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 AS ISO/IEC 17000—2005ISO/IEC 17000:2004

Australian Standard™ 

Conformity assessment—Vocabularyand general principles

A S I   S  O/  I  E C 1 7  0  0  0 —2  0  0  5 

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This Australian Standard was prepared by Committee QR-010, ConformityAssessment. It was approved on behalf of the Council of Standards Australia on22 August 2005.This Standard was published on 21 November 2005.

The following are represented on Committee QR-010:

Association of Accredited Certification Bodies

Australian Information Industry Association

Australian Quarantine and Inspection Service (Commonwealth)

Certification Interests (Australia)

Certification Interests (New Zealand)

Consumer Electronics Suppliers Association

Consumers Federation of AustraliaInternational Accreditation Forum

Joint Accreditation System of Australia and New Zealand

 National Association of Testing Authorit ies Australia

Keeping Standards up-to-date

Standards are living documents which reflect progress in science, technology andsystems. To maintain their currency, all Standards are periodically reviewed, andnew editions are published. Between editions, amendments may be issued.Standards may also be withdrawn. It is important that readers assure themselvesthey are using a current Standard, which should include any amendments whichmay have been published since the Standard was purchased.

Detailed information about Standards can be found by visiting the Standards WebShop at www.standards.com.au and looking up the relevant Standard in the on-linecatalogue.

Alternatively, the printed Catalogue provides information current at 1 January each year, and the monthly magazine, The Global Standard , has a full listing of revisionsand amendments published each month.

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We also welcome suggestions for improvement in our Standards, and especiallyencourage readers to notify us immediately of any apparent inaccuracies orambiguities. Contact us via email at mail@standards.org.au, or write to the ChiefExecutive, Standards Australia, GPO Box 476, Sydney, NSW 2001.

This Standard was issued in draft form for comment as DR 05232.

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 AS ISO/IEC 17000—2005

Australian Standard™ 

Conformity assessment—Vocabularyand general principles

Originated as HB 18.2—1992.Jointly revised and designated HB 18.2:2003.Revised and redesignated AS ISO/IEC 17000—2005.

COPYRIGHT

© Standards Australia

 All rights are reserved. No part o f this work may be reproduced or cop ied in any form or by

any means, electronic or mechanical, including photocopying, without the written

permission of the publisher.

Published by Standards Australia, GPO Box 476, Sydney, NSW 2001, Australia

ISBN 0 7337 6981 0

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 ii

PREFACE

This Standard was prepared by the Australian members of the Joint Standards

Australia/Standards New Zealand Committee QR-010, Conformity Assessment. Afterconsultation with stakeholders in both countries, Standards Australia and Standards New

Zealand decided to develop this Standard as an Australian Standard rather than an

Australian/New Zealand Standard. It supersedes HB 18.2:2003.

This Standard is identical with, and has been reproduced from the English language part of

ISO/IEC 17000:2004, Conformity assessment—Vocabulary and general principles.

The objective of this Standard is to specify 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.

As this Standard is reproduced from an international standard, the following applies:

(a) Its number appears on the cover and title page while the international standard number

appears only on the cover

(b) In the source text ‘ISO/IEC 17000’ or ‘This International Standard’ should read

‘AS ISO/IEC 17000’.

(c) A full point substitutes for a comma when referring to a decimal marker.

(d) Foreign languages in text and on figures should be ignored.

The term ‘informative’ has been used in this Standard to define the application of the annex to

which it applies. An ‘informative’ annex is only for information and guidance.

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  ii i

CONTENTS

Page

1 Scope............................................................................................................................................................1 

2 Terms relating to conformity assessment in general .............................................................................1 

3 Basic terms..................................................................................................................................................2 

4 Conformity assessment terms relating to selection and determination (see Figure A.1) ....................3 

5 Conformity assessment terms relating to review and attestation (see Figure A.1) ..............................3 

6 Conformity assessment terms relating to surveillance (see Figure A.1) ...............................................4 

7 Terms relating to conformity assessment and facilitation of trade..................................................... ..5 

Annex A (informative) Principles of conformity assessment.........................................................................7 

Annex B (informative) Related terms defined in other documents .............................................................12 

Bibliography......................................................................................................................................................13 

Alphabetical index............................................................................................................................................14 

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 iv

INTRODUCTION

0.1 Terms and definitions applicable to conformity assessment

ISO and ISO/IEC Guides and, more recently, International Standards relating generically to conformityassessment activities such as testing, inspection and various forms of certification are prepared by workinggroups of the ISO Committee on conformity assessment (CASCO). For many years, ISO/IEC Guide 2, lastrevised in 1996, has included a core vocabulary for conformity assessment, built up from a small number ofterms and definitions first compiled to facilitate communication and understanding about product certificationbased on standards for traditional manufactured goods.

In 2000, CASCO decided to take conformity assessment terminology (Clauses 12 to 17) out ofISO/IEC Guide 2 and provide instead a self-contained vocabulary more readily applicable within the plannedISO/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 CASCOworking groups, as a consistent framework within which more specific concepts may be defined appropriatelyand denoted by the most appropriate terms. Extra terms for concepts unique to particular activities withinconformity assessment, such as accreditation, certification of persons and marks of conformity, are found inthe International Standard or Guide related to that activity. Such concepts are not included in this InternationalStandard.

Until pre-existing CASCO publications are revised, the terminology used in those documents remains valid inits context; this International Standard is not intended to be applied retrospectively.

Conformity assessment interacts with other fields such as management systems, metrology, standardizationand statistics. This International Standard does not define the boundaries of conformity assessment. Theseremain elastic.

0.2 Terms and definitions applicable to trade policy

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

0.3 A functional approach to conformity assessment

The terms and definitions specified in this International Standard, particularly under Clauses 4 and 5, reflectthe adoption by CASCO in November 2001 of the functional approach recommended earlier that year in thefinal 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 descriptionof 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 todefine. Others it was thought helpful to explain. Many of the general terms used to distinguish conformityassessment 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 relevantterms are given in Annex B with separate alphabetical lists. First are terms applicable to specific aspects ofconformity assessment, as defined in other standards in the ISO/IEC 17000 series. Second are terms forwhich 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 contexts. For the terms “procedure” and

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

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0.5 Changes in terminology

 Attention is drawn to significant changes in the terms or their definitions from the superseded clauses ofISO/IEC Guide 2.

This International Standard does not include a definition of “conformity” on the grounds that it is not necessaryto 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” bymaking 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 longercorrect to refer to “products and services”.

Instead of “product, process or service”, the generic expression used in ISO/IEC Guide 2 for the “subject ofstandardization”, Note 2 to 2.1  introduces the expression “object of conformity assessment” as a means ofreferring to the product, process, system, person or body to which conformity assessment is applied. (The“subject” would more logically be the body doing the assessment.)

Instead of “assurance of conformity”, the term “attestation” (5.2) is used for the activity of conveying assurancethrough the issue of a “statement of conformity”.

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

To avoid ambiguity, the term “body” is used in this International Standard only when referring to conformityassessment bodies or accreditation bodies. Otherwise, the term “organization” is used in its general meaning,as in the ISO 9000 definition. The more specific ISO/IEC Guide 2 definition of an organization as a body

based on membership is not applicable to the field of conformity assessment.

v

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NOTES

vi

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  1

 AUSTRALIAN STANDARD

Conformityassessment —

Vocabulary andgeneral principles

1 Scope

This International Standardspecifies general terms anddefinitions relating to conformity

assessment, including theaccreditation of conformityassessment bodies, and to theuse of conformity assessment tofacilitate trade. A description ofthe functional approach toconformity assessment isincluded in Annex A, as a further aid to understanding among usersof conformity assessment, con-formity assessment bodies andtheir accreditation bodies, in bothvoluntary and regulatory environ-

ments.

This International Standard doesnot set out to provide avocabulary for all of the conceptsthat may need to be used indescribing particular conformityassessment activities. Terms anddefinitions are given only wherethe concept defined would not beunderstandable from the generallanguage use of the term, or where an existing standard

definition is not applicable.

NOTE 1  The notes appended tocertain definitions offer clarification orexamples to facilitate understandingof the concepts described. In certaincases, the notes may differ in differentlanguages for linguistic reasons, or additional notes may be given.

NOTE 2 The terms and definitionsare laid out in a systematic order, withan alphabetical index. A term in adefinition or note that is defined in

another entry is indicated by bold-

 

face followed by its entry number inparentheses. Such terms may bereplaced by their complete definition.

2 Terms relating to conformityassessment in general

2.1conformity assessmentdemonstration that specified requirements  (3.1)relating to a product (3.3), process, system, personor body are fulfilled

NOTE 1  The subject field of conformity assessmentincludes activities defined elsewhere in this InternationalStandard, such as testing  (4.2), inspection  (4.3) andcertification  (5.5), as well as the accreditation  (5.6) ofconformity assessment bodies (2.5).

NOTE 2 The expression “object of conformity

assessment” or “object” is used in this InternationalStandard to encompass any particular material, product,installation, process, system, person or body to whichconformity assessment is applied. A service is covered bythe definition of a product (see Note 1 to 3.3).

2.2first-party conformity assessment activity conformity assessment activity that is performed bythe person or organization that provides the object

NOTE The first-, second- and third-party descriptorsused to characterize conformity assessment activities withrespect to a given object are not to be confused with thelegal identification of the relevant parties to a contract.

2.3second-party conformity assessment

activity

conformity assessment activity that is performed by aperson or organization that has a user interest in theobject

NOTE 1  Persons or organizations performing second-party conformity assessment activities include, for example, purchasers or users of products, or potentialcustomers seeking to rely on a supplier's managementsystem, or organizations representing those interests.

NOTE 2 See Note to 2.2.

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AS ISO/IEC 17000-2005 Conformity assessment -Vocabulary and general principles