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ISO 15189:2022

Medical laboratories — Requirements for quality and competence

General information

Valid from 06.12.2022
Directives or regulations
None

Standard history

Status
Date
Type
Name
06.12.2022
Main
26.10.2016
Main
05.11.2012
Main
This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

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