CE lebel and harmonisation of quality systems in medical laboratories

Abstract

During the past ten years many activities have taken place in medical laboratories to harmonized the quality systems and accreditation activates. At that time, different approaches were followed in European countries concerning the demands for a quality system in a medical laboratory, and for the choice between certification or accreditation. Also, the working group on accreditation, of the European Communities Confederation of Clinical Chemistry (EC4) with as official name WG on Harmonization of Quality Systems and Accreditation was formed. From the start, the European Diagnostic Manufacturers Association (EDMA) was invited to participate, because harmonisation of quality systems and accreditation is of common interest. A crucial point in the quality revolution in medical laboratories is broad-based awareness of total quality management throughout the diagnostic business from manufacturers to laboratories to physicians and patients. In fact, the quality of laboratory tests largely depends on the products supplied (industry) and on quality management (laboratory management). Manufacturers recognize that accreditation gives high value to medical laboratories. However, while clinical laboratory practice is the responsibility of laboratory professionals, the in vitro diagnostics industry has a major role to play as the supplier of high quality goods and services, as training, scientific services, etc. On the other hand, the IVD industry is directly affected by accreditation schemes, and by the changes in laboratory practice and requirements that they initiate. The IVD Directive is a new example of legislative regulation that obliges the manufacturer (those who are not ISO 9000) to implement a quality management system. At the same time, the IVD Directive includes validation of products by competent laboratories, for ?sensitive? products. In fact, clinical laboratories should be assisted by manufacturers that provide reliable documentation, standard information for use, calibration procedure, performance checks and guide for preventive maintenance. The IVD Directive (EC 98/79) is released on December 1998, it is effective since June 2000 and final implementation is obliged from December 2003. IVDD shall ensure that only one safe and effective products will be sold in the European Union (EU), and just a single product approval is required to sell the products throughout the entire European Union. Official mark for products in conformity with the IVD Directive is CE label.