ISO 15189:2022
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ISO 15189:2022
76677

Abstract

 Preview

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 

  •  :  Published
     : 2022-12
  •  : 4
     : 62
  •  : ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
  •  :
    03.120.10 Quality management and quality assurance
    11.100.01 Laboratory medicine in general

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std 1 178 PDF + ePub
std 2 178 Paper
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