I have a smartphone application that uploads files to a server. This server is third-party software (Minio).
This third-party software has a bug which caused uploads to fail. This breaks our smartphone application in a significant way. Sure, we can handle the error gracefully - but critical data is not uploaded.
So, I fixed a bug in the third-party software and now our smartphone application works again.
Question: In order to prevent regression bugs, how do I document requirements and test in a ISO13485 (or ISO9001) compliant QMS?
Ideally, I would like:
- When something is broken, a test fails (if not, write a test to prevent regression)
- When something is fixed, the failing test will now succeed (if not, fix the test so it will succeed)
But surely, I should not write tests about the internal bugs and behavior for third-party software? (Or I'll end up writing specs for every SOUP i use!)