-
julienneviuya replied to the topic Audits in the forum Quality Systems Management 7 years ago
Internal audits are essential to medical device companies because this creates a controlled environment in which the company can comprehensively evaluate how they are doing in terms of their Quality System. Internal audits are less variable than one from a private company or the FDA or ISO. I have taken part in an internal audit, and we had a day prior to the real audit to practice. During this mock audit we made sure the system was running smoothly and every participant could perform their role efficiently. An internal audit would reveal to the company its own weaknesses and where there are holes or improvements to be made. This is important for a company to understand before undergoing an unannounced external audit.