Laboratory quality systems legislative requirements

Community on In-Vitro Diagnostics) is a European legislative regulation directed at in vitro manufacturers. The directive demands that the manufacturer have a quality management system and that products are validated by competent laboratories. It is required that the traceability of values assigned to calibrators or control materials or both must be ensured through available reference measurement procedures and/or available materials of higher order. Explicit statement of the uncertainty of calibrator values is not required, but indirectly the manufacturers have to... 

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