Effect of accreditation schemes on the setting of quality specifications by laboratories

In the future, there will be a universal standard for quality management in medical laboratories: ISO 15189. This standard follows the basic principle s of ISO 17025, the general standard for test laboratories, but also adds s everal specific aspects. A comparison between these standards is given. The language of ISO 15189 is designed to be understood by medical laboratory p rofessionals. As this standard is applicable to all medical laboratory fiel ds, requirements are given in general terms requiring the laboratory to imp lement them correctly. Because it is essential that information provided by laboratory results is useful for healthcare, the requirements covered by I SO 15189 are compared with those needed for providing good medical laborato ry services. The capabilities of the personnel at the laboratory-clinic int erface are the most difficult to assess and evaluate in an adequate quality management system.