ISO 13485 Internal Auditor Training Course

The goal of this ISO 13485 internal auditor course is to equip participants with the knowledge and practical skills needed to conduct effective internal audits in line with ISO 13485:2016. By the end of the training, participants will be able to assess the performance of a medical device quality management system, identify nonconformities, and contribute to continuous improvement and regulatory readiness.

This ISO 13485 internal auditor training course covers the key elements of auditing a quality management system for medical devices. Topics include:

• Structure and requirements of ISO 13485:2016
• Audit principles and ISO 19011-based methodology
• Planning and preparing internal audits
• Conducting interviews and collecting evidence
• Identifying and documenting nonconformities
• Reporting audit results and following up
• Auditor roles, responsibilities, and ethics

Interactive exercises and case studies ensure practical, real-world learning tailored to the medical device industry.