International standards in laboratory medicine

International standards play an important role in establishing quality syst ems. A considerable number of standards have been created by ISO and CEN fo r medical laboratories. Standards can be looked upon in a hierarchal manner but most standards are produced in similarly with iterative consultations and review by the intended users. Most standards are suggested by industry and national or international organisations whereas individuals rarely can influence the contents. An exception is illustrated by a conference arrange d to influence and improve the suggested standard (ISO 15196) on quality sp ecifications in laboratory medicine. Standards may also influence the metho dological practice and the performance of reagents and kits used in analyti cal work. A good example is the standard on traceability of calibrators (IS O 17511) that illustrates the practical importance of concepts like 'uncert ainty in measurements' and 'trueness'. Biological calibrators, e.g., 'WHO b iological standards', constitute a special problem since they often cannot be traced to SI. A reference procedure should be defined and referred. This would be more advantageous than to refer to a reference material that can only be traced to a master preparation. This would reduce the uncertainty a nd guarantee that calibrators of different batches meet certain metrologica l criteria. (C) 2001 Elsevier Science B.V. All rights reserved.