ISO 15189:2012规定了医学实验室的质量和能力要求。 ISO 15189:2012可被医学实验室用于开发质量管理体系和评估自己的能力。它也可用于确认或认可实验室客户，监管机构和认证机构的医疗实验室的能力

ISO 15189:2012 specifies requirements for quality and competence in medical laboratories. 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.