prEN ISO 15189

This document specifies requirements for quality and competence in medical laboratories. This document can be used by medical laboratories in developing their management systems and assessing their competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies. This document includes requirements for Point of Care Testing (POCT). NOTE International, national, or regional regulations or requirements may also apply to specific topics covered in this document.