QMSR keeps the FDA quality-system obligation but incorporates ISO 13485:2016. The practical question is where current evidence no longer tells the story an investigator needs.
A practical route
Separate requirements from evidence, FDA obligations from ISO terminology, and correction from CAPA. Sample real device histories, then show leadership the gaps as risk-ranked decisions instead of a document rewrite project.
What good looks like
The process is visible at the point of work. The person doing the task knows the current requirement, the person approving it can see objective evidence, and the owner can tell whether the control worked. Keep the record small enough to complete in the moment: requirement, result, exception, owner, date, and next decision.
The failure mode to avoid
Do not solve a recurring process problem with a longer form alone. Watch one real job, find the handoff that breaks, and change the workflow or responsibility. Then sample the next few records to confirm the change stuck. The output should be a record someone else can verify. Use the nonconformance workflow. to keep that chain together.