How was it planned? What are the inputs? Are basic performance requirements, regulations, standards considered? Does it consider risk management? What is the output? Product standards, process documentation, inspection specifications, prototypes? Were reviews performed at each step? What validations were done? Self-testing, 3rd party? Has validation been done? Clinical trials, evaluations, user trials?
Is risk management comprehensive? Are measures implemented? Check for consistency with instructions if necessary?
The auditor can often suggest improvements in safety, but may not be well versed in the principles of the product alone. Therefore, they are usually stuck with the documentation.