EN ISO 15189-2012 en Medical laboratories - Requirements for quality and competence《医学实验室 质量和资格的要求》.pdf

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1、BSI Standards PublicationBS EN ISO 15189:2012Incorporating corrigendum October 2014BS EN ISO 15189:2012Medical laboratories Requirements for quality andcompetence (ISO 15189:2012)BS EN ISO 15189:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 15189:2012

2、. It supersedes BS EN ISO 15189:2007 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the nec

3、essary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014ISBN 978 0 580 88018 6ICS 03.120.10; 11.100.01Compliance with a British Standard cannot confer immunity from legal obligations.This Briti

4、sh Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2012.Amendments/corrigenda issued since publicationDate Text affected31 October 2014 Implementation of ISO corrected text 15 August 2014: various editorial correctionsEUROPEAN STANDARD NORME E

5、UROPENNE EUROPISCHE NORM EN ISO 15189 November 2012 ICS 03.120.10; 11.100.01 Supersedes EN ISO 15189:2007English Version Medical laboratories - Requirements for quality and competence (ISO 15189:2012) Laboratoires de biologie mdicale - Exigences concernant la qualit et la comptence (ISO 15189:2012)

6、Medizinische Laboratorien - Anforderungen an die Qualitt und Kompetenz (ISO 15189:2012) This European Standard was approved by CEN on 31 October 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status

7、 of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, Germ

8、an). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia

9、, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and Unit

10、ed Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15189:20

11、12: EBS EN ISO 15189:2012EN ISO 15189:2012 (E) 3 Foreword This document (EN ISO 15189:2012) 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

12、” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2013, and conflicting national standards shall be withdrawn at the latest by November 2015. Attention

13、 is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 15189:2007. According to the CEN/CENELEC Internal Regulations,

14、the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Lat

15、via, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 15189:2012 has been approved by CEN as a EN ISO 15189:2012 without any modification. BS EN ISO 15189:20

16、12EN ISO 15189:2012 (E) 3 Foreword This document (EN ISO 15189:2012) 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 wh

17、ich is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2013, and conflicting national standards shall be withdrawn at the latest by November 2015. Attention is drawn to the possib

18、ility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 15189:2007. According to the CEN/CENELEC Internal Regulations, the national standards

19、organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembo

20、urg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 15189:2012 has been approved by CEN as a EN ISO 15189:2012 without any modification. BS EN ISO 15189:2012EN ISO 15189:2012 (E)

21、 3 Foreword This document (EN ISO 15189:2012) 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. Thi

22、s European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2013, and conflicting national standards shall be withdrawn at the latest by November 2015. Attention is drawn to the possibility that some of the

23、elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 15189:2007. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the fo

24、llowing countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands

25、, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 15189:2012 has been approved by CEN as a EN ISO 15189:2012 without any modification. ISO 15189:2012(E) ISO 2012 All rights reserved iiiContents PageF

26、oreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Management requirements . 64.1 Organization and management responsibility 64.2 Quality management system . 94.3 Document control 104.4 Service agreements 114.5 Examination by referral laboratories . 124.6 Externa

27、l services and supplies . 124.7 Advisory services . 134.8 Resolution of complaints . 134.9 Identification and control of nonconformities .134.10 Corrective action 144.11 Preventive action 144.12 Continual improvement . 144.13 Control of records 154.14 Evaluation and audits .164.15 Management review

28、185 Technical requirements .195.1 Personnel 195.2 Accommodation and environmental conditions 215.3 Laboratory equipment, reagents, and consumables .235.4 Pre-examination processes .265.5 Examination processes . 305.6 Ensuring quality of examination results 335.7 Post-examination processes . 355.8 Re

29、porting of results . 355.9 Release of results . 375.10 Laboratory information management . 38Annex A (informative) Correlation with ISO 9001:2008 and ISO/IEC 17025:2005 40Annex B (informative) Comparison of ISO 15189:2007 to ISO 15189:2012 45Bibliography .50BS EN ISO 15189:2012ISO 15189:2012(E)Forew

30、ordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technic

31、al committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of el

32、ectrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the

33、 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 possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for ident

34、ifying 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.This third edition cancels and replaces the second edition (ISO 15189:2007), which has been technically revised.A correlation between the se

35、cond and third editions of this International Standard is provided as Annex B. The third edition continues the alignment established in ISO/IEC 17025:2005.This corrected version of ISO 15189:2012 includes various editorial corrections.iv ISO 2012 All rights reservedBS EN ISO 15189:2012ISO 15189:2012

36、(E)IntroductionThis International Standard, based upon ISO/IEC 17025 and ISO 9001, specifies requirements for competence and quality that 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

37、professional personnel and their activities and responsibilities in this domain.Medical laboratory services are essential to patient care 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

38、arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent interpretation, reporting and advice, in addition to the considerations of safety and ethics in

39、 medical laboratory work.Whenever allowed by national, regional or local regulations and requirements, it is desirable that medical laboratory services include the examination of patients in consultation cases, and that those services actively participate in the prevention of disease in addition to

40、diagnosis and patient management. Each laboratory should also provide suitable educational and scientific opportunities for professional staff working with it.While this International Standard is intended for use throughout the currently recognized disciplines of medical laboratory services, those w

41、orking in other services and disciplines such as clinical physiology, medical imaging and medical physics could also find it useful and appropriate. In addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this International Standard as the basis f

42、or their activities. If a laboratory seeks accreditation, it should select an accrediting body which operates in accordance with ISO/IEC 17011 and which takes into account the particular requirements of medical laboratories.This International Standard is not intended to be used for the purposes of c

43、ertification, however a medical laboratorys fulfilment of the requirements of this International Standard means the laboratory meets both the technical competence requirements and the management system requirements that are necessary for it to consistently deliver technically valid results. The mana

44、gement system requirements in Clause 4 are written in a language relevant to a medical laboratorys operations and meet the principles of ISO 9001:2008, Quality management systems Requirements, and are aligned with its pertinent requirements (Joint IAF-ILAC-ISO Communiqu issued in 2009).The correlati

45、on between the clauses and subclauses of this third edition of ISO 15189 and those of ISO 9001:2008 and of ISO/IEC 17025:2005 is detailed in Annex A of this International Standard.Environmental issues associated with medical laboratory activity are generally addressed throughout this International S

46、tandard, with specific references in 5.2.2, 5.2.6, 5.3, 5.4, 5.5.1.4 and 5.7.1) In other languages, these laboratories can be designated by the equivalent of the English term “clinical laboratories.” ISO 2012 All rights reserved vBS EN ISO 15189:2012Medical laboratories Requirements for quality and

47、competence1 ScopeThis International Standard specifies requirements for quality and competence in medical laboratories.This International Standard can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming

48、 or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.NOTE International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.2 Normative referencesThe foll

49、owing 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/IEC 17000, Conformity assessment Vocabulary and general principlesISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratoriesISO/IEC Guide 2, Standardization and related activities General vocabularyISO/IEC Guide 99, International vocabulary of metrology Basic and genera