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SSH EN ISO 15189:2022

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

Jan 5, 2023

General information

60.60     Jan 5, 2023

DPS

DPS/KT 140

European Norm

03.120.10  

English  

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 15189:2012

WITHDRAWN
SSH ISO 15189:2012

NOW

PUBLISHED
SSH EN ISO 15189:2022
60.60 Standard published
Jan 5, 2023

CORRIGENDA / AMENDMENTS

PUBLISHED
SSH EN ISO 15189:2022/A11:2023

Related project

Adopted from EN ISO 15189:2022 IDENTICAL