I'm trying to meet the requirements of ISO 13485:2016 4.1.4 within our wiki-based QMS. In previous organizations, I've made sure changes in the process were "evaluated for their impact on the QMS... medical devices produced on this QMS" via a checklist on an ECO/ECN form.
Has anyone developed a streamlined way of meeting these requirements in an electronic QMS without creating a new approval doc each time (ie been able to answer these questions within the workflow)? One idea I'm currently entertaining is to have these two questions (4.1.4 a and b) in a table at the top of each record where it applies. For example, our Design Control SOP would have a table at the top that lists these two requirements, and some "check" or indication they've been considered for the version of the SOP displayed. Any thoughts/conflicts with this? Thanks in advance
Has anyone developed a streamlined way of meeting these requirements in an electronic QMS without creating a new approval doc each time (ie been able to answer these questions within the workflow)? One idea I'm currently entertaining is to have these two questions (4.1.4 a and b) in a table at the top of each record where it applies. For example, our Design Control SOP would have a table at the top that lists these two requirements, and some "check" or indication they've been considered for the version of the SOP displayed. Any thoughts/conflicts with this? Thanks in advance