ISO/TC 212
| Project No. | ISO 15189:2022 |
|---|---|
| Title | <p class="MsoBodyText"><span lang="EN-GB">This document specifies requirements for quality and competence in medical laboratories.</span></p> <p class="MsoBodyText"><span lang="EN-GB">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.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document is also applicable to point-of-care testing (POCT).</span></p> <p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>International, national, or regional regulations or requirements can also apply to specific topics covered in this document.</span></p> |
| Registration number (WIID) | 76677 |
| Scope | <p class="MsoBodyText"><span lang="EN-GB">This document specifies requirements for quality and competence in medical laboratories.</span></p> <p class="MsoBodyText"><span lang="EN-GB">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.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document is also applicable to point-of-care testing (POCT).</span></p> <p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>International, national, or regional regulations or requirements can also apply to specific topics covered in this document.</span></p> |
| Status | Standarts spēkā |
| ICS group | 03.120.10 11.100.01 |