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ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. Organizations seeking to demonstrate compliance with regulatory requirements – whether for CE marking, FDA quality system expectations, or MDSAP participation – rely on competent lead auditors to assess and verify their QMS effectiveness.
This online Lead Auditor training prepares you to fulfill that critical role. You will learn not only what the standard requires, but how to evaluate whether an organization's implementation meets those requirements in practice. Through a structured curriculum combining theoretical knowledge with practical demonstration, you will develop the competence to conduct first-party, second-party, and third-party audits of medical device quality management systems.
The course is delivered entirely online and is self-paced, allowing you to progress through the material according to your own schedule. Upon successful completion, you will receive a certificate documenting your training as an ISO 13485 Lead Auditor.
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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:
This course develops these capabilities through realistic scenarios, video demonstrations of actual audit situations, and practical exercises that mirror the challenges you will face in the field.
The training is organized into nine focused sessions that build your knowledge progressively. Sessions include:
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 the eight 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 provides a comprehensive set of resources that support your learning during the training and serve as valuable references afterward:
This training is designed for individuals who need to develop or formalize their competence in auditing medical device quality management systems. Typical participants include:
The course is appropriate for both those new to auditing and experienced auditors seeking to update their knowledge of ISO 13485:2016 or to add Lead Auditor qualification to their credentials.
The training program concludes with a comprehensive examination meeting Exemplar Global standards. The assessment is in multiple-choice format, without time-constraint, and in open book (as real-world audits are). To pass, you need a score of 60% or higher. If you do not pass on your first attempt, you may retake the exam at no additional charge.
Graduates receive a Certificate of Completion bearing the Exemplar Global accreditation mark. This certificate documents your successful completion of ISO 13485 Lead Auditor training and the successful completion of the final exam.
Certificates are issued in digital format upon passing the final examination. You may download, add to LinkedIn, and print your certificate directly from your course dashboard.
Complete course access including dashboard login, downloadable handouts, and certificate.
Self-paced learning – complete the 40 hours of content on your schedule.
Instructor access and technical support whenever you need assistance.
30-Day Money-Back Guarantee – enroll risk-free.
Instant access after enrollment with 3 months to complete.
Learn on any device – Windows, Mac, iOS, or Android.
Keith Schwartz
2 December 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
25 January 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 ...
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Acquire practical skills you can apply immediately – and the certification 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 have 3 months access to the course content (can be extended upon request). During this time you can complete the training at your own pace and return to review materials whenever you need to refresh your knowledge.
Course access ends upon successfully completing the final exam.
This course fulfills the training requirements for ISO 13485 Lead Auditor qualification and official registration as an Exemplar Global Certified ISO 13485 Lead Auditor.
Yes. The audit checklists provided with the course are designed to be practical tools that you can customize and use for internal audits within your organization. They provide a structured starting point that you can adapt to your specific processes.
To derive maximum benefit from this training, participants should have a general understanding of quality management system concepts, familiarity with the Plan-Do-Check-Act (PDCA) cycle, and awareness of basic quality principles including management commitment, process approach, and risk-based thinking.
A solid understanding of these general quality management concepts is best obtained through our ISO 9001 training.
Prior experience with medical device regulations is helpful but not essential.
While we don't have a sample version of this ISO 13485 course available, you can try the entire course without risk! Your purchase includes our comprehensive 30-Day Money-Back Guarantee.
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