DS/ISO 15189
Medical laboratories – Requirements for quality and competence
active, Most Current
| Organization: | DS |
| Publication Date: | 20 December 2022 |
| Status: | active |
| Page Count: | 74 |
| ICS Code (Quality management and quality assurance): | 03.120.10 |
| ICS Code (Laboratory medicine in general): | 11.100.01 |
scope:
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.
Document History
DS/ISO 15189
December 20, 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...