This International Standard specifies requirements for quality and competence in medical laboratories.ThisInternationalStandardcanbeusedbymedicallaboratoriesindevelopingtheirqualitymanagementsystemsand assessing their own competence. It can also be used for confirming or recognizing the competence ofmedical laboratories by laboratory customers, regulating authorities and accreditation bodies.NOTE International, national or regional regulations or requirements may also apply to specific topics covered inThisInternational Standard.