DIN Standards Committee Health Technologies
DIN EN ISO 15189
Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15); German version EN ISO 15189:2012
Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO 15189:2012, korrigierte Fassung 2014-08-15); Deutsche Fassung EN ISO 15189:2012
Overview
This standard is the result of the revision of EN ISO 15189:2007. The work has been carried out on an international level at 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. The 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 provide a basis for certification of laboratories, however.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible european committee
CEN/TC 140 - In vitro diagnostic medical devices
Responsible international committee
ISO/TC 212/WG 1 - Quality and competence in the medical laboratory
