ISO 15189:2022
Medical laboratories — Requirements for quality and competence
This standard has an identical version adopted as a Singapore Standard. The adopted Singapore version has the same content as this version and is available at a significantly lower cost. To view and / or purchase the adopted Singapore Version, click here .
OVERVIEW
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.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2022 |
| No. of Pages | 62 |
| ICS Classification | 11.100.01 Laboratory medicine in general 03.120.10 Quality management and quality assurance |
| Committee | ISO/TC 212 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO |