International standards in laboratory medicine.
International standards play an important role in establishing quality systems. A considerable number of standards have been created by ISO and CEN for 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 arranged to influence and improve the suggested standard (ISO 15196) on quality specifications in laboratory medicine. Standards may also influence the methodological practice and the performance of reagents and kits used in analytical work. A good example is the standard on traceability of calibrators (ISO 17511) that illustrates the practical importance of concepts like 'uncertainty in measurements' and 'trueness'. Biological calibrators, e.g., 'WHO biological 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 and guarantee that calibrators of different batches meet certain metrological criteria.
Kallner
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Department Clinical Chemistry, Karolinska Hospital, S-171 76, Stockholm, Sweden. anders.kallner@lab.ks.se
D019963:Clinical Chemistry Tests / Q000592:standards*; D006801:Humans; D012016:Reference Values