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SRPS EN ISO 15189:2014

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

Feb 28, 2014
Feb 28, 2014
95.99   Withdrawal of Standard   Feb 28, 2023

General information

95.99     Feb 28, 2023

ISS

Z076

European Norm

03.120.10     11.100.01  

Serbian  

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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

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

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

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS ISO 15189:2008

NOW

WITHDRAWN
SRPS EN ISO 15189:2014
95.99 Withdrawal of Standard
Feb 28, 2023

REVISED BY

PUBLISHED
SRPS EN ISO 15189:2023

Related project

Adopted from EN ISO 15189:2012

Adopted from ISO 15189:2012