EVS-EN ISO 15189:2022

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.

ISO 15189 requirements will help to plan and implement actions to address risks and opportunities for improvement. It can increase the management system's effectiveness, decrease the probability of invalid results, and reduce potential harm to patients, laboratory personnel, the public and the environment.

The main changes in the new edition are:

— Alignment with ISO/IEC 17025:2017 resulted in the management requirements now appearing at the end of the document,
— Requirements for point-of-care testing (POCT) have been incorporated,
— Increased emphasis on risk management.

The international standard has been approved in Europe as EN ISO 15189:2022 without any changes and it supersedes EN ISO 15189:2012.