Internal auditing of a medical device quality system: ISO 13485, MDSAP and the QMSR

How to plan, run and report internal audits that find what matters: from a risk-based audit program to clear findings and closed corrective actions, the way…

This course is for people who run or will run internal audits in a medical device company: quality engineers, quality managers, and colleagues from other departments who are trained as internal auditors. It follows an audit from the program and the plan to the opening meeting, the evidence, the findings, the report and the follow-up, with ISO 13485 clause 8.2.4 and the guidance of ISO 19011. Each lesson is a few short slides, an explanation under each slide and a check question, with worked examples of weak and strong findings. The course ends with a final test and a certificate of completion with a link anyone can use to verify it.

This course is for people who audit a medical device quality system, whether they work for the company or audit it from outside, and for QA/RA managers who plan the audit program. It also suits engineers and managers from other departments who join the audit team, and anyone who wants to see how a real audit runs in companies of different kinds.

Plan a risk-based audit program that covers the whole quality system, and prepare each audit with a plan, good questions and sensible sampling. Run the audit: interviews, observation, tracing records across processes and gathering objective evidence. Audit each process with confidence, from management review and design, including software, AI and usability, to purchasing, production, sterile devices and post-market. Adapt the audit to the kind of company: contract manufacturing, sterile production, software with and without AI, servicing, IVD and implants. Write clear findings, grade them by the organization's definitions, report them, and follow them to effective closure. Prepare your internal audits for review by MDSAP auditors, notified bodies and FDA investigators.