ISO 15189:2012

Medical laboratories — Requirements for quality and competence

Publication date:   Nov 5, 2012

95.99 Withdrawal of Standard   Dec 6, 2022

General information

95.99 Withdrawal of Standard   Dec 6, 2022

ISO

ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems

International Standard

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

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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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 15189:2007

NOW

WITHDRAWN
ISO 15189:2012
95.99 Withdrawal of Standard
Dec 6, 2022

REVISED BY

PUBLISHED
ISO 15189:2022