DANSK DSF/FPREN ISO 15189 PDF

This International Standard specifies requirements for quality and competence in medical laboratories. This International Standard is for use by medical laboratories in developing their quality management systems and assessing their own competence. Laboratory customers, regulating authorities and accreditation bodies may also use it for confirming or recognizing the competence of medical laboratories. This International Standard is not intended to be used as the basis for certification of laboratories. NOTE International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.