BAS EN ISO 15189:2023
Medicinski laboratoriji - Zahtjevi za kvalitet i kompetentnost
Opšte informacije
Status: Važeći
Broj strana: 66
Jezik: Engleski
Izdanje: 4.
Metoda usvajanja: Proglašavanje
Datum objave: 14.06.2023
Tehnički komitet:
Direktiva:
765/2008, Uredba (EC) o utvrđivanju zahtjeva za akreditaciju i za nadzor tržišta u odnosu na stavljanje proizvoda na tržište;
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Apstrakt
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.
Životni ciklus
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Izvorni dokument i stepen usklađenosti
- EN ISO 15189:2022, identičan
- ISO 15189:2022, identičan