MS ISO 15189:2022 Medical Laboratories – Requirements for quality and competence

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).