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ISO 15189:2022

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Medical laboratories - Requirements for quality and competence

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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.

SDO ISO: International Organization for Standardization
Document Number ISO 15189
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 212
Publish Date Document Id Type View
Not Available ISO 15189:2022 Revision
Not Available ISO 15189:2022[S] Revision