Internal audits MUST be completed for all organizations that are ISO 9001/13485/22716 certified. It is a process that an auditor will review whether at surveillance or re-certification. If you don’t perform internal audits in your organization the probability of striking a MAJOR NC against you is extremely high. The objective of the audit program is to ensure continuing compliance to the requirements of ISO 13485, ISO 9001 and ISO 22716. A first party audit (aka internal audit) schedule should always be used. Audits will only be conducted by appropriately trained and competent personnel: trained by a recognized body or successful completion of at least three audits as a trainee auditor completion … Continue reading ISO 9001 / ISO 13485 clause 8.2.2 | ISO 22716 Cosmetics GMP clause 16 – Internal Audit