Effect of current and forthcoming European legislation and standardizationon the setting of quality specifications by laboratories

A network of national and international guidelines and directives developed in the last few decades by various bodies will lead to a new concept of to tal quality for medical laboratory services comprising legislative regulati ons on national and international levels, standardizations backed up by leg islation and recommendations of professional societies. One example is the IVD Directive of the European Community. It will not only stimulate accredi tation in the field of laboratory medicine, but also necessitate numerous s tandardization activities which are presently co-ordinated by the European Committee for Standardization (CEN). Another standardization example is the development of quality management systems, mainly by ISO. The ISO 9000 ser ies has become the most successful family of standards world-wide. Meanwhil e, specific standards for the needs of laboratories (ISO 17025), and in par ticular of medical laboratories (ISO 15189), are being worked out. A new tr end to develop quality management systems towards total quality management systems can be observed including additional aspects such as economic and q uality interests of society, customers and owners of laboratories. The goal of all activities is to create a network of confidence which provides some guarantee to the clients, i.e. the physicians and their patients, that the y will receive a high-quality medical laboratory service.