An update to this post....
During my company's recent ISO 13485 initial registration audit, the auditor didn't bring up the improvement aspect but he did question the quality policy as it did not addresss meeting regulatory requirements.
I did some web surfing and found a couple of quality manuals for ISO 13485 certified companies. None of them had anything about meeting regulatory requirements listed in their quality policy.
Guess it depends on who audits you on any given day.
During my company's recent ISO 13485 initial registration audit, the auditor didn't bring up the improvement aspect but he did question the quality policy as it did not addresss meeting regulatory requirements.
I did some web surfing and found a couple of quality manuals for ISO 13485 certified companies. None of them had anything about meeting regulatory requirements listed in their quality policy.
Guess it depends on who audits you on any given day.
FWIW our quality policy does contain a statement about meeting regulatory requirements.