Course Overview

This specialized course is designed to equip participants with the knowledge and skills necessary to perform internal audits of a Medical Device Quality Management System (MDQMS) based on ISO 13485:2016 requirements.

The course covers auditing principles, techniques, and processes in alignment with ISO 19011 guidelines, providing practical tools for identifying non-conformities, evaluating compliance, and contributing to continual improvement within medical device organizations.

Duration

🕒 3 Days (Total: 24 Hours)

Course Objectives

By the end of this course, participants will be able to:
✅ Understand the structure and requirements of ISO 13485:2016.
✅ Grasp the principles and purpose of internal auditing.
✅ Plan, prepare, and execute effective internal audits.
✅ Identify non-conformities and report audit findings objectively.
✅ Contribute to corrective actions and follow-up activities.
✅ Support continuous improvement initiatives within the MDQMS.

Who Should Attend?

This course is ideal for:
✔ Quality management and regulatory affairs professionals.
✔ Internal audit team members within medical device organizations.
✔ Quality, production, and operations staff involved in QMS maintenance.
✔ Anyone seeking to become an internal auditor for ISO 13485:2016 systems.

Course Contents

📌 Introduction to ISO 13485:2016 – Key clauses and medical device QMS concepts.
📌 Audit Principles & Process – According to ISO 19011 guidelines.
📌 Planning an Internal Audit – Defining scope, criteria, and audit plans.
📌 Conducting the Audit – Interviewing, observing, and sampling techniques.
📌 Reporting Findings – Classifying and documenting non-conformities.
📌 Corrective Action & Follow-up – Ensuring effective closure and improvement.
📌 Case Studies, Role-Playing & Knowledge Checks – Practical, hands-on exercises.

Certification

🎓 Upon successful completion of the course, participants will receive an internationally recognized Internal Auditor Certificate from the RIMAN Training Center.