Sharepoint for ISO 13485 QMS for small IVD company


I have experience transitioning and establishing ISO 9001:2015 using SharePoint site. It is a bad idea having external consultant do this job for your company. After the consultant is done, there will be very little ownership from your stakeholders internally.
It is not that difficult to work internally.

Actually I have experience on setting up the SharePoint pages so that is not an issue. What I am wondering is if BPA Solutions would meet Medical Device requirements as it is different from ISO 9001.
You need to consider so many standards and regulations to comply with. From FDA (21 CFR-Part 11, Part 820), Health Canada Requirements, ISO 13485, ISO 14971 and IEC 62304.

Ed Panek

QA RA Small Med Dev Company
Super Moderator
We used SharePoint for University Research QMS. It had revision controls and we set up process flows but we could not use it for signatures.


Starting to get Involved

We are in the process of rolling out our Enterprise wide SharePoint on our Microsoft 365 platform. I did compare many EQMS platforms (ETQ, HQMS etc...) from cost, QMS functions, scaleability, IT integration ease, ease of use and one that was made for quality people not just a bolt on module in an existing ERP platform that is not designed for quality people.

Being a small company, I recognize cost is a factor which is also why we chose BPA as the cost per user is relatively lower than my experience with larger platforms.

We've decided on implementing the BPA Solutions QMS app that rides on top of the SharePoint Platform. With our Microsoft 365 platform, we can easily manage workflows, responses etc... more easily as our entire communications platforms are Microsoft.

Software Validation with BPA Quality & Risk Management

(Not a paid consultant nor being compensated by BPA Solutions)
Curious if you can share your experience in deploying this system?
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