Abstract

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This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.

The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.

Examinations of properties with results reported on a nominal or ordinal scale are not included.

This document is not applicable to medical laboratories.

NOTE Requirements for medical laboratories are specified in ISO 15189[1].


General information 

  • Status
     : Published
    Publication date
     : 2018-12
  • Edition
     : 2
    Number of pages
     : 8
  • Technical Committee
     : ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
  • ICS
     :
    11.100.99 Other standards related to laboratory medicine

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