hb 18.42-1991 guidelines for third-party certification and accreditation guide 42 - guidelines for a...

7/31/2019 HB 18.42-1991 Guidelines for Third-party Certification and Accreditation Guide 42 - Guidelines for a Step-By

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SAA HB18.421991

SANZ HB18.421991ISO/IEC Guide 421984

Guidelines for third-party

certification and accreditation

Guide 42Guidelines for astep-by-stepapproach to an

internationalcertificationsystem


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STANDARDS ASSOCIATION OF NEW ZEALANDThe Standards Association of New Zealand (SANZ) is th e national Standardsauthority in New Zealand. It is also a n international product certification andquality system accreditation authority. Established in 1932, SANZ is anindependent,non-profit organization governed by the Standards Council, underthe Standards Act 1988 .

STANDARDS AUSTRALIAStandards Australia is an independent not-for-profit organization, establishedin 1922. It operates formally under a Royal Charter as the StandardsAssociation of Australia and has recognition as the peak Standards body inAustralia through a Memorandum of Understanding with the CommonwealthGovernment.

AUSTRALIAN AND NEW ZEALAND STANDARDSAustralian and New Zealand Standards are prepared by committees made upof experts from industry, governments, user groups, and other sectors. Therequirements or recommendations contained in published Standards are aconsensus of the views of representative interests and also take account ofcomments received from other sources. They reflect the latest scientific andindustry experience. Australian and New Zealand Standards are kept undercontinuous review after publication and are u pdated regularly to take accountof changing technology.

INTERNATIONAL INVOLVEMENTStandards Australia and the Standards Association of New Zealand have a nimportant role internationally. They are responsible for ensuring that theAustralian and New Zealand viewpoint is considered in the formulation ofInternational Standards and that latest international experience is incorporatedin national and trans-Tasman Standards. This role is vital in assisting localindustry to compete in international markets. Bo th organizations are membersof th e International Organization for Standardization (ISO) and the International

Electrotechnical Commission (IEC).

Enquiries about subscribing membership, quality assurance services and theother services offered by Standards Australia and the Standards Association ofNew Zealand are welcomed.


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SAA HB18.421991

SANZ HB18.421991ISO/IEC GUIDE 421984

Guidelines for third-party

certification and accreditation

Guide 42Guidelines for astep-by-stepapproach to an

internationalcertificationsystem

In AustraliaFirst published as SAA HB18.42June 1991.

In New ZealandFirst published as SANZ HB18.42June 1991.

PUBLISHED JOINTLY BY:

STANDARDS AUSTRALIA1 T he Crescent,Homebush NSW 2140 Australia

STANDARDS NEW ZEALANDLevel 10 , Standards House,

155 The Terrace,Wellington 6001 New ZealandISBN 0 7262 6894 1


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PREFACE

This handbook is presented as a series of separate publications, each of which is identical with thecorresponding guide published either jointly by the International Organization for Standardization (ISO) andthe International Electrotechnical Commission (IEC) or solely by ISO. It has been issued as a joint publicationunder the terms of the Memorandum of Understanding between Standards Australia and the Standards

Association of New Zealand.The information contained in the various guides making up this handbook is intended to assist organizationsin understanding the basis of product certification and third-party certification systems and how the variousbodies operating such schemes should function. Coverage is also given in some instances to guidance on theestablishment and operation of laboratory accreditation bodies as w ell as the type of information that s uchbodies will require of testing laboratories, including those carrying out calibration, when making application foraccreditation. It is anticipated that these guides will become of greater importance when the forthcoming JointAccreditation SchemeAustralia and New Zealand (JAS ANZ) becomes operational. Reference should alsobe made to the Standards for quality systems which are published jointly in Australia and N ew Zealand as theAS 3900/NZS 9000/ISO 9000 series.

The other guides covered in this handbook are as follows:

Guide 7: Requirements for standards suitable for product certification

Guide 16: Code of principles on third-party certification systems and related standards

Guide 22: Information on manufacturers declaration of conformity with standards or other technical

specificationsGuide 23: Methods of indicating conformity w ith standards for third-party certification systems

Guide 25: General requirements for the competence of calibration and testing laboratories

Guide 27: Guidelines for corrective action to be taken by a certification body in the event of eithermisapplication of its mark of conformity to a product, or products which bear the mark of thecertification body being found to subject persons or property to risk

Guide 28: General rules for a model third-party certification system for products

Guide 39: General requirements for the acceptance of inspection bodies

Guide 40: General requirements for the acceptance of certification bodies

Guide 43: Development and operation of laboratory proficiency testing

Guide 44: General rules for ISO or IEC international third-party certification schemes f or products

Guide 48: Guidelines for third-party assessment and registration of a suppliers Quality System

Guide 53: An approach to the utilization of a suppliers quality system in third-party product certificationGuide 54: Testing laboratory accreditation systemsGeneral recommendations for the acceptance of

accreditation bodies

Guide 55: Testing laboratory accreditation systemsGeneral recommendations for operation

Guide 56: An approach to the review by a certification body of its own internal quality system

Copyright STANDARDS AUSTRALIA/STANDARDS NEW ZEALAND

Users of Standards are reminded that copyright subsists in all Standards Australia and Standards New Zealand publications andsoftware. Except where the Copyright Act allows and except where provided for below no publications or software produced byStandards Australia or Standards New Z ealand may be reproduced, stored in a r etrieval system in any form or t ransmitted by anymeans without prior permission in writing fr om Standards Australia or Standards New Zealand. Permission may be conditional on anappropriate royalty payment. Australian requests for permission and information on commercial software r oyalties should be directedto the head offi ce of Standards Australia. New Zealand requests should be directed to Standards New Zealand.

Up to 10 percent of the t echnical content pages of a Standard may be copied for use exclusively in-house by purchasersof 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 r oyalty payment provided suchprograms are used exclusively i n-house by the creators of the programs.

Care should be taken to ensure t hat material used is from the current edition of the Standard and that it is updated whenever theStandard is amended or r evised. The number and date of t he Standard should t herefore be clearly i dentified.

The use of material in print f orm or in computer software programs to be used commercially, with or without payment, or in

commercial contracts is subject to t he payment of a royalty. This policy may be varied by Standards A ustralia or Standards NewZealand at any time.


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STANDARDS AUSTRALIA/STANDARDS ASSOCIATION OF NEW ZEALAND

Guidelines for a step-by-step approach to an international

certification system

0 Introduction

The basic functions performed by a product certification system involving third-party certification bodies includeevaluation of the product by testing to designated standard(s), inspection and approval of the manufacturing facilityand quality system, subsequent monitoring of the production and quality system, and controlling the methods bywhich conformity is indicated. Obviously, all these functions must be performed within the laws of the country wherethe certification is granted, in accordance with agreed and readily accessible rules and procedures, and executedin a completely non-discriminatory manner.

When the methods for i mplementing these functions on an i nternational basis are contemplated, it is obvious that

they are likely to become complex to administer and co-ordinate. Yet, as difficult as these problems may appear tobe, they still may not pose the most significant drawback to the initiation of a full-fledged certification system.

One of the major obstacles to widespread participation in international certification systems is the lack of confidencewhich certification bodies have in their across-border counterparts and the fear of large scale commitment to a systemwith which they have had no previous experience.

This paper suggests that, through a progressively expanding set of acceptance arrangements, confidence amongcertification b odies at the international level can be fostered and certification bodies can gain experience and therebyhave their fear of participation allayed as they move towards participation in a truly international certification system.

In addition to building confidence in across-border certification bodies, the step-by-step approach to an internationalcertification system enables t he parties to develop bilateral or m ultilateral arrangements which provide advantagesto all the parties and which can adjust readily to different legal systems.

This approach will, where the parties so desire, also permit the continued use of the importing countrys certification

mark on the imported product, thereby avoiding the problems of educating the public to the significance of new andunfamiliar marks of other countries.

Under this approach, the need for duplicate testing or inspection is obviously reduced, especially if the parties agreeupon the use of a common standard. The use of international standards together with the implementation of the otheritems discussed herein will greatly enhance this feature.

There have existed for many years a number of various forms of acceptance arrangements involving across-bordercertification bodies, which have operated successfully without benefit of a formalized international certification system.These arrangements generally involve the recognition or acceptance by one party of the work of another party i ndealing wi th one or more of the elements of a comprehensive certification system (see clause 5).

The approach suggested herein is predicated upon the use of recognized national, regional or, preferably,international standards if available, wh ere the technical requirements on which the certification is based are availableto the general public.

1 Scope and object

This paper is prepared as a guide to those parties who wish to gain some experience in the operation of acceptancearrangements in the international area, but w ho may not be prepared currently t o participate fully in an internationalcertification system.

2 References

ISO Guide 2, General terms and their definitions covering standardization, certification and testing laboratoryaccreditation.

ISO/IEC Guide 7, Requirements for standards suitable for product certification.

COPYRIGHT


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