Abstract

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
     :  Withdrawn
    Publication date
     : 2012-11
    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
     :
    03.120.10 Quality management and quality assurance
    11.100.01 Laboratory medicine in general

Life cycle


Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information.

  2. Store
  3. Standards catalogue
  4. ICS
  5. 03
  6. 03.120
  7. 03.120.10
  8. ISO 15189:2012