Περίληψη:
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. © 2020 Walter de Gruyter GmbH, Berlin/Boston.
Συγγραφείς:
Roelofsen-De Beer, R.
Wielders, J.
Boursier, G.
Vodnik, T.
Vanstapel, F.
Huisman, W.
Vukasović, I.
Vaubourdolle, M.
Sönmez, Ç.
Linko, S.
Brugnoni, D.
Kroupis, C.
Lohmander, M.
Šprongl, L.
Bernabeu-Andreu, F.
Meško Brguljan, P.
Thelen, M.
Λέξεις-κλειδιά:
accreditation; article; clinical chemistry; drawing; human; human experiment; laboratory technique; risk assessment; validation process; accreditation; documentation; Europe; health care organization; standard, Accreditation; Clinical Laboratory Techniques; Documentation; Europe; Humans; Reference Standards; Societies, Scientific
