International Standard
ISO 15189:2022
Medical laboratories — Requirements for quality and competence
Reference number
ISO 15189:2022
Edition 4
2022-12
© ISO 2024
International Standard
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Published (Edition 4, 2022)

ISO 15189:2022

Format
Language
CHF 194
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Abstract

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.

General information

  • Status
     : Published
    Publication date
     : 2022-12
    Stage
    : International Standard published [60.60]
  • Edition
     : 4
    Number of pages
     : 62
  • Technical Committee :
    ISO/TC 212
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Life cycle

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