Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation (CROSBI ID 277340)
Prilog u časopisu | ostalo | međunarodna recenzija
Podaci o odgovornosti
Roelofsen-de Beer ; Roseri ; Wielders, Jos ; Boursier, Guilaine ; Vodnik, Tatjana ; Vanstapel, Florent ; Huisman, Willem ; Vukasović, Ines ; Vaubourdolle, Michel ; Sönmez, Çiğdem ; Linko, Solveig ; Brugnoni, Duilio ; Kroupis, Christos ; Lohmander, Maria ; Šprongl, Luděk ; Bernabeu- Andreu, Francisco ; Meško Brguljan, Pika ; Thelen, Marc
engleski
Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation
This paper reflects the opinion of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO). It aims to provide guidance for drawing up local/national documents about validation and verification of laboratory methods. We demonstrate how risk evaluation can be used to optimize laboratory policies to meet intended use requirements as well as requirements of standards. This is translated in a number of recommendations on how to introduce risk evaluation in various stages of the implementation of new methods ultimately covering the whole process cycle.
EFLM ; ISO 15189 ; examination procedure ; opinion paper ; validation ; verification
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Podaci o izdanju
58 (3)
2020.
361-367
objavljeno
1434-6621
1437-4331
10.1515/cclm-2019-1053
Povezanost rada
Biotehnologija u biomedicini (prirodno područje, biomedicina i zdravstvo, biotehničko područje), Farmacija, Kliničke medicinske znanosti, Temeljne medicinske znanosti
