The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Auditor course is designed for professionals aiming to enhance their expertise in auditing and managing medical device quality management systems. This qualification provides in-depth knowledge of ISO 13485:2016 standards, focusing on regulatory compliance, risk management, and quality assurance in the medical device industry. Participants will gain practical skills to plan and lead audits, evaluate processes, and support continuous improvement initiatives. Through a structured and interactive learning approach, learners will develop the competence and confidence to implement international standards effectively, ensuring safe and high-quality medical devices.
Course Overview
This qualification equips learners with comprehensive knowledge of quality management systems in medical device manufacturing and services. With six detailed study units, the course covers everything from basic principles and regulatory requirements to auditing practices, product realization, and continuous improvement. Participants will acquire practical auditing skills while understanding how to maintain compliance with ISO 13485:2016.
- Qualification Title: LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Auditor
- Awarding Body: LICQual
- Total Units: 6 Units
- GLH: 120
- Total Credits: 40
- Qualification Code: LICQ2200107
Course Study Units
- Introduction to ISO 13485:2016
- Quality Management Principles and Requirements
- Management Responsibility and Leadership
- Resource Management
- Product Realization and Design Control
- Measurement, Analysis, and Improvement
Course Learning Outcomes
1. Introduction to ISO 13485:2016
- Understand the purpose, scope, and structure of ISO 13485:2016
- Recognize the importance of compliance in medical device quality management
- Identify key regulatory requirements affecting medical device organizations
2. Quality Management Principles and Requirements
- Apply quality management principles to medical device processes
- Evaluate organizational processes against ISO 13485 standards
- Understand risk management and process improvement strategies
3. Management Responsibility and Leadership
- Assess management roles and responsibilities in maintaining QMS
- Implement leadership strategies to support compliance and continuous improvement
- Promote a culture of quality and safety within the organization
4. Resource Management
- Identify and manage required resources including personnel, infrastructure, and equipment
- Ensure competence and training of personnel for effective QMS implementation
- Apply effective resource allocation for process efficiency
5. Product Realization and Design Control
- Manage product realization from design to delivery in compliance with ISO 13485
- Implement design control processes and documentation practices
- Ensure traceability and risk mitigation in product development
6. Measurement, Analysis, and Improvement
- Monitor and measure QMS performance using appropriate metrics
- Conduct audits, identify non-conformities, and implement corrective actions
- Support continual improvement of processes and product quality
Course Benefits
- Gain expertise in ISO 13485:2016 standards and auditing techniques
- Enhance career prospects in medical device quality management and regulatory compliance
- Develop practical skills for leading audits and ensuring process compliance
- Improve organizational efficiency, product safety, and customer satisfaction
Ideal Learner
This course is ideal for quality managers, auditors, regulatory affairs professionals, production managers, and anyone involved in medical device quality management and compliance.
Entry Requirements
- Minimum Age: 18 years
- Educational Background: Diploma, Degree, or equivalent in Science, Engineering, or relevant field
- Experience: Previous experience in quality management or medical devices is preferred
- Language Proficiency: English proficiency required
- Commitment to CPD: Willingness to engage in ongoing professional development
- Access to Required Resources: Internet, computer, and access to ISO 13485 standards
Who Can Enroll
- Quality managers and supervisors in medical device organizations
- Internal and external auditors
- Regulatory affairs and compliance professionals
- Professionals seeking ISO 13485 lead auditor certification
Future Progression
Upon completion, learners can pursue roles such as Senior Quality Auditor, Regulatory Compliance Manager, Quality Assurance Manager, or Accreditation Consultant. This qualification also provides a foundation for further certifications in ISO standards and medical device quality management system.