ISO 13485:2016
ISO 13485:2016 Internal Auditor
Plan, conduct and report internal audits of a medical device quality management system
Internal Auditor · 16 hours · Certificate valid 36 months
Internal audit is the one process in ISO 13485:2016 that checks every other process, and regulators read your internal audit records to judge whether your organization can find its own problems. This course trains you to do that well.
You start with the standard itself: what each clause requires, what evidence demonstrates conformity, and where the EU MDR and IVDR, the FDA Quality Management System Regulation and MDSAP add to it. Each clause comes with an auditor tip drawn from real audit practice.
You then learn the auditing fundamentals shared by every management system discipline: audit principles, auditor behaviour, planning, sampling, interviewing, evidence, nonconformity writing, root cause and follow-up.
The practice module brings it together on medical device evidence: design and development files, process validation, complaint and vigilance records, CAPA effectiveness, supplier controls, training, software validation and cleanroom monitoring, with the typical findings experienced auditors look for.
Six scenario discussions, module quizzes and a 30-question final examination confirm that you can apply what you have learned.
What people learn
- Interpret each clause of ISO 13485:2016 and identify the records that demonstrate conformity
- Include applicable regulatory requirements as audit criteria alongside the standard and internal procedures
- Plan an internal audit with a risk-based programme, clear scope, criteria and sampling approach
- Gather objective evidence through document review, interviews, observation and record tracing
- Audit design and development files, process validation, complaints and vigilance, CAPA, suppliers, training, software and cleanroom controls
- Write nonconformities that state the requirement, the evidence and the gap, and classify them appropriately
- Evaluate root cause analysis and corrective action effectiveness before closing findings
- Recognize how the MDSAP audit model and grading differ from certification audits