Duration: Three (3) days

This three-day course is designed to build strong competencies in planning, executing, and following up on internal audits for quality management systems in the medical device industry in accordance with ISO 13485, while applying the principles and guidelines of ISO 19011. Through a balanced combination of theory, practical exercises, and audit simulations, participants will learn to interpret regulatory requirements, identify nonconformities, write effective audit reports, and apply a risk-based approach. The course ensures that internal auditors not only understand the standard but also acquire practical skills to conduct audits that drive continuous improvement and regulatory compliance. Participants who complete this course and pass the final assessment will receive a certificate of completion.

Learning Objectives:
- Explain the purpose, structure, and key requirements of ISO 13485:2016 for medical device quality management systems
- Understand the role of regulatory requirements, risk management, and patient safety within an ISO 13485-based QMS
- Apply ISO 19011 auditing principles and techniques to plan and conduct first-party (internal) audits
- Collect, evaluate, and document objective audit evidence, including identifying nonconformities and observations
- Communicate audit results and support corrective actions and continual improvement within a medical device organization

This course is intended for individuals involved in the planning, conducting, managing, or supporting first-party (internal) audits of a Medical Device Quality Management System (QMS) based on ISO 13485. Typical participants include: Internal auditors, Quality Assurance (QA), Quality Management, and Regulatory Affairs professionals, process owners, supervisors, managers, and medical device professionals (design, production, supplier management, CAPA, post-market or activities.)

Basic knowledge of ISO 13485:2016 and quality management concepts is recommended but not required. DQS will not provide a copy of the standard. If you need a copy, you can purchase one at https://iso.org/.