ISO 15189:2012

Medical laboratories — Requirements for quality and competence 

This International Standard specifies 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 confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

Equipment calibration and metrological traceability
The laboratory shall have a documented procedure for the calibration of equipment that directly or indirectly
affects examination results. This procedure includes:
a) taking into account conditions of use and the manufacturer’s instructions;
b) recording the metrological traceability of the calibration standard and the traceable calibration of the item
of equipment;
c) verifying the required measurement accuracy and the functioning of the measuring system at defined intervals;
d) recording the calibration status and date of re-calibration;
e) ensuring that, where calibration gives rise to a set of correction factors, the previous calibration factors are
correctly updated;
f) safeguards to prevent adjustments or tampering that might invalidate examination results.

Metro logical traceability shall be to a reference material or reference procedure of the higher metro logical
order available.

Equipment shall be maintained in a safe working condition and in working order. This shall include examination
of electrical safety, emergency stop devices where they exist and the safe handling and disposal of chemical,
radioactive and biological materials by authorized persons. At a minimum, manufacturer’s schedules or
instructions, or both, shall be used.