Having a detailed and accurate Quality System is extremely important for a medical device company. The Quality Systems ensure that essentially everything within a medical device company is documented. This includes validations, risk assessments, design history files, etc.

When an auditor such as the FDA or BSI comes into a manufacturing plant to conduct an audit, the first thing they ask to see and review is the Quality System. Usually the Regulatory Department and the Quality Department work together to lead these audits.

Has anybody participated in an audit to some extent from a Regulatory and Quality standpoint? From a Quality perspective, what type of issues/violations arose? Also, what is the mindset that a Quality person has when it comes to leading up to and walking through these type of audits?