ISO/IEC FDIS 17007
(Main)Conformity assessment — Guidance for drafting normative documents suitable for use for conformity assessment
Conformity assessment — Guidance for drafting normative documents suitable for use for conformity assessment
This document provides principles and guidance for developing normative documents that contain: specified requirements for objects of conformity assessment to fulfil; specified requirements for conformity assessment systems that can be employed when demonstrating whether an object of conformity assessment fulfils specified requirements. This document is intended for use by standards developers not applying the ISO/IEC Directives, industry associations and consortia, purchasers, regulators, consumers and non-government groups, accreditation bodies, conformity assessment bodies, conformity assessment scheme owners, and other interested parties, such as insurance organizations.
Évaluation de la conformité — Recommandations pour la rédaction de documents normatifs applicables à l'évaluation de la conformité
Ce document fournit des principes et des directives pour l'élaboration de documents normatifs contenant des exigences spécifiées que les objets de l'évaluation de la conformité doivent satisfaire, des exigences spécifiées relatives aux systèmes d'évaluation de la conformité pouvant être utilisés pour démontrer qu'un objet de l'évaluation de la conformité satisfait aux exigences spécifiées. Ce document est destinée aux développeurs de normes qui n'appliquent pas les Directives ISO/CEI, aux associations et consortiums industriels, aux acheteurs, aux autorités réglementaires, aux consommateurs et organisations non gouvernementales, aux organismes d'accréditation, aux organismes d'évaluation de la conformité, aux propriétaires de systèmes particuliers d'évaluation de la conformité ainsi qu'à d'autres parties intéressées telles que les organismes d'assurance, par exemple.
General Information
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Standards Content (Sample)
FINAL DRAFT
International
Standard
ISO/CASCO
Conformity assessment — Guidance
Secretariat: ISO
for drafting normative documents
Voting begins on:
suitable for use for conformity
2025-08-07
assessment
Voting terminates on:
2025-10-02
Évaluation de la conformité — Recommandations pour la
rédaction de documents normatifs applicables à l'évaluation de
la conformité
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
This draft is submitted to a parallel vote in ISO and in IEC.
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/CASCO
Conformity assessment — Guidance
Secretariat: ISO
for drafting normative documents
Voting begins on:
suitable for use for conformity
assessment
Voting terminates on:
Évaluation de la conformité — Recommandations pour la
rédaction de documents normatifs applicables à l'évaluation de
la conformité
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
This draft is submitted to a parallel vote in ISO and in IEC.
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO/IEC 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
© ISO/IEC 2025 – All rights reserved
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles . 4
4.1 General .4
4.2 Principle 1: separation of types of provisions .4
4.3 Principle 2: neutrality towards parties performing conformity assessment activities .5
4.4 Principle 3: functional approach to conformity assessment .6
4.5 Principle 4: comparability of conformity assessment results.6
4.6 Principle 5: good practice in conformity assessment .7
5 Guidance for the development of normative documents stating specified requirements
for objects of conformity assessment . 7
6 Guidance for the development of normative documents stating specific methods and
procedures for individual conformity assessment activity . 9
7 Guidance for the development of normative documents stating rules and methodology
for conformity assessment .10
Annex A (informative) The CASCO toolbox .12
Annex B (informative) Approach to identify specified requirements, methods and procedures,
rules and methodology for conformity assessment . 14
Bibliography . 17
© ISO/IEC 2025 – All rights reserved
iii
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are
members of ISO or IEC participate in the development of International Standards through technical
committees established by the respective organization to deal with particular fields of technical activity.
ISO and IEC technical committees collaborate in fields of mutual interest. Other international organizations,
governmental and non-governmental, in liaison with ISO and IEC, also take part in the work.
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 document 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 or www.iec.ch/members_experts/refdocs).
ISO and IEC draw attention to the possibility that the implementation of this document may involve the
use of (a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of any
claimed patent rights in respect thereof. As of the date of publication of this document, ISO and IEC had not
received notice of (a) patent(s) which may be required to implement this document. However, implementers
are cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall not be held
responsible for identifying any or all such patent rights.
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.
In the IEC, see www.iec.ch/understanding-standards.
This document was prepared by the ISO Committee on Conformity Assessment (CASCO).
This second edition cancels and replaces the first edition (ISO/IEC 17007:2009), which has been technically
revised.
The main changes are as follows:
— definitions has been aligned with ISO/IEC 17000:2020 with new definitions added;
— 3 categories of provisions in normative documents have been introduced in the Scope and Clause 4;
— references to ISO/IEC 17067 have been added for content regarding schemes;
— the 5 principles described in Clause 4 have been updated;
— in Annex A, an introductory part has been added before the Table A.1 to describe the conformity
assessment and accreditation bodies specified by the CASCO toolbox; Table A.1 has been updated to
contain all toolbox deliverables;
— Annex B has been replaced by a new one describing the approach to identify specified requirements,
methods and procedures, rules and methodology for conformity assessment.
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 and
www.iec.ch/national-committees.
© ISO/IEC 2025 – All rights reserved
iv
Introduction
This document provides principles and guidance on how to develop normative documents, such as standards,
technical specifications, codes of practice and regulations, so that they are concise and clear, especially in
the context of any subsequent conformity assessment activity.
Conformity assessment is a demonstration that specified requirements are fulfilled and includes activities
such as assessment, auditing, design review, evaluation, examination, inspection, testing, surveillance,
validation, verification and certification. The methods and procedures for performing such individual
conformity assessment activities can be stated in normative documents. Likewise, normative documents
can state rules and methodology through which approvals, certificates, consents, licenses, labels, markings,
marks of conformity, permissions, reports and other types of statements of conformity are issued.
Normative documents, developed following the principles and guidance in this document, can be suitable for
use in conformity assessment at national, regional or international levels, both in regulated or non-regulated
applications.
Users of this document can also find useful information in the ISO/IEC Directives, ISO/IEC 17060,ISO/IEC 17067
[38]
and the WTO Agreement on Technical Barriers to Trade, Annex 3.
ISO/IEC Directives, Part 2 covers aspects for conformity assessment, mandatory for standards developers in
ISO, IEC and ISO/IEC committees.
This document also includes reference to documents in the domain of conformity assessment, known as
the CASCO toolbox. These are principally the work of CASCO in cooperation with IEC. Reference to these
standards and guides is included to emphasise that they contain internationally agreed, globally applied
provisions covering conformity assessment. Reliance on these standards and guides as requirements for
conformity assessment bodies and accreditation bodies facilitates acceptance of results around the world.
To make this document as usable as possible, technical terminology has been avoided as much as possible.
However, in some cases, the use of some technical terminology is necessary. For example, the requirements
in normative documents can relate to a particular material, product, service, installation, data, information,
process, system, person or body. In the conformity assessment context, these are all examples of an “object
of conformity assessment”.
In the same context, an “object of conformity assessment” or “object” is a generic term used to represent
anything that can fulfil specified requirements. In a normative document suitable for use in conformity
assessment, the term “object of conformity assessment” or “object” would not be used. A normative document
should include a scope which either explicitly or implicitly specifies the related object of conformity
assessment, for example, a type of product, process, service, installation, project, data, design, material,
claim, person, body, organization, management system, conformity assessment body. In this document, the
term “object of conformity assessment” or “object” is used so that this document can be applied regardless
of the specific scope of any normative document.
© ISO/IEC 2025 – All rights reserved
v
FINAL DRAFT International Standard ISO/IEC FDIS 17007:2025(en)
Conformity assessment — Guidance for drafting normative
documents suitable for use for conformity assessment
1 Scope
This document specifies principles and gives guidance for developing normative documents that contain:
— specified requirements for the object of conformity assessment;
— specific methods and procedures for an individual conformity assessment activity (e.g. test methods);
— rules and methodology for conformity assessment (as part of conformity assessment schemes, including
provisions for organizations that perform conformity assessment activities).
This document is intended for the following users:
— standards developers;
— industry associations and consortia;
— purchasers;
— regulatory authorities;
— accreditation bodies;
— conformity assessment bodies;
— conformity assessment scheme owners;
— other interested parties, e.g. insurance organizations;
— consumers and non-governmental groups.
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. Fo
...
ISO/CASCO
Secretariat: ISO
Date: 2025-05-19
Conformity assessment — Guidance for drafting normative
documents suitable for use for conformity assessment
Évaluation de la conformité — Recommandations pour la rédaction de documents normatifs applicables à
l'évaluation de la conformité
FDIS stage
© ISO/IEC 20242025
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
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO #### /IEC 2025 – All rights reserved
ii
Contents
Foreword . iv
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles . 4
4.1 General . 4
4.2 Principle 1: separation of types of provisions . 4
4.3 Principle 2: neutrality towards parties performing conformity assessment activities . 6
4.4 Principle 3: functional approach to conformity assessment . 6
4.5 Principle 4: comparability of conformity assessment results . 7
4.6 Principle 5: good practice in conformity assessment . 7
5 Guidance for the development of normative documents stating specified requirements
for objects of conformity assessment . 7
6 Guidance for the development of normative documents stating specific methods and
procedures for individual conformity assessment activity . 9
7 Guidance for the development of normative documents stating rules and methodology
for conformity assessment . 10
Annex A (informative) The CASCO toolbox . 12
Annex B (informative) Approach to identify specified requirements, methods and procedures,
rules and methodology for conformity assessment . 15
Bibliography . 18
© ISO/IEC 20242025 – All rights reserved
iii
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are members
of ISO or IEC participate in the development of International Standards through technical committees
established by the respective organization to deal with particular fields of technical activity. ISO and IEC
technical committees collaborate in fields of mutual interest. Other international organizations, governmental
and non-governmental, in liaison with ISO and IEC, also take part in the work.
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
document 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 or www.iec.ch/members_experts/refdocs).
ISO and IEC draw attention to the possibility that the implementation of this document may involve the use of
(a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO and IEC had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent database
available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall not be held responsible for
identifying any or all such patent rights.
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.
In the IEC, see www.iec.ch/understanding-standards.
This document was prepared by the ISO Committee on Conformity Assessment (CASCO).
This second edition cancels and replaces the first edition (ISO/IEC 17007:2009), which has been technically
revised.
The main changes are as follows:
— — definitions has been aligned with ISO/IEC 17000:2020 andwith new definitions added;
— 3 categories of provisions in normative documents have been introduced in the Scope and Clause 4—
introduction of the categorization according to three “buckets” in the scope and clause 4; the specified
requirements for the object of conformity assessment; the specific methods and procedures for an
individual conformity assessment activity; and third the rules and methodology for conformity
assessment;
— — reference added to the revised version of ;
— references to ISO/IEC 17067 have been added for content regarding schemes;
— — update of the 5 principles described in Clause 4clause 4; have been updated;
— in Annex A— annex A, an introductory part has been added before the Table A.1Table A1 to describe the
conformity assessment and accreditation bodies specified by the CASCO toolbox; Table A.1 and table A1
has been updated to contain all Toolbox deliverabletoolbox deliverables;
© ISO #### /IEC 2025 – All rights reserved
iv
— Annex B— annex B has been replaced by a new one describing the approach to identify specified
requirements, methods and procedures, rules and methodology for conformity assessment.
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 and www.iec.ch/national-
committees.
© ISO/IEC 20242025 – All rights reserved
v
Introduction
This document provides principles and guidance on how to develop normative documents, such as standards,
technical specifications, codes of practice and regulations, so that they are concise and clear, especially in the
context of any subsequent conformity assessment activity.
Conformity assessment is a demonstration that specified requirements are fulfilled and includes activities
such as assessment, auditing, design review, evaluation, examination, inspection, testing, surveillance,
validation, verification and certification. The methods and procedures for performing such individual
conformity assessment activities can be stated in normative documents. Likewise, normative documents can
state rules and methodology through which approvals, certificates, consents, licenses, labels, markings, marks
of conformity, permissions, reports and other types of statements of conformity are issued.
This document is intended for the following users:
— — standards developers;
— — industry associations and consortia;
— — purchasers;
— — regulatory authorities;
— — consumers and non-governmental groups;
— — accreditation bodies;
— — conformity assessment bodies;
— — conformity assessment scheme owners; and
— — other interested parties, e.g. insurance organizations.
Normative documents, developed following the principles and guidance in this document, can be suitable for
use in conformity assessment at national, regional or international levels, both in regulated or non-regulated
applications.
Users of this document can also find useful information in the ISO/IEC Directives, ISO/IEC
[38[22] ]
17060,ISO/IEC 17067 and the WTO Agreement on Technical Barriers to Trade, , Annex 3.
ISO/IEC Directives, Part 2 covers aspects for conformity assessment, mandatory for standards developers in
ISO, IEC and ISO/IEC committees.
This document also includes reference to documents in the domain of conformity assessment, known as the
CASCO toolbox. These are principally the work of CASCO in cooperation with IEC. Reference to these standards
and guides is included to emphasise that they contain internationally agreed, globally applied provisions
covering conformity assessment. Reliance on these standards and guides as requirements for conformity
assessment bodies and accreditation bodies facilitates acceptance of results around the world.
To make this document as usable as possible, technical terminology has been avoided as much as possible.
However, in some cases, the use of some technical terminology is necessary. For example, the requirements
in normative documents can relate to a particular material, product, service, installation, data, information,
process, system, person or body. In the conformity assessment context, these are all examples of an “object of
conformity assessment”.
© ISO #### /IEC 2025 – All rights reserved
vi
In the same context, an “object of conformity assessment” or “object” is a generic term used to represent
anything that can fulfil specified requirements. In a normative document suitable for use in conformity
assessment, the term “object of conformity assessment” or “object” would not be used. A normative document
should include a scope which either explicitly or implicitly specifies the related object of conformity
assessment, for example, a type of product, process, service, installation, project, data, design, material, claim,
person, body, organization, management system, conformity assessment body, etc. In this document, the term
“object of conformity assessment” or “object” is used so that this document can be applied regardless of the
specific scope of any normative document.
© ISO/IEC 20242025 – All rights reserved
vii
DRAFT International Standard ISO/IEC DIS 17007:2024(en)
Conformity assessment — Guidance for drafting normative
documents suitable for use for conformity assessment
1 Scope
This document specifies principles and gives guidance for developing normative documents that contain:
— — specified requirements for the object of conformity assessment;
— — specific methods and procedures for an individual conformity assessment activity (e.g. test methods);
— — rules and methodology for conformity assessment (as part of conformity assessment schemes,
including provisions for organizations that perform conformity assessment activities).
This document is intended for the following users:
— This document is intended for use by standards developers, ;
— industry associations and consortia, ;
— purchasers, ;
— regulatory authorities, ;
— accreditation bodies, ;
— conformity assessment bodies, ;
— conformity assessment scheme owners, and ;
— other interested parties, such ase.g. insurance organizations, ;
— consumers and non-governmental groups.
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/IEC 17000:2020, Conformity assessment — Vocabulary and general principles
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC 17000 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— — ISO Online browsing platform: available at https://www.iso.org/obp
© ISO/IEC 2024 – All rights reserved
— — IEC Electropedia: available at https://www.electropedia.org/
3.1 3.1
specified requirement
need or expectation that is stated
Note 1 to entry: Specified requirements can be stated in normative documents (3.2(3.2).).
Note 2 to entry: Specified requirements can be detailed or general.
[SOURCE: ISO/IEC 17000:2020, 5.1, modified — Examples of normative documents have been removed from
note 1 to entry.]
3.2 3.2
normative document
document that provides:
a) a) specified requirements (3.1(3.1)) for the object of conformity assessment (3.3(3.3););
b) b) specific methods and procedures for an individual conformity assessment ac
...
PROJET FINAL
Norme
internationale
ISO/CASCO
Évaluation de la conformité —
Secrétariat: ISO
Recommandations pour la
Début de vote:
rédaction de documents normatifs
2025-08-07
applicables à l'évaluation de la
Vote clos le:
conformité
2025-10-02
Conformity assessment — Guidance for drafting normative
documents suitable for use for conformity assessment
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
Ce projet est soumis à un vote parallèle à ISO et à IEC.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
PROJET FINAL
Norme
internationale
ISO/CASCO
Évaluation de la conformité —
Secrétariat: ISO
Recommandations pour la
Début de vote:
rédaction de documents normatifs
2025-08-07
applicables à l'évaluation de la
Vote clos le:
conformité
2025-10-02
Conformity assessment — Guidance for drafting normative
documents suitable for use for conformity assessment
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
Ce projet est soumis à un vote parallèle à ISO et à IEC.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
© ISO/IEC 2025
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
PROJETS DE NORMES
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
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
Numéro de référence
© ISO/IEC 2025 – Tous droits réservés
ii
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Principes . 4
4.1 Généralités .4
4.2 Principe 1: séparation des types de dispositions .4
4.3 Principe 2: neutralité à l’égard des parties qui réalisent les activités d’évaluation de la
conformité .6
4.4 Principe 3: approche fonctionnelle de l’évaluation de la conformité .6
4.5 Principe 4: comparabilité des résultats de l’évaluation de la conformité .7
4.6 Principe 5: bonnes pratiques en matière d’évaluation de la conformité .7
5 Recommandations relatives à l’élaboration de documents normatifs formulant les
exigences spécifiées pour des objets de l’évaluation de la conformité . 8
6 Recommandations relatives à l’élaboration de documents normatifs précisant des
méthodes et des procédures spécifiques pour l’activité d’évaluation de la conformité .10
7 Recommandations relatives à l’élaboration de documents normatifs indiquant des
règles et une méthodologie pour l’évaluation de la conformité .11
Annexe A (informative) La boîte à outils CASCO .13
Annexe B (informative) Approche permettant d’identifier les exigences spécifiées, les méthodes
et procédures, les règles et la méthodologie en matière d’évaluation de la conformité.16
Bibliographie . 19
© ISO/IEC 2025 – Tous droits réservés
iii
Avant-propos
L’ISO (Organisation internationale de normalisation) et l’IEC (Commission électrotechnique internationale)
forment le système spécialisé de la normalisation mondiale. Les organismes nationaux membres de l’ISO ou
de l’IEC participent au développement de Normes internationales par l’intermédiaire des comités techniques
créés par l’organisation concernée afin de s’occuper des domaines particuliers de l’activité technique.
Les comités techniques de l’ISO et de l’IEC collaborent dans des domaines d’intérêt commun. D’autres
organisations internationales, gouvernementales et non gouvernementales, en liaison avec l’ISO et l’IEC,
participent également aux travaux.
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. Le présent document a été rédigé conformément
aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www.iso.org/directives ou
www.iec.ch/members_experts/refdocs).
L’ISO et l’IEC attirent l’attention sur le fait que la mise en application du présent document peut entraîner
l’utilisation d’un ou de plusieurs brevets. L’ISO et l’IEC ne prennent pas position quant à la preuve, à la validité
et à l’applicabilité de tout droit de propriété revendiqué à cet égard. À la date de publication du présent
document, l’ISO et l’IEC n’avaient pas reçu notification qu’un ou plusieurs brevets pouvaient être nécessaires
à sa mise en application. Toutefois, il y a lieu d’avertir les responsables de la mise en application du présent
document que des informations plus récentes sont susceptibles de figurer dans la base de données de
brevets, disponible à l’adresse www.iso.org/brevets et https://patents.iec.ch. L’ISO et l’IEC ne sauraient être
tenues pour responsables de ne pas avoir identifié tout ou partie de tels droits de propriété.
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/iso/fr/avant-propos.html. Pour l’IEC, voir www.iec.ch/understanding-standards.
Le présent document a été élaboré par le comité ISO pour l’évaluation de la conformité (CASCO).
Cette deuxième édition annule et remplace la première édition (ISO/IEC 17007:2009), qui a fait l’objet d’une
révision technique.
Les principales modifications sont les suivantes:
— les définitions ont été alignées sur l’ISO/IEC 17000:2020 et de nouvelles définitions ont été ajoutées;
— 3 catégories de dispositions dans les documents normatifs ont été introduites dans le domaine
d’application et à l’Article 4;
— des références à l’ISO/IEC 17067 ont été ajoutées pour le contenu concernant les systèmes particuliers;
— les 5 principes décrits à l’Article 4 ont été mis à jour;
— dans l’Annexe A, une partie introductive a été ajoutée avant le Tableau A.1 pour décrire les organismes
d’évaluation de la conformité et les organismes d’accréditation spécifiés par la boîte à outils CASCO; le
Tableau A.1 a été mis à jour pour contenir tous les livrables de la boîte à outils;
— l’Annexe B a été remplacée par une nouvelle annexe décrivant l’approche permettant d’identifier les
exigences spécifiées, les méthodes et procédures, les règles et la méthodologie en matière d’évaluation
de la conformité.
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 et www.iec.ch/national-committees.
© ISO/IEC 2025 – Tous droits réservés
iv
Introduction
Le présent document fournit des principes et des recommandations concernant la rédaction de documents
normatifs, tels que les normes, les spécifications techniques, les codes de bonne pratique et les règlements, de
manière claire et concise, plus particulièrement dans le contexte des activités d’évaluation de la conformité
ultérieures.
L’évaluation de la conformité permet de démontrer que les exigences spécifiées sont satisfaites et inclut
des activités telles que les évaluations, l’audit, la revue de conception, l’examen, l’inspection, les essais, la
surveillance, la validation, la vérification et la certification. Les méthodes et procédures pour réaliser ces
activités individuelles d’évaluation de la conformité peuvent être formulées dans des documents normatifs.
De même, les documents normatifs peuvent formuler des règles et une méthodologie permettant de délivrer
des homologations, des certificats, des consentements, des licences, des labels, des marquages, des marques
de conformité, des autorisations, des rapports et d’autres types de déclarations de conformité.
Les documents normatifs, élaborés conformément aux principes et aux recommandations du présent
document, peuvent être utilisés dans l’évaluation de la conformité aux niveaux national, régional ou
international et dans des applications réglementées ou non.
Les utilisateurs du présent document peuvent également trouver des informations utiles dans les Directives
[38]
ISO/IEC, l’ISO/IEC 17060, l’ISO/IEC 17067 et l’Accord sur les obstacles techniques au commerce de l’OMC ,
Annexe 3.
Les Directives ISO/IEC, Partie 2 traitent d’aspects relatifs à l’évaluation de la conformité, obligatoires pour
les rédacteurs de normes de l’ISO, de l’IEC et des comités ISO/IEC.
Le présent document inclut également une référence à des documents propres au domaine de l’évaluation
de la conformité, formant la «boîte à outils CASCO». Ces documents sont principalement élaborés par le
CASCO en coopération avec l’IEC. Une référence à ces normes et guides est incluse pour insister sur le fait
qu’ils contiennent des dispositions acceptées internationalement et appliquées au niveau mondial traitant
de l’évaluation de la conformité. Le recours à ces normes et guides en tant qu’exigences pour les organismes
d’évaluation de la conformité et les organismes d’accréditation facilite l’acceptation des résultats dans le
monde entier.
Afin de faciliter l’utilisation du présent document, la terminologie technique a été évitée autant que possible.
Toutefois, dans certains cas, le recours à des termes techniques est nécessaire. Par exemple, les exigences
dans les documents normatifs peuvent concerner un matériau, un produit, un service, une installation, des
données, des informations, un processus, un système, une personne ou un organisme particuliers. Dans le
contexte de l’évaluation de la conformité, ces derniers sont tous des exemples d’«objet de l’évaluation de la
conformité».
Dans le même contexte, un «objet de l’évaluation de la conformité» ou «objet» est un terme générique utilisé
pour représenter tout ce qui peut répondre aux exigences spécifiées. Dans un document normatif applicable
à l’évaluation de la conformité, le terme «objet de l’évaluation de la conformité» ou «objet» ne serait pas
utilisé. Il convient qu’un document normatif comprenne un domaine d’application qui spécifie explicitement
ou implicitement l’objet de l’évaluation de la conformité concerné, par exemple, un type de produit, de
processus, de service, d’installation, de projet, de données, de conception, de m
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