DIN EN ISO 15189-2014 Medical laboratories - Requirements for quality and competence (ISO 15189 2012 Corrected version 2014-08-15) German version EN ISO 15189 2012《医学实验室 质量和资格要求(IS.pdf

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1、November 2014 Translation by DIN-Sprachendienst.English price group 23No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).I

2、CS 11.100.01!%6“2270219www.din.deDDIN EN ISO 15189Medical laboratories Requirements for quality and competence (ISO 15189:2012, Correctedversion 2014-08-15);English version EN ISO 15189:2012,English translation of DIN EN ISO 15189:2014-11Medizinische Laboratorien Anforderungen an die Qualitt und Kom

3、petenz (ISO 15189:2012, korrigierte Fassung2014-08-15);Englische Fassung EN ISO 15189:2012,Englische bersetzung von DIN EN ISO 15189:2014-11Laboratoires de biologie mdicale Exigences concernant la qualit et la comptence (ISO 15189:2012, Version corrige2014-08-15);Version anglaise EN ISO 15189:2012,T

4、raduction anglaise de DIN EN ISO 15189:2014-11SupersedesDIN EN ISO 15189:2013-03www.beuth.deDocument comprises 61 pagesIn case of doubt, the German-language original shall be considered authoritative.11.14 DIN EN ISO 15189:2014-11 2 A comma is used as the decimal marker. Start of application The sta

5、rt of application of this standard is 2014-11-01. DIN EN ISO 15189:2007-08 may be used in parallel until 2015-10-31. National 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 collabora

6、tion with Technical Committee CEN/TC 140 “In vitro diagnostic medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-03-03 AA Qualittsmanagement in medizini

7、schen Laboratorien. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 3534-1 DIN ISO 3534-1 ISO 9000 DIN EN ISO 9000 ISO 9001 DIN EN ISO 9001 ISO 5725-1 DIN ISO 5725-1 ISO 15194 DIN EN ISO 15194 ISO/IEC 17011 DIN EN ISO/IEC 17011 ISO/IEC

8、17025 DIN EN ISO/IEC 17025 ISO/IEC 17043 DIN EN ISO/IEC 17043 ISO/TS 22367 DIN SPEC 1106 Amendments This standard differs from DIN EN ISO 15189:2007-08 as follows: a) the title of the standard has been modified; b) terms and definitions have been updated to comply with ISO/IEC Guide 99:2007 and furt

9、her terms and definitions have been introduced; c) normative references and the Bibliography have been updated; d) the content of the standard has been completely revised; e) subclauses have been introduced for the sake of legibility; f) requirements relating to environmental issues have been includ

10、ed; g) the correlation of this document with ISO 9001:2008 has been updated; h) the former informative Annex B has been changed to a normative text relating to laboratory information management (5.10). DIN EN ISO 15189:2014-11 3 Compared with DIN EN ISO 15189:2013-03, the following corrections have

11、been made: a) various editorial modifications have been made (for example, correction of sources in Clause 3 and of references throughout the document, updating of tables in Annexes A and B). Previous editions DIN EN ISO 15189: 2003-12, 2007-08, 2013-03 DIN EN ISO 15189:2014-11 4 National Annex NA (

12、informative) Bibliography DIN SPEC 1106, Medical laboratories Reduction of error through risk management and continual improvement DIN ISO 3534-1, Statistics Vocabulary and symbols Part 1: General statistical terms and terms used in probability DIN ISO 5725-1, Accuracy (trueness and precision) of me

13、asurement methods and results Part 1: General principles and definitions DIN EN ISO 9000, Quality management systems Fundamentals and vocabulary DIN EN ISO 9001, Quality management systems Requirements DIN EN ISO 15194, In vitro diagnostic medical devices Measurement of quantities in samples of biol

14、ogical origin Requirements for certified reference materials and the content of supporting documentation DIN EN ISO/IEC 17011, Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies DIN EN ISO/IEC 17025, General requirements for the competence of

15、 testing and calibration laboratories DIN EN ISO/IEC 17043, Conformity assessment General requirements for proficiency testing EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15189 November 2012 ICS 03.120.10; 11.100.01 Supersedes EN ISO 15189:2007English Version Medical laboratories - Requ

16、irements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15) Laboratoires de biologie mdicale -Exigences concernant la qualit et la comptence(ISO 15189:2012, Version corrige 2014-08-15) Medizinische Laboratorien -Anforderungen an die Qualittund Kompetenz(ISO 15189:2012, korrigi

17、erte Fassung 2014-08-15) 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 of a national standard without any alteration. Up-to-date list

18、s 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, German). A version in any other language made by translation under

19、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, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yug

20、oslav 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 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPE

21、N DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC 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 15189:2012 EContents PageForeword .3Introduction 41 Scope .

22、 52 Normative references 53 Terms and definitions . 54 Management requirements 104.1 Organization and management responsibility .104.2 Quality management system 134.3 Document control 144.4 Service agreements 154.5 Examination by referral laboratories .164.6 External services and supplies . 164.7 Ad

23、visory services . 174.8 Resolution of complaints . 174.9 Identification and control of nonconformities .174.10 Corrective action 184.11 Preventive action 184.12 Continual improvement . 184.13 Control of records 194.14 Evaluation and audits .204.15 Management review 225 Technical requirements .235.1

24、Personnel 235.2 Accommodation and environmental conditions 255.3 Laboratory equipment, reagents, and consumables .275.4 Pre-examination processes .305.5 Examination processes . 345.6 Ensuring quality of examination results 375.7 Post-examination processes . 395.8 Reporting of results . 395.9 Release

25、 of results . 415.10 Laboratory information management . 42Annex A (informative) Correlation with ISO 9001:2008 and ISO/IEC 17025:2005 44Annex B (informative) Comparison of ISO 15189:2007 to ISO 15189:2012 49Bibliography .54DIN EN ISO 15189:2014-11 EN ISO 15189:2012 (E) 2 DIN EN ISO 15189:2014-11 EN

26、 ISO 15189:2012 (E) 3Foreword 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 i

27、s 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 possibility

28、 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 organ

29、isations 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, Luxembourg,

30、Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 15189:2012, Corrected version 2014-08-15 has been approved by CEN as EN ISO 15189:2012 without any modification. IntroductionThis I

31、nternational 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 professional personne

32、l 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 arrangements for exam

33、ination 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 medical laboratory w

34、ork.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 diagnosis and patient

35、 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 working in other servi

36、ces 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 for their activities.

37、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 certification, however

38、 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 management system require

39、ments 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 correlation between the clause

40、s 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 Standard, with specifi

41、c 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.”DIN EN ISO 15189:2014-11 EN ISO 15189:2012 (E) 4 1 ScopeThis International Standard specifies requirements for quality and

42、 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 or recognizing the competence of medical laboratories by laboratory customers, reg

43、ulating 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 following referenced documents are indispensable for the application of this document.

44、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

45、and calibration laboratoriesISO/IEC Guide 2, Standardization and related activities General vocabularyISO/IEC Guide 99, International vocabulary of metrology Basic and general concepts and associated terms (VIM)3 Terms and definitionsFor the purposes of this document, the terms and definitions given

46、 in ISO/IEC 17000, ISO/IEC Guide 2 and ISO/IEC Guide 99 and the following apply.3.1accreditationprocedure by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks3.2alert intervalcritical intervalinterval of examination results for an aler

47、t (critical) test that indicates an immediate risk to the patient of injury or deathNote 1 to entry: The interval may be open ended, where only a threshold is defined.Note 2 to entry: The laboratory determines the appropriate list of alert tests for its patients and users.3.3automated selection and

48、reporting of resultsprocess by which patient examination results are sent to the laboratory information system and compared with laboratory-defined acceptance criteria, and in which results that fall within the defined criteria are automatically included in patient report formats without any additional interventionDIN EN ISO 15189:2014-11 EN ISO 15189:2012 (E)