European medical laboratory accreditation. Present situation and steps to harmonisation.

摘要: Accreditation of medical laboratories in Europe is primarily according to ISO15189. The percentage accredited still small. time spent on an assessment quite different between countries. More important the way process carried out. Harmonisation accrediting main task Health Care Committee within EA (European cooperation Accreditation). EFCC Working Group strongly contributes as representative laboratory professionals. An item use flexible scope. intention that all tests a discipline are offered for accreditation. This not yet normal practice. Other items concern accreditation point-of-care testing (POCT) - reliability pre-analytical phase, when phlebotomy done by laboratory, and practical uncertainty verification. Also diversity discussed. added value dependent upon assessors who have task. Their training calibration needs continuous input. professionals should participate aspects concerning quality system, starting with standard, working guidelines, itself, input bodies.