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Identification of Reference Measurement Laboratories _________________________________________

Identification of Reference Measurement Laboratories _________________________________________. JCTLM WG-2 Lothar Siekmann Institute of Clinical Biochemistry – University of Bonn, Germany. µ c (y). SI-Unit Definition of the Measurand. BIPM, CGPM. BIPM:

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Identification of Reference Measurement Laboratories _________________________________________

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  1. Identification of Reference Measurement Laboratories_________________________________________ JCTLM WG-2 Lothar Siekmann Institute of Clinical Biochemistry – University of Bonn, Germany

  2. µc(y) SI-Unit Definition of the Measurand BIPM, CGPM BIPM: Bureau International of Weights and Measures CGPM: General Conference on Weights and Measures NMI: National Metrology Institute ARML: Accredited Reference Measurement Laboratory ML: Manufacturer‘s Laboratory Certification of a reference material (purity) NMI NMI, ARML Primary calibrator Primary reference measurement procedure NMI, ARML Secondary calibrator ARML, ML Traceability Secondary reference measurement procedure ML,ARML Manufacturer‘s working (master) calibrator ML Manufacturer‘s standing measurement procedure ML Mf.´s product calibrator ML Manufacturer and/or End-user End-user´s routine measurement procedure Routine sample End-user RESULT End-user

  3. Hierarchy of Laboratories National Metrology Institutes Accredited Reference (Calibration) Laboratories (universities, hospitals, manufacturers) Routine (Testing) Laboratories

  4. Identification of Reference Laboratories________________________________________________________________________________________________________________ • Reference Measurement Laboratories will be • Identified • - according to the metrological level of the reference procedures applied; JCTLM –listed  WG1, • - on the basis of accreditation according to ISO 17025 and ISO15195 as reference/calibration laboratory; • or NMI listed in Appendix C of the CIPM MRA (peer reviewed), • - on the basis of their ability to demonstrate performance in regular inter-laboratory comparisons (ring trials) .

  5. ISO 15195: Requirements for Reference Measurement (Calibration) Laboratories__________________________________________________________________________________________________ • Technical Requirements • Premises and environmental • conditions • Handling of samples • Equipment • Reference materials • Reference measurement procedures • Metrological traceability – Uncertainty • Quality assurance • Reporting results • Management System • Requirements • Quality management system • Personnel • Documentation and records • Contracting

  6. WG-2) IFCC EQASfor Reference Laboratories________________________________________ Lothar Siekmann Institute of Clinical Biochemistry, Universität Bonn Reference Institute of Bioanalysis http://www.dgkl-rfb.de

  7. SUM 160 SUM 160

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