Hello everybody,
In the new EN ISO 13485:2016, Risk Management must be included in all processes in the Quality Management System (QMS). How would the QMS be updated to include Risk Management in all process? Is it enough to have a general Risk management SOP or should the Risk Management be considered in each SOP separately?
Thanks in advance for your help
In the new EN ISO 13485:2016, Risk Management must be included in all processes in the Quality Management System (QMS). How would the QMS be updated to include Risk Management in all process? Is it enough to have a general Risk management SOP or should the Risk Management be considered in each SOP separately?
Thanks in advance for your help