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This standard is the result of the revision of EN ISO 15189:2007. The work has been carried out in ISO/TC 212 and CEN/TC 140. NA 063-03-03 AA "Qualitätsmanagement in medizinischen Laboratorien" ("Quality management in medical laboratories") is responsible for the work on a national level. The standard specifies requirements for quality and competence in medical laboratories. It is intended to be used by medical laboratories in developing their quality management systems and assessing their own competence. This document can be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies. This standard is not intended to be used for the purposes of certification of laboratories, however.
This document replaces DIN EN ISO 15189:2007-08 .
This document has been replaced by: DIN EN ISO 15189:2023-03 , DIN EN ISO 15189:2014-11 .