ISO 15195:2003 Laboratory medicine - Requirements for reference measurement laboratories

standard by International Organization for Standardization, 10/01/2003

Full Description

ISO 15195:2003 gives the specific requirements for reference measurement laboratories in laboratory medicine. Examinations of properties with results reported on a nominal or ordinal scale are not included.

ISO 15195:2003 is not applicable to routine medical laboratories.

The general requirements for the competence of calibration laboratories are laid down in ISO/IEC 17025 for testing and calibration laboratories. ISO 15195:2003 refers to the specific aspects of calibration laboratories in the field of laboratory medicine where such calibration laboratories are usually denoted as reference measurement laboratories.

ISO 15195:2003 may form a basis for the accreditation of a reference measurement laboratory that applies for official recognition of the performance of a reference measurement procedure. Reference measurement laboratories are usually accredited by national metrology institutes or national accrediting bodies.