Course Description

This course equips participants with the knowledge and skills to perform effective internal audits of a Quality Management System (QMS) in accordance with ISO 13485:2016. Designed for organizations involved in the medical device lifecycle, the training focuses on assessing conformity with the standard’s requirements, regulatory expectations, and risk-based controls. It also integrates ISO 19011 audit principles and provides practical techniques for planning, executing, and reporting internal audits that support certification and continual improvement.

What You’ll Learn

By the end of the course, you will be able to:

• Understand the structure and key requirements of ISO 13485:2016.

• Explain the internal audit process based on ISO 19011:2018.

• Plan internal audits based on process, risk, and regulatory focus areas.

• Develop audit checklists and gather objective evidence through records and interviews.

• Assess implementation of procedures, documentation, traceability, and control of outsourced processes.

• Identify nonconformities and generate clear, actionable audit findings.

• Write professional audit reports and communicate results to stakeholders.

• Follow up on corrective actions and verify effectiveness.

• Contribute to continual improvement and readiness for regulatory inspections or certification audits.

• Evaluate supplier audits and integration into the internal audit program.

Who Should Attend

• Internal Auditors in medical device organizations

• QMS Coordinators and Quality Assurance Staff

• Regulatory Compliance Officers

• Manufacturing and Operations Managers

• Design and Development Engineers

• Consultants supporting ISO 13485 compliance

Recommended

• Familiarity with ISO 13485:2016 or your organization’s medical device QMS is helpful

• No prior internal audit experience is required

• Basic understanding of medical device regulatory context is beneficial