SN EN ISO 15189:2022
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.
- Originator
- INB
- Published
- 2022-12-01
- ICS
- 11.100.01, 03.120.10
SN EN ISO 15189:2022
Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO 15189:2022)
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.
Content pages for this standard
guide
ISO 15189:2022 Overview - Medical Laboratories Requirements
Discover the key requirements and importance of ISO 15189:2022 for medical laboratories, ensuring quality and competence in healthcare technology.
ISO 15189:2022 Compliance Requirements Guide for Medical Laboratories
Discover the essential ISO 15189:2022 compliance requirements for medical laboratories and how to achieve certification.