INTERNATIONAL ISO/IEC

STANDARD 17000

Redline version
compares Second edition to
First edition

Conformity assessment — Vocabulary

and general principles
Évaluation de la conformité — Vocabulaire et principes généraux
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Reference number
ISO/IEC 17000:redline:2020(E)

© ISO/IEC 2020
ISO/IEC 17000:redline:2020(E)


IMPORTANT
This marked-up version uses the following colour-coding in the marked-up text:

Text example 1 — Text has been added (in green)

Text example 2 — Text has been deleted (in red)
— Graphic figure has been added
— Graphic figure has been deleted
1.x ... — If there are changes in a clause/subclause, the corresponding clause/
subclause number is highlighted in yellow in the Table of contents

DISCLAIMER
This marked-up version highlights the main changes in this edition of the document
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compared with the previous edition. It does not focus on details (e.g. changes in

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punctuation).
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This marked-up version does not constitute the official ISO document and is not intended to
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be used for implementation purposes.

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COPYRIGHT PROTECTED DOCUMENT

© ISO/IEC 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland

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 ISO/IEC 17000:redline:2020(E)


Contents Page

Foreword......................................................................................................................................................................................................................................... iv
Introduction................................................................................................................................................................................................................................. vi
0.1 Terms and definitions applicable to conformity assessment......................................................................... vi
0.2 Terms and definitions applicable to trade policy...................................................................................................... vi
0.3 A functional approach to conformity assessment.................................................................................................... vi
0.4 Selection of terms and definitions......................................................................................................................................... vi
0.5 Changes in terminology................................................................................................................................................................. vii
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references....................................................................................................................................................................................... 1
3 Terms and definitions...................................................................................................................................................................................... 1
2 4 Terms relating related to conformity assessment in general.................................................................................. 1
3 5 Basic terms Terms related to basic concepts............................................................................................................................ 4
4 6 Conformity assessment terms Terms relating to selection and determination
(see Figure A.1)....................................................................................................................................................................................................... 5
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5 7 Conformity assessment terms Terms relating to review, decision and attestation

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(see Figure A.1)....................................................................................................................................................................................................... 6

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6 8 Conformity assessment terms Terms relating to surveillance(see Figure A.1).................................... 7
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7 9 Terms relating to conformity assessment and facilitation of trade trade and regulation........ 8
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Annex A (informative) Principles of conformity assessment...................................................................................................11

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Annex B (informative) Related terms defined in other documents standards.......................................................17

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Bibliography.............................................................................................................................................................................................................................. 25
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Alphabetical index..............................................................................................................................................................................................................27
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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. In the field of conformity assessment, the ISO Committee on conformity assessment (CASCO) is
responsible for the development of International Standards and Guides.
International Standards areThe procedures used to develop this document and those intended for its
further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval
criteria needed for the different types of document should be noted. This document was drafted in
accordance with the rules given ineditorial rules of the ISO/IEC Directives, Part 2 (see www​​.iso​​.org/​
directives).
Draft International Standards adopted by the technical committees are circulated to the member
bodies for voting. Publication as an International Standard requires approval by at least 75 % of the
member bodies casting a vote.
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Attention is drawn to the possibility that some of the elements of this document may be the subject
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of patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent
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rights. Details of any patent rights identified during the development of the document will be in the
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Introduction and/or on the ISO list of patent declarations received (see www​​.iso​​.org/​patents) or the IEC
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list of patent declarations received (see http:​//​patents​​.iec​​.ch).

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Any trade name used in this document is information given for the convenience of users and does not
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constitute an endorsement.
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For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
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expressions related to conformity assessment, as well as information about ISO's adherence to the
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World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www​​.iso​​.org/​
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iso/​foreword​​.html.
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ISO/IEC 17000This document was prepared by the ISO Committee on conformity assessmentConformity

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Assessment (CASCO).
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It was circulated for voting to the national bodies of both ISO and IEC, and was approved by both
organizations.
This firstsecond edition cancels and replaces Clauses 12 to 17 of ISO/IEC Guide 2:1996. Clauses 1 to
11 of ISO/IEC Guide 2 are not the responsibility of ISO/CASCO and are unaffected by this International
Standardthe first edition (ISO/IEC 17000:2004), which has been technically revised.
The main changes compared to the previous edition are as follows:
— addition of new terms: “object of conformity assessment” (see 4.2), “owner” (see 4.13), “impartiality”
(see 5.3), “independence” (see 5.4), “validation” (see 6.5), “verification” (see 6.6), “decision” (see 7.2),
“expiry” (see 8.4) and “restoration” (see 8.5);
— change of concept of conformity assessment system;
— deletion of the definition of the term “product” from the body of the document and addition to
Annex B;
— editorial revision of Annex A limited to changes in the terms and definitions in Clauses 4 to 9;
— extension of Annex B.

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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

0.1 Terms and definitions applicable to conformity assessment

ISO and ISO/IEC Guides and, more recently, International Standards relating generically to conformity
assessment activities such as testing, inspection and various forms of certification are prepared by
working groups of the ISO Committee on conformity assessment (CASCO). For many years, ISO/IEC
Guide 2, last revised in 1996, has included a core vocabulary for conformity assessment, built up from
a small number of terms and definitions first compiled to facilitate communication and understanding
about product certification based on standards for traditional manufactured goods.
In 2000, CASCO decided to take conformity assessment terminology (Clauses 12 to 17) out of ISO/IEC
Guide 2 and provide instead a self-contained vocabulary more readily applicable within the planned
ISO/IEC 17000 series of standards and in the drafting or revision of related guides. CASCO Working
Group 5, Definitions, has accordingly prepared this International Standard in consultation with other
active CASCO working groups, as a consistent framework within which more specific concepts may be
defined appropriately and denoted by the most appropriate terms. Extra terms for concepts unique to
particular activities within conformity assessment, such as accreditation, certification of persons and
marks of conformity, are found in the International Standard or Guide related to that activity. Such
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Until pre-existing CASCO publications are revised, the terminology used in those documents remains

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valid in its context; this International Standard is not intended to be applied retrospectively.
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Conformity assessment interacts with other fields such as management systems, metrology,
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standardization and statistics. This International Standard does not define the boundaries of
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conformity assessment. These remain elastic.

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0.2 Terms and definitions applicable to trade policy

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Clause 7 includes some terms and definitions, drawn mainly from the superseded clauses of ISO/IEC
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Guide 2, for several broader concepts. These are intended not only to standardize usage within the
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conformity assessment community, but also to help policy makers concerned with the facilitation of
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trade within regulatory and international treaty frameworks.

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0.3 A functional approach to conformity assessment

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The terms and definitions specified in this International Standard, particularly under Clauses 4 and 5,
reflect the adoption by CASCO in November 2001 of the functional approach recommended earlier that
year in the final report of a CASCO – CEN/CENELEC TC 1 joint working group.
To provide a better understanding of the defined concepts, their grouping and their relationships, a
description of the functional approach is included in Annex A for information.

0.4 Selection of terms and definitions

Some of the terms included in this International Standard relate to concepts it was considered essential
to define. Others it was thought helpful to explain. Many of the general terms used to distinguish
conformity assessment concepts are used in common language in a broader sense or with a wider range
of meanings. Some also appear in other standard vocabularies with definitions specific to the relevant
field of application.
An alphabetical index lists the terms defined in this International Standard. Standards defining
other relevant terms are given in Annex B with separate alphabetical lists. First are terms applicable
to specific aspects of conformity assessment, as defined in other standards in the ISO/IEC  17000
series. Second are terms for which the definitions given in either the International vocabulary of basic
and general terms in metrology (VIM) or ISO 9000 are generally applicable in conformity assessment

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contexts. For the terms “procedure” and “product”, both used extensively in other definitions, the
ISO 9000:2000 definitions are reproduced in 3.2 and 3.3.

0.5 Changes in terminology

Attention is drawn to significant changes in the terms or their definitions from the superseded clauses
of ISO/IEC Guide 2.
This International Standard does not include a definition of “conformity” on the grounds that it is not
necessary to do so. “Conformity” does not feature in the definition of “conformity assessment”. The
concept of “conformity assessment” is concerned with “fulfilment of specified requirements”, not with
the wider concept of “conformity”. A definition of the term “specified requirement” (3.1) is included.
In English, the term “compliance” is used to distinguish the action of doing what is required (e.g. an
organization “complies” by making something conform or by fulfilling a regulatory requirement).
The ISO 9000 definition of “product” (3.3) includes services as a product category, so that it is no longer
correct to refer to “products and services”.
Instead of “product, process or service”, the generic expression used in ISO/IEC Guide 2 for the “subject
of standardization”, Note 2 to 2.1 introduces the expression “object of conformity assessment” as a
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applied. (The “subject” would more logically be the body doing the assessment.)

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Instead of “assurance of conformity”, the term “attestation” (5.2) is used for the activity of conveying
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The term “accreditation” is now applicable only to attestation regarding a conformity assessment body.
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The definition in ISO/IEC Guide 2, by contrast, would have been equally applicable to the certification of
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persons, as specified in ISO/IEC 17024. Following this change, the terms “conformity assessment body”
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(2.5) and “accreditation body” (2.6) are defined separately. More specific terms relating to accreditation
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are defined in ISO/IEC 17011.

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To avoid ambiguity, the term “body” is used in this International Standard only when referring to
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conformity assessment bodies or accreditation bodies. Otherwise, the term “organization” is used in
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its general meaning, as in the ISO 9000 definition. The more specific ISO/IEC Guide 2 definition of an
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organization as a body based on membership is not applicable to the field of conformity assessment.
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The ISO Committee on conformity assessment (CASCO) develops International Standards relating to
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conformity assessment activities such as testing, inspection and various forms of certification. For
many years, ISO/IEC Guide 2 included a core vocabulary for conformity assessment, built up from a
small number of terms and definitions first compiled to facilitate communication and understanding
about product certification based on standards for traditional manufactured goods.
In 2000, CASCO decided to remove conformity assessment terminology from ISO/IEC Guide 2 and
provide instead a self-contained vocabulary more readily applicable within the planned international
standards on conformity assessment and in the drafting or revision of related documents. The first
edition of this document was published in 2004, as a consistent framework within which more specific
concepts could be defined appropriately and denoted by the most appropriate terms.
Additional concepts unique to particular activities such as accreditation, certification of persons
and use of marks of conformity are not included in this document but are provided in International
Standards related to those activities.
Terms and definitions related to trade and regulation are given in Clause 9. These are intended not
only to standardize usage within the conformity assessment community, but also to help policy makers
concerned with the facilitation of trade within regulatory and international treaty frameworks.
The terms and definitions specified in this document, particularly in Clauses 6 and 7, reflect the
adoption by CASCO in November 2001 of the functional approach.

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To provide a better understanding of the defined concepts, their grouping and their relationships, a
description of the functional approach is included in Annex A for information.
The terms included in this document relate to concepts considered essential to define. General terms
used to denote conformity assessment concepts for which common language usage is sufficient are
not included in this document. Terms not common across all International Standards for conformity
assessment and with definitions specific to a particular application are not included in this document
but are included in the specific relevant standard.
Relevant terms defined in other documents are listed in Annex B:
— terms applicable to specific aspects of conformity assessment, as defined in other conformity
assessment standards;
— terms generally applicable in conformity assessment contexts for which definitions are published
outside conformity assessment standards.

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INTERNATIONAL STANDARD ISO/IEC 17000:redline:2020(E)

Conformity assessment — Vocabulary and general

principles

1 Scope
This International Standarddocument specifies general terms and definitions relating to conformity
assessment (including the accreditation of conformity assessment bodies,) and to the use of conformity
assessment to facilitate trade. A description of the functional approach to conformity assessment is
included in Annex A, as a further aid to understanding among users of conformity assessment, con­form­
ity assessment bodies and their accreditation bodies, in both voluntary and regulatory environ­ments.
The general principles of conformity assessment and a description of the functional approach to
conformity assessment are provided in Annex A.
This International Standard does not set out to provide a vocabulary for all of the concepts that may
need to be used in describing particular conformity assessment activities. Terms and definitions are
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given only where the concept defined would not be understandable from the general language use of the

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term, or where an existing standard definition is not applicableConformity assessment interacts with

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other fields such as management systems, metrology, standardization and statistics. The boundaries of
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conformity assessment are not defined in this document. 17 ist

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NOTE 1 The notes appended to certain definitions offer clarification or examples to facilitate understanding
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of the concepts described. In certain cases, the notes may differ in different languages for linguistic reasons, or
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additional notes may be given.

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NOTE 2 The terms and definitions are laid out in a systematic order, with an alphabetical index. A term in
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a definition or note that is defined in another entry is indicated by bold­face followed by its entry number in
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parentheses. Such terms may be replaced by their complete definition.

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2 Normative references
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There are no normative references in this document.

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3 Terms and definitions

ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:​//​w ww​​.iso​​.org/​obp
— IEC Electropedia: available at http:​//​w ww​​.electropedia​​.org/​

2 4 Terms relating related to conformity assessment in general

2.1 4.1
conformity assessment
demonstration that specified requirements (3.1 5.1) relating to a  product (3.3), process, system, person
or body  are fulfilled
Note 1 to entry: The process of conformity assessment as described in the functional approach in Annex A can
have a negative outcome, i.e. demonstrating that the specified requirements are not fulfilled.

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Note 2 to entry: The subject field of conformity Conformity assessment includes activities defined elsewhere
in this International Standard document, such as but not limited to testing (4.2 6.2), inspection (4.3 6.3), and ,
certification (5.5  validation (6.5), as well as the  verification (6.6), certification (7.6), and accreditation (5.6 7.7)
of  conformity assessment bodies (2.5).

Note 3 to entry: Conformity assessment is explained in Annex A as a series of functions. Activities contributing to

any of these functions can be described as conformity assessment activities.

Note 4 to entry: The expression “object of conformity assessment” or “object” is used in this International
Standard to encompass any particular material, product, installation, process, system, person or body to
which conformity assessment is applied. A service is covered by T his document does not include a definition of
“conformity”. “Conformity” does not feature in the definition of a product (see Note 1 to  “conformity assessment”.
Nor does this document address the concept of compliance3.3) .

4.2
object of conformity assessment
object
entity to which specified requirements (5.1) apply
EXAMPLE Product, process, service, system, installation, project, data, design, material, claim, person, body
or organization, or any combination thereof.

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Note 1 to entry: The term “body” is used in this document to refer to conformity assessment bodies (4.6) and

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accreditation bodies (4.7). The term “organization” is used in its general meaning and may include bodies

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according to the context. The more specific ISO/IEC Guide 2 definition of an organization as a body based on
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2.2 4.3
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first-party conformity assessment activity

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conformity assessment activity that is performed by the person or organization that provides the
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object or that is the object of conformity assessment (4.2)

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Note  1  to entry:  The first-, second- and third-party descriptors used to characterize conformity assessment
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activities with respect in relation to a given object are not to be confused with the legal identification of the
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relevant parties to a contract.

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EXAMPLE Activities performed by providers, designers or owners of the object, investors in the object, and
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advertisers or promoters of the object.

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Note 2 to entry: If an activity is performed by an external body acting on behalf of and controlled by a person or
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organization that provides or is the object, the activity is still called a first-party conformity assessment activity
(e.g. internal audits performed by a consultant who is not part of the organization).

2.3 4.4
second-party conformity assessment activity
conformity assessment activity that is performed by a person or organization that has a user interest in
the object object of conformity assessment (4.2)
Note  1  to entry:  The first-, second- and third-party descriptors used to characterize conformity assessment
activities in relation to a given object are not to be confused with the legal identification of the relevant parties
to a contract.

EXAMPLE Persons or organizations performing second-party conformity assessment activities include, for
example, purchasers or users of products, or potential customers seeking to rely on a supplier's management
system, or organizations representing those interests. Examples of organizations representing user interest
include consumer advocacy organizations, regulators implementing legislation governing products and services
for the protection of consumer and public interests, centralized government procurement organizations and
private sector purchasing agents.

Note 2 to entry: Persons or organizations performing If an activity is performed by an external body acting on

behalf of and controlled by a person or organization with a user interest, the activity is still called a second-party
conformity assessment activities include, for example, purchasers or users of products, or potential customers
seeking to rely on a supplier's management system, or organizations representing those interests activity (e.g.
supply chain audits conducted by an external body on behalf of the purchaser).

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Note 3 to entry: See Note to 2.2.

2.4 4.5
third-party conformity assessment activity
conformity assessment activity that is performed by a person or body organization that is independent
of the person or organization that provides the object, provider of the object of conformity assessment
(4.2) and of user interests in that has no user interest in the object
Note 1 to entry: Criteria for the independence of conformity assessment bodies and accreditation bodies are
provided in the International Standards and Guides applicable to their activities (see T he first-, second- and third-
party descriptors used to characterize conformity assessment activities in relation to a given object are not to be
confused with the legal identification of the relevant parties to Bibliography) a contract.

Note 2 to entry: See Note to 2.2.

2.5 4.6
conformity assessment body
body that performs conformity assessment services activities, excluding accreditation (7.7)
Note 1 to entry: An accreditation body (2.6) is not a conformity assessment body.

2.6 4.7
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authoritative body that performs accreditation (5.6 7.7)
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Note 1 to entry: The authority of an accreditation body is generally can be derived from government, public
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authorities, contracts, market acceptance or scheme owners.

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2.7 4.8
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conformity assessment system

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rules, set of rules and procedures (3.2 5.2) and management for carrying out for the management of
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similar or related conformity assessment schemes (2.1 4.9)

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Note 1 to entry: Conformity assessment systems may A conformity assessment system can be operated at an

international, regional, national or , sub-national, or industry sector level.
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conformity assessment scheme

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conformity assessment programme

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set of rules and conformity assessment system (2.7 procedures (5.2) related to specified objects
of conformity assessment t hat describes the objects of conformity assessment (4.2), to which the
same identifies the specified requirements (3.1 5.1), specific rules  and procedures (3.2) apply provides the
methodology for performing conformity assessment (4.1)
Note 1 to entry: A conformity assessment scheme can be managed within a conformity assessment system (4.8).

Note 2 to entry: Conformity assessment schemes may A conformity assessment scheme can be operated at an
international, regional, national or  sub-national, or industry sector level.

Note 3 to entry: A scheme can cover all or part of the conformity assessment functions explained in Annex A.

2.9 4.10
access
access to a system or  scheme
opportunity for an applicant to obtain a conformity assessment (2.1 4.1) under the rules of the system or
scheme service from a body under a conformity assessment scheme (4.9)

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