Medical Devices : ISO 13485 Internal Auditor

ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. Internal audits are a critical component of this system, helping organizations verify compliance and identify opportunities for improvement.

This course provides a practical, interactive introduction to internal auditing based on ISO 13485:2016 and ISO 19011:2018 guidelines. Developed by industry experts, it guides you through the full audit lifecycle, including audit planning, execution, reporting, and follow-up, with a focus on real-world application in medical device environments.

🚀 Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

✅ Who should enroll?

• Quality Assurance Managers
• Regulatory Affairs Specialists
• Quality Systems Engineers
• Internal auditors

 
🎯 What you’ll learn?

• Principles and requirements of ISO 13485:2016
• How to plan, conduct, and report internal audits
• Apply ISO 19011 auditing guidelines in medical device environments
• Identify nonconformities and support corrective and preventive actions

Curriculum:

Introduction
Overview of ISO 13485 : 2016 Standard Internal
Lesson 1: Quality Management System</strong
Lesson 2: Management Responsibility
Lesson 3: Resource Management
Lesson 4: Product Realization
Lesson 5: Measurement, Analysis, and Improvement
Glossary
Evaluation