The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor course equips professionals with the knowledge and skills to effectively audit and manage quality systems in medical device manufacturing. Participants gain a comprehensive understanding of ISO 13485:2016 standards, regulatory requirements, and best practices for maintaining compliance throughout the product lifecycle. The course covers risk management, internal auditing, document control, and continuous improvement, enabling learners to ensure the safety and quality of medical devices. Delivered through flexible, assignment-based learning, this program is ideal for quality managers, auditors, regulatory personnel, and professionals responsible for compliance. Completing this course empowers participants to conduct thorough internal audits, identify non-conformities, and drive improvements in quality management systems, enhancing organizational performance and regulatory adherence.
Course Overview
Qualification Title: LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor
Awarding Body: LICQual
Total Units: 6
Total Credits: 40
Guided Learning Hours (GLH): 120
Course Study Units
- Introduction to ISO 13485:2016 and Medical Devices Quality Management Systems
- Quality Management System (QMS) Requirements in ISO 13485:2016
- Risk Management and Compliance in Medical Device Manufacturing
- Internal Auditing in Medical Device Quality Management Systems
- Document and Record Control in Compliance with ISO 13485:2016
- Maintaining Regulatory Compliance and Continuous Improvement in Medical Devices
Course Learning Outcomes
Unit 1: Introduction to ISO 13485:2016 and Medical Devices Quality Management Systems
- Understand the purpose and scope of ISO 13485:2016
- Recognize the regulatory framework for medical devices
- Explain the role of quality management systems in ensuring product safety
Unit 2: Quality Management System (QMS) Requirements in ISO 13485:2016
- Identify key requirements of ISO 13485:2016 QMS
- Understand procedures, policies, and responsibilities for compliance
- Implement effective quality management strategies in medical device organizations
Unit 3: Risk Management and Compliance in Medical Device Manufacturing
- Apply risk assessment techniques to medical device processes
- Understand risk control and mitigation strategies
- Ensure compliance with relevant regulatory requirements
Unit 4: Internal Auditing in Medical Device Quality Management Systems
- Conduct internal audits effectively and systematically
- Identify non-conformities and opportunities for improvement
- Report audit findings and support corrective actions
Unit 5: Document and Record Control in Compliance with ISO 13485:2016
- Implement document control procedures according to ISO standards
- Maintain accurate records and traceability of quality-related information
- Ensure proper documentation for audits and regulatory inspections
Unit 6: Maintaining Regulatory Compliance and Continuous Improvement in Medical Devices
- Monitor and maintain ongoing compliance with ISO 13485:2016
- Apply continuous improvement principles to QMS
- Integrate best practices to enhance product quality and safety
Course Benefits
This course provides participants with the skills to become competent internal auditors in the medical device industry, ensuring ISO 13485:2016 compliance and enhancing organizational quality management. By mastering auditing techniques and QMS requirements, learners can improve product safety, regulatory adherence, and overall operational performance.
Key Benefits
- Gain comprehensive knowledge of ISO 13485:2016 standards
- Develop expertise in internal auditing for medical devices
- Enhance compliance with regulatory requirements
- Implement effective risk management and continuous improvement practices
- Strengthen organizational quality culture and product safety
Ideal Learner
This course is ideal for professionals seeking to specialize in quality management and auditing in the medical device industry. It suits quality managers, internal auditors, regulatory personnel, and other staff responsible for compliance and operational excellence.
Ideal Learner Profile
- Quality managers and auditors in medical device organizations
- Regulatory compliance personnel
- Professionals responsible for internal audits or quality assurance
- Individuals seeking career advancement in medical device quality management
Entry Requirements
The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor course is designed to be accessible to professionals with a basic understanding of quality systems or experience in the medical device sector.
Minimum Age
- 18 years or older
Educational Background
- High school diploma or equivalent required
- Knowledge of basic quality management principles preferred
Experience
- No prior auditing certification required
- Relevant experience in medical device manufacturing or quality systems advantageous
Language Proficiency
- Proficiency in English (reading and writing) to complete assignments
Additional Requirements
- Access to a computer and internet for assignment submission
- Commitment to self-paced, assignment-based learning
Who Can Enroll
This course is open to professionals involved in medical device quality management and those seeking to develop internal auditing skills in compliance with ISO 13485:2016.
Eligible Enrollees
- Quality managers and internal auditors
- Regulatory affairs personnel
- Manufacturing and production staff responsible for QMS
- Professionals seeking formal certification in ISO 13485:2016 auditing
Future Progression
Completing this course enables participants to pursue advanced roles and certifications in medical device quality management and auditing. Learners can advance to lead auditor training, regulatory consultancy, or managerial roles in compliance and quality assurance.
Future Progression Opportunities
- LICQual Lead Auditor Certification for ISO 13485:2016
- Senior roles in quality management or regulatory affairs
- Specialization in risk management, compliance, or internal auditing
- Career advancement in medical device manufacturing and healthcare technology