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About This Item

 

Full Description

This document specifies requirements for quality and competence in medical laboratories.

This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.

This document is also applicable to point-of-care testing (POCT).

NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
 

Document History

  1. ISO 15189:2022

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    Medical laboratories - Requirements for quality and competence

    • Most Recent
  2. ISO 22870:2016


    Point-of-care testing (POCT) - Requirements for quality and competence

    • Historical Version
  3. ISO 15189:2012 - Redline Version


    Medical laboratories - Requirements for quality and competence

    • Historical Version
  4. ISO 15189:2012


    Medical laboratories - Requirements for quality and competence

    • Historical Version
  5. ISO 15189:2012 Plus Redline


    Medical laboratories - Requirements for quality and competence (includes Redline Version)

    • Historical Version
  6. ISO 15189:2007


    Medical laboratories - Particular requirements for quality and competence

    • Historical Version
  7. ISO 22870:2006


    Point-of-care testing (POCT) - Requirements for quality and competence

    • Historical Version
  8. ISO 15189:2003


    Medical laboratories - Particular requirements for quality and competence

    • Historical Version