QHS034

Medical Laboratories - Requirements for quality and competence

ISO 15189:2022 is an international standard that specifies the requirements for quality and competence in medical laboratories. The standard was updated in 2022 to align with ISO 17025:2017, the standard for the competence of testing and calibration laboratories. The standard requires labs to develop a reliable quality management system (QMS) to establish their competence. The revised standard contains enhanced requirements for medical laboratories to plan and implement actions to address risks, especially risks to the patients, and opportunities for improvement. The standard 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