Risk considerations and implementation of a risk-based approach in your QMS processes is one of the most significant changes to the current version of ISO 13485. Medical device organizations must define how they manage risk in their processes and how the risk of one process affects other risk aspects of the QMS. The concepts of risk management are not new. In previous editions of ISO 13485, risk management primarily focused on product risk using design risk. ISO 13485:2016 places greater emphasis on the inclusion of risk management throughout the QMS and the use of feedback for improvement.
This webinar, presented by R&Q, will explain the concept of risk-based approach in ISO 13485:2016, establishing processes that incorporate the risk-based approach, determining acceptable residual risks, the use of feedback and overall conformity of your QMS.