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1、BRITISH STANDARD BS EN ISO 15195:2003 Laboratory medicine Requirements for reference measurement laboratories The European Standard EN ISO 15195:2003 has the status of a British Standard ICS 11.100 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:59:19 GMT+00:00 2006, Uncontrolled Copy, (
2、c) BSI BS EN ISO 15195:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2003 BSI 31 October 2003 ISBN 0 580 42847 8 National foreword This British Standard is the official English language version of EN ISO 15195:2003. It is id
3、entical with ISO 15195:2003. 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 The British Standards which imp
4、lement 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 Standards Online. This publication d
5、oes 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 responsible international/Europ
6、ean 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 cover, the EN ISO title page,
7、 the EN ISO foreword page, the ISO title page, pages ii to vi, pages 1 to 12, the Annex ZA page and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun shef
8、fieldun, na, Fri Nov 17 09:59:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15195 October 2003 ICS 11.100 English version Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003) Mdecine de laboratoires - Exig
9、ences pour les laboratoires ralisant des mesurages de rfrence (ISO 15195:2003) Laboratoriumsmedizin - Anforderungen an Referenzmesslaboratorien (ISO 15195:2003) This European Standard was approved by CEN on 24 July 2003. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which
10、 stipulate the conditions for giving this European Standard the status 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 Management Centre or to any CEN member. This European Standar
11、d exists in three official versions (English, French, German). A version in any other language 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
12、 bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION E
13、UROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2003 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15195:2003 E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:59:19 GMT+00:00 200
14、6, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 15195:2003) 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
15、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 April 2004, and conflicting national standards shall be withdrawn at the latest by April 2004. According to the CEN/CENELEC
16、 Internal Regulations, the national standards organizations of 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, Slova
17、kia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 15195:2003 has been approved by CEN as EN ISO 15195:2003 without any modifications. NOTE Normative references to International Standards are listed in Annex ZA (normative). EN ISO 15195:2003 Licensed Copy: she
18、ffieldun sheffieldun, na, Fri Nov 17 09:59:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 15195:2003(E) INTERNATIONAL STANDARD ISO 15195 First edition 2003-10-01 Laboratory medicine Requirements for reference measurement laboratories Mdecine de laboratoires Exigences pour les lab
19、oratoires ralisant des mesurages de rfrence EN ISO 15195:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:59:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS:59151 O3002(E) DPlcsid Fremia ihTs PDF file mya ctnoian emdebt dedyfepcaes. In ccacnadrow eitA hebods licnesilop gnic,y tihs fil
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24、2 14 + 9 74 E-mial coirypthgis.o gro We bwww.is.o gro ii EN ISO 15195:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:59:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Contents Page Forewordiv Introduction v 1 Scope1 2 Normative references .1 3 Terms and definitions.2 4 Management
25、system requirements.4 4.1 Organization and management .4 4.2 Quality management system .5 4.3 Personnel.6 4.4 Measurement documentation and records 6 4.5 Contracting6 5 Technical requirements7 5.1 Premises and environmental conditions7 5.2 Handling of samples.7 5.3 Equipment7 5.4 Reference materials
26、8 5.5 Reference measurement procedures8 5.6 Metrological traceability Uncertainty of measurement 8 5.7 Quality assurance .9 5.8 Reporting results 9 Annex A (informative) Cross-references to ISO/IEC 17025:1999.11 Bibliography .12 EN ISO 15195:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 1
27、7 09:59:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Foreword ISO (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 committee
28、s. 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 take part in the work. ISO collaborates closely with the Inter
29、national 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 is to prepare International Standards. Draft International St
30、andards 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 possibility that some of the elements of this document may be the sub
31、ject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15195 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. EN ISO 15195:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17
32、 09:59:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v Introduction The general requirements for the competence of calibration laboratories are laid down in ISO/IEC 17025 for testing and calibration laboratories. This International Standard refers to the specific aspects of calibration laboratories
33、in the field of laboratory medicine where such “calibration laboratories” are usually denoted as “reference measurement laboratories.” The results produced by medical laboratories should be traceable to reference materials and/or reference measurement procedures of higher order, whenever these are a
34、vailable. This is necessary in order to allow transferability of measurement results in patient samples irrespective of the place and time of measurement. In order to achieve this goal, the first and essential step is to define the quantity to be measured. Once the quantity has been defined, a refer
35、ence measurement system should be established, consisting of reference materials, reference measurement procedures, and reference measurement laboratories. The reference measurement laboratories should be embedded in international (global) networks organized under the auspices of, for example, Inter
36、national Federation of Clinical Chemistry and Laboratory Medecine (IFCC) and International Committee of weights and Measures (CIPM). Reference measurement laboratories must operate with a traceability to the highest metrological level available and with a lower uncertainty than routine laboratories.
37、 The metrological level of the results provided by reference measurement laboratories should be appropriate to enable routine laboratories to fulfil medical requirements. The specific requirements of medical laboratories carrying out routine measurements are addressed in ISO 15189. The presentation
38、of reference measurement procedures and the description of reference materials are the subject of ISO standards (ISO 15193 and ISO 15194, respectively). This International Standard describes the performance characteristics required for reference measurement laboratories in laboratory medicine. These
39、 are highly specialized laboratories often attached to or subcontracted by entities such as national metrology institutes, quality assessment/proficiency testing organizations, academic centres, or in vitro diagnostic medical device manufacturers. Reference measurement laboratories should implement
40、reference measurement procedures and produce results of measurement that are accurate and traceable to national or international primary reference materials when such are available. Whenever possible, traceability should be established to a reference material which forms an embodiment of the SI unit
41、 (ISO 17511). In many instances, properties of biological materials cannot be expressed in SI units as the molecular structure of their analytes is not exactly known and may be different in a reference material from that in a native sample of human origin (e.g. state of glycosylation of a protein);
42、then the traceability chain ends at a lower level, e.g., at an arbitrary international unit (int. unit). However, the reference measurement laboratory should provide traceable values on reference materials supplied by customers to the highest available level of reference measurement procedures or re
43、ference materials. Even if the value for a property of a biological material is not traceable to an SI unit, each step of a reference measurement procedure (e.g. gravimetry, volumetry, temperature measurement) should have values that are traceable to the respective SI unit. EN ISO 15195:2003 License
44、d Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:59:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI vi The traceability concept, its applicability and limitations are described in detail in the standard “Metrological traceability of values assigned to calibrators and control materials” (ISO 17511).
45、Further tasks of reference measurement laboratories may include upon request: assisting in investigation of new or existing measurement procedures with regard to their trueness, providing accurate (true and precise) assigned values with stated uncertainty to materials for calibration, internal quali
46、ty control, and external quality assessment, acting as consultants to government, industry, and organizations conducting external quality assessment schemes as well as to specialized individual laboratories. The requirements described in this document and in ISO/IEC 17025 are prerequisites for refer
47、ence measurement laboratories to perform their tasks adequately. When the reference measurement laboratory is integrated into a routine laboratory, the management system, personnel and equipment requirements of the reference laboratory should comply with this International Standard and be independen
48、t of the routine laboratory. This International Standard should aid in establishing confidence in reference measurement laboratories that are able to demonstrate their competence in accordance with the requirements laid down here. This International Standard may form a basis for the accreditation of
49、 a reference measurement laboratory that applies for official recognition of the performance of a reference measurement procedure. Reference measurement laboratories are usually accredited by the national metrology institutes or national accrediting bodies. NOTE The requirements for recognition and operation are set out in ISO/IEC Guide 58. The International Laboratory Accreditation Cooperation (ILAC) coordinates and supervises the regional organizations of national accreditin