Creating risk based quality management system in a company producing medical devices

When the establishment, operation and historical development of the Quality Management System in medical device manufacturing sites are monitored, legal obligations have been imposed in time to protect public health. Although the certification of medical equipment manufacturing facilities all over the world requires compliance with regional standards and legislations, the main purpose of all of them is to protect human health by establishing a quality management system in production. Compliance is a key to the success of an organization. At the same time, compliance with the legislation mandated by the competent authorities of different countries is critical for manufacturers to improve their sales networks. In this study, ISO 13485: 2016 Quality Management System Standard for Medical Devices and 21 CFR Part 820 Quality System Regulation are compared and integrated to a medical device manufacturing company. As a result, it is observed that the most important stage is the risk assessment. Risk assessment methods are examined within the scope of related standards. Failure Mode Effect Analysis (FMEA) and Hazard and Operability (HAZOP) methods are integrated to each other and implemented to manufacturing processes. All risks are determined and necessary actions are taken. At the end of the study, all risks are reduced to acceptable levels.