ISO 13485 Internal Auditor Training (In-Person)
Recognized by Exemplar Global
Days: 3 • CEU Hours: 2.4
7:30 AM – 5:30 PM MST
OverviewIn the highly regulated medical device industry, ensuring compliance with ISO 13485 and FDA requirements is essential for maintaining quality, meeting customer expectations, and achieving market success. Internal auditing is a critical function that helps organizations identify risks and drive continuous improvement. This in-person ISO 13485 Internal Auditor Training provides an immersive, face-to-face learning environment where you can engage directly with expert instructors and industry peers. Unlike online training, this in-person format allows for real-time feedback, hands-on exercises, and collaborative discussions, ensuring you leave with the confidence and competence to conduct internal audits effectively. Recognized by Exemplar Global, this immersive training experience ensures you leave with practical auditing techniques and a deep understanding of the standard’s requirements, so that you can immediately apply them in your organization. Led by expert instructors, you’ll gain insight into every stage of the internal audit process, including:
With case studies, group exercises, and audit role-playing, you’ll gain practical experience that you simply can’t get from a virtual classroom. The face-to-face setting fosters deeper engagement, encourages networking with other quality professionals, and ensures you receive immediate, personalized guidance tailored to your needs. |
PrerequisitesThere are no required prerequisites for this training. This ISO 13845 course for internal auditor training is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it. All students are required to bring their own printed copy of the ISO 13485:2016 standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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Exemplar Global Certified Training Provider
Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this ISO 13485 course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: |
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This ISO 13485 course is recognized by Exemplar Global as meeting the knowledge requirements for Internal Auditor Certification in Medical Device Quality Management Systems.
ISO 13485 Internal Auditor Objectives
- Develop the knowledge and skills required to become an Internal Auditor.
- Improve your understanding of the international standard and 21 CFR 820.
- Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
- Fulfill the education requirements of the Exemplar Global Certified Internal Auditor program.
Agenda
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