ISO 15189 specifies requirements for quality and competence in medical laboratories. It applies to medical laboratories developing their management systems and assessing their competence. ISO 15189 is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
The amendment covers the relationship between ISO 15189 and the requirements of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history.
The international standard has been approved in Europe as EN ISO 15189:2022 without any changes and supersedes EN ISO 15189:2012. EN ISO 15189:2022/A11:2023 modifies the European standard EN ISO 15189:2022.