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A superficial internal audit creates false confidence. Procedures may look complete while problems in design controls, supplier management, process validation, corrective action, or risk management remain hidden until a certification audit, regulatory inspection, or product issue exposes them.
This course teaches you how to look beyond paperwork. You will learn to prepare for an audit, ask productive questions, follow objective evidence, recognize nonconformities, and document findings that support effective corrective action.
The training combines ISO 13485:2016 requirements with a practical internal-audit process, preparing you to make a valuable contribution to the audit team. These skills are especially important 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 Auditor Certificate of Attainment bearing the Exemplar Global logo.
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If the course is not right for you, request a full refund within 30 days, provided you have not completed it.
The value of an internal auditor lies in finding weaknesses before customers, certification auditors, or regulators do. A competent ISO 13485 auditor must be able to:
By the end of the course, you will have a repeatable approach to internal auditing and practical resources you can adapt for immediate use in your organization.
Eight focused sessions take you from the purpose and requirements of ISO 13485 through audit preparation, evidence gathering, reporting, risk management, and corrective-action follow-up. Each session includes:
Session 1: Overview of ISO 13485:2016
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 regulatory requirements.
What you'll learn: The role of ISO 13485 in medical device quality management and its relationship to global regulatory frameworks.
Session 2: ISO 13485:2016 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 13485:2016 Requirements
A comprehensive clause-by-clause review of the ISO 13485:2016 standard. You will examine each requirement in depth, understanding what constitutes acceptable evidence of conformity. Particular attention is given to areas where organizations commonly need guidance.
What you'll learn: Detailed understanding of ISO 13485:2016 requirements and how to evaluate conformity during an internal audit.
Session 4: Control of Documents and Records
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.
What you'll learn: How to audit document control systems and identify when documentation is insufficient or ineffective.
Session 5: ISO 13485 Internal Audit Process
This session introduces the complete internal audit cycle, from planning through follow-up. You will learn audit methodologies, how to prepare for an audit, and how to conduct audit activities professionally.
What you'll learn: How to plan and conduct internal audits of medical device quality management systems.
Session 6: ISO 13485 Internal Audit Records
Audit proceedings and findings must be documented according to ISO 13485 requirements. This session covers audit preparation documentation, conducting the audit and gathering evidence, audit reporting, and audit completion with follow-up activities.
What you'll learn: How to properly document audit activities and maintain records that demonstrate compliance.
Session 7: Risk Management
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.
What you'll learn: How to assess risk management processes during an internal audit and identify gaps in risk-based thinking.
Session 8: Steps for ISO 13485 QMS Installation & Certification
The final session examines the steps necessary to implement an ISO 13485 Quality Management System for Medical Devices and achieve certification. Understanding this process helps auditors provide valuable insights during internal audits.
What you'll learn: The implementation and certification pathway, and how internal audits support this process.
The course gives you more than training alone. Its downloadable resources support your learning now and remain useful references for future internal audits:
This course is designed for professionals who conduct assigned audit activities as members of an ISO 13485 internal audit team. It is particularly suited to:
No previous auditing role is required. The course begins with ISO 13485 fundamentals before progressing to audit preparation, evidence gathering, reporting, and corrective-action follow-up.
This is the right course if you will perform assigned audit activities as part of an audit team. If you need to plan complete audits, lead audit teams, or manage an audit program, choose ISO 13485 Lead Auditor Training.
The course includes session assessments and a comprehensive online final examination. All assessments use a multiple-choice format. 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 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 1.6 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 internal 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 internal auditor or building a complete audit 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 16-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.
Isabella Torres
July 20, 2025
Absolutely fantastic course! The ISO 13485 Auditor Training gave me the confidence to handle internal audits for our medical device company. The audit checklist with ...
Clara Nguyen
April 8, 2025
This course was a game-changer for me as a new internal auditor. The content was clear, with practical examples that made ISO 13485 requirements easy ...
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.
Auditor Training focuses on conducting assigned audit activities as a member of an internal 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.
Yes. The 200+ question audit checklist is organized by ISO 13485:2016 clause and by department. You can customize it for your organization’s 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.
Yes. After passing the final examination, you receive an ISO 13485:2016 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.
Participate effectively in ISO 13485 internal audits. You will be prepared to perform assigned audit activities as part of an audit team, including preparing for audits, gathering objective evidence, documenting findings, and supporting corrective-action follow-up.
The charts below show our approval ratings based on post-course surveys from 2000+ learners. Enroll risk-free with our 30-Day Money-Back Guarantee.
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