ISO 13485:2016 Internal Auditor Training Course (Self-Paced Online)

What you will learn

• The seven principles of auditing and the ISO 19011:2026 audit framework
• How to plan a process based internal audit from initiation to checklist
• Evidence gathering techniques: interview, observation, document and record sampling
• How to audit the medical device file, design controls, and risk management to ISO 14971
• How to audit sterile and implantable device requirements, traceability, and UDI
• How to audit the feedback, complaint handling, and regulatory reporting chain
• How to write factual, clause referenced nonconformity reports and evaluate corrective action
• All ISO 13485:2016 clauses from an internal auditor perspective

Who is this for?

Open to everyone. Ideal for quality and regulatory coordinators, engineers, supervisors, and team members who conduct or plan to conduct internal audits in a medical device organisation. No prior audit experience required.

Case study

This course is built around a realistic case study that runs throughout all modules. You will apply your skills to real world medical device scenarios: from document and record review and audit planning through to opening meetings, evidence gathering, NCR writing, and corrective action evaluation.

Becoming an internal auditor in ISO 13485:2016 and ISO 19011:2026 strengthens your value to any organisation running a medical device quality management system. This course enables you to:

• Plan and conduct internal audits with confidence and consistency
• Surface the issues that matter, including gaps in risk management, design controls, and regulatory reporting
• Help your organisation stay audit ready for certification, surveillance, and MDSAP
• Take a clear next step in your auditing career, including towards the Lead Auditor qualification

Why learning online works for you

• Learn anytime, anywhere. Study on demand, on site or off site, whenever it suits you
• Self paced. Move at your own speed and spend more time on the areas you want to master
• Cost effective. No travel, accommodation, or time away from the office to fund
• Lifetime access. Return to the materials whenever you need them
• Built to stick. Interactive, multi format lessons keep you engaged and improve retention

By the end of this course you will be able to:

• Explain the purpose of a medical device quality management system and of internal auditing
• Plan, conduct, report, and follow up an internal audit in accordance with ISO 19011:2026
• Prepare an audit plan from the requirements of ISO 13485:2016
• Gather and evaluate objective evidence, and distinguish evidence from inference
• Audit the medical device file, design controls, risk management to ISO 14971, sterile and implantable device requirements, traceability, and the feedback and complaint and regulatory reporting chain
• Write Major NC, Minor NC, and OFI statements that are factual and defensible
• Verify the effectiveness of corrective action, including that it does not adversely affect regulatory compliance or device safety and performance

This course also explains how ISO certification works. You will learn what ISO certification is, the role of accredited certification bodies and accreditation, the two stage certification audit, and how organisations achieve and maintain certification through surveillance and recertification.

This course is designed for anyone who plans, conducts, or supports internal audits of a medical device management system, including:

• New and developing internal auditors
• Quality and regulatory staff who implement or maintain the QMS
• Management representatives, engineers, and consultants
• Suppliers to the medical device industry seeking to strengthen their audit capability
• Anyone preparing to progress to the Lead Auditor qualification
• Those helping their organisation prepare for certification, surveillance, or MDSAP audits

There are no prerequisites for this course.

A working knowledge of ISO 13485:2016 is recommended and will help you get the most from the material. If you are new to the standard, you can build this foundation through our ISO 13485:2016 Foundation course.

You will need a computer, laptop, or tablet with a reliable internet connection. The course works in any modern web browser, such as Google Chrome, Microsoft Edge, Mozilla Firefox, or Apple Safari. For the best experience, keep your browser updated to the latest version.