Regulation (EC) No 765/2008 of the European Parliament and of the Council, Decision No 768/2008/EC of the European Parliament and of the Council, Regulation (EC) No 1221/2009 of the European Parliament and of the Council )
1.1 This International Standard specifies the requirements for quality and competence in medical laboratories. 1.2 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. 1.3 International, national, or regional regulations or requirements may apply to specific topics covered in this International Standard and shall be followed when applicable.