Establishing Reference Systems in Laboratory Medicine on the Basis of ISO/CEN Standards

ISO/IEC has issued several International Standards concerning the concept of traceability in laboratory medicine. prEN ISO 17511 Metrological traceability of values assigned to calibrators and control materials, prEN ISO 18153 Metrological traceability of values for catalytic concentrations of enzymes assigned to calibrators and control materials, prEN ISO 15193 Presentation of reference measurement procedures, prEN ISO 15194 Description of reference materials prEN ISO 15195 Requirements for reference laboratories The concept of traceability provides the most important strategy to achieve comparable measurement results independent of the laboratory and the applied measurement procedure. The implementation of this concept requires the development of further vertical standards by international organisations, the development of reference measurement procedures, the provision of reference materials, the establishing of a global infrastructure which approves reference procedures, reference materials and reference laboratories. The activities of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the Joint Committee on Traceability in Laboratory Medicine (JCTLM) for the establishing of reference systems on the basis of ISO standards are demonstrated in some examples.