JIS-Q-0043-2-1998-R2004-ENG.pdf
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1、J IS JAPANESE I NDUSTRIAL STANDARD Translated and Published by Japanese Standards Association JIS Q 0043-2 11998 (IS0 / IEC GUIDE 43 -2 1997) Proficiency testing by interlaboratory comparisons - Part 2: Selection and use of proficiency testing schemes by laboratory accreditat ion bodies ICs 03.120.2
2、0; 19.020 Descriptors : certificates of conformity, approval laboratories, inspectors, approval testing, Reference number : JIS Q 0043-2 : 1998 (E) personnel management, laboratory accreditation, quality assurance systems PROTECTED BY COPYRIGHT 6s Copyright Japanese Standards Association Provided by
3、 IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 07:42:52 MDTNo reproduction or networking permitted without license from IHS -,-,- Q 0043-2 : 1998 (ISO/IEC GUIDE 43-2:1997) Foreword This translation has been made based on the original Japane
4、se Industrial Standard established by the Minister of International Trade and Industry through deliberations at the Japanese Industrial Standards Committee in accordance with the Industrial Standardization Law. JIS Q 0043 consists of the following two parts with the title ofproficiency testing by in
5、terlaboratory comparisons. Part 1: Development and operation of proficiency testing schemes Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies Date of Establishment: 1998-11-20 Date of Public Notice in Official Gazette: 1998-11-20 Investigated by: Japanese In
6、dustrial Standards Committee Divisional Council on Accreditation and Certification JIS Q 0043-2: 1998, First English edition published in 2002-09 Translated and published by: Japanese Standards Association 4-1-24, Akasaka, Minato-ku, Tokyo, 107-8440 JAPAN In the event of any doubts arising as to the
7、 contents, the original JIS is to be the final authority. (C JSA 2002 All rights reserved. Unless otherwise specified, no 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
8、from the publisher. Printed in Japan PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 07:42:52 MDTNo reproduction or networking permitted without license from IHS -,-,
9、- Q 0043-2 : 1998 (ISOAEC GUIDE 43-2 1997) Contents Page O Introduction 1 1 Scope 1 2 References . 2 3 Definitions 2 4 Selection of proficiency testing schemes . 2 5 Policies on participation in proficiency testing schemes 3 6 Use of results by laboratory accreditation bodies . 4 7 Action and feedba
10、ck by laboratories 5 (i) PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/11/2007 07:42:52 MDTNo reproduction or networking permitted without license from IHS -,-,- JAPANESE I
11、NDUSTRIAL STANDARD JIS Q 0043-2 : 1998 (ISO/IEC GUIDE 43-2 : 1997) Proficiency testing by interlaboratory comparisons - Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies O Introduction 0.1 This Japanese Industrial Standard has been prepared based on the firs
12、t edition of ISO/IEC GUIDE 43-2, Proficiency testing by interlaboratory comparisons - Part 2: Selection und use of proficiency testing schemes by laboratory accreditation bodies published in 1997 without modifying the technical contents. Portions underlined with dots are the matters not stated in th
13、e original Guide. 0.2 Part 1 of JIS Q 0043 provides guidance on the development and operation of interlaboratory comparisons for use in proficiency testing schemes. This part of J1S.Q 0043 is intended to provide a harmonized model for selection and use of proficiency testing schemes. This will facil
14、itate national and interna- tional harmonization and thus acceptance of test data from accredited laboratories in various locations. Proficiency testing schemes may be operated either by laboratory accreditation bodies or by other organizations. As the results of laboratories performance in proficie
15、ncy testing schemes are used in judging their technical competence, it is critical that the proficiency testing schemes used by accreditation bodies be operated competently, effectively and fairly. The objective of laboratory accreditation is to provide an independent recognition that a laboratory i
16、s competent to perform specific tests, measurements, calibrations or sampling. The procedures used to determine competence include assessment of laboratories specific capabilities by independent technical assessors who judge both technical competence and the compliance of the laboratories with appro
17、priate techni- cal and quality systems criteria such as those described in JIS Z 9325. Most laboratory accreditation bodies complement their on-site assessments with various forms of practical testing, to judge whether a laboratorys data are compa- rable to either reference data or to data provided
18、by a laboratory or laboratories al- ready determined to be competent in the relevant tests or measurements. Some of the practical testing or audit testing may be of an ad hoc nature involving a single laboratory, such as through submission of a certified reference material or a reference calibration
19、 artefact to a single laboratory. This part of JIS Q 0043 is not intended to cover this technique to evaluate a single laboratorys performance. 1 a) Scope The objectives of this part of JIS Q 0043 are: to establish principles for the selection of proficiency testing schemes for use in laboratory acc
20、reditation programmes; and to assist in harmonizing the use of results of proficiency testing schemes by laboratory accreditation bodies. b) PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not
21、for Resale, 03/11/2007 07:42:52 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 Q 0043-2 : 1998 (ISO/IEC GUIDE 43-2 : 1997) As results from proficiency testing schemes may be used in accreditation decisions, it is important that both the accreditation bodies and participa
22、ting laboratories have confidence in the design and operation of the schemes, It is also important for participating laboratories and laboratory accreditation assessors to have a clear understanding of the accreditation bodies policies for par- ticipation in such schemes, the criteria they use for j
23、udging successful performance in proficiency testing schemes, and their policies and procedures for following up any unsatisfactory results from a proficiency test. It should be recognized, however, that laboratory accreditation bodies and their assessors may take into account the suitability of tes
24、t data produced from other ac- tivities apart from proficiency testing schemes. This includes results of laboratories own internal quality control procedures with control samples, comparison with split- sample data from other laboratories, performance of audit tests with certified refer- ence materi
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