S
snoopy2017
Hi everyone,
I've been reading ISO 13485:2016 practical guide and some other white papers on 13485:2016 risk-based approach. I understand that we are taking a risk-based approach to our QMS processes. How many processes are there? There are a large number of SOPs at my company but not all of them are directed toward a QMS process; many are instructions for day-to-day activities. In this case, how would I incorporate an explicit risk-based approach in these SOPs? I was told there is no particular formula to take a risk-based approach (e.g. not at the level of 14971) but some form of risk-based thinking. This is a small company and we don't have a risk-management team, I would appreciate any advice.
Thank you
I've been reading ISO 13485:2016 practical guide and some other white papers on 13485:2016 risk-based approach. I understand that we are taking a risk-based approach to our QMS processes. How many processes are there? There are a large number of SOPs at my company but not all of them are directed toward a QMS process; many are instructions for day-to-day activities. In this case, how would I incorporate an explicit risk-based approach in these SOPs? I was told there is no particular formula to take a risk-based approach (e.g. not at the level of 14971) but some form of risk-based thinking. This is a small company and we don't have a risk-management team, I would appreciate any advice.
Thank you