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.