ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor
The ISO 13485:2016 MDQMS Internal Auditor course equips learners with the knowledge and skills to conduct internal audits of medical device quality management systems. Participants study regulatory requirements, risk management, process control, and compliance with ISO 13485:2016 standards. This training prepares professionals to identify gaps, implement corrective actions, and ensure consistent quality and regulatory compliance in medical device manufacturing and services.
- 4 Modules
- 18 Credits
- DLH 60
- Course Code #
- Educational Qualification
- Diploma, Bachelor’s, or Master’s degree in Engineering, Science, Biotechnology, Medical Technology, Pharmacy, or any related technical field.
- Work Experience
- Minimum 1-2 years experience working in medical device manufacturing, quality assurance, regulatory affairs, or related fields.
- Experience with Quality Management Systems (QMS), preferably in medical devices or regulated industries.
- Knowledge & Skills
- Basic understanding of quality management principles and regulatory requirements related to medical devices (FDA, MDR, etc.).
- Familiarity with ISO 13485 standard is preferred but not mandatory.
- Good communication, analytical, and auditing skills.
| Course Code | Curriculum Title | Credit | DLH |
|---|---|---|---|
| # | Introduction to ISO 13485:2016 | 3 | 10 |
| # | Understanding ISO 13485 Requirements | 3 | 10 |
| # | Regulatory and Compliance Requirements | 3 | 10 |
| # | Principles of Auditing | 3 | 10 |
| # | Audit Planning and Preparation | 3 | 10 |
| # | Practical Exercises and Case Studies | 3 | 10 |
After completing this course, learners will be able to:
Understand ISO 13485:2016 requirements for medical device QMS
Plan, conduct, and report internal audits of MDQMS processes
Evaluate compliance with regulatory and quality management standards
Identify non-conformities and recommend corrective and preventive actions
Assess process controls, risk management, and document control systems
Apply auditing techniques, checklists, and reporting tools effectively
Support continual improvement in medical device quality management
Ensure adherence to international regulatory requirements
Communicate audit findings and recommendations clearly
Promote a culture of quality and compliance within medical device organizations
- Quality Assurance and Quality Control Personnel
- Regulatory Affairs Professionals
- Production and Manufacturing Managers
- Design and Development Engineers
- Internal and External Auditors
- Consultants and Trainers
- Anyone with a Science or Engineering Background
- All Modules within this qualification are assessed internally by the approved training Centre and externally verified by Innoqual. The program uses a criterion-referenced assessment approach to ensure that learners successfully meet all required learning outcomes.
- A Pass in any unit is granted only when the learner submits valid, reliable, and authentic evidence that demonstrates achievement of the assessment criteria. The Assessor is responsible for reviewing this evidence and confirming that the learner has attained the expected standard.
Expert Instructors
Learn from certified trainers with real industry experience.
Career-Oriented
Master practical skills aligned with current workplace standards.
Recognized Certification
Gain a qualification respected by employers worldwide.
Career Advancement
Improve your skills and open new professional opportunities.
Ready to Gain High Demand Skills?
Apply for the ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor today and build your confidence.