Laboratories establish and implement a laboratory quality management system so as to demonstrate their technical competence and ability to provide accurate and consistent results of tests and measurements performed.

ISO 17025:2017 is the international standard for testing and calibration laboratories. It is applicable to all laboratories involved in calibration, verification, sampling and testing, regardless of size or number of personnel involved. Laboratories use ISO 17025:2017 to develop and implement a system that will improve their ability to consistently produce valid results and as a certificate to confirm its competence to customers, regulatory authorities and accreditation bodies.

ISO 15189:2012 is the international standard that specifies the quality management system requirements particular to medical laboratories. It takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.