento ha sido traducido por el Grupo de Trabajo Spanish Translation Task Force (STTF) del
Comité Técnico ISO/TC 176, Gestión y aseguramiento de la calidad, en el que participan representantes de
los organismos nacionales de normalización y representantes del sector empresarial de los siguientes
países:
Argentina, Bolivia, Brasil, Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, España, Estados
Unidos de América, México, Panamá, Perú y Uruguay.
Igualmente, en el citado Grupo de Trabajo participan representantes de COPANT (Comisión
Panamericana de Normas Técnicas) e INLAC (Instituto Latinoamericano de la Calidad).
Esta traducción es parte del resultado del trabajo que el Grupo ISO/TC 176/STTF viene desarrollando
desde su creación en el año 1999 para lograr la unificación de la terminología en lengua española en el
ámbito de la gestión de la calidad.
Traducción oficial/Official translation/Traduction officielle
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ISO 10013:2021 (traducción oficial)
Introducción
La Norma ISO 9001 requiere que una organización mantenga y conserve información documentada
para apoyar la operación de sus procesos y tener confianza en que los procesos se están llevando a cabo
según lo planificado.
La información documentada es la información requerida a ser controlada y mantenida por una
organización y el medio en el que está contenida. La información documentada se puede utilizar para
comunicar, para proporcionar evidencia objetiva o para compartir conocimiento.
La información documentada permite preservar los conocimientos y las experiencias de la organización
y puede generar valor para apoyar la mejora de productos o servicios.
Este documento proporciona orientación para el desarrollo y mantenimiento de la información
documentada.
La adopción de un sistema de gestión de la calidad es una decisión estratégica para una organización
que puede ayudar a mejorar su desempeño global y proporcionar una base sólida para las iniciativas
de desarrollo sostenible. Es aplicable a todas las organizaciones, independientemente de su tamaño,
complejidad o modelo de negocio. Su objetivo es incrementar la toma de conciencia de la organización
sobre sus tareas y su compromiso para satisfacer las necesidades y expectativas de sus clientes y sus
partes interesadas y lograr la satisfacción con sus productos y servicios.
Es importante considerar el contexto de la organización, incluido el marco legal y regulatorio, las
necesidades y expectativas de las partes interesadas, los riesgos y las oportunidades, y la dirección
estratégica de la organización, cuando una organización planifica qué información documentada
mantener y conservar para su sistema de gestión de la calidad. Si bien la adopción de un sistema de
gestión de la calidad es estratégica, esto también aplica a su información documentada
La información documentada puede relacionarse con todas las actividades de la organización o
con una parte seleccionada de esas actividades; por ejemplo, requisitos especificados que dependen
de la naturaleza de los productos y servicios, procesos, requisitos contractuales, requisitos legales y
reglamentarios y el contexto de la propia organización.
Es importante que el contenido de la información documentada también cumpla los requisitos de las
normas que pretenden satisfacer; por ejemplo, requisitos específicos del sector.
Las organizaciones han pasado de los sistemas en papel a los medios electrónicos en las últimas
dos décadas. La Norma ISO 9001 ha reflejado este cambio, reemplazando la terminología como
"documentación, manual de la calidad, procedimientos documentados y registros" con "información
documentada". Este documento de orientación utiliza la palabra "información documentada" para
referirse a la información que necesita ser controlada por la organización y "documentos" para referirse
a la información. También utiliza la palabra "documentar" como verbo en algunos lugares.
Las normas de sistema de gestión ISO han adoptado la estructura de alto nivel e ISO ha alentado el uso
de sistemas integrados de gestión. Este documento de orientación, por su diseño y alcance, se centra en
el sistema de gestión de la calidad y utiliza la terminología de la Norma ISO 9000:2015. Sin embargo,
nada prohíbe su uso en otras normas de sistemas de gestión.
En la versión anterior de esta norma de orientación se sugirió una jerarquía de documentación tal como:
manual de la calidad, procedimientos, instrucciones de trabajo y formularios/listas de verificación
como una forma de documentar el sistema de gestión de la calidad. Este documento no prescribe una
jerarquía en particular, sino que refleja la capacidad de los medios electrónicos para organizarse de
muchas maneras. Es importante darse cuenta que, aunque no se requiere un manual de la calidad,
éste aún puede ser de utilidad, y varias normas de sectores específicos aún requieren "manuales de la
calidad y procedimientos documentados".
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NORMA INTERNACIONAL ISO 10013:2021 (traducción oficial)
Sistemas de gestión de la calidad — Orientación para la
información documentada
1 Objeto y campo de aplicación
Este documento proporciona orientación para el desarrollo y mantenimiento de la información
documentada necesaria para apoyar un sistema de gestión de la calidad eficaz, adaptado a las
necesidades específicas de la organización.
Este documento también se puede utilizar para apoyar otros sistemas de gestión, por ejemplo, sistemas
de gestión ambiental o de seguridad y salud en el trabajo.
2 Referencias normativas
En el texto se hace referencia a los siguientes documentos de manera que parte o la totalidad de su
contenido constituyen requisitos de este documento. Para las referencias con fecha, solo se aplica la
edición citada. Para las referencias sin fecha se aplica la última edición (incluida cualquier modificación
de esta).
ISO 9000:2015, Sistemas de gestión de la calidad — Fundamentos y vocabulario
3 Términos y definiciones
Para los fines de este documento, se aplican los términos y definiciones incluidos en la Norma
ISO 9000:2015 y los siguientes.
ISO e IEC mantienen bases de datos terminológicas para su utilización en normalización en las siguientes
direcciones:
— Plataforma de búsqueda en línea de ISO: disponible en https:// www .iso .org/ obp
— Electropedia de IEC: disponible en https:// www .electropedia .org/
3.1
instrucciones de trabajo
descripciones detalladas de cómo realizar tareas
EJEMPLO Descripciones escritas detalladas, diagramas de flujo, plantillas, modelos, notas técnicas
incorporadas en dibujos, especificaciones, manuales de instrucción de equipo, imágenes, audios y videos, listas
de verificación o combinaciones de los mismos.
Nota 1 a la entrada: Las instrucciones de trabajo pueden estar documentadas.
Nota 2 a la entrada: Las instrucciones de trabajo describen cualquier material, equipo e información documentada
a utilizar. Cuando sea pertinente, las instrucciones de trabajo incluyen criterios de aceptación.
3.2
formulario
información documentada que se mantiene y se usa para registrar los datos requeridos por el sistema
de gestión de la calidad
Nota 1 a la entrada: Un formulario se convierte en información documentada a conservar (por ejemplo, un
registro) cuando se ingresan los datos.
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ISO 10013:2021 (traducción oficial)
3.3
flujo de trabajo
serie de actividades necesarias para completar una tarea
Nota 1 a la entrada: Un flujo de trabajo que se realiza de forma parcial o completa sin interferencia manual puede
denominarse “flujo de trabajo automatizado”.
Nota 2 a la entrada: Los flujos de trabajo pueden estar documentados.
4 Información documentada
4.1 Generalidades
4.1.1 Estructura
La información documentada puede estructurarse y crearse de muchas maneras en función de las
necesidades de la organización, y otros factores tales como el liderazgo, los resultados previstos
del sistema de gestión, el contexto (incluidos los requisitos legales y reglamentarios) y las partes
interesadas.
La estructura de la información documentada utilizada en el sistema de gestión de la calidad puede
describirse en una jerarquía. Esta estructura facilita la distribución, el mantenimiento y la comprensión
de la información documentada. Los sistemas electrónicos proporcionan opciones adicionales para
estructurar la información documentada. El Anexo A ilustra ejemplos de estructuras de información
documentada. Las organizaciones más pequeñas pueden elegir una estructura de información
documentada simplificada para satisfacer sus necesidades.
El tipo y la extensión de la información documentada necesaria para el sistema de gestión de la calidad
debería basarse en un análisis de procesos y pueden diferir de una organización a otra debido a, por
ejemplo:
a) el tamaño de la organización y el tipo de actividades;
b) la complejidad de los procesos y sus interacciones;
c) la madurez del sistema de gestión de la calidad;
d) los riesgos y las oportunidades;
e) la competencia de las personas;
f) los requisitos legales y reglamentarios;
g) los requisitos del cliente y otras partes interesadas;
h) la necesidad de evidencia de los resultados alcanzados;
i) la necesidad de apoyar la accesibilidad y la recuperabilidad de manera remota.
4.1.2 Definiciones
La información documentada puede incluir definiciones. Para mejorar la comprensión, la organización
debería considerar el uso del vocabulario que está de acuerdo con los términos y definiciones
normalizados a los que se hace referencia en la Norma ISO 9000, en el uso general del diccionario o que
puede ser específico de la organización. El sistema de gestión de la calidad de una organización puede
usar una terminología diferente para los tipos definidos de información documentada.
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ISO 10013:2021 (traducción oficial)
4.1.3 Contenido
La información documentada de una organización debería incluir lo siguiente:
a) el alcance del sistema de gestión de la calidad (véase 4.2.1);
b) una política de la calidad (véase 4.2.2);
c) los objetivos de la calidad (véase 4.2.3);
d) la información que la organización ha determinado como necesaria para apoyar la operación del
sistema de gestión de la calidad y sus procesos, incluyendo, según corresponda:
1) el manual de la calidad (véase 4.2.4.2);
2) los diagramas organizacionales (véase 4.2.4.3);
3) los mapas de procesos, los diagramas de flujo de procesos y/o las descripciones de procesos
(véase 4.2.4.4);
4) los procedimientos e instrucciones de trabajo (véase 4.2.4.5);
5) los flujos de trabajo automatizados (véase 4.2.4.6);
6) las especificaciones de productos y servicios (véase 4.2.4.7);
7) las comunicaciones internas y externas (véase 4.2.4.8);
8) los planes, los cronogramas y las listas (véase 4.2.4.9);
9) los formularios y las listas de verificación (véase 4.2.4.10);
10) la información documentada de origen externo (véase 4.2.4.11);
e) la información documentada a conservar (es decir, registros) para proporcionar evidencia de los
resultados alcanzados (véase 4.3).
La información documentada puede estar en cualquier tipo de medio, tales como papel, electrónico,
fotografía o muestra física.
NOTA Las ventajas de los medios electrónicos, son por ejemplo:
— facilitar el acceso a las versiones pertinentes, incluido el acceso desde ubicaciones remotas;
— facilitar el control de los cambios; incluyendo el retiro de información documentada obsoleta;
— la distribución inmediata y controlada;
— la recuperabilidad y la conservación frente al papel u otros medios físicos.
4.1.4 Propósitos
Los propósitos de tener información documentada para una organización incluyen:
a) la comunicación de la información;
b) la evidencia del logro de resultados o actividades realizadas;
c) el intercambio de conocimientos;
d) la preservación del conocimiento;
e) la descripción del sistema de gestión de la calidad de la organización.
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ISO 10013:2021 (traducción oficial)
4.1.5 Beneficios
Los beneficios de tener información documentada para una organización incluyen:
a) demostrar el cumplimiento de los requisitos legales y reglamentarios;
b) proporcionar información a los grupos interfuncionales para que puedan comprender mejor las
interrelaciones;
c) comunicar el compromiso de la organización con la calidad a las partes interesadas pertinentes;
d) ayudar a las personas a comprender su rol dentro de la organización, proporcionando así una base
para las expectativas de desempeño laboral;
e) facilitar la comprensión mutua entre los diferentes niveles de la organización;
f) proporcionar evidencia objetiva de que se han cumplido los requisitos especificados;
g) abordar los riesgos y las oportunidades para mejorar el desempeño organizacional, la conformidad
del producto o servicio y la satisfacción del cliente;
h) proporcionar conocimiento organizacional, incluyendo la base para la competencia y la formación
de personas y otras partes interesadas pertinentes;
i) establecer cómo se hacen las cosas para cumplir de manera coherente los requisitos especificados,
promoviendo así condiciones controladas y proporcionando una base para la mejora continua;
j) demostrar a las partes interesadas las capacidades dentro de la organización, proporcionando así
confianza;
k) proporcionar requisitos para proveedores externos;
l) proporcionar una base para auditar y evaluar la eficacia y la idoneidad continua del sistema de
gestión de la calidad.
4.2 Información documentada para ser mantenida
4.2.1 Alcance del sistema de gestión de la calidad
El alcance del sistema de gestión de la calidad se debería documentar con base en la determinación de los
límites y la aplicabilidad del sistema de gestión de la calidad. El alcance de un sistema de gestión puede
incluir la totalidad de la organización, funciones específicas e identificadas de la organización, secciones
específicas e identificadas de la organización, o una o más funciones en un grupo de organizaciones.
El alcance debería indicar los tipos de productos y servicios cubiertos y, si es necesario, proporcionar
justificación para cualquier requisito de la norma de la calidad pertinente que la organización
determine que no es aplicable al alcance de su sistema de gestión de la calidad. El alcance del sistema de
gestión de la calidad se debería basar en la naturaleza de los productos y servicios de la organización,
sus procesos operativos, las cuestiones que surjan al establecer el contexto de la organización y los
requisitos pertinentes de las partes interesadas, los resultados del pensamiento basado en el riesgo, las
consideraciones comerciales y los requisitos contractuales, legales y reglamentarios.
4.2.2 Política de la calidad
La política de la calidad ayuda a que las personas de una organización se comprometan con la cultura
de la calidad de su organización. Ésta debería estar alineada con la dirección estratégica, la misión y la
visión de la organización. Proporciona un compromiso verificable con la calidad a las partes interesadas
pertinentes.
Una organización puede tener otras políticas, además de la política de la calidad, relacionadas con el
sistema de gestión de la calidad.
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ISO 10013:2021 (traducción oficial)
4.2.3 Objetivos de la calidad
Los objetivos de la calidad deberían reflejar los resultados que logrará la organización con respecto a su
dirección estratégica, la política de la calidad, los riesgos y oportunidades y los requisitos aplicables al
sistema de gestión de la calidad.
4.2.4 Información que la organización determina como necesaria para apoyar la operación del
sistema de gestión de la calidad y sus procesos
4.2.4.1 Generalidades
La organización debería determinar el tipo y la extensión de la información documentada necesaria
para apoyar la operación de sus procesos, los formatos que se utilizarán y los medios para comunicarse
con los usuarios. La organización puede decidir qué términos usa para su información documentada. Si
bien a continuación se utilizan términos como “procedimientos”, “instrucciones de trabajo” y “manual
de la calidad”, la organización no está obligada a adoptar dicha terminología.
4.2.4.2 Manual de la calidad
Hay muchas formas en que una organización puede documentar su sistema de gestión de la calidad.
Las organizaciones pueden optar por utilizar un manual de la calidad, o los requisitos externos
de la organización pueden exigir un manual de la calidad. Un manual de la calidad es exclusivo de
cada organización. Este puede proporcionar la estructura, el formato, el contenido o el método de
presentación para documentar el sistema de gestión de la calidad y sus procesos para todo tipo de
organizaciones.
Una organización pequeña puede considerar apropiado incluir la descripción de todo su sistema de
gestión de la calidad en un solo manual, incluida toda la información documentada que mantiene. Las
grandes organizaciones multinacionales pueden necesitar manuales a diferentes niveles (por ejemplo,
a nivel global, nacional o regional) y una jerarquía más compleja de información documentada. Si la
organización elige implementar un manual de la calidad, puede incluir procedimientos documentados
o una referencia a ellos, y una descripción de los procesos del sistema de gestión de la calidad y sus
interacciones.
La información sobre la organización, como el nombre, la ubicación, el contexto y los medios de
comunicación, incluido
...
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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
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
© ISO 2020 – All rights reserved iii
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oSIST ISO/DIS 10013:2020
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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oSIST ISO/DIS 10013:2020
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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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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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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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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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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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
...
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.
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Published in Switzerland
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ISO 10013:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Documented information . 2
4.1 General . 2
4.1.1 Structure . 2
4.1.2 Definitions . 2
4.1.3 Content . 2
4.1.4 Purpose . 3
4.1.5 Benefits . 3
4.2 Documented information to be maintained . 4
4.2.1 Scope of the quality management system . 4
4.2.2 Quality policy . 4
4.2.3 Quality objectives . 4
4.2.4 Information that the organization determined necessary to support the
operation of the quality management system and its processes . 5
4.3 Documented information to be retained . 9
5 Creating and updating documented information . 9
5.1 Implementation . 9
5.1.1 General. 9
5.1.2 Use of references .10
5.1.3 Responsibility for creation of documented information .10
5.1.4 Identification and description .10
5.1.5 Format and media .10
5.1.6 Review and approval .11
5.2 Control of documented information .11
5.2.1 Availability.11
5.2.2 Protection .11
5.2.3 Distribution, access, retrieval and use .11
5.2.4 Storage and preservation .11
5.2.5 Updating documented information and control of changes .11
5.2.6 Retention and disposition .12
Annex A (informative) Examples of documented information structures .13
Bibliography .14
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ISO 10013:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 176, Quality management and quality
assurance, Subcommittee SC 3, Supporting technologies.
This second edition of ISO 10013 cancels and replaces ISO/TR 10013:2001, which has been technically
revised. The main changes compared with ISO/TR 10013:2001 are as follows:
— it has been aligned with the new structure and requirements of ISO 9001:2015, notably the
documentation requirements;
— the original hierarchy of documentation is no longer used but left open for the user.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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ISO 10013:2021(E)
Introduction
ISO 9001 requires an organization to maintain and retain documented information to support the
operation of its processes and to have confidence that the processes are being carried out as planned.
Documented information is information required to be controlled and maintained by an organization
and the medium on which it is contained. Documented information can be used to communicate, to
provide objective evidence or for sharing knowledge.
Documented information enables the knowledge and experiences of the organization to be preserved
and can generate value to support the improvement of products or services.
This document provides guidance for the development and maintenance of documented information.
The adoption of a quality management system is a strategic decision for an organization that can help
to improve its overall performance and provide a sound basis for sustainable development initiatives. It
is applicable to all organizations, regardless of size, complexity or business model. Its aim is to increase
an organization’s awareness of its duties and commitment in fulfilling the needs and expectations of its
customers and interested parties, and in achieving satisfaction with its products and services.
It is important to consider the context of the organization, including the legal and regulatory framework,
needs and expectations of interested parties, risks and opportunities, and strategic direction of the
organization, when an organization plans what documented information to maintain and retain for its
quality management system. While the adoption of a quality management system is strategic, this also
applies to its documented information.
Documented information can relate to an organization’s total activities or to a selected part of those
activities, e.g. specified requirements depending upon the nature of products and services, processes,
contractual requirements, statutory and regulatory requirements, the context of the organization itself.
It is important that the content of the documented information also conforms to the requirements of
the standards they intend to satisfy, e.g. sector-specific requirements.
Organizations have been moving from paper-based systems to electronic media in the last two decades.
ISO 9001 has reflected this change, replacing terminology such as “documentation, quality manual,
documented procedures, and records” with “documented information.” This guidance document
uses the word “documented information” to refer to information that needs to be controlled by the
organization and “documents” to refer to information. It also uses the word “document” as a verb in a
few places.
ISO management system standards use a high-level structure to encourage the use of integrated
management systems. This guidance document by its design and scope is focused on the quality
management system and uses terminology from ISO 9000:2015. However, nothing prohibits its use in
other management system standards.
In the previous version of this document, a hierarchy of documentation, such as a quality manual,
procedures, work instructions and forms/checklists, was suggested as a way of documenting the
quality management system. This document does not prescribe a particular hierarchy but reflects the
ability of electronic media to organize itself in a multitude of ways. It is important to realize that while
a quality manual is not required, it can still be useful, and many sector-specific standards still require
“quality manuals and documented procedures”.
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INTERNATIONAL STANDARD ISO 10013:2021(E)
Quality management systems — Guidance for documented
information
1 Scope
This document gives guidance for the development and maintenance of the documented information
necessary to support an effective quality management system, tailored to the specific needs of the
organization.
This document can also be used to support other management systems, e.g. environmental or
occupational health and safety management systems.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
work instruction
detailed description of how to perform tasks
EXAMPLE Detailed written descriptions, flow charts, templates, models, technical notes incorporated into
drawings, specifications, equipment instruction manuals, pictures, audios and videos, checklists or combinations
thereof.
Note 1 to entry: Work instructions can be documented.
Note 2 to entry: Work instructions describe any materials, equipment and documented information to be used.
When relevant, work instructions include acceptance criteria.
3.2
form
documented information to be maintained and used to record data required by the quality
management system
Note 1 to entry: A form becomes documented information to be retained (i.e. a record) when data are entered.
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3.3
workflow
series of activities necessary to complete a task
Note 1 to entry: A workflow that is partially or completely carried out without manual interference can be
referred to as an “automated workflow”.
Note 2 to entry: Workflows can be documented.
4 Documented information
4.1 General
4.1.1 Structure
Documented information can be structured and created in many ways based on the needs of the
organization and other factors such as leadership, intended results of the management system, context
(including statutory and regulatory requirements) and interested parties.
The structure of the documented information used in the quality management system can be described
in a hierarchy. This structure facilitates the distribution, maintenance and understanding of the
documented information. Electronic systems provide additional choices for structuring documented
information. Annex A illustrates examples of documented information structures. Smaller organizations
may choose a simplified documented information structure to meet their needs.
The type and extent of the documented information needed for the quality management system should
be based on an analysis of processes and can differ from one organization to another due to, for example:
a) the size of the organization and type of activities;
b) the complexity of processes and their interactions;
c) the maturity of the quality management system;
d) risks and opportunities;
e) the competence of persons;
f) statutory and regulatory requirements;
g) customer and other interested party requirements;
h) the need for evidence of results achieved;
i) the need to support accessibility and retrievability remotely.
4.1.2 Definitions
Documented information can include definitions. To enhance comprehension, the organization
should consider using vocabulary that is in accordance with standard terms and definitions which
are referenced in ISO 9000, in general dictionary usage or which can be specific to the organization.
An organization's quality management system may use different terminology for the defined types of
documented information.
4.1.3 Content
An organization’s documented information should include the following:
a) the scope of the quality management system (see 4.2.1);
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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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ISO 10013:2021(E)
and what is the final step of the process or its output. Some process flow chart formats document the
input and output for each process step, the control points and the related acceptance criteria.
A process description is a textual description of the process. It explains the process steps in words.
Process owners should be identified for quality management system processes. Process owners are
usually assigned by top management and given the authority and responsibility for a process from start
to finish, and therefore should understand their role and be competent in the process. This is especially
important since processes can cut across functional or departmental boundaries.
4.2.4.5 Procedures and work instructions
The structure and format of documented procedures should be defined by the organization either
through text, flow charts, automated workflows, tables, a combination of the above or any other
suitable method according to the needs of the organization. A procedure generally answers questions
such as who, what, when, where and with what resources. Documented procedures should contain the
information necessary to properly carry out the activities that comprise the process and reference any
requirements to retain documented information. and should be uniquely identified.
The level of detail can vary depending on the complexity of the activities, risks and opportunities,
the methods used, and the levels of competency of people that is necessary to perform the activities.
Irrespective of the level of detail, the following aspects should be considered, as applicable:
— defining the needs of the organization and its relevant interested parties;
— describing the process(es) in terms of text, or other methods (e.g. flow charts, photos, videos) related
to the required activities;
— describing what is to be done, by whom or by which organizational function, why, when and where;
— describing process controls and controls of the identified activities;
— addressing risks and opportunities in a process as it affects the overall objectives of the organization;
— defining the resources needed for the activities (e.g. in terms of people, infrastructure and materials);
— defining the appropriate internal a
...
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