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1、BRITISH STANDARD BS EN ISO 15189:2003 Incorporating Corrigendum No. 1 Medical laboratories Particular requirements for quality and competence The European Standard EN ISO 15189:2003 has the status of a British Standard ICS 11.100 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:38 GMT+
2、00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 15189:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 11 March 2003 BSI 23 October 2003 ISBN 0 580 41405 1 National foreword This British Standard is the official English language version
3、of EN ISO 15189:2003. It is identical with ISO 15189:2003. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references T
4、he British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standa
5、rds Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the r
6、esponsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front
7、 cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 39, the Annex ZA, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publi
8、cation Amd. No. DateComments 14768 Corrigendum No. 1 23 October 2003 Correction to EN ISO foreword page and incorporation of the Annex ZA page Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM
9、EN ISO 15189 February 2003 ICS 11.100 English version Medical laboratories - Particular requirements for quality and competence (ISO 15189:2003) Laboratoires danalyses de biologie mdicale - Exigences particulires concernant la qualit et la comptence (ISO 15189:2003) Medizinische Laboratorien - Beson
10、dere Anforderungen an die Qualitt und Kompetenz (ISO 15189:2003) This European Standard was approved by CEN on 17 January 2003. CEN 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
11、 without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other languag
12、e made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hunga
13、ry, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovak Republic, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2
14、003 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15189:2003 E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CORRECTED 2003-09-24 Foreword This document (EN ISO 1518
15、9:2003) has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems“ in collaboration with Technical Committee CEN/TC 140 “In vitro diagnostic medical devices“, the secretariat of which is held by DIN. This European Standard shall be given th
16、e status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2003, and conflicting national standards shall be withdrawn at the latest by August 2003. According to the CEN/CENELEC Internal Regulations, the national standards organizations of
17、the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom. Endorse
18、ment notice The text of ISO 15189:2003 has been approved by CEN as EN ISO 15189:2003 without any modifications. NOTE Normative references to International Standards are listed in Annex ZA (normative). EN ISO 15189:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:38 GMT+00:00 2006, U
19、ncontrolled Copy, (c) BSI Reference number ISO 15189:2003(E) INTERNATIONAL STANDARD ISO 15189 First edition 2003-02-15 Medical laboratories Particular requirements for quality and competence Laboratoires danalyses de biologie mdicale Exigences particulires concernant la qualit et la comptence EN ISO
20、 15189:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 15189:2003 ii Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS:98151 O3002(E) I SO 3002 All irhgts seredevr iii C
21、ontents Page Forewordiv Introduction v 1 Scope1 2 Normative references .1 3 Terms and definitions.1 4 Management requirements 4 4.1 Organization and management .4 4.2 Quality management system .4 4.3 Document control .6 4.4 Review of contracts7 4.5 Examination by referral laboratories 7 4.6 External
22、 services and supplies .8 4.7 Advisory services .8 4.8 Resolution of complaints.9 4.9 Identification and control of nonconformities .9 4.10 Corrective action.9 4.11 Preventive action 10 4.12 Continual improvement10 4.13 Quality and technical records10 4.14 Internal audits11 4.15 Management review11
23、5 Technical requirements12 5.1 Personnel.12 5.2 Accommodation and environmental conditions14 5.3 Laboratory equipment15 5.4 Pre-examination procedures17 5.5 Examination procedures19 5.6 Assuring quality of examination procedures.21 5.7 Post-examination procedures .22 5.8 Reporting of results22 Annex
24、 A (normative) Correlation with ISO 9001:2000 and ISO/IEC 17025:1999 25 Annex B (informative) Recommendations for protection of laboratory information systems (LIS)29 Annex C (informative) Ethics in laboratory medicine.33 Bibliography .36 EN ISO 15189:2003 iii Licensed Copy: sheffieldun sheffieldun,
25、 na, Fri Nov 17 10:07:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS:98151 O3002(E) vi I SO 3002 All irhgts seredevr Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Sta
26、ndards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also
27、take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees
28、 is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibi
29、lity that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15189 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. EN ISO 151
30、89:2003 iv Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS:98151 O3002(E) I SO 3002 All irhgts seredevr v Introduction This International Standard, based upon ISO/IEC 17025 and ISO 9001, provides requirements for competence and quality th
31、at are particular to medical laboratories1). It is acknowledged that a country could have its own specific regulations or requirements applicable to some or all its professional personnel and their activities and responsibilities in this domain. Medical laboratory services are essential to patient c
32、are and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients. Such services include arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing
33、and examination of clinical samples, together with subsequent validation, interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work. Whenever allowed by national regulations, it is desirable that medical laboratory services include the ex
34、amination of patients in consultation cases, and that those services actively participate in the prevention of disease in addition to diagnosis and patient management. Each laboratory ought also to provide suitable educational and scientific opportunities for professional staff working with it. Whil
35、e this International Standard is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines could also find it useful and appropriate. In addition, bodies engaged in the recognition of the competence of medical lab
36、oratories will be able to use this International Standard as the basis for their activities. For it is surely preferable that a laboratory seeking accreditation select an accrediting body which operates to appropriate international standards and which takes into account the particular requirements o
37、f medical laboratories. During the preparation of this International Standard, ISO 9001 and ISO/IEC 17025 were under revision, and it was therefore impossible to present this International Standard in a format and style which corresponded precisely to those of either of the aforementioned documents.
38、 The correlation that nevertheless does exist between the clauses and subclauses of this first edition of ISO 15189 and those of ISO 9001:2000 and of ISO/IEC 17025:1999 is detailed in Annex A of this International Standard. A second edition of this International Standard, aimed at more closely align
39、ing it with a second edition of ISO/IEC 17025 and with ISO 9001:2000, is anticipated. Moreover, terminology has changed within the disciplines concerned and this has created differences of expression such that certain terms (e.g. “sensitivity”) now have entirely different meanings between discipline
40、s. Furthermore, it is planned to replace yet another document related to this International Standard, ISO/IEC Guide 58, by ISO/IEC 17011. The second edition of ISO 15189 is to take all this into account. 1) In the French language, these laboratories are termed “laboratoires danalyses de biologie mdi
41、cale”, while in other languages they might be referred to using a term equivalent to the English “clinical laboratories”. EN ISO 15189:2003 v Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Fri Nov
42、 17 10:07:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTENRATIONAL TSANDADR IS:98151 O3002(E) I SO 3002 All irhgts seredevr 1 Medical laboratories Particular requirements for quality and competence 1 Scope This International Standard specifies requirements for quality and competence particular to
43、 medical laboratories. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO
44、 31 (all parts), Standardisation and related activities General vocabulary ISO Guide 31, Quantities and units ISO/IEC Guide 43-1, Proficiency testing by interlaboratory comparisons Part 1: Development and operation of proficiency testing schemes ISO 9000, Quality management systems Fundamentals and
45、vocabulary ISO 9001:2000, Quality management systems Requirements ISO/IEC 17025:1999, General requirements for the competence of testing and calibration laboratories International vocabulary of basic and general terms in metrology (VIM). BIPM, IEC, IFCC, ISO, IUPAC, IUPAP, OIML 3 Terms and definitio
46、ns For the purposes of this document, the terms and definitions given in ISO 9000, ISO/IEC Guide 2, VIM and the following apply. 3.1 accuracy of measurement closeness of the agreement between the result of a measurement and a true value of the measurand VIM: 1993, definition 3.5 3.2 biological refer
47、ence interval reference interval central 95 % interval of the distribution of reference values NOTE 1 This supersedes such incorrectly used terms as “normal range”. EN ISO 15189:2003 1 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS:98151
48、 O3002(E) 2 I SO 3002 All irhgts seredevr NOTE 2 It is an arbitrary but common convention to define the reference interval as the central 95 % interval. Another size or an asymmetrical location of the reference interval could be more appropriate in particular cases. See 10. 3.3 examination set of op
49、erations having the object of determining the value or characteristics of a property NOTE In some disciplines (e.g. microbiology) an examination is the total activity of a number of tests, observations or measurements. 3.4 laboratory capability physical, environmental and information resources, personnel, skills and expertise available for the examinations in question NOTE A review of laboratory capability could include results of earlier participation in inte