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 BS EN ISO 15195:2003 This British Standard was published under the authority of the Standards Policy a
2、nd 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 identical with ISO 15195:2003. The UK participation in its preparation was entrusted to Technical Committee CH/
3、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 implement international or European publications referred to in this document may be found in the BSI Catalogue
4、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 does not purport to include all the necessary provisions of a contract. Users are responsible for its correct
5、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/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informe
6、d; 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, the EN ISO foreword page, the ISO title page, pages ii to vi, pages 1 to 12, the Annex ZA page and a back co
7、ver. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO15195 October2003 ICS11.100 Englishversion LaboratorymedicineRequirementsforreferencemea
8、surement laboratories(ISO15195:2003) MdecinedelaboratoiresExigencespourleslaboratoires ralisantdesmesuragesderfrence(ISO15195:2003) LaboratoriumsmedizinAnforderungenan Referenzmesslaboratorien(ISO15195:2003) ThisEuropeanStandardwasapprovedbyCENon24July2003. CENmembersareboundtocomplywiththeCEN/CENEL
9、ECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthree
10、officialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,Fra
11、nce,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandUn ited Kingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2003CEN Allri
12、ghtsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO15195:2003EForeword Thisdocument(ENISO15195:2003)hasbeenpreparedbyTechnicalCommitteeISO/TC212 “Clinicallaboratorytestingandinvitrodiagnostictestsystems“incollaborationwithTechnical CommitteeCEN/TC140“Invitro
13、diagnosticmedicaldevices“,thesecretariatofwhichisheldby DIN. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationof anidenticaltextorbyendorsement,atthelatestbyApril2004,andconflictingnational standardsshallbewithdrawnatthelatestbyApril2004. AccordingtotheCEN/CENELECInter
14、nalRegulations,thenationalstandardsorganizationsof thefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Czech Republic,Denmark,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy, Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,Switzerlandand theUni
15、tedKingdom. Endorsementnotice ThetextofISO15195:2003hasbeenapprovedbyCENasENISO15195:2003withoutany modifications. NOTENormativereferencestoInternationalStandardsarelistedinAnnexZA(normative). ENISO15195:2003 Reference number ISO 15195:2003(E)INTERNATIONAL STANDARD ISO 15195 First edition 2003-10-01
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21、aF0 947 22 14 + 9 74 E-mial coirypthgis.o gro We bwww.is.o groii ENISO15195:2003 iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 2 4 Management system requirements. 4 4.1 Organization and management . 4 4.2 Quality management system . 5 4.3 P
22、ersonnel. 6 4.4 Measurement documentation and records 6 4.5 Contracting 6 5 Technical requirements 7 5.1 Premises and environmental conditions 7 5.2 Handling of samples . 7 5.3 Equipment 7 5.4 Reference materials 8 5.5 Reference measurement procedures 8 5.6 Metrological traceability Uncertainty of m
23、easurement 8 5.7 Quality assurance . 9 5.8 Reporting results 9 Annex A (informative) Cross-references to ISO/IEC 17025:1999. 11 Bibliography . 12 ENISO15195:2003iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bod
24、ies). The work of preparing International Standards 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
25、 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 electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives,
26、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 member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies cast
27、ing 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 identifying any or all such patent rights. ISO 15195 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and
28、 in vitro diagnostic test systems. ENISO15195:2003 vIntroduction 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 in
29、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 avai
30、lable. 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 referenc
31、e 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, Internat
32、ional 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. Th
33、e 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 of
34、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 ar
35、e 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 ref
36、erence 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 (I
37、SO 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); the
38、n 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 refer
39、ence 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. ENISO15195:2003vi The tracea
40、bility concept, its applicability and limitations are described in detail in the standard “Metrological traceability of values assigned to calibrators and control materials” (ISO 17511). Further tasks of reference measurement laboratories may include upon request: assisting in investigation of new o
41、r existing measurement procedures with regard to their trueness, providing accurate (true and precise) assigned values with stated uncertainty to materials for calibration, internal quality control, and external quality assessment, acting as consultants to government, industry, and organizations con
42、ducting 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 reference measurement laboratories to perform their tasks adequately. When the reference measurement laboratory is int
43、egrated into a routine laboratory, the management system, personnel and equipment requirements of the reference laboratory should comply with this International Standard and be independent of the routine laboratory. This International Standard should aid in establishing confidence in reference measu
44、rement 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 a reference measurement laboratory that applies for official recognition of the performance of a reference measu
45、rement 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) coordina
46、tes and supervises the regional organizations of national accrediting bodies, such as the European Cooperation for Accreditation (EA), which ensures that member bodies recognize each others accreditation certificates. This International Standard may furthermore facilitate collaboration between refer
47、ence measurement laboratories performing interlaboratory comparisons and encourage the highly desirable formation of international networks of reference measurement laboratories. It is understood that reference measurement procedures should be of high metrological order and the analytical principle
48、of measurement applied should allow an adequately low uncertainty. The results of reference measurements should be traceable to reference materials or to a reference procedure of higher order when available. ENISO15195:2003INTENRATIONAL TSANDADR IS:59151 O3002(E)1Laboratory medicine Requirements for reference measurement laboratories 1 Scope This International Standard gives the specific requirements f
