Overview

This International Standard is the result of the revision of EN ISO 15189:2013. 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 This document contains the requirements for point-of-care testing (POCT) and replaces ISO 22870, which was withdrawn upon publication of this document. This document is the consolidated version with the purely European amendment that adds Annex ZA as part of the M/580 Standardization Request relating to accreditation and conformity assessment in support of Regulation (EC) No. 765/2008. This document has been prepared by Technical Committee ISO/TC 212 "Clinical laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee CEN/TC 140 "In vitro diagnostic systems" (secretariat: DIN, Germany). Working Committee NA 176-08-08 AA "Quality management in medical laboratories" at DIN Standards Committee Medicine (NAMed) is responsible for this standard.

Document: references other documents

Responsible national committee

NA 176-08-08 AA - Quality management in medical laboratories  

Responsible european committee

CEN/TC 140 - In vitro diagnostic medical devices