Kliniska laboratorier - Krav på kvalitet och kompetens (ISO 15189:2012, Rättad version 2014-08-15)
This International Standard specifes requirements for quality and competence in medical laboratories.
This International Standard can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confrming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
NOTE International, national or regional regulations or requirements may also apply to specifc topics covered in this International Standard.