MDSAP Audit Approach (MDSAP AU P0002) C3-T10: Run planned internal audits under a documented procedure with trained, independent auditors, and follow up findings with corrections, corrective actions and verification

What does C3-T10 require?

Internal audits of the QMS must follow planned arrangements and a documented procedure to show conformity with QMS and regulatory requirements and to judge effectiveness, using trained auditors who do not audit their own work, and must lead to corrections, corrective actions, follow-up and verification of those actions. Clauses: ISO 13485:2016 6.2, 8.2.4; TG(MD)R Sch 3 Pt 1 cl 1.4(5)(b)(iii); RDC 665/2022 Arts 122 to 124; MO169 Arts 22, 23, 56.