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prEN ISO 15189

Medical laboratories - Requirements for quality and competence (ISO/DIS 15189:2021)

General information
Draft
Base Documents
ISO/DIS 15189; prEN ISO 15189
Directives or regulations
None
Standard history
Status
Date
Type
Name
09.09.2013
Corrigendum
05.12.2012
Main
This document specifies requirements for quality and competence in medical laboratories. This document can be used by medical laboratories in developing their management systems and assessing their competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies. This document includes requirements for Point of Care Testing (POCT). NOTE International, national, or regional regulations or requirements may also apply to specific topics covered in this document.
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Standard monitoring