ISO/IEC Guide 2:1996
(Main)Standardization and related activities — General vocabulary
Standardization and related activities — General vocabulary
Provides general terms and definitions concerning standardization and related activities. It is intended to contribute towards mutual understanding amongst the members of ISO and IEC and the various governmental and non-governmental bodies involved in standardization at international and national levels.
Normalisation et activités connexes — Vocabulaire général
General Information
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ISO/IEC GUIDE 2:1996(E/F/R)
Page
Contents
v
.............................................................................................
Foreword
xi
Introduction .
1
..................................................................................................
Scope
2
Standardization . .
1
............................................................... 6
2 Aims of standardization
10
Normative documents .
3
..................... 16
4 Bodies responsible for standards and regulations.
................................................... ................... 20
5 Types of standards
24
Harmonization of standards .
6
................................................ 30
7 Content of normative documents
.............................................. 34
8 Structure of normative documents
34
Preparation of normative documents .
9
................................... 38
IO Implementation of normative documents
40
.....................................
11 References to standards in regulations.
44
12 Conformity assessment in general. .
.................................................. 52
13 Determination of characteristics
54
Conformity evaluation. .
14
56
15 Assurance of conformity .
...................................... 60
16 Approval and recognition arrangements
62
....
17 Accreditation of conformity assessment bodies and persons
Alphabetical indexes
................................................ 64
English (en) .
67
French (fr) . .
70
Russian (ru) .
................................................................................. 72
German (de)
74
Spanish (es) . .
76
Italian (it) . .
78
Dutch (nl) . .
Swedish (sv) . . 80
0 ISO/IEC 1996
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
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Internet centraI@isocs.iso.ch
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Printed in Switzerland / lmprime en Sursse
II
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ISO/IEC GUIDE 2:1996(E/F/R)
@ lSO/IEC
Sommaire Page
Avant-propos . . vii
Introduction . . . xii
1
Domaine d’application . .
1 Normalisation . . 2
2 Objectifs de la normalisation . . 6
Documents normatifs . . . 10
3
4 Organismes responsables des normes et des reglements . 16
20
5 Types de normes .
6 Harmonisation des normes . . 24
7 Contenu des documents normatifs . 30
Structure des documents normatifs . 34
8
9 Preparation des documents normatifs . 34
10 Mise en ceuvre des documents normatifs . 38
11 Reference aux normes dans la reglementation . 40
44
12 lkaluation de la conformite, en general .
13 Determination des caracteristiques . . 52
14 ivaluation de la conformite . 54
15 Assurance de conformite . . 56
16 Arrangements d’homologation et de reconnaissance. . 60
17 Accreditation des organismes d’evaluation de la conformite et
62
des personnes .
Index alphabetiques
Anglais (en) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Francais (fr) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
70
Russe (ru) . .
Allemand (de) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
74
Espagnol (es) . .
Italien (it) . . 76
78
Neerlandais (nl) .
Suedois (sv) . . 80
. . 0
III
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0 lSO/IEC
ISO/IEC GUIDE 2:1996(E/F/R)
CTP.
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.................................................................................. 70
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.............................................................................
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76
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........................................................................... 78
ronnaHflcKMti (nl)
............................................................................... 80
MBeuCKPlti (SV)
iv
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ISO/IEC GUIDE 2:1996(E/F/R)
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Foreword
IS0 (the International Organization for Standardization) and IEC (the Inter-
national Electrotechnical Commission) form the specialized system for
worldwide standardization. National bodies that are members of IS0 or IEC
participate in the development of International Standards through technical
committees established by the respective organization to deal with particu-
lar fields of technical activity. IS0 and IEC technical committees collab-
orate in fields of mutual interest. Other international organizations,
governmental and non-governmental, in liaison with IS0 and IEC, also take
part in the work.
The first edition of this Guide was published by IS0 in 1976. It was pre-
pared by the United Nations Economic Commission for Europe (UN/ECE) in
consultation with ISO, primarily to facilitate the work of the UN/ECE aimed
at removal of barriers to international trade arising from lack of harmoniz-
ation of standards or inadequate international application of standards.
The second, thirdand fourth editions of IS0 Guide 2 added new terms and
definitions in more or less isolated groups, within no overall planned
framework. Work on a systematically structured revision was authorized
by IS0 Council in 1981 as the principal task of a working group within the
IS0 Committee on standardization principles (ISO/STACO), including IEC
and UN/ECE spokesmen and in cooperation with the IS0 Committee on
conformity assessment (ISO/CASCO) and the International Laboratory
Accreditation Conference (I LAC).
The main reason for this activity was a request from UN/ECE for complete
and urgent revision of IS0 Guide 2 to take into account a number’ of
specific problems raised by the UN/ECE Government Officials Responsible
for Standardization Policies as well as the proposed terminology being
prepared in the UN/ECE Working Party on Building.
Moreover, IS0 was publishing an increasing number of Guides on stan-
dardization policies and procedures, several of them in conjunction with
I EC. To guard against terminological inconsistencies, a clear understanding
of basic concepts needed to be established, and unambiguous general
terms and definitions provided.
The resulting fifth edition of Guide 2 was issued, for the first time as a joint
lSO/l EC publication, in 1986.
The sixth edition (1991) incorporated amendments in response to specific
questions raised by IS0 and IEC members, requests from the General
Agreement on Tariffs and Trade (GATT) and the UN/ECE, and proposals
from lSO/CASCO.
This seventh edition (1996) preserves the structure of its recent prede-
cessors by grouping related concepts under generic clause headings. Thus,
clauses 1 to 11 concern standardization, proceeding from the more general
to more specific aspects. Similarly, the terms and definitions given in the
newly revised clauses 12 to 17 cover the broad spectrum of conformity
assessment. These latter clauses have been modified on the recommen-
dations of lSO/CASCO to reflect recent developments in conformity
V
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ISO/IEC GUIDE 2:1996(E/F/R)
0 lSO/IEC
assessment activities, and were approved by the national bodies of IS0
and IEC in 1994. They are not intended to provide a comprehensive classi-
fication but include, in particular, concepts related to the following typical
sequence:
a) determination of product, process or service characteristics
(clause 13);
b) comparison of characteristics with specified requirements, i.e. con-
formity evaluation (clause 14);
assurance of conformity, e.g. by supplier’s declaration or by certifi-
d
cation (clause 15).
vi
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@ lSO/lEC ISO/IEC GUIDE 2:1996(E/F/R)
Avant-propos
L’ISO (Organisation internationale de normalisation) et la CEI (Commission
electrotechnique internationale) forment ensemble le systeme specialise
de la normalisation mondiale. Les organismes nationaux membres de I’ISO
ou de la CEI participent au developpement de Normes internationales par
I’intermediaire des comites techniques c&s par I’organisation concernee
afin de s’occuper des domaines particuliers de I’activite technique. Les
comites techniques de I’ISO et de la CEI collaborent dans des domaines
d’interet commun. D’autres organisations internationales, gouvernementa-
les ou non gouvernementales, en liaison avec I’ISO et la CEI participent
egalement aux travaux.
La premi&e tidition du present Guide a ete publiee par I’ISO en 1976. Elle
a ete preparee par la Commission economique des Nations Unies pour
I’Europe (UN/ECE), en collaboration avec I’ISO, principalement pour faciliter
les travaux de l’UN/ECE visant a la suppression des obstacles au
commerce international dus a l’absence de normes harmonisees ou a une
application inadequate des normes au niveau international.
Les deuxieme, troisi6me et quatheme 6ditions du Guide IS0 2 ont inclus
de nouveaux termes et definitions en groupes plus ou moins isoles, sans
plan d’ensemble. Le Conseil de I’ISO a done accepte en 1981 une mise en
revision systematique et structuree comme mission principale d’un groupe
de travail au sein du Comite de I’ISO pour les principes de la normalisation
(lSO/STACO) et comprenant des representants de la CEI et de I’UN/ECE,
egalement en cooperation avec le Comite de I’ISO pour I’evaluation de la
conformite (lSO/CASCO) et la Conference internationale sur I’agrement
des laboratoires d’essais (ILAC).
Cette activite faisait notamment suite a une demande de l’UN/ECE portant
sur une revision urgente du Guide IS0 2 afin de tenir compte a la fois d’un
certain nombre de questions particulieres soulevees par les responsables
gouvernementaux de l’UN/ECE en mat&e de politique de normalisation et
des propositions de terminologie en preparation au sein du groupe de
travail UN/ECE charge du batiment.
En outre, I’ISO publiait un nombre croissant de Guides sur les politiques et
les procedures de normalisation dont plusieurs en collaboration avec la
CEI. Afin d’eviter des incoherences terminologiques, il etait done neces-
saire d’assurer une comprehension precise des concepts fondamentaux et
de retenir des termes generaux et leurs definitions denues d’ambigu’l’te.
La cinqui&me 6dition du Guide 2 resultant de ces travaux a ete publiee,
pour la premiere fois comme publication commune ISO/CEl, en 1986.
La sixi&me &dition (1991) a incorpore des amendements qui ont ete elabo-
res faisant suite a des questions particulieres soulevees par les membres
de I’ISO et de la CEI, a des demandes de I’Accord general sur les tarifs
douaniers et le commerce (GATT) et de l’UN/ECE ainsi qu’a des propo-
sitions de I’ISO/CASCO.
La presente septi&me Edition (1996) conserve la structure des editions les
plus recentes en regroupant les concepts connexes en sections generi-
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ISO/IEC GUIDE 2:1996(E/F/R)
0 lSO/IEC
ques. Ainsi, les articles 1 a 11, qui concernent la normalisation, commen-
cent par les aspects les plus generaux pour aboutir aux plus specifiques.
D’une man&e semblable, les termes et definitions figurant dans les
articles 12 a 17, qui viennent d’etre revises, couvrent le domaine de I’eva-
luation de la conformite. Ces derniers articles ont ete modifies sur la base
de recommandations de I’ISOKASCO, afin de refleter les developpements
intervenus recemment dans les activites d’evaluation de la conformite; ces
articles ont ete approuves par les organismes nationaux de I’ISO et de la
CEI en 1994. L’objet n’est pas de fournir une classification exhaustive,
mais d’inclure, en particulier, les concepts se rapportant 8 la skquence
type suivante:
determination des caracteristiques d’un produit, processus ou service
a)
(article 13);
b) comparaison des caracteristiques avec des exigences specifiques,
c’est-a-dire bvaluation de la conformit (article 14);
assurance de la conformit& par exemple par la dbclaration du fournis-
cl
seur ou par la certification (article 15).
. . .
VIII
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ISO/IEC GUIDE 2:1996(E/F/R)
0 lSO/IEC
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ISO/IEC GUIDE 2:1996(E/F/R)
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X
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ISO/IEC GUIDE 2:1996(E/F/R)
@ PSO/IEC
Introduction
Whilst IS0 and IEC jointly provide the international framework for stan-
dardization, covering a wide range of mainly technical matters, the general
concept of standardization extends beyond their terms of reference. For
IS0 and IEC purposes, the definition of standardization (1 .I) should
accordingly be read in conjunction with the definitions of standard (3.2)
and consensus (1.7).
The general terminological principles guiding the revisions of Guide 2 since
1986 have been those established by Technical Committee ISOnC 37,
Terminology (principles and coordination).
Terms expressing more specific concepts may generally be constructed by
a combination of terms representing more general concepts. The latter
terms thus form “building blocks”, and the selection of terms and the con-
struction of definitions within this Guide has been based on this approach
in cases where equivalent English, French and Russian combined terms
contain the same “building blocks”.
In this way, additional terms can be readily constructed within the frame-
work of the Guide. For example, the term safety standard can be defined
as a standard (3.2) concerned with freedom from unacceptable risk of
harm (definition of safety in 2.5).
Words placed between parentheses “( . . . )” within some terms may be
omitted if it is unlikely that this will cause confusion.
The definitions included in this Guide are directly equivalent in the English,
French and Russian languages. They have been drawn up as concisely as
practicable. Where they first occur in other definitions, terms which have
themselves been defined in this Guide are printed in bold type.
The notes appended to certain definitions offer clarification, explanation or
examples to facilitate understanding of the concepts described. In certain
cases, the notes may differ in different languages for linguistic reasons, or
additional notes may be given.
In science and technology, the English word “standard” is used with two
different meanings: as a normative document as defined in 3.2 (in French
“norme”, in Russian “CTatinapT”) and also as a measurement standard (in
French “btalon”, in Russian “3TanoH”). This Guide is concerned solely
with the first meaning. The second is the province of the International
vocabulary of basic and general terms in metrology (V/M).
xi
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ISO/IEC GUIDE 2:1996(E/F/R)
@ lSO/IEC
Introduction
Alors que I’ISO et la CEI constituent conjointement le cadre international
de la normalisation couvrant toute une gamme de sujets principalement
techniques, le concept general de normalisation s’etend au-dela de leur
mandat. Pour les besoins de I’ISO et de la CEI, il convient done de lire la
definition de la normalisation (1 .I) conjointement avec les definitions de la
norme (3.2) et du consensus (I .7).
Les principes terminologiques generaux qui ont preside aux revisions du
Guide 2 depuis 1986 ont ete ceux definis au sein du Comite technique
lSO/TC 37, Terminologie (principes et coordination).
Les termes exprimant des concepts plus specifiques peuvent generale-
ment etre form& par la combinaison d’expressions representant des
concepts plus generaux. Ces derniers constituent done des ((elements de
construction)) et le choix des termes ainsi que l’elaboration des definitions
dans le present Guide se fondent sur cette methode lorsque les termes
combines equivalents en anglais, francais et russe cornportent les memes
((elements de construction )).
Des termes supplementaires peuvent ainsi etre aisement construits dans
le cadre de ce Guide. Par exemple, I’expression norme de shurit6 peut
etre definie comme &ant une norme (3.2) visant a I’absence de tout
risque de dommage inacceptable (definition de la skurit6 en 2.5).
Les mots places entre parentheses ((( . . . 1)) peuvent etre omis lorsqu’il n’y
a pas de confusion possible.
Les definitions contenues dans le present Guide sont directement equiva-
lentes en anglais, en francais et en russe. Elles ont ete etablies de facon
aussi concise que possible. Lorsque des termes deja definis dans le pre-
sent Guide interviennent dans d’autres definitions, ils sont imprimes en
caracteres gras lors de leur premiere occurrence.
Les notes relatives a certaines definitions apportent des clarifications,
commentaires ou exemples, pour faciliter la comprehension des concepts
decrits. Dans certains cas, pour des raisons linguistiques, les notes pour-
ront etre differentes ou le texte pourra appeler des notes supplementaires.
Dans le domaine des sciences et de la technique, le terme anglais
((standard)) peut avoir deux sens differents: le premier concerne un
document normatif au sens defini en 3.2 (en francais ((norme)), en russe
(
(&talon)), en russe (wanotw). Dans le present Guide, le mot est employe
exclusivement dans sa premiere acception. La deuxieme acception s’em-
ploie dans le cadre du Vocabulaire international des termes fondamentaux
et g&Graux de m&rologie (VIM).
XII
---------------------- Page: 12 ----------------------
ISO/IEC GUIDE 2:1996(E/F/R)
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