ISO 15189:2022
Medical laboratories — Requirements for quality and competence
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.
This document is available in electronic format only.
Details
Date of Publication: December 1, 2022
Order Code PDF: ISO15189E
Order Code Print: print not available
Edition: Fourth
Pages: 62
ISO 15189:2022 Additional Details
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Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.