ISO 13485 and QMSR Internal Auditor Course
Train to plan, conduct and report internal audits against ISO 13485 and the FDA QMSR, with practical exercises, finding-writing examples and follow-up methods.
Internal audits are the best early warning a quality system has, and one of the first things external auditors and inspectors examine. This course trains you to plan, conduct, report and follow up internal audits against ISO 13485 and the FDA QMSR, so findings are specific, defensible and lead to real fixes rather than paperwork.
Who this course is for
- Quality engineers and specialists who are, or are about to become, internal auditors.
- Quality managers building or improving an audit programme.
- Regulatory, manufacturing and R&D staff who support audits and respond to findings.
- Small manufacturers that need a competent, independent audit capability.
What you will learn
| Module | Focus | Outcome |
|---|---|---|
| 1. ISO 13485 and QMSR essentials | Structure of the standard, how FDA incorporates it, key regulatory overlays | Know what you are auditing against |
| 2. Audit programme design | Risk-based planning, scope, frequency, auditor independence | Draft a defensible annual programme |
| 3. Audit technique | Principles from ISO 19011, sampling, interviewing, tracing records end to end | Collect objective evidence efficiently |
| 4. High-risk process audits | Design controls, CAPA, complaints, suppliers, production and software | Focus on areas where failures matter most |
| 5. Findings and reporting | Writing findings that cite requirement, evidence and gap; grading | Produce reports that management can act on |
| 6. Follow-up and management review | Corrective action verification, effectiveness checks, feeding management review | Close the loop from audit to improvement |
How the course works
Learning is practical: you write audit plans, sample records, draft findings from realistic scenarios and practise closing actions. Format and schedule are agreed on enquiry, for individuals or for company groups.
What you take away
- An audit programme template and audit plan format.
- Question sets for the main QMS processes that you can adapt.
- A finding-writing guide with weak and strong examples.
- A way to connect audit results to CAPA and management review.
Read before you enrol
Start with the guides on internal audits and management review, ISO 13485 and MDSAP audit readiness, CAPA and complaint handling and FDA inspections under the QMSR.
Frequently asked questions
Will this make me a certified lead auditor?
No. This is a training course from AptSkill MedTech, not a certification body qualification. Certification body or registered auditor courses are separate programmes.
Is it useful if my company is not yet ISO 13485 certified?
Yes. Internal audits are required by the standard and are a core part of preparing for certification, and the skills apply to any regulated QMS.
Can the course be tailored to our procedures?
For company teams, the exercises can use your own process areas and examples. Mention this when you enquire.
How do I get dates, format and fees?
Use the enquiry form below and the team will respond with current options.
Enquire about this course
Tell us your role, your QMS and how many people would attend.
Enquire about the Internal Auditor course
Ready to take the next step?
Questions? Email aptskill6@gmail.com and the AptSkill team will respond promptly.