Hi thuytienlecao
Internal audits could be done by the manufacturer itself or by hiring auditor.Both 21 CFR Part 820, the Quality System Regulation (QSR), and ISO 13485:2003 require internal quality audits. In QSR, the audits have two primary purposes: Assure that the quality system is in compliance with the established quality system requirements, and determine the effectiveness of the quality system. Internal audits help highlight opportunities for improvements in the medical device itself (including flagging non-conforming materials). An internal audit can also help uncover non-value added activities, allowing a company to focus on streamlining operations to rationalize workflow, resources and realize strategic cost savings. Manufacturers should apply CAPA systems and internal audits as their best and most trusted assets in promoting quality, safety and reliability. I wish this helpful!.