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Norm

ISO 15189:2022

Issue date: 2022 12 06

Medical laboratories — Requirements for quality and competence

This document specifies requirements for quality and competence in medical laboratories. This document is applicable to medical laboratories in developing their managemen...
Valid

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.

ISO 15189:2022
2022 12 06
Medical laboratories — Requirements for quality and competence
Norm
ISO 22870:2016
2016 10 26
Point-of-care testing (POCT) — Requirements for quality and competence
Norm
ISO 15189:2012
2012 11 05
Medical laboratories — Requirements for quality and competence
Norm
ISO 15189:2007
2007 04 19
Medical laboratories — Particular requirements for quality and competence (Corrected version 2007-04...
Norm
ISO 22870:2006
2006 02 03
Point-of-care testing (POCT) — Requirements for quality and competence
Norm
ISO 15189:2003
2003 02 10
Medical laboratories — Particular requirements for quality and competence (Corrected version 2003-07...
Norm
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