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.

  • Code CYS EN ISO 15189:2022
  • Title Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
  • ICS Code 03.120.10 Quality management and quality assurance
  • Status Published
  • Replaces CYS EN ISO 15189:2012, CYS EN ISO 22870:2016
  • Publication Date 20.01.2023
  • Technical Committee CEN/TC 140
  • Work Item Number 00140135
  • Corrigenda/Amendments Including A11:2023 - 15/12/2023