SR EN ISO 15189:2023

Medical laboratories - Requirements for quality and competence (ISO 15189:2022)

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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General information

Status : Valid
Approval date : 1/31/2023
Number of pages : 66
ICS : 03.120.10 Quality management and quality assurance,11.100.01 Laboratory medicine in general
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 15189:2013
Replaces SR EN ISO 22870:2017
Replaces SR EN ISO 15189:2013/C91:2016
Normative reference SR GHID ISO/CEI 99:2010
Normative reference SR EN ISO/IEC 17000:2020
Normative reference SR EN ISO/IEC 17025:2018
Amended by SR EN ISO 15189:2023/A11:2023