Medical Reference laboratories

The general requirements for accreditation of medical reference laboratories are laid down in ISO 15195: Laboratory medicine: Requirement for Reference Measurement Laboratories.

NOTE: ISO 15195 is not applicable to routine medical 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 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