ISO 15189 specifies requirements for quality and competence in medical laboratories. It applies to medical laboratories in 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.
ISO 15189 requirements will help to plan and implement actions to address risks and opportunities for improvement. It can increase the effectiveness of the management system, decrease the probability of invalid results, and reduce potential harm to patients, laboratory personnel, the public and the environment.
The international standard has been approved in Europe as EN ISO 15189:2022 without any changes and it supersedes EN ISO 15189:2012. This consolidated version consists of the main text and the amendment, which can also be found separately from the standards history. 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.
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