EN ISO 15189:2022

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

Publication date:   Mar 16, 2023

General information

60.60 Standard published   Dec 14, 2022

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

03.120.10   Quality management and quality assurance | 11.100.01   Laboratory medicine in general

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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.

Related legislation

Legislation related to this standard

765/2008

REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 15189:2012

WITHDRAWN
EN ISO 22870:2016

NOW

PUBLISHED
EN ISO 15189:2022
60.60 Standard published
Dec 14, 2022

CORRIGENDA / AMENDMENTS

PUBLISHED
EN ISO 15189:2022/A11:2023