AS/NZS 3843:1998

ISO/IEC Guide 65:1996

Australian/New Zealand Standard™

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

Guide 65: General requirements

for bodies operating product
certification systems
 AS/NZS 3843:1998

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publications, new editions and amendments, and of withdrawn Standards.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 98212.

 AS/NZS 3843:1998

Australian/New Zealand Standard™

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

Guide 65: General requirements

for bodies operating product
certification systems

First published as AS/NZS 3843:1998.

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 2255 5
 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 65:1996, which was prepared by the ISO Committee on Conformity Assessment (CASCO).
ISO/IEC Guide 65:1996 was first published and is currently available as a Handbook, SAA/SNZ
HB18.65, i.e. part of the Series HB18, Guidelines for third-party certification and accreditation.
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
and title page.
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(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.
Reference 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 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
ISO/IEC SAA
Guide 2 Standardization and related HB18 Guidelines for third-party
activities — General vocabulary certification and accreditation
HB18.2 Guide 2 — General terms and their
definitions concerning
standardization and related activities
(SANZ HB18.2)
SAA/SNZ
Guide 7 Guidelines for drafting of standards HB18.7 Guide 7 — Guidelines for drafting of
suitable for use for conformity standards suitable for use for
assessment conformity assessment

Guide 23 Methods of indicating conformity
with standards for third-party
certification systems
Guide 25 General requirements for the
competence of calibration and testing
laboratories
SAA
HB18.23 Methods of indicating conformity
with standards for third-party
certification systems
(SANZ HB18.23)
HB18.25 Guide 25 — General requirements for
the competence of calibration and
testing laboratories (SANZ HB18.25)
 iii
ISO/IEC SAA
Guide 27 Guidelines for corrective action to be HB18.27 Guide 27 — Guidelines for corrective
taken by a certification body in the action to be taken by a certification
event of misuse of its mark on body in the event of misuse of its
conformity mark of conformity
(SANZ HB18.27)
Guide 28 General rules for a model third-party HB18.28 Guide 28 — General rules for a
certification system for products model third-party certification
system for products (SANZ
HB18.28)
Guide 39 General requirements for the HB18.39 Guide 39 — General requirements for
acceptance of inspection bodies the acceptance of inspection bodies
(SANZ HB18.39)
Guide 53 An approach to the utilization of a HB18.53 Guide 53 — An approach to the
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supplier’s quality system in third- utilization of a supplier’s quality

party product certification system in third-party product
certification (SANZ HB18.53)
AS/NZS
Guide 62 General requirements for bodies 3842 Guide 62: General requirements for
operating assessment and bodies operating assessment and
certification/registration of quality certification/registration of quality
systems systems

© 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
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

4 Certification body . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.1 General provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.2 Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.3 Operations, . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4.4 Subcontracting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
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4.5 Quality system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

4.6 Conditions and procedures for granting, maintaining
extending, suspending and withdrawing certification . . . . . . 4
4.7 Internal audits and management reviews . . . . . . . . . . . . . . 4
4.8 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.9 Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.10 Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

5 Certification body personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

5.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.2 Qualification criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

6 Changes in the certification requirements . . . . . . . . . . . . . . . . . . 6

7 Appeals, complaints and disputes . . . . . . . . . . . . . . . . . . . . . . . . 6

8 Application for certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

8.1 Information an the procedure . . . . . . . . . . . . . . . . . . . . . . . 6
8.2 The application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

9 Preparation for evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

10 Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

11 Evaluation report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

12 Decision on certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

13 Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

14 Use of licences, certificates and marks of conformity . . . . . . . . . . 8

15 Complaints to suppliers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
 v

INTRODUCTION

Certification of a product (a term used to include a process or service) is a

means of providing assurance that it complies with specified standards and
other normative documents. Some product certification systems may include
initial testing of a product and assessment of its suppliers’ quality systems,
followed by surveillance that takes into account the factory quality system
and the testing of samples from the factory and the open market. Other
systems rely on initial testing and surveillance testing, while still others
comprise type testing only.

This Guide specifies requirements, the observance of which is intended to

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ensure that certification bodies operate third-party certification systems in a

consistent and reliable manner, thereby facilitating their acceptance on a
national and international basis and so furthering international trade.

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

considered as general criteria for organizations operating product
certification systems; they may have to be amplified when specific industrial
or other sectors make use of them, or when particular requirements such as
health and safety have to be taken into account.

Assertion of conformity to the appropriate standards or other normative

documents will be in the form of certificates or marks of conformity. Systems
for certifying particular products or product groups to specified standards or
other normative documents will, in many cases, require their own explanatory
documentation.

While this Guide is concerned with third-parties providing product

certification, many of its provisions may also be useful in first- and
second-party product conformity assessment procedures.

The diversity in certification systems may at first seem unnecessary and

even confuse newcomers in the field, clients and operators alike. The
ISO/IEC publication Certification and related activities is available for
background reading and will help to answer questions regarding the
practices of the worldwide conformity assessment community.
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vi

NOTES
 1
AUSTRALIAN/NEW ZEALAND STANDARD
Guide 65: General requirements for bodies operating product
certification systems
1 Scope
1.1 This Guide specifies general requirements
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that a third-party operating a product certification
system shall meet if it is to be recognized as
competent and reliable.
In this Guide the term “certification body” is used
to cover any body operating a product certification
system. The word “product” is used in its widest
sense and includes processes and services; the
word “standard” is used to include other normative
documents such as specifications or technical
regulations.
1.2 The certification system used by the
certification body may include one or more of the
following, which could be coupled with production
surveillance or assessment and surveillance of the
supplier’s quality system or both, as described in
ISO/IEC Guide 53:
a) type testing or examination;
b) testing or inspection of samples taken from
the market or from supplier’s stock or from
a combination of both;
c) testing or inspection of every product or of a
particular product, whether new or already
in use;
d) batch testing or inspection;
e) design appraisal.
NOTE 1 ISO/IEC Guide 28 may be consulted for a model of
one form of a third-party product certification system.
2 References
ISO 8402:1994, Quality management and quality
assurance — Vocabulary.
ISO 10011-1:1990, Guidelines for auditing quality
systems — Part 1: Auditing.
COPYRIGHT
ISO/IEC Guide 2:1996, Standardization and
related activities — General vocabulary.
ISO/IEC Guide 7:1994, Guidelines for drafting of
standards suitable for use for conformity
assessment.
ISO/IEC Guide 23:1982, Methods of indicating
conformity with standards for third-party
certification systems.
ISO/IEC Guide 25:1990, General requirements for
the competence of calibration and testing
laboratories.
ISO/IEC Guide 27:1983, Guidelines for corrective
action to be taken by a certification body in the
event of misuse of its mark of conformity.
ISO/EC Guide 28:1982, General rules for a model
third-party certification system for products.
ISO/IEC Guide 39:1988, General requirements for
the acceptance of inspection bodies.
ISO/IEC Guide 53:1988, An approach to the
utilization of a supplier’s quality system in
third-party product certification.
ISO/IEC Guide 62:1996, General requirements for
bodies operating assessment and certification/
registration of quality systems.
3 Definitions
For the purposes of this Guide, the relevant
definitions given in ISO/IEC Guide 2 and ISO
8402 apply, together with the following definition.
3.1 supplier: The party that is responsible for
ensuring that products meet and, if applicable,
continue to meet, the requirements on which the
certification is based.
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AS/NZS 3843:1998, Guide 65: General

requirements for bodies operating product
certification systems
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.

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