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A lead auditor’s job is not simply to confirm that procedures exist – it is to uncover whether the QMS actually protects product quality and controls risk. Weaknesses in design controls, supplier management, process validation, corrective action, or risk management can remain hidden until an effective audit brings them to light.
This online course gives you a structured approach to interpret ISO 13485 requirements, plan an audit, direct an audit team, gather objective evidence, and turn findings into clear, defensible conclusions. Video demonstrations let you observe audit interviews and opening and closing meetings instead of learning from theory alone.
You will be prepared to lead first-party, second-party, and third-party audits of medical-device quality management systems – valuable expertise for organizations pursuing ISO 13485 certification, CE marking, FDA QMSR compliance, or MDSAP participation.
The course is delivered entirely online and is self-paced, allowing you to study around your schedule. After passing the final examination, you receive an ISO 13485:2016 Lead Auditor Certificate of Attainment bearing the Exemplar Global logo.
30-Day Money-Back Guarantee
If the course is not right for you, request a full refund within 30 days, provided you have not completed it.
The difference between an auditor who simply checks boxes and one who adds genuine value lies in understanding context. A lead auditor must be able to:
By the end of the course, you will have both a repeatable method for leading audits and practical resources you can adapt for use in the field.
Nine focused sessions take you from the medical-device regulatory context and ISO 13485 requirements through audit planning, evidence gathering, reporting, and corrective-action follow-up. Each session includes:
Session 1: Overview of ISO 13485
An introduction to the ISO 13485 standard – its purpose, scope, and position within the medical device regulatory landscape. You will understand who uses this standard, why certification matters, and how the standard relates to other requirements such as regional regulations and MDSAP.
What you'll learn: The role of ISO 13485 in medical device quality management and its relationship to global regulatory frameworks.
Session 2: Quality Management Principles
An examination of the foundational principles that underpin effective quality management in medical device organizations. Topics include customer focus, leadership engagement, process approach, evidence-based decision making, and continual improvement.
What you'll learn: How quality management principles apply specifically to medical-device organizations.
Session 3: ISO 13485 Requirements in Detail
A comprehensive clause-by-clause review of the ISO 13485:2016 standard. You will examine each requirement in depth, understanding not only what is specified but what constitutes acceptable evidence of conformity. Particular attention is given to areas where organizations commonly struggle, including design controls, supplier management, and process validation.
What you'll learn: Detailed understanding of all ISO 13485:2016 requirements and how to evaluate conformity during an audit.
Session 4: Document and Record Control
A focused examination of documented information requirements. You will learn the practical differences between documents (which are maintained and updated) and records (which are retained as evidence). The session covers document approval, distribution, version control, and retention requirements appropriate to medical device organizations.
What you'll learn: How to audit document control systems and identify when documentation is insufficient or ineffective.
Session 5: Risk Management in ISO 13485
ISO 13485 requires risk-based thinking throughout the quality management system. This session explains how risk considerations apply to processes, products, and the QMS itself. You will learn to evaluate whether an organization has appropriately identified and addressed risks in areas such as supplier selection, design changes, and production controls.
What you'll learn: How to assess risk management processes during an audit and identify gaps in risk-based thinking.
Session 6: The Internal Audit Process
This session introduces the complete audit cycle, from planning through follow-up. A video demonstration shows an auditor conducting an opening meeting – you will observe the key elements that must be covered and the professional approach that establishes credibility from the outset.
What you'll learn: How to plan audits, conduct opening meetings, and manage the audit process from start to finish.
Session 7: Audit Terminology, Roles, and Responsibilities
A clear understanding of audit terminology is essential for professional communication. This session defines key terms according to ISO 19011 and explains the distinct roles within an audit team – lead auditor, auditor, technical expert, guide, and observer. You will learn the specific responsibilities of the lead auditor in managing team dynamics and ensuring consistent evaluation.
What you'll learn: Professional audit vocabulary and the distinct responsibilities of each audit team role.
Session 8: Performing the Audit
This practical session demonstrates audit execution through video examples of actual audit scenarios. You will observe effective questioning techniques and learn how to gather objective evidence that supports your findings. The session includes a sample quality manual for document review practice.
What you'll learn: Practical techniques for conducting audit interviews, gathering evidence, and evaluating documentation.
Session 9: Nonconformities and Corrective Action
Identifying a nonconformity is only the first step. This session teaches you how to classify findings appropriately, write clear nonconformity statements, and evaluate the adequacy of proposed corrective actions. A video demonstration shows an auditor conducting a closing meeting, illustrating how to present findings professionally and handle questions or disagreements.
What you'll learn: How to classify findings, write effective nonconformity statements, and conduct professional closing meetings.
The course gives you more than training alone. Its downloadable resources support your learning now and remain useful references for future audits:
This course is designed for professionals who need to plan complete audits, lead audit teams, or manage an ISO 13485 audit program. It is particularly suited to:
No previous auditing role is required. The course begins with ISO 13485 and auditing fundamentals before progressing to audit leadership, team management, reporting, and corrective-action follow-up.
The course concludes with an online, open-book multiple-choice examination developed to meet Exemplar Global requirements. There is no time limit. A score of 60% is required, and unlimited retakes are included at no additional charge.
After passing the final examination, you receive an ISO 13485:2016 Lead Auditor Certificate of Attainment bearing the Exemplar Global logo. It provides internationally recognized evidence of your professional training and opens a pathway toward relevant Exemplar Global personnel certification.
The certificate also bears the IACET accreditation mark, and the course awards 4.0 IACET CEUs.
Download your digital certificate directly from your course dashboard to print, share with employers or clients, and add to your LinkedIn profile.
Training multiple lead auditors for your ISO 13485 quality management system? Our platform makes it simple to purchase multiple seats and manage enrollment across your organization.
Whether you’re training a single lead auditor or building a complete audit leadership team, the manager dashboard makes it easy to manage enrollments and keep everything organized.
Course access, materials, certificate plus manager dashboard for bulk enrollment.
Self-paced learning – fit the 40-hour program into your schedule without disrupting business.
Instructor access and technical support whenever you need assistance.
30-Day Money-Back Guarantee – enroll risk-free.
Instant access after enrollment with up to 3 months to complete.
Learn on any device – Windows, Mac, iOS, or Android.
Keith Schwartz
December 2, 2025
Thank you, I enjoyed this class. It was well done, the instructor was easy to understand, the examples clarified a lot of the theory. ...
Mary Owens
January 25, 2026
I liked this course and I learned a lot even though I had taken the internal auditor class before. I guess it helps to hear ...
TPECS-Certified Provider
Certified by Exemplar Global – one of a select group of training organizations worldwide.
Career-Focused Training
Acquire practical skills you can apply immediately – and the certificate to prove it.
Learning Resources
Courses include materials you can download, keep, and refer back to long after completion.
Learn on Your Schedule
Self-paced format lets you pause, resume, and switch between devices without losing progress.
Once enrolled: You receive up to 3 months of course access. Access ends when you pass the final examination. Extensions are available upon request for an additional fee.
Before enrollment: If the learner is not enrolled during purchase, the course manager has up to 12 months to enroll them.
Yes. After passing the final examination, you receive an ISO 13485:2016 Lead Auditor Certificate of Attainment bearing the Exemplar Global logo.
It provides internationally recognized evidence of your professional training and opens a pathway toward relevant Exemplar Global personnel certification.
Yes. The 400+ question audit checklist is a practical tool that you can customize for your organization, products, processes, and regulatory environment.
No formal prerequisite is required. Familiarity with quality management systems, the Plan-Do-Check-Act cycle, and risk-based thinking will help you progress more easily. Prior medical-device or regulatory experience is helpful but not essential.
Yes. You can access the complete course after purchase.
If it is not right for you, request a full refund within 30 days, provided you have not completed it.
Yes. Select the number of seats you need and the applicable volume discount is applied automatically.
Designate a course manager during checkout to enroll learners and track their progress from one dashboard.
First-, second-, and third-party audits. The course prepares you to plan, conduct, lead, and report on internal audits, supplier audits, and third-party audits of medical-device quality management systems.
Auditor Training focuses on conducting assigned audit activities as a member of an audit team.
Lead Auditor Training adds the skills needed to plan complete audits, lead audit teams, communicate with auditees, report findings, and manage audit programs.
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