One Supplier Audit Checklist to cover ISO 9001:2008 and 13485:2003


Involved In Discussions
Dear Covers,

I need an advise whether should we combine ISO 9001:2008 and 13485:2003 clauses or requirements under 1 supplier audit checklist. If it is combined how would be the justifications or scores given to the respectives suppliers. This checklist is applicable only for those suppliers who are common part producers.



I was brought into my Company's Quality dept. in order to help with the transition from ISO9001 to ISO13485. My Management declined to seek 9001 AND 13485 simultaneously as a largely redundant measure. In other words, the requirements of 13485 are seen as equal to or greater than 9001 (except that continual improvement is nominally changed to QMS 'maintenance', and customer satisfaction is similarly changed to 'feedback') Therefore, wouldn't a thorough vetting to an ISO13485 checklist ensure an adequate system in terms of 9001???
Top Bottom