Risk management culture in healthcare: ISO 7101:2023 requirements and advantages of the HFMEA method

Abstract

The importance of clauses 6.1.2 and 6.1.3 of the ISO 7101:2023 standard and the HFMEA method in shaping the risk management process in the healthcare system has been studied. Differences in risk assessment criteria, patient safety orientation, and monitoring between classical FMEA and HFMEA in ISO 9001:2015 are analyzed. The classical 5-step HFMEA model was compared with the requirements of ISO 7101:2023. The new 8-step HFMEA model based on PDSA and the improved decision tree are substantiated as effective solutions in terms of clinical management, patient safety, and continuous improvement.