Abstract 

ISO 15189:2007 specifies requirements for quality and competence particular to medical laboratories.

ISO 15189:2007 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.


General information

  • Status :  Withdrawn
    Publication date : 2007-04
    Corrected version (fr) : 2007-09
  • Edition : 2
    Number of pages : 40
  • Technical Committee
    :
    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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