Quality management in the medical laboratory: a comparison of draft standards.

Clinical laboratories used to rely almost completely on functional tests to monitor and assess their performance. This is known as internal quality control (IQC). A supporting approach is the interlaboratory comparison. In many countries and other disciplines this is known as proficiency testing, whereas, in Europe, the procedure is better known as external quality assessment taken care of by different schemes (EQAS). Probably all laboratories participate in some kind of EQAS and in some countries it is mandatory. It has gradually become apparent that functional tests are not sufficient to achieve, assure and develop quality in medical laboratories. Therefore other means must be sought. The principles laid down in the ISO 9000 series and the total quality concept has become interesting; in particular, accreditation. Accreditation of laboratories has been available for many years and in fact is routine in some specialities e.g. food, water laboratories and in some countries also for laboratories in the veterinary field. The present paper describes some features of the available and planned ISO standards that deal with accreditation of laboratories and particularly those adopted for the medical laboratories.