Overview

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.

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