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ISO 15189:2012

Medical laboratories — Requirements for quality and competence

Standard Details

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.

General Information

Standard Type: Main
Document No: ISO 15189:2012
Document Year: 2012
Pages: 53
Edition: 3
  • Section Volume:
  • ISO/TC 212. Clinical laboratory testing and in vitro diagnostic test systems
  • ICS:
  • 03.120.10 Quality management and quality assurance
  • 11.100.01 Laboratory medicine in general

Life Cycle


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ISO 15189:2012
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