ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

ISO 15189:2022 specifies requirements for quality and competence in medical laboratories. This standard contains requirements for the medical laboratory to plan and implement actions to address risks and opportunities for improvement. Besides being applicable to medical laboratories developing their management systems and assessing their competence, ISO 15189 is also applicable for users, regulatory authorities, and accreditation bodies confirming or recognizing the competence of medical laboratories by laboratory.

Benefits of this standard’s approach include:

• Increasing the effectiveness of the management system
• Decreasing probability of invalid results
• Reducing potential harm to patients, laboratory personnel, the public and the environment