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60.60 Standard published Dec 6, 2022
ISO
ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
International Standard
11.100.01 Laboratory medicine in general | 03.120.10 Quality management and quality assurance
Published
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
ISO 15189:2022
60.60
Standard published
Dec 6, 2022