SAA/SNZ HB18.43.

1:1998 ISO/IEC Guide 43-1:1997

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Guidelines for third-party certication and accreditation

Guide 43 Prociency testing by interlaboratory comparisons Part 1: Development and operation of prociency testing schemes

SAA/SNZ HB18.43.1:1998 This Joint Australian/New Zealand Handbook was prepared by Joint Technical Committee QR/10, Conformity Assessment. It was published on 5 September 1998.

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The following interests are represented on Committee QR/10: Australian Chamber of Manufactures 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 Queensland Purchasing Third-party certication 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 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which subscribing members receive, and which give details of new publications, new editions and amendments, and of withdrawn Standards.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. Notication 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.

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

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Guidelines for third-party certication and accreditation

Guide 43 Prociency testing by interlaboratory comparisons Part 1: Development and operation of prociency testing schemes
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 2168 0

ii

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 International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) or solely by ISO. The information contained in the various guides making up this Handbook is intended to assist organizations in understanding the basis of product certication and third-party certication systems and how the various bodies operating such schemes should function. Coverage is also given to guidance on the establishment and operation of laboratory accreditation bodies as well as the type of information that such bodies will require of testing laboratories, including those carrying out calibration, when making application for accreditation. It is anticipated that this Guide will be relevant to laboratories and laboratory accreditation bodies. This Guide supersedes in part SAA HB18.431991/SANZ HB18.431991/ISO/IEC Guide 43 1984, Guide 43: Development and operation of laboratory prociency testing. The other guides covered in this Handbook are as follows: Guide 2: General terms and their denitions concerning standardization and related activities Guide 7: Guidelines for drafting of Standards suitable for use for conformity assessment Guide 22: Information on manufacturers declaration of conformity with Standards or other technical specications Guide 23: Methods of indicating conformity with Standards for third-party certication systems Guide 25: General requirements for the competence of calibration and testing laboratories Guide 27: Guidelines for corrective action to be taken by a certication body in the event of either misapplication of its mark of conformity to a product, or products which bear the mark of the certication body being found to subject persons or property to risk Guide 28: General rules for a model third-party certication system for products Guide 39: General requirements for the acceptance of inspection bodies Guide 42: Guidelines for a step-by-step approach to an international certication system Guide 44: General rules for ISO or IEC international third-party certication schemes for products Guide 53: An approach to the utilization of a suppliers quality system in third-party product certication Guide 56: An approach to the review by a certication body of its own internal quality system Guide 57: Guidelines for the presentation of inspection results Guide 58: Calibration and testing laboratory accreditation systems General requirements for operation and recognition Guide 60: Code of good practice for conformity assessment Guide 61: General requirements for assessment and accreditation of certication/registration bodies Guide 62: General requirements for bodies operating assessment and certication/registration of quality systems Guide 65: General requirements for bodies operating product certication systems

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iii

CONTENTS
Page
1 2 3 4 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Denitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Types of prociency testing . . . . . . . . . . . 4.1 General . . . . . . . . . . . . . . . . . . . . . . 4.2 Measurement comparison schemes 4.3 Interlaboratory testing schemes . . . 4.4 Split-sample testing schemes . . . . . 4.5 Qualitative schemes . . . . . . . . . . . . 4.6 Known-value schemes . . . . . . . . . . . 4.7 Partial-process schemes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 2 3 3 3 4 4 5 5 5 5 5 6 6 6 6 7 7 7 8 8 8 8 8 8 9 9 10 10 10

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Organization and design . . . . . . . . . . . . . . . . 5.1 Framework . . . . . . . . . . . . . . . . . . . . . . . 5.2 Staff . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3 Data-processing equipment . . . . . . . . . . 5.4 Statistical design . . . . . . . . . . . . . . . . . . 5.5 Test item preparation . . . . . . . . . . . . . . . 5.6 Test item management . . . . . . . . . . . . . . 5.7 Choice of method/procedure . . . . . . . . . 5.8 Evolution of prociency testing schemes Operation and reporting . . . . . . . . . . 6.1 Coordination and documentation 6.2 Instructions . . . . . . . . . . . . . . . . 6.3 Packaging and transportation . . 6.4 Data analysis and records . . . . . 6.5 Scheme reports . . . . . . . . . . . . . 6.6 Evaluation of performance . . . . . 6.7 Communication with participants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Condentiality/ethical considerations . . . . . . . . . . . . . . . . . . . . 7.1 Condentiality of records . . . . . . . . . . . . . . . . . . . . . . . . . . 7.2 Collusion and falsication of results . . . . . . . . . . . . . . . . .

Annexes A Examples of statistical methods for treatment of prociency test data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B Quality management of prociency testing schemes . . . . . . . . C Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11 15 16

iv FOREWORD
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. National bodies that are members of ISO or IEC participate in the development of International Standards through technical committees established by the respective organization to deal with particular elds of technical activity. ISO and IEC technical committees collaborate in elds of mutual interest. Other international organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the work. ISO/IEC Guide 43-1 was prepared by ISO/CASCO Ad Hoc Group for Revision of ISO/IEC Guide 43. A draft was circulated to CASCO members and IEC National Committees for comments. A nal draft has subsequently been approved by ISO/CASCO and by IEC Council for publication as an ISO/IEC Guide. Parts 1 and 2 of ISO/IEC Guide 43 cancel and replace the rst edition (ISO/IEC Guide 43:1984). ISO/IEC Guide 43:1984 covered guidance on development and operation of laboratory prociency testing with limited emphasis on the use of the outcomes of prociency testing by accreditation bodies. It is now intended to provide guidance in three areas, namely: a) b) c) to distinguish between use of interlaboratory comparisons for prociency testing and for other purposes; the development and operation of interlaboratory comparisons for use in prociency testing schemes, and the selection and use of prociency testing schemes by laboratory accreditation bodies.

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ISO/IEC Guide 43 consists of the following parts, under the general title Prociency testing by interlaboratory comparisons: Part 1: Development and operation of prociency testing schemes Part 2: Selection and use of prociency testing schemes by laboratory accreditation bodies Annexes to this part of ISO/IEC Guide 43 provide statistical guidance on treatment of data from prociency testing schemes and guidelines on documentation (Quality Manual) for the operation of prociency testing schemes.

v INTRODUCTION
Interlaboratory comparisons are conducted for a number of purposes and 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 specic tests or measurements and to monitor laboratories continuing performance; identify problems in laboratories and initiate remedial actions which may be related to, for example, individual staff performance or calibration of instrumentation; establish the effectiveness and comparability of new test or measurement methods and similarly to monitor established methods; provide additional condence to laboratory clients; identify interlaboratory differences; determine the performance characteristics of a method often known as collaborative trials; assign values to reference materials (RMs) and assess their suitability for use in specic test or measurement procedures.

b)

c)
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d) e) f) g)

Prociency testing is the use of interlaboratory comparisons for purpose a); i.e. the determination of laboratory testing or measurement performance. However, the operation of prociency testing schemes may often also provide information for the other purposes listed above.
Participation in prociency testing schemes provides laboratories with an objective means of assessing and demonstrating the reliability of the data they are producing. Although there are several types of prociency testing schemes (see clause 4), most share the common feature of the comparison of test and measurement results obtained by two or more laboratories. One of the main uses of prociency testing schemes is to assess laboratories ability to perform tests competently. This may include assessment by laboratories themselves, by their clients, or by other parties such as accreditation or regulatory bodies. It thus supplements laboratories own internal quality control procedures by providing an additional external measure of their testing capability. These activities also complement the technique of on-site laboratory assessment by technical specialists (usually used by laboratory accreditation bodies). Condence that a testing or calibration laboratory consistently obtains reliable results is of major importance to users of laboratory services. Users seeking such an assurance may undertake their own evaluation of results or may use the evaluation of other bodies.

vi
While the emphasis of this part of ISO/IEC Guide 43 is on operation of interlaboratory comparisons for prociency testing, most of the principles and guidance given are applicable to operation of interlaboratory comparisons for other purposes. While many laboratory accreditation bodies operate their own prociency testing schemes, a signicant number also use prociency testing schemes or other forms of interlaboratory comparisons operated by other bodies. The purpose of part 2 of ISO/IEC Guide 43 is to provide harmonized principles for the selection of suitable interlaboratory comparisons for use as prociency testing schemes by laboratory accreditation bodies. Most bodies assessing the technical competence of laboratories require or expect satisfactory performance in prociency testing schemes as signicant evidence of a laboratorys ability to produce reliable results (except where prociency testing is inappropriate).
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However, it is emphasized that a major distinction exists between: a) b) the evaluation of the competence of a laboratory by the assessment of its total operation against predetermined requirements; and the examination of the results of a laboratorys participation in prociency testing which may only be considered as giving information about the technical competence of the testing laboratory at a single point of time under the specic conditions of the test (or tests) involved in a particular prociency testing scheme.

In preparing this Guide, reference was made to a number of guidance documents relevant to prociency 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 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.

Guidelines for third-party certication and accreditation Guide 43 Prociency testing by interlaboratory comparisons Part 1: Development and operation of prociency testing schemes

Scope

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 certied reference materials or other well-characterized test items. A bibliography is given in annex C.

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While there are a number of uses of interlaboratory comparisons, and variations in their design and implementation, 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 denes those principles and describes the factors which should be taken into account in the organization and conduct of prociency testing schemes. Part 2 of ISO/IEC Guide 43 describes how laboratory accreditation bodies, who assess technical competence of laboratories, should select and use prociency testing schemes. This part of ISO/IEC Guide 43 is intended for use by prociency testing operators and users such as participant laboratories, accreditation bodies, regulatory authorities and clients of laboratory services who have a need to assess the technical competence of laboratories. It is particularly useful for laboratories in selfevaluation, but recognizes that prociency testing is only one mechanism which can contribute to the establishment of mutual condence between users of different testing laboratories. It is currently a condition of some accreditation bodies that laboratories participate regularly in prociency testing schemes that they have accepted as t for purpose. Therefore, it is essential that operators of such schemes comply with principles for conduct of professionally managed prociency schemes, both in terms of technical requirements, statistical procedures (see examples in annex A), and in quality management (see guidance in annex B). The methods of operation within different prociency testing organizations are not expected to be identical and this Guide does not give specic operational details for interlaboratory comparisons The contents of this Guide are intended only as a framework to be modied appropriately for particular situations, includ-

References

ISO 3534-1:1993, Statistics Vocabulary and symbols 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 denitions. ISO 5725-2:1994, Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method. ISO 5725-4:1994, Accuracy (trueness and precision) 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 denitions concerning standardization and related activities. ISO/IEC Guide 25:1990, General requirements for the competence of calibration and testing laboratories. ISO/IEC Guide 43-2:1997, Prociency testing by interlaboratory comparisons Part 2: Selection and use

COPYRIGHT

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HB 18.43.1:1998, Guidelines for third-party certification and accreditation Guide 43 Proficiency testing by interlaboratory comparisons - Part 1: Development and operation of proficiency testing schemes

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