Lessons Learned from External Audits in Medical Device Testing Laboratories: Best Practices and Recommendations for Quality Management

Calibration, measurement and test laboratories should provide reliable, accurate and timely service in accordance with the technological conditions of the day. The ability of laboratories to provide such a service is explained in detail in the ISO/IEC 17025:2017 “General Requirements for the Competence of Experiment and Calibration Laboratories” standard. There are some unclear situations in the application of the ISO/IEC 17025 standard in laboratories serving in the medical field, in other words, performing calibration, measurement and testing of devices in hospitals. Most of the medical devices are multi-parameter measuring devices. Therefore, the calibrators, analyzers or simulators used in the measurements and testing of these devices are generally multifunctional devices. In this article, the most common problems in the technical accreditation audits of medical laboratories will be examined and solution suggestions will be presented. In this paper, lessons learned from external audits in medical device testing laboratories are shared. Best practices and recommendations for quality management will be presented.