Quality management systems: a reliable proof of conformity.
Doubts have been raised about whether proof of conformity via a certified full quality management system is appropriate for in vitro diagnostic products used for screening blood donations, for example, tests for HIV and hepatitis B and C. This article reviews all the arguments and finds in favour of the proposed system because it involves requirements that extend beyond the normal quality system standard.
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European Diagnostic Manufacturers Association, Brussels, Belgium.
D001771:Blood Banks; D002568:Certification; D019411:Clinical Laboratory Techniques / Q000295:instrumentation / Q000592:standards*; D003257:Consumer Product Safety; D005060:Europe; D006801:Humans; D066298:In Vitro Techniques; D017749:Total Quality Management / Q000458:organization & administration*