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Quality management systems: a reliable proof of conformity
1European Diagnostic Manufacturers Association, Brussels, Belgium.
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.
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.