Reinforcing the technical competence and laboratory accreditation according to the 3rd edition of ISO 15189: 2012

doi:10.3877/cma.j.issn.2095-5820.2013.01.003

Abstract

Abstract:

Three important requirements are stressed in “5 technical requirements”of ISO 15189(2012) 3rd edition as follows: 5.3.1.4 Equipment calibration and metrology traceability; 5.5.1.3(2) Validation of examination procedure; and 5.5.1.4 Measurement uncertainty of measured quantity values”. Chinese medical laboratories will prompt their technical competence and assure the reliability of measurement results once they meet these requirements. Guidelines and technical reports shall be prepared by Chinese Laboratory Accreditation Organization and more papers about these topics should be published on this journal to appeal for the attention and participation of laboratory professionals.

Key words: Traceability, Validation, Measurement, Uncertainty

Zhenhua Yang. Reinforcing the technical competence and laboratory accreditation according to the 3rd edition of ISO 15189: 2012[J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2013, 01(01): 13-16.

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Figures/Tables 5

References 8

1	Clinical and Laboratory Standards Institute. CLSI document X5-R 2006. Metrology traceability and its implementation, a report. Wayne:CLSI, 2006.
2	International Organization for Standardization. 2012 ISO 15189. Medical laboratory-particular requirements on quality and competence. 3rd ed.Geneva: ISO, 2012.
3	International Organization for Standardization. 2003 ISO 17511.In vitro diagnostic devices-measurement of quantities in samples of biological origin-metrological traceability of values assigned to calibrator and control materials. Geneva: ISO, 2003.
4	Berding C, Ciesiolka T, Fischer A, et al. Procedure of standardization of clinical chemistry and immunoassays. Roche Diagnostics AG Switzerland, 2010: 33.
5	Evropean Community. 98/79/EC. In vitro diagnostic medical device directive. EC, 2002.
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8	Clinical and Laboratory Standards Institute. CLSI document EP 15-A2 2005.User verification of performancefor precision and trueness,second approval. Wayne: CLSI, 2005.

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