ISO 13485 is a quality management system standard specifically designed for medical device manufacturers. QMII’s ISO 13485 Lead Auditor training program is designed to equip participants with the necessary knowledge and skills to effectively conduct audits of medical device quality management systems in accordance with ISO 13485 requirements. 

This course covers key aspects of auditing, including planning, conducting, and reporting audits. Participants will learn how to apply ISO 13485 requirements to assess the effectiveness of a medical device quality management system and identify opportunities for improvement. 

This 4-day training also covers the roles and responsibilities of lead auditors, including communication with stakeholders, team management, and ethical considerations. Participants will gain a comprehensive understanding of the audit process and learn how to manage audit findings and non-conformities. 

Upon completion of QMII’s ISO 13485 Lead Auditor training, participants will have the skills and knowledge to plan and conduct effective audits, as well as provide valuable insights into the continuous improvement of medical device quality management systems.