Overview

In the highly regulated medical device industry, maintaining compliance with ISO 13485 and FDA requirements is essential for ensuring product quality, meeting customer expectations, and achieving regulatory approval. Internal auditing plays a critical role in sustaining an effective Quality Management System (QMS), and well-trained auditors are key to identifying risks, ensuring compliance, and driving continuous improvement.

This interactive, live-online ISO 13485 course for Internal Auditor training provides the essential knowledge and hands-on skills needed to conduct internal audits in accordance with ISO 13485:2016 and 21 CFR 820. Recognized by Exemplar Global, this training equips you with practical auditing techniques and a deep understanding of the standard’s requirements, so that you can apply them effectively within 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

This course goes beyond theory and uses real-world case studies, role-playing exercises, and interactive discussions to build confidence and competence in auditing. By the end of the training, you’ll be prepared to conduct internal and supplier audits as well as help your organization maintain compliance and improve its QMS.

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