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ISO 15189:2022

Medical laboratories — Requirements for quality and competence

Dec 6, 2022

General information

60.60     Dec 6, 2022

ISO

ISO/TC 212

International Standard

11.100.01     03.120.10  

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 15189:2012

WITHDRAWN
ISO 22870:2016

NOW

PUBLISHED
ISO 15189:2022
60.60 Standard published
Dec 6, 2022