Overview

In 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:

• Audit planning and preparation
• Conducting opening meetings
• Document and records review
• Interviewing auditees
• Closing meetings and reporting findings

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.

Prerequisites

There 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.

Who Should Attend

• Quality Managers
• Management Representatives
• Audit Program Managers
• Those involved in designing a QMS for their organizations
• Internal Auditors
• Quality Consultants
• Top Management
• Managers who are audited in QMS audits
• Those who perform supplier audits
• Those who perform third-party (ISO certification) audits
• Anyone looking to improve their organization’s quality management system

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:
MD – Medical Devices Management Systems
AU – Auditing Management Systems