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The role of standardization in quality assurance
1Faculty of Medicine, University of Leuven, Belgium.
Annali Dell'Istituto Superiore Di Sanita
|January 1, 1995
Abstract:
The main organizations involved in standardization of laboratory medicine are described. At the international level these are mainly: ISO, IEC, WHO, ICSH, IFCC and COWS/WASP, while at the European level CEN, CENELEC and BCR are involved in standardization activities in Europe. At the present the European Commission is preparing a directive on in vitro diagnostic. This document will rely, for its implementation, on standards prepared by CEN/CENELEC.