Quality Policy: How applies to your function in post market surveillance?

How do you know what is required of you in your job?

Complaints Review - MDRs Submitted? Timely? Investigator may request to view records electronically.

What are the complaint trends? How used?

Non Conformance System: What are the trends? How related to Complaints, product, design?

CAPA: How many open? Closed? Timely? Root Cause Investigations? Effective?

Supplier Quality: Process, Qualified, Scars? Information from other subsystems

Design Changes? Compliance with the regulations? Process Validation? P&PC:

Management Review, Frequency? Agenda, Participants?

Training: There should be no gaps in training. Address before the inspection.

3'rd party I distributors I consultants. If doing work on behalf of the company - they should be trained.

Labs I Areas: Walkthroughs; Instrument Calibrations; test method validations