ESSENTIAL CRITERIA FOR QUALITY SYSTEMS IN MEDICAL LABORATORIES

The introduction of total quality systems in medical and clinical labo ratories and accreditation of these laboratories is gaining more and m ore interest. In several countries laboratories have set up quality sy stems, and accrediation schemes are also operating. The standards of t hese schemes have much in common although several differences exist. T here exists uncertainty in several countries on the choice of a system . Laboratory specialists are confronted with a new way of thinking con cerning the management and daily practice of their laboratories. It is not clear, which standards should be used as a basis, and certainly n ot how to interpret such standards. Particulary in the European Union, harmonisation of criteria for quality systems is desirable. In the pr esent paper, the document entitled ''Essential Criteria for Quality Sy stems in Medical Laboratories'' is presented. The document has been ac cepted in the general Assembly of the European Communities Confederati on of Clinical Chemistry (EC4) and by the working group on Good Labora tory Services of the European Council on Laboratory Medicine (ECLM). T he criteria in the document are focussed on the particular situation o f medical laboratories, including pre- and post-analytical aspects. Re ference is made, where applicable, to EN 45001, ISO 9001 and ISO guide 25 draft 3.