ISO 15189:2022
International Standard
Current Edition
·
Approved on
06 December 2022
Medical laboratories — Requirements for quality and competence
ISO 15189:2022 Files
English
62 Pages
Current Edition
91.47 BHD
ISO 15189:2022 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.
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