NA 063

DIN Standards Committee Medicine

Standards [CURRENT]

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

Title (German)

Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO 15189:2012, korrigierte Fassung 2014-08-15); Deutsche Fassung EN ISO 15189:2012


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 063-03-03 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 

Edition 2014-11
Original language German
Translation English
Price from 137.70 €
Table of contents


Dipl.-Ing. (FH)

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