SR EN ISO 15189:2013

Medical laboratories - Requirements for quality and competence (ISO 15189:2012)

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.

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General information

Status : Withdrawn
Approval date : 4/30/2013
Withdrawal date : 12/31/2025
Number of pages : 56
ICS : 03.120.10 Quality management and quality assurance,11.100.01 Laboratory medicine in general
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 15189:2007
Normative reference SR GHID ISO/CEI 99:2010
Normative reference SR EN ISO/CEI 17000:2005
Normative reference SR EN ISO/CEI 17025:2005
Replaced by SR EN ISO 15189:2023
Amended by SR EN ISO 15189:2013/C91:2016