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. Effective auditing is a cornerstone of a strong Quality Management System (QMS), and skilled auditors are vital for helping organizations navigate complex regulatory landscapes.

This interactive, live-online ISO 13485 Lead Auditor Training course provides the knowledge and practical skills needed to conduct QMS audits in accordance with ISO 13485:2016 and 21 CFR 820. Recognized by Exemplar Global, this course prepares you to interpret the standard’s requirements and apply them to your own organization, ensuring compliance with both international and U.S. regulations.

Guided by expert instructors, you’ll explore every phase of the audit process, including:

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

This practical, hands-on ISO 13485 lead auditor training course goes beyond theory, using case studies, role-playing, and interactive exercises to build real-world auditing competence. By the end of the training, you’ll have the confidence and expertise to conduct internal, supplier, and third-party audits, helping your organization maintain compliance and drive continuous improvement.

Prerequisites

There are no required prerequisites for this training.

This ISO 13845 lead auditor training course 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
• Lead Auditor Candidates
• 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 lead auditor training course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
MD – Medical Devices Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams