Overview

Compliance with ISO 13485 and FDA regulations is critical for medical device manufacturers to ensure product quality, meet customer expectations, and maintain regulatory approval. A well-executed audit program is essential for identifying risks, improving processes, and demonstrating compliance. Skilled lead auditors play a crucial role in helping organizations uphold these standards and achieve long-term success.

This in-person ISO 13485 Lead Auditor Training course provides a structured, hands-on approach to auditing Medical Device Quality Management Systems (QMS). Recognized by Exemplar Global, this program equips participants with the knowledge and practical skills to conduct audits in alignment with ISO 13485:2016 and 21 CFR 820. Through real-world applications, you’ll learn how to interpret and apply the standard’s requirements within your organization.

Led by experienced instructors, this course covers every stage of the audit process, including:

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

This ISO 13485 Lead Auditor in-person training experience provides direct interaction with instructors and peers, fostering deeper discussions, immediate feedback, and a more immersive learning environment. Hands-on exercises, role-playing scenarios, and case studies reinforce key auditing techniques, ensuring you leave the course with practical, applicable skills.

By the end of the program, you’ll be prepared to conduct internal, supplier, and third-party audits with confidence, 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