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

What you will learn

• Lead an audit team from initiation through to a certification recommendation
• Manage an audit programme using risk based planning and effectiveness metrics
• Conduct Stage 1 and Stage 2 certification audits of a medical device QMS
• Audit the regulatory role determination, outsourcing controls, and written quality agreements
• Audit nonapplication justifications, design transfer and design files across the device life cycle
• Audit complaint handling, adverse event reporting, and advisory notice readiness
• Write Major NC, Minor NC, and OFI statements that are factual and defensible
• Evaluate corrective action adequacy using root cause analysis, and draft a full certification style audit report
• Audit all ISO 13485:2016 clauses from a lead auditor perspective

Who is this for?

Open to everyone. Ideal for experienced internal auditors, quality and regulatory managers, and consultants in the medical device sector ready to advance to lead auditor level. Particularly suited to those preparing to conduct or oversee third party certification and MDSAP audits.

Case study

This course is built around a realistic case study that runs throughout all modules. You will lead a full certification audit, Stage 1 and Stage 2, applying your skills across real world medical device scenarios including multisite planning, evidence gathering, Major and Minor NC writing, and certification recommendation.

Becoming a lead auditor in ISO 13485:2016 and ISO 19011:2026 gives you a real edge in the medical device sector. This course enables you to:

• Lead audits with confidence and precision, fully aligned to international standards
• Assure device safety and performance by surfacing the issues that matter across risk management, design, and regulatory reporting
• Help organisations maintain the effectiveness of their QMS and meet applicable regulatory requirements
• Open new career opportunities with a globally recognised certification, including work under the MDSAP model

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:

• Lead a medical device QMS audit team from initiation through to a certification recommendation
• Manage a QMS audit programme using risk based planning and effectiveness metrics
• Plan, conduct, report, and follow up a QMS audit in accordance with ISO 19011:2026
• Conduct Stage 1 and Stage 2 certification audits as part of the initial certification process
• Audit regulatory role determination, outsourcing controls and quality agreements, nonapplication justifications, design transfer and design files, and the complaint and adverse event reporting and advisory notice chain
• Write Major NC, Minor NC, and OFI statements for medical device findings that are factual and defensible
• Evaluate the adequacy of corrective action using root cause analysis, and draft a complete lead auditor standard audit report with a certification recommendation

Beyond auditing technique, this course explains how ISO certification works, so you understand the system you audit within. You will cover the role of certification bodies and accreditation, the two stage initial certification audit (Stage 1 and Stage 2), how the certification decision is made independently of the audit team, and how certification is maintained through surveillance and recertification.

This course is designed for anyone who needs to conduct external audits of medical device management systems, including:

• Individuals working towards Exemplar Global certification
• Exemplar Global certified auditors and lead auditors extending into ISO 13485
• Quality and regulatory managers, engineers, and consultants
• Anyone aiming to become an internal or third party medical device auditor
• Professionals seeking a formal auditing qualification, including for the MDSAP model
• Those leading their organisation towards ISO 13485 certification

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.