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SSH EN ISO 15189:2012

Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)

Apr 18, 2013
95.99 Withdrawal of Standard   Jan 5, 2023

General information

95.99     Jan 5, 2023

DPS

DPS/KT 140

European Norm

03.120.10     11.100.01  

English  

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Scope

ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.
ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

Related directives

Directives related to this standards.

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
Directive 765/2008

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 15189:2007

NOW

WITHDRAWN
SSH EN ISO 15189:2012
95.99 Withdrawal of Standard
Jan 5, 2023

REVISED BY

PUBLISHED
SSH EN ISO 15189:2022

Related project

Adopted from EN ISO 15189:2012