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Abstract Preview

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

  • Status :  Published
    Publication date : 2012-11
    Corrected version (en) : 2014-08
    Corrected version (fr) : 2014-08
  • Edition : 3
    Number of pages : 53
  • Technical Committee
    :
    ISO/TC 212
    Clinical laboratory testing and in vitro diagnostic test systems
  • ICS :
    11.100.01
    Laboratory medicine in general
    03.120.10
    Quality management and quality assurance

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A standard is reviewed every 5 years



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