Medical laboratories – Requirements for quality and competence (Third revision) (ISO 15189:2022, IDT)
(Published by Department of Standards Malaysia in 2023)
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.
Published
N/A
PDF
28/04/2023
77
NSC 18 - Medical Devices and Facilities for Healthcare
