The medical device audit checklist allows quality managers to document evidence of compliance based on processes, standard requirements, and process characteristics.
ISO 13485 that was initially published in 1996, underwent significant revisions in 2003 and again in 2016, including changes in guidelines that apply specifically to suppliers and manufacturers of medical device components. The standard also emphasizes that manufacturers are expected to use a risk-based approach to all quality processes, which reiterates the value of an ISO 13485 checklist.