SIST ISO/IEC Vodilo 59:2023
(Main)ISO and IEC recommended practices for standardization by national bodies
ISO and IEC recommended practices for standardization by national bodies
This document provides recommended standardization practices that are intended to support the application of the following:
— the WTO TBT Committee decision on principles for the development of international standards, guides and recommendations (G/TBT/9, 13 November 2000);
— the WTO TBT Agreement's Code of Good Practice for the Preparation, Adoption and Application of Standards (Annex 3 of the 1995 WTO TBT Agreement).
This document is intended to be used by the national members of ISO and IEC, hereafter referred to as national bodies.
Pratiques de normalisation recommandées par l'ISO et l'IEC à leurs organismes nationaux
Le présent document fournit des pratiques de normalisation recommandées, destinées à aider dans l'application des documents suivants:
— la décision du Comité OTC de l'OMC sur les principes devant régir l'élaboration de normes, guides et recommandations internationaux (G/TBT/9, 13 novembre 2000);
— le Code de pratique du comité OTC de l'OMC pour l'élaboration, l'adoption et l'application des normes (Annexe 3 de l'Accord OTC de l'OMC, 1995).
Le présent document est destiné à être utilisé par les membres nationaux de l'ISO et de l'IEC, ci-après désignés en tant qu'organismes nationaux.
Priporočene prakse ISO in IEC za standardizacijo, ki jo izvajo nacionalni organi
Ta dokument podaja priporočene prakse za standardizacijo, ki so namenjene za podporo:
– odločitve Odbora za tehnične ovire v trgovini (TBT) v okviru Svetovne trgovinske organizacije (WTO) o načelih za razvoj mednarodnih standardov, smernic in priporočil (G/TBT/9, 13. november 2000);
– Kodeksa dobrih navad za pripravo, sprejetje in uporabo standardov iz Sporazuma o tehničnih ovirah v trgovini (dodatek 3 Sporazuma o tehničnih ovirah v trgovini iz leta 1995).
Ta dokument je namenjen nacionalnim članom ISO in IEC (v nadaljevanju: »nacionalni organi«).
General Information
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Buy Standard
Standards Content (Sample)
SLOVENSKI STANDARD
SIST ISO/IEC Vodilo 59:2023
01-marec-2023
Nadomešča:
SIST ISO/IEC Vodilo 59:1997
Priporočene prakse ISO in IEC za standardizacijo, ki jo izvajo nacionalni organi
ISO and IEC recommended practices for standardization by national bodies
Pratiques de normalisation recommandées par l'ISO et l'IEC à leurs organismes
nationaux
Ta slovenski standard je istoveten z: ISO/IEC Guide 59:2019
ICS:
01.120 Standardizacija. Splošna Standardization. General
pravila rules
SIST ISO/IEC Vodilo 59:2023 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST ISO/IEC Vodilo 59:2023
GUIDE 59
Second edition
2019-08
ISO and IEC recommended practices
for standardization by national bodies
Pratiques de normalisation recommandées par l'ISO et l'IEC à leurs
organismes nationaux
Reference number
ISO/IEC GUIDE 59:2019(E)
©
ISO/IEC 2019
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SIST ISO/IEC Vodilo 59:2023
ISO/IEC GUIDE 59:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2019
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/IEC 2019 – All rights reserved
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Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Guidance with respect to the implementation of the principles of standards development 3
4.1 General . 3
4.2 Transparency . 3
4.3 Openness . 4
4.4 Impartiality and consensus . 5
4.5 Effectiveness and relevance . 7
4.6 Coherence . 8
4.7 Development dimension . 9
5 Guidance with respect to the implementation of the WTO TBT Agreement’s Code of
Good Practice for the Preparation, Adoption and Application of Standards .9
5.1 General . 9
5.2 Notification of acceptance of/withdrawal from the Code of Good Practice . 9
5.3 Non-discrimination principle . 9
5.4 Avoidance of unnecessary barriers to trade . 9
5.5 Using ISO and IEC standards as a basis for national standards .10
5.6 Playing a full part in the development of ISO and IEC standards .10
5.7 Avoiding duplication of work .10
5.8 Specifying standards based on performance requirements .10
5.9 Standards work programme .11
5.10 Submission of comments on the draft standard by stakeholders .11
5.11 Publishing of standards .11
5.12 Procedure for appeals .12
Annex A (informative) Principles for the development of international standards, guides
and recommendations .13
Annex B (informative) Participant categories .16
Annex C (informative) Forms related to the WTO TBT Agreement’s Code of Good Practice
for the Preparation, Adoption and Application of Standards .17
Bibliography .18
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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).
Attention is drawn to the possibility that some of the elements of this document may be the subject
of patent rights. ISO and IEC 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) or the IEC
list of patent declarations received (see http: //patents .iec .ch).
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 a Joint Working Group of the ISO Technical Management Board and the
IEC Standards Management Board.
This second edition cancels and replaces the first edition (ISO/IEC Guide 59:1994), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— the structure, content and language used have been updated to allow easier application;
— a scope has been added to define the subject of the document and the aspects covered, thereby
indicating the limits of applicability of the document;
— Clauses 4 and 5 have been added to support the implementation of the WTO TBT agreement.
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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Introduction
Standardization brings technological, economic and societal benefits. Standards help to harmonize
technical and other specifications of products and services making industry more efficient and
removing barriers to trade.
Standards are considered an essential component of the “quality infrastructure”, the system comprising
organizations (public and private), policies, relevant legal and regulatory framework and practices
which is needed to support and enhance the quality, safety, and sustainable soundness of goods,
services and processes.
Standards are developed by many bodies, at the national, regional and international levels. Alongside
the growth of international trade, technological and societal cooperation, standards bodies have
developed procedures and modes of cooperation which are commonly considered to constitute good
practices for standards development at all levels. The use of standards is voluntary unless they are
cited as requirements in legislation or in legal contracts.
The foundations of ISO’s and IEC’s membership and participation models are at the national level. ISO
and IEC, together with their national bodies, are responsible for fostering and ensuring coherence and
coordination.
The ISO and IEC system for standardization is based on collaboration agreements between ISO and IEC
and an extensive array of collaboration agreements among regional, national and other standards bodies.
The WTO TBT agreement has provided a framework to facilitate international trade through
international standards. ISO and IEC are committed to the implementation of the WTO TBT framework
when developing International Standards (see Annex A). The national bodies should set guidelines to
define their organizational culture, which consists of the values, beliefs, attitudes and behaviour that
their national experts should share and use regularly in their work. ISO and IEC have developed and
apply Codes of Conduct to be followed by participants in standardization work. These Codes of Conduct
include responsibilities to consider:
— inclusiveness;
— consensus-building attitude and skills;
— compliance with the procedures;
— efficiency;
— impartiality;
— commitment to quality;
— dedication of personnel and experts.
International deliverables other than International Standards can perform similar functions in
reducing technical barriers to trade and thereby facilitating trade. Information about other deliverables
published by ISO and/or IEC can be found in the ISO/IEC Directives, Part 1.
The first edition of this document predated the existence of both the WTO TBT Committee decision on
principles for the development of international standards, guides and recommendations (G/TBT/9, 13
November 2000) and the WTO TBT Agreement’s Code of Good Practice for the Preparation, Adoption
and Application of Standards (Annex 3 of the 1995 WTO TBT agreement). The purpose of this edition
of this document is to provide recommendations for implementing good standardization practices that
are intended to support, but do not replace or supersede, the two WTO TBT Committee documents.
This document does not constitute an official interpretation of the two WTO TBT documents cited above.
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GUIDE ISO/IEC GUIDE 59:2019(E)
ISO and IEC recommended practices for standardization by
national bodies
1 Scope
This document provides recommended standardization practices that are intended to support the
application of the following:
— the WTO TBT Committee decision on principles for the development of international standards,
guides and recommendations (G/TBT/9, 13 November 2000);
— the WTO TBT Agreement’s Code of Good Practice for the Preparation, Adoption and Application of
Standards (Annex 3 of the 1995 WTO TBT Agreement).
This document is intended to be used by the national members of ISO and IEC, hereafter referred to as
national bodies.
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 Guide 2, Standardization and related activities — General vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 2 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
basic standard
standard (3.8) that has a wide-ranging coverage or contains general provisions for one particular field
Note 1 to entry: A basic standard may function as a standard for direct application or as a basis for other
standards.
[SOURCE: ISO/IEC Guide 2:2004, 5.1]
3.2
consensus
general agreement, characterized by the absence of sustained opposition to substantial issues by any
important part of the concerned interests and by a process that involves seeking to take into account
the views of all parties concerned and to reconcile any conflicting arguments
Note 1 to entry: Consensus need not imply unanimity.
[SOURCE: ISO/IEC Guide 2:2004, 1.7]
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3.3
current version
status assigned by a national body (3.6) to a normative document at the time of publication, or to a draft
at the time of issue, and which remains in effect until withdrawal or being superseded
Note 1 to entry: The status “current” does not indicate the validity or non-validity of a normative document.
Note 2 to entry: A standard (3.8) can be either a current version or a historical version (3.4).
3.4
historical version
status assigned by a national body (3.6) to a normative document or draft at the time of withdrawal or
being superseded
Note 1 to entry: The status “historical” does not indicate the validity or non-validity of a normative document.
Note 2 to entry: A standard (3.8) can be either a current version (3.3) or a historical version.
3.5
stakeholder
organization, company, public entity or individual that can affect, be affected by or perceive itself to be
affected by a decision or activity coming from a standardization process or its deliverables
Note 1 to entry: In English, the term "stakeholder" is equivalent to "interested party".
3.6
national body
ISO member body or IEC National Committee
Note 1 to entry: This term refers to any current or future ISO member body or IEC National Committee that
develops national standards (3.8).
3.7
participant
stakeholder (3.5) that becomes involved in the standards (3.8) development process
3.8
standard
document, established by consensus (3.2) and approved by a recognized body, that provides, for
common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at
the achievement of the optimum degree of order in a given context
Note 1 to entry: Standards should be based on the consolidated results of science, technology and experience,
and aimed at the promotion of optimum community benefits.
[SOURCE: ISO/IEC Guide 2:2004, 3.2]
3.9
standardization
activity of establishing, with regard to actual or potential problems, provisions for common and
repeated use, aimed at the achievement of the optimum degree of order in a given context
Note 1 to entry: In particular, the activity consists of the processes of formulating, issuing and implementing
standards (3.8).
Note 2 to entry: Important benefits of standardization are improvement of the suitability of products, processes
and services for their intended purposes, prevention of barriers to trade and facilitation of technological
cooperation.
[SOURCE: ISO/IEC Guide 2:2004, 1.1]
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3.10
withdrawn standard
standard (3.8) that has been discontinued by the publishing standards developer following consultation
with its responsible committee, because it no longer represents the most current, reliable and/or
available technical information
3.11
superseded standard
standard (3.8) that has been replaced with a newer version of the same standard, or by a suitable other
standard that contains the most current, reliable and/or available technical information
4 Guidance with respect to the implementation of the principles of standards
development
4.1 General
This clause provides guidance to support the application of the WTO TBT Committee decision on
principles for the development of international standards, guides and recommendations (G/TBT/9, 13
November 2000).
The development of consensus-based standards is a process that, at the national level, consists of
several distinct, but closely related activities.
— The first phase is the identification of the need for a standard, followed by prioritization of the work
required to develop the standard based on the available resources.
— The second phase is the development of the standard, usually in a committee, taking into account all
stakeholders concerned at the national level.
— The third phase is the open consultation to allow for public input and consideration of comments
received by the committee during public consultation.
— The fourth phase corresponds to the approval of the standard.
— The last phase is the publication, promotion and maintenance of the standard.
The recommendations given in 4.2 to 4.7 should be followed when national bodies are developing
standards or contributing to international standardization work. These recommendations are aligned
with the WTO TBT Committee decision on principles for the development of international standards,
guides and recommendations (see Annex A).
4.2 Transparency
4.2.1 Transparency implies that sufficient and regularly updated information is easily accessible in due
time to allow all stakeholders to participate in the standardization process if they want to. Procedures
should be established so that adequate time and opportunities are provided for the submission of written
comments. Information on these procedures should be effectively disseminated.
4.2.2 The national body should have appropriately documented procedures to support its standards
management and development processes. These procedures should be up to date and freely available to
any stakeholder.
4.2.3 When a new standard is proposed, the national body should make this information publicly
available at an early stage in the standards development process, so that stakeholders can follow or
take an active part in the process as participants. A brief description of the scope of the draft standard,
including its objective and rationale should be provided. The notice used to communicate this proposal
should be clear and easily understood by all stakeholders.
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4.2.4 Participants should receive all draft documents and should be informed of the action taken on
any comments they have made relating to drafts.
4.2.5 Once consensus is reached and the draft standard is ready for open consultation, it should be
made available to stakeholders. At least 60 days should be provided to allow stakeholders the opportunity
to submit written comments. This period may, however, be shortened in cases where urgent problems of
safety, health or environment should be addressed. A clear and well-understood procedure should be in
place for the management of these comments (see 5.10).
4.2.6 Information on current versions of standards as well as on historical and withdrawn standards
should be made available by adequate means such as via websites, subscriptions, etc.
4.2.7 The national body should make an up-to-date work programme available publicly. The standards
work programme should contain relevant information, as described in 5.9.
4.3 Openness
4.3.1 Participation in standards development should be open via the national body at all stages of
the standards development process on a non-discriminatory basis to all stakeholders. This includes
participation at every stage of standards development, such as the following:
— proposal and acceptance of new work items;
— technical discussion on proposals;
— submission of comments on drafts;
— review of existing standards;
— resolution of comments and approval of standards;
— availability of approved standards.
4.3.2 National bodies should facilitate the participation of a range of stakeholders appropriate to each
standard under development. Participation should be inclusive and not impose undue membership
barriers.
4.3.3 The national body should promote and enable the involvement of all stakeholders, including
those potentially under-represented, such as small and medium-sized enterprises and representatives
of societal interests. National bodies can consider putting in place awareness-raising activities, as well as
procedures for monitoring the participation of different categories of stakeholders.
4.3.4 The national body should promote its commitment to openness by maintaining and making
publicly available its standards development procedures, which address issues such as conditions for
participation (e.g. membership, participation fees, waiver provisions, copyright, intellectual property
rights and privacy obligations).
4.3.5 The national body should provide advance notice of standards development meetings, and it
should ensure availability of meeting agendas and documents prior to the meeting, according to specified
timeframes.
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4.4 Impartiality and consensus
4.4.1 Impartiality should be accorded throughout the standards development process with respect to
the following (among other things):
— access to participation in work;
— submission of comments on drafts;
— consideration of views expressed and comments made;
— decision-making through consensus;
— obtaining information and documents;
— availability of draft and approved standards;
— adopting an ISO or IEC standard as a regional or national standard;
— revision of the standard.
4.4.2 When addressing consensus and impartiality, the national body should provide an impartial and
neutral platform for its standards development work, with equal access for all participants. The work is
expected to be conducted in a consensual and impartial manner, where no party is favoured over another
(see 4.4.5). No one organization or participant category should dominate the standards development
process. Furthermore, the national body should examine its governance structure, which should support
neutrality with respect to the representation of specific private or public interests across all its relevant
governing bodies.
4.4.3 The national body should have a standardization process that remains collaborative and
consensus-based, and that takes into account all views expressed and brings together diverging opinions.
4.4.4 The national body should assist its participants and those in leadership positions (such as the
committee chair) in building consensus. For this, the good practices below are recommended.
a) Promoting the right attitude
The national body should invite the participants involved to cooperate fully and in good faith in the
standardization work.
b) Dealing with objections
In the process of reaching consensus, many different points of views will be expressed and
addressed as the document evolves. However, “sustained opposition” constitutes views expressed
and maintained by an important part of the stakeholders and which are incompatible with the
committee decision. Those expressing sustained opposition have a right to be heard and the
following approach is recommended when sustained opposition is declared.
— The leadership should first assess whether the opposition constitutes sustained opposition, If
this is not the case, the leadership may register the opposition (e.g. in the minutes) and continue
to lead the work on the document.
— If the leadership determines that there is sustained opposition, it should try to resolve it in good
faith. However, sustained opposition cannot be interpreted as a right to veto. The obligation
to address the sustained opposition does not imply an obligation to successfully resolve it.
The responsibility for assessing whether or not consensus has been reached rests with the
leadership. This includes assessing whether there is sustained opposition or whether any
sustained opposition can be resolved without compromising the existing level of consensus on
the rest of the document. In such cases, the leadership will register the opposition and continue
the work.
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— In all cases, the national body is expected to demonstrate efforts to identify solutions that
resolve any sustained opposition, while considering the interests of all participants.
— Those maintaining sustained opposition and who are dissatisfied with the process or the
outcome may make use of appeals mechanisms (see 5.12).
c) Achieving consensus rather than voting
The national body should take decisions in accordance with the consensus principle to the extent
possible. Formal voting should only be used under specific conditions and when the voting process
has been detailed in established procedures.
d) Documenting decisions
It is good practice to document the standpoints expressed with rationales, including any sustained
opposition, the decisions taken, the actions launched and, if necessary, the initiatives taken to reach
consensus.
4.4.5 The national body should protect the standards development process, ensuring its integrity,
avoiding taking a technical position on the standards under consideration, and keeping an impartial
and independent position by providing the opportunity for representation by an appropriate balance of
interests in the standards development process.
It is good practice to categorize stakeholders and participants according to broad areas of interest.
Annex B gives an example of the participant categories. The relevance of the various participant
categories should be assessed taking account of the standard under development. Not all categories are
relevant to all standards projects.
The national body’s rules should grant the same rights to all part
...
GUIDE 59
Second edition
2019-08
ISO and IEC recommended practices
for standardization by national bodies
Pratiques de normalisation recommandées par l'ISO et l'IEC à leurs
organismes nationaux
Reference number
ISO/IEC GUIDE 59:2019(E)
©
ISO/IEC 2019
---------------------- Page: 1 ----------------------
ISO/IEC GUIDE 59:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2019
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/IEC 2019 – All rights reserved
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ISO/IEC GUIDE 59:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Guidance with respect to the implementation of the principles of standards development 3
4.1 General . 3
4.2 Transparency . 3
4.3 Openness . 4
4.4 Impartiality and consensus . 5
4.5 Effectiveness and relevance . 7
4.6 Coherence . 8
4.7 Development dimension . 9
5 Guidance with respect to the implementation of the WTO TBT Agreement’s Code of
Good Practice for the Preparation, Adoption and Application of Standards .9
5.1 General . 9
5.2 Notification of acceptance of/withdrawal from the Code of Good Practice . 9
5.3 Non-discrimination principle . 9
5.4 Avoidance of unnecessary barriers to trade . 9
5.5 Using ISO and IEC standards as a basis for national standards .10
5.6 Playing a full part in the development of ISO and IEC standards .10
5.7 Avoiding duplication of work .10
5.8 Specifying standards based on performance requirements .10
5.9 Standards work programme .11
5.10 Submission of comments on the draft standard by stakeholders .11
5.11 Publishing of standards .11
5.12 Procedure for appeals .12
Annex A (informative) Principles for the development of international standards, guides
and recommendations .13
Annex B (informative) Participant categories .16
Annex C (informative) Forms related to the WTO TBT Agreement’s Code of Good Practice
for the Preparation, Adoption and Application of Standards .17
Bibliography .18
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ISO/IEC GUIDE 59:2019(E)
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject
of patent rights. ISO and IEC 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) or the IEC
list of patent declarations received (see http: //patents .iec .ch).
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 a Joint Working Group of the ISO Technical Management Board and the
IEC Standards Management Board.
This second edition cancels and replaces the first edition (ISO/IEC Guide 59:1994), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— the structure, content and language used have been updated to allow easier application;
— a scope has been added to define the subject of the document and the aspects covered, thereby
indicating the limits of applicability of the document;
— Clauses 4 and 5 have been added to support the implementation of the WTO TBT agreement.
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/IEC 2019 – All rights reserved
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ISO/IEC GUIDE 59:2019(E)
Introduction
Standardization brings technological, economic and societal benefits. Standards help to harmonize
technical and other specifications of products and services making industry more efficient and
removing barriers to trade.
Standards are considered an essential component of the “quality infrastructure”, the system comprising
organizations (public and private), policies, relevant legal and regulatory framework and practices
which is needed to support and enhance the quality, safety, and sustainable soundness of goods,
services and processes.
Standards are developed by many bodies, at the national, regional and international levels. Alongside
the growth of international trade, technological and societal cooperation, standards bodies have
developed procedures and modes of cooperation which are commonly considered to constitute good
practices for standards development at all levels. The use of standards is voluntary unless they are
cited as requirements in legislation or in legal contracts.
The foundations of ISO’s and IEC’s membership and participation models are at the national level. ISO
and IEC, together with their national bodies, are responsible for fostering and ensuring coherence and
coordination.
The ISO and IEC system for standardization is based on collaboration agreements between ISO and IEC
and an extensive array of collaboration agreements among regional, national and other standards bodies.
The WTO TBT agreement has provided a framework to facilitate international trade through
international standards. ISO and IEC are committed to the implementation of the WTO TBT framework
when developing International Standards (see Annex A). The national bodies should set guidelines to
define their organizational culture, which consists of the values, beliefs, attitudes and behaviour that
their national experts should share and use regularly in their work. ISO and IEC have developed and
apply Codes of Conduct to be followed by participants in standardization work. These Codes of Conduct
include responsibilities to consider:
— inclusiveness;
— consensus-building attitude and skills;
— compliance with the procedures;
— efficiency;
— impartiality;
— commitment to quality;
— dedication of personnel and experts.
International deliverables other than International Standards can perform similar functions in
reducing technical barriers to trade and thereby facilitating trade. Information about other deliverables
published by ISO and/or IEC can be found in the ISO/IEC Directives, Part 1.
The first edition of this document predated the existence of both the WTO TBT Committee decision on
principles for the development of international standards, guides and recommendations (G/TBT/9, 13
November 2000) and the WTO TBT Agreement’s Code of Good Practice for the Preparation, Adoption
and Application of Standards (Annex 3 of the 1995 WTO TBT agreement). The purpose of this edition
of this document is to provide recommendations for implementing good standardization practices that
are intended to support, but do not replace or supersede, the two WTO TBT Committee documents.
This document does not constitute an official interpretation of the two WTO TBT documents cited above.
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GUIDE ISO/IEC GUIDE 59:2019(E)
ISO and IEC recommended practices for standardization by
national bodies
1 Scope
This document provides recommended standardization practices that are intended to support the
application of the following:
— the WTO TBT Committee decision on principles for the development of international standards,
guides and recommendations (G/TBT/9, 13 November 2000);
— the WTO TBT Agreement’s Code of Good Practice for the Preparation, Adoption and Application of
Standards (Annex 3 of the 1995 WTO TBT Agreement).
This document is intended to be used by the national members of ISO and IEC, hereafter referred to as
national bodies.
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 Guide 2, Standardization and related activities — General vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 2 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
basic standard
standard (3.8) that has a wide-ranging coverage or contains general provisions for one particular field
Note 1 to entry: A basic standard may function as a standard for direct application or as a basis for other
standards.
[SOURCE: ISO/IEC Guide 2:2004, 5.1]
3.2
consensus
general agreement, characterized by the absence of sustained opposition to substantial issues by any
important part of the concerned interests and by a process that involves seeking to take into account
the views of all parties concerned and to reconcile any conflicting arguments
Note 1 to entry: Consensus need not imply unanimity.
[SOURCE: ISO/IEC Guide 2:2004, 1.7]
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3.3
current version
status assigned by a national body (3.6) to a normative document at the time of publication, or to a draft
at the time of issue, and which remains in effect until withdrawal or being superseded
Note 1 to entry: The status “current” does not indicate the validity or non-validity of a normative document.
Note 2 to entry: A standard (3.8) can be either a current version or a historical version (3.4).
3.4
historical version
status assigned by a national body (3.6) to a normative document or draft at the time of withdrawal or
being superseded
Note 1 to entry: The status “historical” does not indicate the validity or non-validity of a normative document.
Note 2 to entry: A standard (3.8) can be either a current version (3.3) or a historical version.
3.5
stakeholder
organization, company, public entity or individual that can affect, be affected by or perceive itself to be
affected by a decision or activity coming from a standardization process or its deliverables
Note 1 to entry: In English, the term "stakeholder" is equivalent to "interested party".
3.6
national body
ISO member body or IEC National Committee
Note 1 to entry: This term refers to any current or future ISO member body or IEC National Committee that
develops national standards (3.8).
3.7
participant
stakeholder (3.5) that becomes involved in the standards (3.8) development process
3.8
standard
document, established by consensus (3.2) and approved by a recognized body, that provides, for
common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at
the achievement of the optimum degree of order in a given context
Note 1 to entry: Standards should be based on the consolidated results of science, technology and experience,
and aimed at the promotion of optimum community benefits.
[SOURCE: ISO/IEC Guide 2:2004, 3.2]
3.9
standardization
activity of establishing, with regard to actual or potential problems, provisions for common and
repeated use, aimed at the achievement of the optimum degree of order in a given context
Note 1 to entry: In particular, the activity consists of the processes of formulating, issuing and implementing
standards (3.8).
Note 2 to entry: Important benefits of standardization are improvement of the suitability of products, processes
and services for their intended purposes, prevention of barriers to trade and facilitation of technological
cooperation.
[SOURCE: ISO/IEC Guide 2:2004, 1.1]
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ISO/IEC GUIDE 59:2019(E)
3.10
withdrawn standard
standard (3.8) that has been discontinued by the publishing standards developer following consultation
with its responsible committee, because it no longer represents the most current, reliable and/or
available technical information
3.11
superseded standard
standard (3.8) that has been replaced with a newer version of the same standard, or by a suitable other
standard that contains the most current, reliable and/or available technical information
4 Guidance with respect to the implementation of the principles of standards
development
4.1 General
This clause provides guidance to support the application of the WTO TBT Committee decision on
principles for the development of international standards, guides and recommendations (G/TBT/9, 13
November 2000).
The development of consensus-based standards is a process that, at the national level, consists of
several distinct, but closely related activities.
— The first phase is the identification of the need for a standard, followed by prioritization of the work
required to develop the standard based on the available resources.
— The second phase is the development of the standard, usually in a committee, taking into account all
stakeholders concerned at the national level.
— The third phase is the open consultation to allow for public input and consideration of comments
received by the committee during public consultation.
— The fourth phase corresponds to the approval of the standard.
— The last phase is the publication, promotion and maintenance of the standard.
The recommendations given in 4.2 to 4.7 should be followed when national bodies are developing
standards or contributing to international standardization work. These recommendations are aligned
with the WTO TBT Committee decision on principles for the development of international standards,
guides and recommendations (see Annex A).
4.2 Transparency
4.2.1 Transparency implies that sufficient and regularly updated information is easily accessible in due
time to allow all stakeholders to participate in the standardization process if they want to. Procedures
should be established so that adequate time and opportunities are provided for the submission of written
comments. Information on these procedures should be effectively disseminated.
4.2.2 The national body should have appropriately documented procedures to support its standards
management and development processes. These procedures should be up to date and freely available to
any stakeholder.
4.2.3 When a new standard is proposed, the national body should make this information publicly
available at an early stage in the standards development process, so that stakeholders can follow or
take an active part in the process as participants. A brief description of the scope of the draft standard,
including its objective and rationale should be provided. The notice used to communicate this proposal
should be clear and easily understood by all stakeholders.
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4.2.4 Participants should receive all draft documents and should be informed of the action taken on
any comments they have made relating to drafts.
4.2.5 Once consensus is reached and the draft standard is ready for open consultation, it should be
made available to stakeholders. At least 60 days should be provided to allow stakeholders the opportunity
to submit written comments. This period may, however, be shortened in cases where urgent problems of
safety, health or environment should be addressed. A clear and well-understood procedure should be in
place for the management of these comments (see 5.10).
4.2.6 Information on current versions of standards as well as on historical and withdrawn standards
should be made available by adequate means such as via websites, subscriptions, etc.
4.2.7 The national body should make an up-to-date work programme available publicly. The standards
work programme should contain relevant information, as described in 5.9.
4.3 Openness
4.3.1 Participation in standards development should be open via the national body at all stages of
the standards development process on a non-discriminatory basis to all stakeholders. This includes
participation at every stage of standards development, such as the following:
— proposal and acceptance of new work items;
— technical discussion on proposals;
— submission of comments on drafts;
— review of existing standards;
— resolution of comments and approval of standards;
— availability of approved standards.
4.3.2 National bodies should facilitate the participation of a range of stakeholders appropriate to each
standard under development. Participation should be inclusive and not impose undue membership
barriers.
4.3.3 The national body should promote and enable the involvement of all stakeholders, including
those potentially under-represented, such as small and medium-sized enterprises and representatives
of societal interests. National bodies can consider putting in place awareness-raising activities, as well as
procedures for monitoring the participation of different categories of stakeholders.
4.3.4 The national body should promote its commitment to openness by maintaining and making
publicly available its standards development procedures, which address issues such as conditions for
participation (e.g. membership, participation fees, waiver provisions, copyright, intellectual property
rights and privacy obligations).
4.3.5 The national body should provide advance notice of standards development meetings, and it
should ensure availability of meeting agendas and documents prior to the meeting, according to specified
timeframes.
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ISO/IEC GUIDE 59:2019(E)
4.4 Impartiality and consensus
4.4.1 Impartiality should be accorded throughout the standards development process with respect to
the following (among other things):
— access to participation in work;
— submission of comments on drafts;
— consideration of views expressed and comments made;
— decision-making through consensus;
— obtaining information and documents;
— availability of draft and approved standards;
— adopting an ISO or IEC standard as a regional or national standard;
— revision of the standard.
4.4.2 When addressing consensus and impartiality, the national body should provide an impartial and
neutral platform for its standards development work, with equal access for all participants. The work is
expected to be conducted in a consensual and impartial manner, where no party is favoured over another
(see 4.4.5). No one organization or participant category should dominate the standards development
process. Furthermore, the national body should examine its governance structure, which should support
neutrality with respect to the representation of specific private or public interests across all its relevant
governing bodies.
4.4.3 The national body should have a standardization process that remains collaborative and
consensus-based, and that takes into account all views expressed and brings together diverging opinions.
4.4.4 The national body should assist its participants and those in leadership positions (such as the
committee chair) in building consensus. For this, the good practices below are recommended.
a) Promoting the right attitude
The national body should invite the participants involved to cooperate fully and in good faith in the
standardization work.
b) Dealing with objections
In the process of reaching consensus, many different points of views will be expressed and
addressed as the document evolves. However, “sustained opposition” constitutes views expressed
and maintained by an important part of the stakeholders and which are incompatible with the
committee decision. Those expressing sustained opposition have a right to be heard and the
following approach is recommended when sustained opposition is declared.
— The leadership should first assess whether the opposition constitutes sustained opposition, If
this is not the case, the leadership may register the opposition (e.g. in the minutes) and continue
to lead the work on the document.
— If the leadership determines that there is sustained opposition, it should try to resolve it in good
faith. However, sustained opposition cannot be interpreted as a right to veto. The obligation
to address the sustained opposition does not imply an obligation to successfully resolve it.
The responsibility for assessing whether or not consensus has been reached rests with the
leadership. This includes assessing whether there is sustained opposition or whether any
sustained opposition can be resolved without compromising the existing level of consensus on
the rest of the document. In such cases, the leadership will register the opposition and continue
the work.
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ISO/IEC GUIDE 59:2019(E)
— In all cases, the national body is expected to demonstrate efforts to identify solutions that
resolve any sustained opposition, while considering the interests of all participants.
— Those maintaining sustained opposition and who are dissatisfied with the process or the
outcome may make use of appeals mechanisms (see 5.12).
c) Achieving consensus rather than voting
The national body should take decisions in accordance with the consensus principle to the extent
possible. Formal voting should only be used under specific conditions and when the voting process
has been detailed in established procedures.
d) Documenting decisions
It is good practice to document the standpoints expressed with rationales, including any sustained
opposition, the decisions taken, the actions launched and, if necessary, the initiatives taken to reach
consensus.
4.4.5 The national body should protect the standards development process, ensuring its integrity,
avoiding taking a technical position on the standards under consideration, and keeping an impartial
and independent position by providing the opportunity for representation by an appropriate balance of
interests in the standards development process.
It is good practice to categorize stakeholders and participants according to broad areas of interest.
Annex B gives an example of the participant categories. The relevance of the various participant
categories should be assessed taking account of the standard under development. Not all categories are
relevant to all standards projects.
The national body’s rules should grant the same rights to all participants in the standardization work
to express their opinions and to have them duly taken into account. It is good practice for the national
body’s rules to state that all timely and relevant contributions submitted in accordance with established
procedures are duly considered, without favouring or ignoring any of them.
For this, it is good practice for the national body to formally request those leading the standards
development process to act impartially in the discussions and normative work in which they take part,
and to record their commitment. The rules and procedures of the national body should be communicated
to those leading the standards development process who are responsible for ensuring that they and the
participants follow these rules and procedures.
With respect to the representation of industry and commerce, it is good practice to pay particular
attention to the representation of small businesses, as recommended in ISO/IEC Guide 17.
4.4.6 The national body should maintain a governance structure that is neutral, impartial and
independent with respect to the specific interests of the participants. The national body should
...
GUIDE 59
Deuxième édition
2019-08
Pratiques de normalisation
recommandées par l'ISO et l'IEC à
leurs organismes nationaux
ISO and IEC recommended practices for standardization by
national bodies
Numéro de référence
ISO/IEC GUIDE 59:2019(F)
©
ISO/IEC 2019
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ISO/IEC GUIDE 59:2019(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO/IEC 2019
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
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E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
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ISO/IEC GUIDE 59:2019(F)
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Recommandations relatives à la mise en œuvre des principes d’élaboration des normes .3
4.1 Généralités . 3
4.2 Transparence . 3
4.3 Ouverture . 4
4.4 Impartialité et consensus. 5
4.5 Efficacité et pertinence . 7
4.6 Cohérence . 8
4.7 Dimension développement . 9
5 Conseils de mise en œuvre du Code de pratique pour l’élaboration, l’adoption et
l’application des normes de l'Accord OTC de l’OMC . 9
5.1 Généralités . 9
5.2 Notification d’acceptation/de dénonciation du Code de pratique . 9
5.3 Principe de non-discrimination .10
5.4 Dispositions visant à éviter les obstacles non nécessaires au commerce.10
5.5 Utilisation des normes ISO et IEC comme base pour les normes nationales .10
5.6 Participer pleinement à l’élaboration des normes ISO et IEC .11
5.7 Éviter la duplication des travaux .11
5.8 Spécifier des normes sur la base d’exigences de résultat .11
5.9 Programme de travail de normalisation .11
5.10 Soumission de commentaires sur le projet de norme par les parties intéressées .12
5.11 Publication des normes .12
5.12 Procédure d’appel .12
Annexe A (informative) Principes d’élaboration de normes, guides et recommandations
internationaux .13
Annexe B (informative) Catégories de participants .16
Annexe C (informative) Formulaires relatifs au Code de pratique pour l’élaboration,
l’adoption et l’application des normes de l’Accord OTC de l’OMC .17
Bibliographie .18
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ISO/IEC GUIDE 59:2019(F)
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 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 et l’IEC ne sauraient être tenues pour
responsables 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) ou dans la liste des déclarations de brevets
reçues par l'IEC (voir http: //patents .iec .ch).
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/avant -propos.
Le présent document a été élaboré par un groupe de travail mixte du Bureau de gestion technique de
l’ISO et du Bureau de gestion de la normalisation de l’IEC.
Cette deuxième édition annule et remplace la première édition (Guide ISO/IEC 59:1994), qui a fait l’objet
d’une révision technique.
Les principales modifications par rapport à l’édition précédente sont les suivantes:
— la structure, le contenu et le langage utilisé ont été mis à jour pour faciliter l’application du document;
— un domaine d’application a été ajouté afin de définir l’objet du document et les aspects couverts,
indiquant ainsi les limites d’applicabilité du document;
— les Articles 4 et 5 ont été ajoutés pour soutenir la mise en œuvre de l’accord de l’OMC sur les obstacles
techniques au commerce (OTC).
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/members .html.
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ISO/IEC GUIDE 59:2019(F)
Introduction
La normalisation apporte des avantages technologiques, économiques et sociétaux. Les normes aident
à harmoniser les spécifications techniques et d’autres spécifications de produits et de services, ce qui
rend l’industrie plus efficace et élimine les obstacles au commerce.
Les normes sont considérées comme un élément essentiel de l’« infrastructure de la qualité », le système
comprenant les organismes (publics et privés), les politiques, le cadre légal et réglementaire pertinent
et les pratiques nécessaires au soutien et à l’amélioration de la qualité, de la sécurité et de la durabilité
des biens, services et processus.
Les normes sont élaborées par de nombreux organismes aux plans national, régional et international.
Parallèlement à l’essor du commerce et de la coopération au niveau international, tant du point de vue
des technologies que de la société, les organismes de normalisation ont développé des procédures et
des modes de coopération généralement considérés comme constituant de bonnes pratiques pour
l’élaboration des normes à tous les niveaux. L’utilisation de normes est volontaire, à moins qu’elles ne
soient citées à titre d’exigences dans la législation ou dans des contrats.
Les fondations des modèles d’adhésion et de participation de l’ISO et de l’IEC se situent au plan national.
L’ISO et l’IEC, en collaboration avec leurs organismes nationaux, sont chargés de promouvoir et d’assurer
la cohérence et la coordination.
Le système de normalisation de l’ISO et de l’IEC est fondé sur des accords de collaboration entre l’ISO
et l’IEC et un ensemble considérable d’accords de collaboration entre les organismes de normalisation
régionaux, nationaux et autres.
L’accord de l’OMC sur les OTC a fourni un cadre pour faciliter le commerce international par le biais de
normes internationales. L’ISO et l’IEC s’engagent à mettre en œuvre le cadre de l’OMC sur les OTC lors
de l’élaboration des Normes internationales (voir l’Annexe A). Il convient que les organismes nationaux
établissent des lignes directrices afin de définir leur culture organisationnelle, à savoir les valeurs,
les convictions, les attitudes et le comportement qu’il convient que les experts nationaux partagent
et utilisent régulièrement dans le cadre de leurs travaux. L’ISO et l’IEC ont élaboré et appliquent des
Codes de conduite devant être respectés par les participants aux travaux de normalisation. Ces Codes
de conduite incluent les responsabilités à exercer:
— inclusivité;
— attitude consensuelle et compétences;
— respect des procédures;
— efficacité;
— impartialité;
— engagement dans la qualité;
— engagement du personnel et des experts.
Des documents internationaux autres que les Normes internationales peuvent remplir des fonctions
similaires en réduisant les obstacles techniques au commerce et en facilitant ainsi le commerce. Les
Directives ISO/IEC, Partie 1, fournissent des informations sur les autres documents publiés par l’ISO et/
ou l’IEC.
La première édition du présent document était antérieure à la décision du Comité OTC de l’OMC sur les
principes devant régir l’élaboration de normes, guides et recommandations internationaux (G/TBT/9,
13 novembre 2000) et au Code de pratique de l’Accord OTC de l’OMC pour l’élaboration, l’adoption
et l’application des normes (Annexe 3 de l’Accord OTC de l’OMC, 1995). La présente édition de ce
document a pour objet de fournir des recommandations pour la mise en œuvre de bonnes pratiques de
normalisation qui sont destinées à soutenir, mais pas à remplacer ni se substituer aux documents du
comité OTC de l’OMC.
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ISO/IEC GUIDE 59:2019(F)
Le présent document ne constitue pas une interprétation officielle des deux documents OTC de l’OMC
susmentionnés.
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GUIDE ISO/IEC GUIDE 59:2019(F)
Pratiques de normalisation recommandées par l'ISO et
l'IEC à leurs organismes nationaux
1 Domaine d’application
Le présent document fournit des pratiques de normalisation recommandées, destinées à aider dans
l’application des documents suivants:
— la décision du Comité OTC de l’OMC sur les principes devant régir l’élaboration de normes, guides et
recommandations internationaux (G/TBT/9, 13 novembre 2000);
— le Code de pratique du comité OTC de l’OMC pour l’élaboration, l’adoption et l’application des normes
(Annexe 3 de l’Accord OTC de l’OMC, 1995).
Le présent document est destiné à être utilisé par les membres nationaux de l’ISO et de l’IEC, ci-après
désignés en tant qu’organismes nationaux.
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).
Guide ISO/IEC 2, Normalisation et activités connexes — Vocabulaire général
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions du Guide ISO/IEC 2 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
norme de base
norme (3.8) de portée générale ou qui comporte des dispositions d’ensemble pour un domaine
particulier
Note 1 à l'article: Une norme de base peut être utilisée comme une norme d’application directe ou servir de base
à d’autres normes.
[SOURCE: Guide ISO/IEC 2:2004, 5.1]
3.2
consensus
accord général caractérisé par l’absence d’opposition ferme à l’encontre de l’essentiel du sujet émanant
d’une partie importante des intérêts en jeu et par un processus de recherche de prise en considération
des vues de toutes les parties concernées et de rapprochement des positions divergentes éventuelles
Note 1 à l'article: Le consensus n’implique pas nécessairement l’unanimité.
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[SOURCE: Guide ISO/IEC 2:2004, 1.7]
3.3
version en vigueur
statut assigné par un organisme national (3.6) à un document normatif au moment de sa publication, ou
à un projet au moment de sa diffusion, et qui reste en vigueur jusqu’à son retrait ou son remplacement
Note 1 à l'article: Le statut « en vigueur » n’indique pas la validité ou la non-validité d’un document normatif.
Note 2 à l'article: Une norme (3.8) peut être soit une version en vigueur soit une version antérieure (3.4).
3.4
version antérieure
statut assigné par un organisme national (3.6) à un document normatif ou à un projet au moment de son
retrait ou de son remplacement
Note 1 à l'article: Le statut « antérieur » n’indique pas la validité ou la non-validité d’un document normatif.
Note 2 à l'article: Une norme (3.8) peut être soit une version en vigueur (3.3) soit une version antérieure.
3.5
partie intéressée
organisme, entreprise, entité publique ou individu qui peut soit influer sur une décision ou une activité,
soit être influencé ou s’estimer influencé par une décision ou une activité découlant d’un processus de
normalisation ou des documents connexes
3.6
organisme national
comité membre de l’ISO ou comité national de l’IEC
Note 1 à l'article: Ce terme se rapporte à tout comité membre de l’ISO ou comité national de l’IEC, présent ou
futur, qui élabore des normes (3.8) nationales.
3.7
participant
partie intéressée (3.5) qui s’implique dans le processus d’élaboration de normes (3.8)
3.8
norme
document, établi par consensus (3.2) et approuvé par un organisme reconnu, qui fournit, pour des
usages communs et répétés, des règles, des lignes directrices ou des caractéristiques, pour des activités
ou leurs résultats, garantissant un niveau d’ordre optimal dans un contexte donné
Note 1 à l'article: Il convient que les normes soient fondées sur les acquis conjugués de la science, de la technique
et de l’expérience et visent à l’avantage optimal de la communauté.
[SOURCE: Guide ISO/IEC 2:2004, 3.2]
3.9
normalisation
activité propre à établir, face à des problèmes réels ou potentiels, des dispositions destinées à un usage
commun et répété, visant à l’obtention du degré optimal d’ordre dans un contexte donné
Note 1 à l'article: Cette activité concerne, en particulier, la formulation, la diffusion et la mise en application de
normes (3.8).
Note 2 à l'article: La normalisation offre d’importants avantages, notamment par une meilleure adaptation
des produits, des processus et des services aux fins qui leur sont assignées, par la prévention des obstacles au
commerce et en facilitant la coopération technologique.
[SOURCE: Guide ISO/IEC 2:2004, 1.1]
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3.10
norme retirée
norme (3.8) qui a été abandonnée par le normalisateur après consultation de son comité responsable,
parce qu’elle ne représente plus les informations techniques les plus récentes, fiables et/ou disponibles
3.11
norme remplacée
norme (3.8) qui a été remplacée par une version plus récente de la même norme, ou par une autre norme
appropriée, qui contient les informations techniques les plus récentes, fiables et/ou disponibles
4 Recommandations relatives à la mise en œuvre des principes d’élaboration
des normes
4.1 Généralités
Le présent article fournit des recommandations pour soutenir l’application de la décision du Comité
OTC de l’OMC sur les principes devant régir l’élaboration de normes, guides et recommandations
internationaux (G/TBT/9, 13 novembre 2000).
L’élaboration de normes consensuelles est un processus qui, au niveau national, comporte plusieurs
activités distinctes, mais étroitement liées.
— La première phase consiste à identifier le besoin d’une norme, puis le degré de priorité du travail
d’élaboration requis pour élaborer la norme en fonction des ressources disponibles.
— La deuxième phase est l’élaboration de la norme, généralement au sein d’un comité, en tenant compte
des intérêts de toutes les parties intéressées concernées au niveau national.
— La troisième phase est la consultation ouverte pour permettre la participation du public et la prise
en compte des commentaires reçus par le comité pendant la consultation publique.
— La quatrième phase correspond à l’approbation de la norme.
— La dernière phase est la publication, la promotion et la maintenance de la norme.
Il convient de suivre les recommandations données en 4.2 à 4.7 lorsque des organismes
nationaux élaborent des normes ou participent à des travaux de normalisation internationale. Ces
recommandations sont alignées sur la décision du Comité OTC de l’OMC sur les principes devant régir
l’élaboration de normes, guides et recommandations internationaux (voir l’Annexe A).
4.2 Transparence
4.2.1 Au titre de la transparence, il convient que des informations suffisantes et régulièrement mises
à jour soient rendues accessibles en temps utile pour permettre à toutes les parties intéressées de
participer au processus de normalisation si elles le souhaitent. Il convient d’établir des procédures afin
de ménager un délai suffisant et des possibilités adéquates pour la soumission de commentaires par
écrit. Il convient que des informations sur ces procédures soient diffusées de manière efficace.
4.2.2 Il convient que l’organisme national dispose de procédures documentées appropriées à l’appui
de ses processus d’élaboration et de gestion des normes. Il convient que ces procédures soient tenues à
jour et librement accessibles à toute partie intéressée.
4.2.3 Lorsqu’une nouvelle norme est proposée, il convient que l’organisme national de normalisation
mette cette information à la disposition du public à un stade précoce du processus d’élaboration des
normes, afin que les parties intéressées puissent suivre ou participer au processus. Il convient de fournir
une brève description du domaine d’application du projet de norme, y compris son objectif et sa raison
d’être. Il convient que l’avis utilisé pour communiquer cette proposition soit clair et facile à comprendre
pour toutes les parties intéressées.
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4.2.4 Il convient que les participants reçoivent tous les projets de document et soient informés des
actions engagées à la suite des commentaires qu’ils ont faits sur les projets.
4.2.5 Lorsqu’un consensus est atteint et que le projet de norme est prêt pour une consultation ouverte,
il convient qu’il soit mis à la disposition des parties intéressées. Il convient de prévoir au moins 60 jours
pour permettre aux parties intéressées de soumettre leurs commentaires par écrit. Cette période peut
toutefois être écourtée dans les cas où il convient de traiter de problèmes urgents en matière de sécurité,
de santé ou d’environnement. Il convient de mettre en place une procédure claire et bien comprise pour
la gestion de ces commentaires (voir 5.10).
4.2.6 Il convient que les informations concernant les versions en vigueur des normes ainsi que les
normes antérieures et retirées soient mises à disposition par des moyens adéquats tels que des sites
web, des abonnements, etc.
4.2.7 Il convient que l’organisme national mette à la disposition du public un programme de travail à
jour. Il convient que ce programme de travail normatif contienne des informations pertinentes, telles que
décrites en 5.9.
4.3 Ouverture
4.3.1 Il convient que la participation à l’élaboration des normes soit ouverte par le biais de l’organisme
national, sans discrimination, à toutes les parties intéressées et ce, à toutes les étapes du processus de
travail normatif. Cela inclut une participation à chaque étape de l’élaboration des normes, telle que:
— proposition et acceptation de nouveaux sujets d’études;
— examen technique des propositions;
— soumission de commentaires sur les projets;
— revue des normes existantes;
— résolution des commentaires et approbation des normes;
— mise à disposition des normes approuvées.
4.3.2 Il convient que les organismes nationaux facilitent la participation d’un éventail approprié de
parties intéressées pour chaque norme en cours d’élaboration. Il convient que la participation soit
inclusive et n’impose pas d’obstacles indus à l’adhésion.
4.3.3 Il convient que l’organisme national encourage et permette l’implication de toutes les parties
intéressées, y compris celles qui sont potentiellement sous-représentées telles que les petites et
moyennes entreprises et les représentants des intérêts sociétaux. Les organismes nationaux peuvent
envisager la mise en place d’activités de sensibilisation ainsi que de procédures permettant de surveiller
la participation des différentes catégories de parties intéressées.
4.3.4 Il convient que l’organisme national promeuve son engagement d’ouverture en tenant à jour et
en mettant à la disposition du public ses procédures d’élaboration des normes, qui traitent de questions
telles que les conditions de participation (par exemple adhésion, frais de participation, dispositions de
renonciation, droits d’auteur, droits de propriété intellectuelle et obligations en matière de protection de
la vie privée).
4.3.5 Il convient que l’organisme national prévienne à l’avance de la tenue des réunions d’élaboration
de normes et s’assure que l’ordre du jour des réunions et les documents connexes sont mis à disposition
avant la réunion, selon des délais spécifiés.
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4.4 Impartialité et consensus
4.4.1 Il convient d’assurer l’impartialité tout au long du processus d’élaboration des normes,
notamment pour ce qui est de:
— l’accès à la participation aux travaux;
— la soumission de commentaires sur les projets;
— la considération des avis exprimés et des commentaires faits;
— la prise de décision par consensus;
— l’obtention d’informations et de documents;
— la mise à disposition des projets de norme et des normes approuvées;
— l’adoption d’une norme ISO ou IEC en tant que norme régionale ou nationale;
— la révision de la norme.
4.4.2 Au titre du consensus et de l’impartialité, il convient que l’organisme national fournisse une
plate-forme impartiale et neutre pour ses travaux normatifs, avec un accès égal pour tous les participants.
Les travaux sont censés être menés de manière consensuelle et impartiale, sans privilégier une partie
par rapport à une autre(voir 4.4.5). Il convient qu’aucun organisme ou catégorie de participants ne
domine le processus d’élaboration des normes. Par ailleurs, il convient que l’organisme national examine
sa structure de gouvernance, dont il convient d’assurer la neutralité en termes de représentation des
intérêts privés ou publics spécifiques.
4.4.3 Il convient que l’organisme national dispose d’un processus de normalisation qui reste
collaboratif et fondé sur le consensus et qui tient compte de tous les points de vue exprimés et cherche à
rapprocher les opinions divergentes.
4.4.4 Il convient que l’organisme national aide les participants et ceux occupant des fonctions de
direction (tel que le président du comité) à parvenir à un consensus. Pour ce faire, les bonnes pratiques
ci-dessous sont recommandées.
a) Promouvoir la bonne attitude
Il convient que l’organisme national invite les participants impliqués à coopérer pleinement et de
bonne foi aux travaux de normalisation.
b) Traiter les objections
Dans le processus de recherche d’un consensus, de nombreux points de vue différents seront
exprimés et traités au fur et à mesure de l’évolution du document. Toutefois, une « opposition
ferme » constitue des opinions exprimées et maintenues par une proportion importante des
participants et incompatibles avec la décision du comité. Ceux qui expriment une opposition ferme
ont le droit d’être entendus et l’approche suivante est recommandée lorsqu’une opposition ferme
est déclarée.
— Il convient tout d’abord que la direction évalue si l’opposition constitue une opposition ferme. Si
ce n’est pas le cas, la direction peut enregistrer l’opposition (par exemple dans le procès-verbal)
et continuer à diriger les travaux sur le document.
— Si la direction détermine que l’opposition est ferme, il convient qu’elle essaie de la résoudre en
toute bonne foi. Une opposition ferme ne peut toutefois pas être interprétée comme un droit de
veto. L’obligation de traiter l’opposition ferme n’implique pas une obligation de la résoudre avec
succès. Il incombe à la direction d’évaluer si un consensus a été atteint ou non. Cela consiste
notamment à évaluer s’il existe une opposition ferme ou si toute opposition ferme peut être
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résolue sans compromettre le niveau de consensus existant pour le reste du document. Dans de
tels cas, la direction en
...
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