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1、BRITISH STANDARD BS 7501:1989 EN 45001: 1989 General criteria for the operation of testing laboratories This European Standard EN 45001 has the status of a British Standard UDC 620.1.008.6 Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:24:12 GMT+00:00 2006,
2、Uncontrolled Copy, (c) BSI BS 7501:1989 This British Standard, having been prepared under the direction of the Committee for Quality Policy, was published under the authority of the Board of BSI and comes into effect on 31 October 1989 BSI 11-1998 The following BSI references relate to the work on t
3、his standard: Committee reference OC/16 Draft for comment 87/00265 DC ISBN 0 580 17939 7 Cooperating organizations The joint European Standards Institution, under whose supervision this European Standard was prepared, comprises the national standards organizations and the national electrotechnical c
4、ommittees of the following Western European countries. Austria Belgium Denmark Finland France Germany Greece Iceland Ireland Italy Luxemburg Netherlands Norway Portugal Spain Sweden Switzerland United Kingdom Amendments issued since publication Amd. No.DateComments Licensed Copy: London South Bank U
5、niversity, London South Bank University, Fri Dec 08 10:24:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7501:1989 BSI 11-1998i Contents Page Cooperating organizationsInside front cover National forewordii Brief history2 Foreword2 Text of EN 450015 Licensed Copy: London South Bank University, Lond
6、on South Bank University, Fri Dec 08 10:24:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7501:1989 ii BSI 11-1998 National foreword This British Standard is identical with EN 45001 “General criteria for the operation of testing laboratories”. It has been adopted nationally under the direction of
7、the BSI Board Committee for Quality Policy (OC/16). This series of standards specifies criteria which will provide the basis for confidence in facilities engaged in testing and certification. The standards will assist the process of mutual recognition between facilities, the development of national
8、accreditation on a harmonized basis, and the nomination of facilities by Governments as required by European directives. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance wit
9、h a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 10 and a back cover. This standard has been updated (see copyright date) and may have had amend
10、ments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:24:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPEENNE EUROPISCHE NORM EN 45001 June 1989
11、 UDC 620.1.008.6 Key words: Testing laboratories; performance evaluation; organization; test equipment; quality assurance English version General criteria for the operation of testing laboratories Critres gnraux concernant le fonctionnement de laboratoires dessais Allgemeine Kriterien zum Betreiben
12、von Prflaboratorien This European Standard was accepted by CEN/CENELEC on 23 June 1989. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-
13、to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN/CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translat
14、ion under the responsibility of a CEN/CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN/CENELEC members are the national standards organizations and national electrotechnical committees, respectively, of Austria, Belgium, D
15、enmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxemburg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN/CENELEC The joint European Standards Institution Organisation Commune Europenne de Normalisation Die gemeinsame Europische Normeninstitution
16、en Central Secretariat: rue Brderode 2, B-1000 Brussels CEN/CENELEC 1989 Copyright reserved to all CEN and CENELEC members Ref. No. EN 45 001:1989 E Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:24:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 45001 2 BS
17、I 11-1998 Brief history This European Standard has been prepared under mandate of the Commission of the European Communities and the European Free Trade Association, by a joint CEN/CENELEC Working Group on Certification. The documents Certif. 87/15 and Certif. 87/16, prepared by two Working Groups o
18、f the Commission of the European Communities, were circulated under the common CEN/CENELEC enquiry procedure in November 1987. The comments were discussed during the Brussels meeting in June 1988 where it was decided to submit an updated draft split in 7 separate documents to the formal voting. The
19、text of these drafts was approved and ratified by the CENELEC Technical Board on 13 June 1989 and by the CEN Technical Board on 23 June 1989. According to the Common CEN/CENELEC Rules, the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France,
20、Germany, Greece, Iceland, Ireland, Italy, Luxemburg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Foreword This European Standard has been drawn up with the objective of promoting confidence in those laboratories which conform to it. In order to arrive at this result
21、, the various relevant European and international documents have been examined. This standard is based very much on ISO/IEC guides in particular 2, “General terms and their definitions concerning standardization and related activities”, ISO/IEC guide 25, “General requirements for the technical compe
22、tence of testing laboratories”, ISO/IEC guide 38, “General requirements for the acceptance of testing laboratories”, ISO/IEC guide 43, “Development and operation of laboratory proficiency testing”, ISO/IEC guide 45, “Guidelines for the presentation of test results” and ISO/IEC guide 49, “Guidelines
23、for development of a quality manual for testing laboratory” and on the work of ILAC (International Laboratory Accreditation Conference). In some instances these texts required modification or clarification for European purposes. Such modifications or clarifications are the exception rather than the
24、rule. The criteria set out in this standard are those to which laboratories should conform and which should be used by accreditation bodies in accrediting laboratories, by public authorities when designating laboratories for regulatory purposes and by any other organizations assessing laboratories.
25、The criteria are, above all, written to be considered as general criteria covering all fields of testing including calibration. This implies that the set of criteria may have to be supplemented when certain industrial or other sectors (e.g. health and safety) make use of it. This standard forms part
26、 of the following series of standards covering testing, certification and accreditation: EN 45 001, General criteria for the operation of testing laboratories. EN 45 002, General criteria for the assessment of testing laboratories. EN 45 003, General criteria for laboratory accreditation bodies. EN
27、45 011, General criteria for certification bodies operating product certification. EN 45 012, General criteria for certification bodies operating Quality System certification. EN 45 013, General criteria for certification bodies operating certification of personnel. EN 45 014. General criteria for s
28、uppliers declaration of conformity. This foreword does not form an integral part of the standard. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:24:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 45001 BSI 11-19983 Contents Page Foreword2 1Object and field
29、of application5 2Definitions5 2.1test5 2.2test method5 2.3test report5 2.4testing laboratory5 2.5interlaboratory test comparisons5 2.6(laboratory) proficiency testing5 2.7(laboratory) accreditation5 2.8(laboratory) accreditation system5 2.9(laboratory) accreditation body5 2.10accreditated laboratory
30、5 2.11(laboratory) accreditation criteria5 2.12laboratory assessment5 2.13laboratory assessor5 3Legal identity5 4Impartiality, independence and integrity5 5Technical competence6 5.1Management and organization6 5.2Personnel6 5.3Premises and equipment6 5.3.1Availability6 5.3.2Premises and environment6
31、 5.3.3Equipment6 5.4Working procedures7 5.4.1Test methods and procedures7 5.4.2Quality System7 5.4.3Test reports7 5.4.4Records8 5.4.5Handling of test samples or items8 5.4.6Confidentiality and security9 5.4.7Subcontracting9 6Cooperation9 6.1Cooperation with clients9 6.2Cooperation with bodies granti
32、ng accreditation9 6.3Cooperation with other laboratories and with bodies producing standards and regulations9 7Duties resulting from the use of accreditation10 Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:24:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 4
33、blank Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:24:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 45001 BSI 11-19985 1 Object and field of application This European Standard specifies general criteria for the technical competence of testing laboratori
34、es including calibration laboratories, irrespective of the sector involved. It is intended for the use of testing laboratories and their accreditation bodies as well as other bodies concerned with recognizing the competence of testing laboratories. This set of criteria may have to be supplemented wh
35、en applied to a particular sector. 2 Definitions For the purpose of this European Standard the following definitions contained in ISO/IEC Guide 2, edition 1986, “General terms and their definitions concerning standardization and related activities” are applicable: 2.1 test technical operation that c
36、onsists of the determination of one or more characteristics of a given product, process or service according to a specified procedure 2.2 test method specified technical procedure for performing a test 2.3 test report document that presents test results and other information relevant to a test 2.4 t
37、esting laboratory laboratory that performs tests 2.5 interlaboratory test comparisons organization, performance and evaluation of tests on the same or similar items or materials by two or more laboratories in accordance with predetermined conditions 2.6 (laboratory) proficiency testing determination
38、 of laboratory testing performance by means of interlaboratory test comparisons 2.7 (laboratory) accreditation formal recognition that a testing laboratory is competent to carry out specific tests or specific types of tests 2.8 (laboratory) accreditation system system that has its own rules of proce
39、dure and management for carrying out laboratory accreditation 2.9 (laboratory) accreditation body body that conducts and administers a laboratory accreditation system and grants accreditation 2.10 accredited laboratory testing laboratory to which accreditation has been granted 2.11 (laboratory) accr
40、editation criteria set of requirements that is used by an accreditation body, to be fulfilled by a testing laboratory in order to be accredited 2.12 laboratory assessment examination of a testing laboratory to evaluate its compliance with specific laboratory accreditation criteria 2.13 laboratory as
41、sessor person who carries out some or all functions related to laboratory assessment 3 Legal identity The laboratory shall be legally identifiable. 4 Impartiality, independence and integrity The testing laboratory and its personnel shall be free from any commercial, financial and other pressures whi
42、ch might influence their technical judgement. Any influence on the results of examinations and tests exercised by persons or organizations external to the testing laboratory shall be excluded. The testing laboratory shall not engage in any activities that may endanger the trust in its independence o
43、f judgement and integrity in relation to its testing activities. The remuneration of the personnel engaged in testing activities shall not depend on the number of tests carried out nor on the results of such tests. When products are tested by bodies, (e.g. manufacturers) who have been concerned with
44、 their design, manufacture or sale, provision for a clear separation of different responsibilities and an appropriate statement shall be made. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:24:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 45001 6 BSI 11-1
45、998 5 Technical competence 5.1 Management and organization The testing laboratory shall be competent to perform the tests concerned. In the absence of a recognized test procedure agreement between the client and the laboratory to the test procedure shall be documented. The testing laboratory shall b
46、e organized in such a way that each member of personnel is aware of both the extent and the limitation of his area of responsibility. The organization shall provide supervision by persons familiar with the test methods and procedures, the objective of the test and the assessment of the test results.
47、The proportion of supervisory to non-supervisory personnel shall be such as to ensure adequate supervision. The testing laboratory shall have a technical manager who has overall responsibility for the technical operations of the laboratory. A document showing the organization and distribution of res
48、ponsibilities of the testing laboratory shall be available and kept up-to-date. 5.2 Personnel The testing laboratory shall have sufficient personnel, having the necessary education, training, technical knowledge and experience for their assigned functions. The testing laboratory shall ensure that th
49、e training of its personnel is kept up-to-date. Information on the relevant qualifications, training and experience of the technical personnel shall be maintained by the laboratory. 5.3 Premises and equipment 5.3.1 Availability The testing laboratory shall be furnished with all items of equipment required for correct performance of the tests and measurements which it claims to be competent to carry out. In the exceptional case where the laboratory is obliged to use outside equipment, it shall ensure the quality of that equipment. 5.3.2 Premises and environment The env
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