Meeting the requirements of ISO 13485:2016 Cl. 4.1.4 within a wiki-based QMS

keldez

Involved In Discussions
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
 

yodon

Leader
Super Moderator
How do you normally control changes to your documents? I think it's pretty typical to have some kind of ECN or ECO system that allows you to describe the changes needed (and make the assessments for impact).

You mentioned only the first 2 items in 4.1.4 - the evaluations - but there's a 3rd point about control. That should take you to 4.2.4 and the note about how changes are reviewed and approved.
 

keldez

Involved In Discussions
We use a workflow plugin (Comala Workflows) that is Part 11 compliant. So I can assign approvals to SMEs and provide a description of changes, put restrictions on docs, assign training, etc. I just can't currently find a way within this plugin to get more detailed in doing an impact assessment. To you're point about control - I believe we are compliant in that area, just lacking in detail on impact and providing the info I would like for each change.
Another option is, if this is a 2016 requirement, I can wait until I get more resource support from upper management. For the time being I'm solo in QA efforts.
Thanks
 

yodon

Leader
Super Moderator
If you can't modify the workflow to force those inputs, you could always do it procedurally, including in the change description.
 
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