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1、GUIDE 43-1 Proficiency testing by interlaboratory comparisons - Part 1: Development and operation of proficiency testing schemes Second edition 1997 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for
2、Resale, 04/19/2007 00:55:59 MDTNo reproduction or networking permitted without license from IHS -,-,- llSO/IEC GUIDE 43=1:1997(E) Contents Page 1 Scope 2 References 3 Definitions . 4 Types of proficiency testing 4.1 General . 4.2 Measurement comparison schemes . 4.3 Interlaboratory testing schemes 4
3、.4 Split-sample testing schemes 4.5 Qualitative schemes 4.6 Known-value schemes . 4.7 Partial-process schemes 5 Organization and design 51 . 5.2 53 . 54 . 5.5 5.6 57 . 5.8 Framework . Staff Data-processing equipment . Statistical design Test item preparation . Test item management Choice of method/p
4、rocedure . Evolution of proficiency testing schemes 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 0 ISOAEC 1997 1 1 2 All rights reserved. Unless otherwise specified, no
5、part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Organization for Standardization Case postale 56 l CH-1211 Geneve 20 l Switzerland Inter
6、net centraliso.ch x.400 c=ch; a=400net; p=iso; o=isocs; s=central Printed in Switzerland ii Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:55:59 MDTNo reproduction or network
7、ing permitted without license from IHS -,-,- 0 lSO/IEC ISO/IEC GUIDE 43=1:1997(E) 6.6 Evaluation of performance . . . . . . . . . . . . . . . . . . . . . . . . . . 6.7 Communication with participants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Confidentialit
8、y/ethical considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.1 Confidentiality of records . . . . . . . . . . . . . . . . *. 7.2 Collusion and falsification of results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9、. . Annexes A Examples of statistical methods for treatment of proficiency test data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B Quality management of proficiency testing schemes - C Bibliography .*. 9 9 IO IO IO II 15 16 . . . III Copyright Intern
10、ational Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:55:59 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO/IEC GUIDE 43=1:1997(E) ISO/IEC Foreword IS0 (the Internatio
11、nal Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. National bodies that are members of IS0 or IEC participate in the development of International Standards through technical committees established b
12、y the respective organization to deal with particular fields of technical activity. IS0 and IEC technical committees collaborate in fields of mutual interest. Other international organizations, governmental and non-governmental, in liaison with IS0 and IEC, also take part in the work. lSO/IEC Guide
13、43-l was prepared by lSO/CASCO Ad Hoc Group for Re- vision of lSO/IEC Guide 43. A draft was circulated to CASCO members and IEC National Committees for comments. A final draft has subsequently been approved by lSO/CASCO and by IEC Council for publication as an lSO/IEC Guide. Parts 1 and 2 of lSO/IEC
14、 Guide 43 cancel and replace the first edition (lSO/IEC Guide 43:1984). lSO/IEC Guide 43:1984 covered guidance on development and operation of laboratory proficiency testing with limited emphasis on the use of the out- comes of proficiency testing by accreditation bodies. It is now intended to provi
15、de 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 for use in proficiency testing schemes; and d the selection and use of proficiency testin
16、g schemes by laboratory accreditation bodies. lSO/IEC Guide 43 consists of the following parts, under the general title Proficiency testing by in terlabora tory comparisons: - Part 1: Development and operation of proficiency testing schemes - Part 2: Selection and use of proficiency testing schemes
17、by laboratory accreditation bodies Annexes to this part of lSO/IEC Guide 43 provide statistical guidance on treatment of data from proficiency testing schemes and guidelines on documentation (Quality Manual) for the operation of proficiency testing schemes. IV Copyright International Organization fo
18、r Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:55:59 MDTNo reproduction or networking permitted without license from IHS -,-,- 0 lSO/IEC ISO/IEC GUIDE 43=1:1997(E) Introduction Interlaboratory comparisons are cond
19、ucted 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 specific tests or measurements and to monitor laboratories continuing perform- ance; b
20、) identify problems in laboratories and initiate remedial actions which may be related to, for example, individual staff performance or calibration of instrumentation; d establish the effectiveness and comparability of new test or meas- urement methods and similarly to monitor established methods; d
21、) provide additional confidence to laboratory clients; e) identify interlaboratory differences; f 1 determine the performance characteristics of a method - often known as collaborative trials; 9) assign values to reference materials (RMs) and assess their suitability for use in specific test or meas
22、urement procedures. Proficiency testing is the use of interlaboratory comparisons for purpose a); i.e. the determination of laboratory testing or measurement performance. However, the operation of proficiency testing schemes may often also provide information for the other purposes listed above. Par
23、ticipation in proficiency 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 proficiency testing schemes (see clause 41, most share the common feature of the compari- son of
24、test and measurement results obtained by two or more labora- tories. One of the main uses of proficiency testing schemes is to assess labora- tories ability to perform tests competently. This may include assessment by laboratories themselves, by their clients, or by other parties such as accreditati
25、on 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 laborat
26、ory accreditation bodies). Confidence 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. V Copy
27、right International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:55:59 MDTNo reproduction or networking permitted without license from IHS -,-,- RSO/IEC GUIDE 43=1:1997(E) 0 lSO/IEC While the emph
28、asis of this part of lSO/lEC Guide 43 is on operation of interlaboratory comparisons for proficiency testing, most of the principles and guidance given are applicable to operation of interlaboratory compari- sons for other purposes. While many laboratory accreditation bodies operate their own profic
29、iency testing schemes, a significant number also use proficiency testing schemes or other forms of interlaboratory comparisons operated by other bodies. The purpose of part 2 of lSO/IEC Guide 43 is to provide harmonized principles for the selection of suitable interlaboratory comparisons for use as
30、proficiency testing schemes by laboratory accreditation bodies. Most bodies assessing the technical competence of laboratories require or expect satisfactory performance in proficiency testing schemes as signifi- cant evidence of a laboratorys ability to produce reliable results (except where profic
31、iency testing is inappropriate). However, it is emphasized that a major distinction exists between: a) the evaluation of the competence of a laboratory by the assessment of its total operation against predetermined requirements; and b) the examination of the results of a laboratorys participation in
32、 pro- ficiency 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 specific conditions of the test (or tests) in- volved in a particular proficiency testing scheme. In preparing this Guide, reference
33、was made to a number of guidance documents relevant to proficiency testing produced by ILAC; IS0 (TC 69); ISO/REMCO; IUPAC; AOAC; ASTM; and WECC and WELAC (now combined as EAL). VI Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical
34、 Standards 1/9972545001 Not for Resale, 04/19/2007 00:55:59 MDTNo reproduction or networking permitted without license from IHS -,-,- lSQ/IEC ISO/IEC GUIDE 43=1:1997(E) Proficiency testing by interlaboratory comparisons - Part 1: Development and operation of proficiency testing schemes 1 Scope While
35、 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 lSO/IEC Guide 43 de- fines those principles and describe
36、s the factors which should be taken into account in the organization and conduct of proficiency testing schemes. Part 2 of lSO/IEC Guide 43 describes how laboratory accreditation bodies, who assess technical com- petence of laboratories, should select and use proficiency testing schemes. This part o
37、f lSO/IEC Guide 43 is intended for use by proficiency 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 labora
38、tories in self-evaluation, but recognizes that proficiency testing is only one mechanism which can contribute to the establishment of mutual confidence between users of different testing laboratories. It is currently a condition of some accreditation bodies that laboratories participate regularly in
39、 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 pro- cedures (see examples in anne
40、x A), and in quality management (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
41、 only as a framework to be modified appropriately for particular situations, including 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
42、 reference materials or other well-characterized test items. A bibliography is given in annex C. 2 References IS0 3534-l :I 993, Statistics - Vocabulary and sym- bols - Part 7: Probability and general statistical terms. IS0 5725-l : 1994, Accuracy (trueness and precision) of measurement methods and
43、results - Part 7: General principles and definitions. IS0 5725-2: 1994, Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determination of repeatability and re- producibility of a standard measurement method. IS0 5725-4: 1994, Accuracy (trueness and
44、precision) of measurement methods and results - Part 4: Basic methods for the determination of the trueness of a standard measurement method. IS0 9000 Quality Management Compendium, 1994. lSO/IEC Guide 2:1996, General terms and their defi- nitions concerning standardization and related activi- ties.
45、 lSO/IEC Guide 25:1990, General requirements for the competence of calibration and testing labora tories. lSO/IEC Guide 43-2:1997, Proficiency testing by inter- labora tory comparisons - Part 2: Selection and use of Copyright International Organization for Standardization Provided by IHS under licen
46、se with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:55:59 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO/IEC GUIDE 43-1:1997(E) 0 lSO/IEC proficiency testing schemes ta tion bodies. bY labora tory accredi- Guide to the Expression of
47、 Uncertainty in Measure- ment: 7993, issued by BIPM; IEC; IFCC; ISO; IUPAC; IUPAP; OIML. International vocabulary of basic and general terms in metrology: 1993, issued by BIPM; IEC; IFCC; ISO; IUPAC; IUPAP; OIML. VIM:19931 The International Harmonized Protocol for the Pro- ficiency Testing of (Chemi
48、cal) Analytical Laboratories. Journal of AOAC International, 76, No. 4, 1993, pp. 926-940. Evaluation of Matrix Effects: Proposed Guideline, NCCLS Document EP-14P. National Committee for Clinical Laboratory Standards, Villanova, PA, 1994. 3 Definitions For the purposes of this Guide, the following defi- nitions apply. Some definitions are taken from other IS0 Guides and International Standards, as shown. 31 test technical operation that consists of the determination of one or more characteristics of a given product, process or service according to a specifi