The role of standardization in quality assurance.
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.
Verwilghen
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RL
Faculty of Medicine, University of Leuven, Belgium.
D005060:Europe; D007390:International Agencies / Q000458:organization & administration; D011785:Quality Assurance, Health Care / Q000458:organization & administration / Q000592:standards*; D012955:Societies, Medical / Q000458:organization & administration; D014944:World Health Organization