The new ISO and CEN standards for quality and accreditation of medical laboratories

Abstract

The new international standard EN ISO 15189:2003 ?Medical laboratories - particular requirements for quality and competence?, after many delays, was finally published in February 2003. This standard has been developed specifically to address requirements for accreditation of medical laboratories. It takes into account the special constraints imposed by the medical environment and the essential contribution of the medical laboratory service to patient care. It recognizes that medical laboratories provide not only testing of patient samples, but also advisory, interpretative and educational services. It also acknowledges the role of diagnostics manufacturers in maintaining the quality of medical laboratory services. The international standard ISO/IEC 17025 ?General requirements for the competence of testing and calibration laboratories? is already used in some countries for accreditation of medical laboratories. This is a standard which was developed mainly for use in industrial testing laboratories, and has serious deficiencies when used in the medical environment. While still in draft form, 15189 was already approved by ILAC (International Laboratory Accreditation Co-operation) as a suitable basis for accrediting medical laboratories. It is expected that this document will be used widely in Europe and throughout the world as the preferred standard for this purpose. An informal survey of FESCC member societies shows that 15189, alone or in combination with other standards, will be used in almost all European countries for accreditation of medical laboratories. A further complementary standard, ISO 15190 ?Medical laboratories - requirements for safety? has now been published. A standard for quality and competence in Point Of Care Testing (POCT) is under development, and will be published as a new Annex to EN ISO 15189. These standards will for the first time provide a common basis for the development of quality systems and requirements for competence in medical laboratories throughout the world.