CEN/TC 140
| Project No. | EN ISO 15189:2022 |
|---|---|
| Title | 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. |
| Registration number (WIID) | 68157 |
| 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. |
| Status | Standarts spēkā |
| ICS group | 03.120.10 11.100.01 |