AS/NZS 3841:1998

ISO/IEC Guide 61:1996

Australian/New Zealand Standard™

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Guide 61: General requirements

for assessment and accreditation
of certification/registration bodies
 AS/NZS 3841:1998

This Joint Australian/New Zealand Standard was prepared by Joint Technical

Committee QR/10, Conformity Assessment. It was approved on behalf of the
Council of Standards Australia on 18 September 1998 and on behalf of the
Council of Standards New Zealand on 12 October 1998. It was published on
5 December 1998.

The following interests are represented on Committee QR/10:

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Australian Chamber of Manufacturers

Australian Quarantine and Inspection Service (Commonwealth)
Department of Industry, Science and Tourism (Commonwealth)
Joint Accreditation System of Australia and New Zealand
Ministry of Commerce, New Zealand
Ministry of Defence, New Zealand
National Association of Testing Authorities, Australia
Queensland Purchasing
Third-party certification bodies, Australia and New Zealand

Review of Standards. To keep abreast of progress in industry, Joint Australian/

New Zealand Standards are subject to periodic review and are kept up to date by the
issue of amendments or new editions as necessary. It is important therefore that
Standards users ensure that they are in possession of the latest edition, and any
amendments thereto.
Full details of all Joint Standards and related publications will be found in the Standards
Australia and Standards New Zealand Catalogue of Publications; this information is
supplemented each month by the magazines ‘The Australian Standard’ and ‘Standards
New Zealand’, which subscribing members receive, and which give details of new
publications, new editions and amendments, and of withdrawn Standards.
Suggestions for improvements to Joint Standards, addressed to the head office of either
Standards Australia or Standards New Zealand, are welcomed. Notification of any
inaccuracy or ambiguity found in a Joint Australian/New Zealand Standard should be
made without delay in order that the matter may be investigated and appropriate action
taken.

This Standard was issued in draft form for comment as DR 98210.

 AS/NZS 3841:1998

Australian/New Zealand Standard™

This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.

Guide 61: General requirements

for assessment and accreditation
of certification/registration bodies

First published as AS/NZS 3841:1998.

Published jointly by:

Standards Australia
1 The Crescent,
Homebush NSW 2140 Australia

Standards New Zealand

Level 10, Radio New Zealand House,
155 The Terrace,
Wellington 6001 New Zealand
ISBN 0 7337 2253 9
 ii

PREFACE

This Standard was prepared by the Joint Standards Australia / Standards New Zealand Committee
QR/10, Conformity Assessment. It is identical with, and has been reproduced from ISO/IEC
Guide 61:1996, which was prepared by the ISO Committee on Conformity Assessment (CASCO).
ISO/IEC Guide 61:1996 was first published and is currently available in Australia and New Zealand
as a Handbook, SAA/SNZ HB18.61, i.e. part of the Series HB18, Guidelines for third-party
certification and accreditation procedures. However, Committee QR/10 considers that it should also
be available as a Standard, i.e. as a normative document providing a suitable basis for certification
and accreditation procedures.
As this Standard is reproduced from an international Standard, the following applies:
(a) Its number does not appear on each page of text and its identity is shown only on the cover
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and title page.

(b) In the source text ‘this Guide’ should read ‘this Australian/New Zealand Standard’.
(c) A full point substitutes for a comma when referring to a decimal marker.
References to International Standards should be replaced by Australian or Joint Australian/
New Zealand Standards as follows:
Reference to International Standard or other Australian or Joint Australian/New Zealand
publication Standard
ISO/IEC SAA
Guide 2 General terms and their definitions HB18 Guidelines for third-party
concerning standardization and certification and accreditation
related activities HB18.2 Guide 2 — General terms and their
definitions concerning
standardization and related activities
(SANZ HB18.2)
Guide 25 General requirements for the HB18.25 Guide 25 — General requirements for
competence of calibration and testing the competence of calibration and
laboratories testing laboratories (SANZ HB18.25)

Guide 27 Guidelines for corrective action to be
taken by a certification body in the
event of misuse of its mark on
conformity
Guide 28 General rules for a model third-party
certification system for products
Guide 40 General requirements for bodies
operating product certification
systems
Guide 62 General requirements for bodies
operating assessment and
certification/registration of quality
systems
HB18.27 Guide 27 — Guidelines for corrective
action to be taken by a certification
body in the event of misuse of its
mark of conformity
(SANZ HB18.27)
HB18.28 Guide 28 — General rules for a
model third-party certification
system for products (SANZ
HB18.28)
AS/NZS
3843 Guide 65: General requirements for
bodies operating product certification
systems
3842 Guide 62: General requirements for
bodies operating assessment and
certification/registration of quality
systems
 iii
ISO AS/NZS
8402 Quality management and quality ISO 8402 Quality management and quality
assurance — Vocabulary assurance—Vocabulary
AS
10011 Guidelines for auditing quality 3911 Guidelines for auditing quality
systems systems
10011-1 Part 1: Auditing 3911.1 Part 1: Auditing (NZS 10011.1)
10011-2 Part 2: Qualification criteria for 3911.2 Part 2: Qualification criteria for
quality systems quality systems auditors
(NZS 10011.2)
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© Copyright STANDARDS AUSTRALIA / STANDARDS NEW ZEALAND

Users of Standards are reminded that copyright subsists in all Standards Australia and Standards New Zealand publications and software.
Except where the Copyright Act allows and except where provided for below no publications or software produced by
Standards Australia or Standards New Zealand may be reproduced, stored in a retrieval system in any form or transmitted by any means
without prior permission in writing from Standards Australia or Standards New Zealand. Permission may be conditional on an
appropriate royalty payment. Australian requests for permission and information on commercial software royalties should be directed to
the head office of Standards Australia. New Zealand requests should be directed to Standards New Zealand.
Up to 10 percent of the technical content pages of a Standard may be copied for use exclusively in-house by purchasers of the
Standard without payment of a royalty or advice to Standards Australia or Standards New Zealand.
Inclusion of copyright material in computer software programs is also permitted without royalty payment provided such programs
are used exclusively in-house by the creators of the programs.
Care should be taken to ensure that material used is from the current edition of the Standard and that it is updated whenever the Standard
is amended or revised. The number and date of the Standard should therefore be clearly identified.
The use of material in print form or in computer software programs to be used commercially, with or without payment, or in commercial
contracts is subject to the payment of a royalty. This policy may be varied by Standards Australia or Standards New Zealand at any time.
 iv

CONTENTS
Page
Section 1: General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Section 2: Requirements for accreditation bodies . . . . . . . . . . . . . . 3

2.1 Accreditation body . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1.1 General provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
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2.1.2 Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1.3 Subcontracting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1.4 Quality system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1.5 Conditions for granting, maintaining, extending,
reducing, suspending and withdrawing accreditation . . . . . . . 5
2.1.6 Internal audits and management reviews . . . . . . . . . . . . . . . 5
2.1.7 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.1.8 Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.1.9 Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.2 Accreditation body personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.2.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.2.2 Qualification criteria for auditors and technical experts . . . . . 6
2.2.3 Selection procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.2.4 Contracting of assessment personnel . . . . . . . . . . . . . . . . . 7
2.2.5 Assessment personnel records . . . . . . . . . . . . . . . . . . . . . . 7
2.2.6 Procedures for assessment teams . . . . . . . . . . . . . . . . . . . . 7
2.3 Decision on accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.4 References to accredited status . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.5 Change in the accreditation requirements . . . . . . . . . . . . . . . . . . . 8
2.6 Appeals, complaints and disputes . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.7 Access to records of appeals, complaints and disputes . . . . . . . . . 8

Section 3: Requirements for assessment . . . . . . . . . . . . . . . . . . . . . 9

3.1 Application for accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.1.1 Information on the procedure . . . . . . . . . . . . . . . . . . . . . . . 9
3.1.2 The application ................................. 9
3.2 Preparation for assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.3 Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.4 Assessment report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.5 Surveillance and reassessment procedures . . . . . . . . . . . . . . . . . 10
 v

INTRODUCTION

The requirements contained in this Guide are written, above all, to be

considered as general requirements for bodies operating accreditation
systems. This Guide, however, is in three sections so that if used by
organizations other than accreditation bodies concerned with recognition of
competence, Sections 1 and 3 apply, and users need simply replace
“accreditation” by “recognition”.
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vi

NOTES
 1

AUSTRALIAN/NEW ZEALAND STANDARD

Guide 61: General requirements for assessment and accreditation

of certification/registration bodies

Section 1: General
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1.1 Scope exchange of staff or training programmes. In particular, with a

This Guide specifies general requirements for a
body to follow if it is to be recognized at a national
or international level as competent and reliable in
assessing and subsequently accrediting
certification bodies or registration bodies.
Conformity to the requirements of this Guide will
promote equivalence of national systems and
facilitate agreements on mutual recognition of
accreditations between such bodies.
view to create confidence and harmonize the interpretation and
implementation of standards, each accreditation body should
encourage technical cooperation and exchange of experience
among bodies accredited by it, and it should be prepared to
exchange information on accreditation procedures and
practices with other accreditation bodies. Certification and
certification/registration body standards often contain
non-specific requirements such as “staff shall be competent”.
Mutual recognition of accreditation requires harmonization of
interpretation of such clauses.

The primary objective of this Guide is to describe

accreditation as providing, by means of
assessment and subsequent surveillance, an
assurance that the market can rely on certificates
1.2 References
issued by the accredited bodies. However,
organizations other than accreditation bodies,
ISO/IEC Guide 2:1996, General terms and their
concerned with recognition of competence, may
also use it by replacing “accreditation” by
definitions concerning standardization and related
“recognition”.
activities.

In some countries, bodies which verify conformity

ISO/IEC Guide 25:1990, General requirements for
of products, processes, services or systems to
specified standards are called “certification
the competence of calibration and testing
bodies”, in other countries “registration bodies”,
laboratories.
and in still others “assessment bodies”. For ease
of understanding, this Guide always refers to such
ISO/IEC Guide 27:1983, Guidelines for corrective
bodies as “bodies”. This should not be understood
to be limiting, as this Guide may also be
action to be taken by a certification body in the
applicable to the assessment and accreditation of
event of misuse of its mark of conformity.
conformity assessment bodies other than
certification or registration bodies, such as
ISO/IEC Guide 28:1982, General rules for a model
inspection bodies.
third-party certification system for products.
NOTE 1 It is recognized that agreements on mutual
recognition of accreditations aiming at the removal of barriers ISO/IEC Guide 40:—1), General requirements for
to cross-border trade may have to cover other aspects not bodies operating product certification systems.
explicitly specified in these general requirements, such as the

1) To be published. (Revision of ISO/IEC Guide 40:1983)

COPYRIGHT
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AS/NZS 3841:1998, Guide 61: General

requirements for assessment and accreditation of
certification/registration bodies
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.

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