SS ISO 15189:2023

Medical laboratories — Requirements for quality and competence

OVERVIEW

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).

COMMENTS

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PRODUCT DETAILS

Status Current
Edition 2023
No. of Pages 75
ICS Classification 03.120.10 Quality management and quality assurance
11.100.01 Laboratory medicine in general
Committee Biomedical and Health Standards Committee
Available for Purchase Global
Adoption ISO 15189 : 2022 IDT