hb 18.43.1-1998 guidelines for third-party certification and accreditation guide 43 - proficiency...

7/31/2019 HB 18.43.1-1998 Guidelines for Third-party Certification and Accreditation Guide 43 - Proficiency Testing By

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SAA/SN Z HB18.43.1:1998ISO/IEC Guide 43-1:1997

Gui del ine s for third-party

certification and accreditation

Guide 43Proficiency testing

by interlaboratorycomparisonsPart 1: D evel opmentand operation ofproficiency testing

schemes


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SAA/SNZ HB18.43.1:1998

This Joint Australian/New Zealand Handbook was prepared by Joint TechnicalCommittee QR/10, Conformity Assessment. It was published on 5 September 1998.

The following interests are represented on Committee QR/10:

Australian Chamber of ManufacturesAustralian Quarantine and Inspection Service (Commonwealth)Department of Industry, Science and Tourism (Commonwealth)Joint Accreditation System of Australia and New ZealandMinistry of Commerce, New ZealandMinistry of Defence, New ZealandQueensland PurchasingThird-party certification bodies, Australia and New Zealand

Additional interests participating in preparation of Standard:

NATA, Australia

International Accreditation 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 issueof amendments or new editions as necessary. It is important therefore that Standards usersensure 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 StandardsAustralia and Standards New Zealand Catalogue of Publications; this information issupplemented each month by the magazines The Australian Standard and StandardsNew Zealand, which subscribing members receive, and which give details of newpublications, new editions and amendments, and of withdrawn Standards.

Suggestions for improvements to Joint Standards, addressed to the head office of eitherStandards Australia or Standards New Zealand, are welcomed. Notification of anyinaccuracy or ambiguity found in a Joint Australian/New Zealand Standard should be madewithout delay in order that the matter may be investigated and appropriate action taken.


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PREFACE

This Joint Handbook, prepared by the Joint Standards Australia/Standards New Zealand

Committee QR/10, Conformity Assessment, is presented as a series of separate publications,each of which is identical with the corresponding guide published either jointly by the InternationalOrganization for Standardization (ISO) and the International Electrotechnical Commission (IEC) orsolely by ISO.

The information contained in the various guides making up this Handbook is intended to assistorganizations in understanding the basis of product certification and third-party certificationsystems and how the various bodies operating such schemes should function. Coverage is alsogiven to guidance on the establishment and operation of laboratory accreditation bodies as well asthe type of information that such bodies will require of testing laboratories, including thosecarrying out calibration, when making application for accreditation. It is anticipated that this Guidewill be relevant to laboratories and laboratory accreditation bodies.

This Guide supersedes in part SAA HB18.43 1991/SANZ HB18.431991/ISO/IEC Guide 43 1984,

Guide 43: Development and operation of laboratory proficiency testing.

The other guides covered in this Handbook are as follows:

Guide 2: General terms and their definitions concerning standardization and related activitiesGuide 7: Guidelines for drafting of Standards suitable for use for conformity assessmentGuide 22: Information on manufacturers declaration of conformity with Standards or other

technical specificationsGuide 23: Methods of indicating conformity with Standards for third-party certification systemsGuide 25: General requirements for the competence of calibration and testing laboratoriesGuide 27: Guidelines for corrective action to be taken by a certification body in the event of

either misapplication of its mark of conformity to a product, or products which bear themark of the certification body being found to subject persons or property to risk

Guide 28: General rules for a model third-party certification system for productsGuide 39: General requirements for the acceptance of inspection bodiesGuide 42: Guidelines for a step-by-step approach to an international certification systemGuide 44: General rules for ISO or IEC international third-party certification schemes for

productsGuide 53: An approach to the utilization of a suppliers quality system in third-party product

certificationGuide 56: An approach to the review by a certification body of its own internal quality systemGuide 57: Guidelines for the presentation of inspection resultsGuide 58: Calibration and testing laboratory accreditation systems General requirements for

operation and recognitionGuide 60: Code of good practice for conformity assessment

Guide 61: General requirements for assessment and accreditation of certification/registrationbodies

Guide 62: General requirements for bodies operating assessment and certification/registration ofquality systems

Guide 65: General requirements for bodies operating product certification systems


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CONTENTS

Page

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

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

3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

4 Types of proficiency testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

4.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

4.2 Measurement comparison schemes . . . . . . . . . . . . . . . . . . 3

4.3 Interlaboratory testing schemes . . . . . . . . . . . . . . . . . . . . . 4

4.4 Split-sample testing schemes . . . . . . . . . . . . . . . . . . . . . . . 4

4.5 Qualitative schemes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

4.6 Known-value schemes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

4.7 Partial-process schemes . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

5 Organization and design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

5.1 Framework . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

5.2 Staff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

5.3 Data-processing equipment . . . . . . . . . . . . . . . . . . . . . . . . . 6

5.4 Statistical design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

5.5 Test item preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

5.6 Test item management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

5.7 Choice of method/procedure . . . . . . . . . . . . . . . . . . . . . . . . 75.8 Evolution of proficiency testing schemes . . . . . . . . . . . . . . . 7

6 Operation and reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

6.1 Coordination and documentation . . . . . . . . . . . . . . . . . . . . . 8

6.2 Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

6.3 Packaging and transportation . . . . . . . . . . . . . . . . . . . . . . . 8

6.4 Data analysis and records . . . . . . . . . . . . . . . . . . . . . . . . . . 8

6.5 Scheme reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

6.6 Evaluation of performance . . . . . . . . . . . . . . . . . . . . . . . . . . 9

6.7 Communication with participants . . . . . . . . . . . . . . . . . . . . . 9

7 Confidentiality/ethical considerations . . . . . . . . . . . . . . . . . . . . 10

7.1 Confidentiality of records . . . . . . . . . . . . . . . . . . . . . . . . . . 10

7.2 Collusion and falsification of results . . . . . . . . . . . . . . . . . 10

Annexes

A Examples of statistical methods for treatment ofproficiency test data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

B Quality management of proficiency testing schemes . . . . . . . . 15

C Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16


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FOREWORD

ISO (the International Organization for Standardization) and IEC (theInternational Electrotechnical Commission) form the specialized system

for worldwide standardization. National bodies that are members of ISOor IEC participate in the development of International Standards throughtechnical committees established by the respective organization to dealwith particular fields of technical activity. ISO and IEC technical com-mittees collaborate in fields of mutual interest. Other internationalorganizations, governmental and non-governmental, in liaison with ISOand IEC, also take part in the work.

ISO/IEC Guide 43-1 was prepared by ISO/CASCO Ad Hoc Group for Re-vision of ISO/IEC Guide 43. A draft was circulated to CASCO membersand IEC National Committees for comments. A final draft has sub-sequently been approved by ISO/CASCO and by IEC Council forpublication as an ISO/IEC Guide.

Parts 1 and 2 of ISO/IEC Guide 43 cancel and replace the first edition(ISO/IEC Guide 43:1984).

ISO/IEC Guide 43:1984 covered guidance on development and opera-tion of laboratory proficiency testing with limited emphasis on the use ofthe outcomes of proficiency testing by accreditation bodies. It is nowintended to provide guidance in three areas, namely:

a) to distinguish between use of interlaboratory comparisons for pro-ficiency testing and for other purposes;

b) the development and operation of interlaboratory comparisons foruse in proficiency testing schemes, and

c) the selection and use of proficiency testing schemes by laboratoryaccreditation bodies.

ISO/IEC Guide 43 consists of the following parts, under the general titleProficiency testing by interlaboratory comparisons:

Part 1: Development and operation of proficiency testing schemes

Part 2: Selection and use of proficiency testing schemes bylaboratory accreditation bodies

Annexes to this part of ISO/IEC Guide 43 provide statistical guidance ontreatment of data from proficiency testing schemes and guidelines ondocumentation (Quality Manual) for the operation of proficiency testingschemes.


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INTRODUCTION

Interlaboratory comparisons are conducted for a number of purposesand may be used by participating laboratories and other parties.

Interlaboratory comparisons may be used, for example, to:

a) determine the performance of individual laboratories for specifictests or measurements and to monitor laboratories continuingperformance;

b) identify problems in laboratories and initiate remedial actions whichmay be related to, for example, individual staff performance orcalibration of instrumentation;

c) establish the effectiveness and comparability of new test or meas-urement methods and similarly to monitor established methods;

d) provide additional confidence to laboratory clients;

e) identify interlaboratory differences;

f) determine the performance characteristics of a method oftenknown as collaborative trials;

g) assign values to reference materials (RMs) and assess theirsuitability for use in specific test or measurement procedures.

Proficiency testing is the use of interlaboratory comparisons for purposea); i .e. the determination of laboratory testing or measurementperformance. However, the operation of proficiency testing schemesmay often also provide information for the other purposes listed above.

Participation in proficiency testing schemes provides laboratories withan objective means of assessing and demonstrating the reliability of thedata they are producing. Although there are several types of proficiencytesting schemes (see clause 4), most share the common feature of thecomparison of test and measurement results obtained by two or morelaboratories.

One of the main uses of proficiency testing schemes is to assess labora-tories ability to perform tests competently. This may include assessmentby laboratories themselves, by their clients, or by other parties such asaccreditation or regulatory bodies. It thus supplements laboratories owninternal quality control procedures by providing an additional externalmeasure of their testing capability. These activities also complement thetechnique of on-site laboratory assessment by technical specialists(usually used by laboratory accreditation bodies). Confidence that atesting or calibration laboratory consistently obtains reliable results is ofmajor importance to users of laboratory services. Users seeking such anassurance may undertake their own evaluation of results or may use theevaluation of other bodies.


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While the emphasis of this part of ISO/IEC Guide 43 is on operation ofinterlaboratory comparisons for proficiency testing, most of the princi-ples and guidance given are applicable to operation of interlaboratorycomparisons for other purposes.

While many laboratory accreditation bodies operate their own pro-ficiency testing schemes, a significant number also use proficiencytesting schemes or other forms of interlaboratory comparisons operatedby other bodies. The purpose of part 2 of ISO/IEC Guide 43 is to provideharmonized principles for the selection of suitable interlaboratorycomparisons for use as proficiency testing schemes by laboratoryaccreditation bodies.

Most bodies assessing the technical competence of laboratories requireor expect satisfactory performance in proficiency testing schemes assignificant evidence of a laboratorys ability to produce reliable results(except where proficiency testing is inappropriate).

However, it is emphasized that a major distinction exists between:

a) the evaluation of the competence of a laboratory by the assessmentof its total operation against predetermined requirements; and

b) the examination of the results of a laboratorys participation in pro-ficiency testing which may only be considered as giving informationabout the technical competence of the testing laboratory at a singlepoint of time under the specific conditions of the test (or tests) in-volved in a particular proficiency testing scheme.

In preparing this Guide, reference was made to a number of guidancedocuments relevant to proficiency testing produced by ILAC: ISO(TC 69); ISO/REMCO; IUPAC; AOAC; ASTM; and WECC and WELAC(now combined as EAL).

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 byStandards Australia or Standards New Zealand may be reproduced, stored in a retrieval system in any form or transmitted by any meanswithout prior permission in writing from Standards Australia or Standards New Zealand. Permission may be conditional on anappropriate royalty payment. Australian requests for permission and information on commercial software royalties should be directed tothe 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 theStandard 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 programsare 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 commercialcontracts is subject to the payment of a royalty. This policy may be varied by Standards Australia or Standards New Zealand at any time.


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Guidelines for third-party certification and accreditation

Guide 43Proficiency testing by interlaboratory comparisonsPart 1: Development and operation of proficiency testing schemes

1 Scope

While there are a number of uses of interlaboratory

comparisons, and variations in their design and im-

plementation, it is still possible to specify the essential

principles that need to be considered when organizing

such comparisons. This part of ISO/IEC Guide 43 de-

fines those principles and describes the factors whichshould be taken into account in the organization and

conduct of proficiency testing schemes.

Part 2 of ISO/IEC Guide 43 describes how laboratory

accreditation bodies, who assess technical compe-

tence of laboratories, should select and use pro-

ficiency testing schemes.

This part of ISO/IEC Guide 43 is intended for use by

proficiency testing operators and users such as parti-

cipant laboratories, accreditation bodies, regulatory

authorities and clients of laboratory services who have

a need to assess the technical competence of labora-

tories. It is particularly useful for laboratories in self-

evaluation, but recognizes that proficiency testing is

only one mechanism which can contribute to the esta-

blishment of mutual confidence between users of dif-

ferent testing laboratories.

It is currently a condition of some accreditation bodies

that laboratories participate regularly in proficiency

testing schemes that they have accepted as fit for

purpose. Therefore, it is essential that operators of

such schemes comply with principles for conduct of

professionally managed proficiency schemes, both in

terms of technical requirements, statistical procedures

(see examples in annex A), and in quality manage-ment (see guidance in annex B).

The methods of operation within different proficiency

testing organizations are not expected to be identical

and this Guide does not give specific operational de-

tails for interlaboratory comparisons The contents of

this Guide are intended only as a framework to be

modified appropriately for particular situations, includ-

ing schemes with either small or large numbers of

participants.

This Guide is not intended to cover a technique often

used by organizations to evaluate a single laboratorys

performance through submissions of certified refer-

ence materials or other well-characterized test items.

A bibliography is given in annex C.

2 References

ISO 3534-1:1993, Statistics Vocabulary and sym-

bols Part 1: Probability and general statistical

terms.

ISO 5725-1:1994, Accuracy (trueness and precision)

of measurement methods and results Part 1:

General principles and definitions.


of measurement methods and results Part 2: Basic

method for the determination of repeatability and re-

producibility of a standard measurement method.


of measurement methods and results Part 4: Basic

methods for the determination of the trueness of a

standard measurement method.

ISO 9000 Quality Management Compendium, 1994.

ISO/IEC Guide 2:1996, General terms and their defi-nitions concerning standardization and related activi-

ties.

ISO/IEC Guide 25:1990, General requirements for the

competence of calibration and testing laboratories.

ISO/IEC Guide 43-2:1997, Proficiency testing by inter-

laboratory comparisons Part 2: Selection and use

COPYRIGHT


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