The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor course is a globally recognized qualification designed for professionals working in the medical devices sector. This program provides participants with a comprehensive understanding of ISO 13485:2016 requirements, internal auditing processes, and compliance practices that are vital to ensuring the safety, reliability, and regulatory compliance of medical devices.
With the growing importance of quality assurance in healthcare and medical device manufacturing, organizations require skilled professionals who can carry out effective internal audits. This course equips learners with the ability to interpret ISO 13485 standards, apply auditing methodologies, identify risks, and contribute to continuous improvement.
Learners will develop both theoretical knowledge and practical auditing skills that align with international best practices and global regulatory requirements. By the end of this course, participants will be able to effectively plan, conduct, and report internal audits in accordance with ISO 13485:2016.
This qualification is ideal for quality professionals, auditors, regulatory compliance officers, and individuals aiming to build a successful career in medical device quality management. Whether you are new to auditing or seeking to upgrade your professional profile, this course provides a solid foundation for advancing in this highly regulated industry.
Course Overview
Qualification Title: LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor
Regulated by: LICQual
Guided Learning Hours (GLH): 60 hours
Credits: 15
Level: Intermediate / Professional Level
Mandatory 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
Upon completing this qualification, learners will be able to:
- Introduction to ISO 13485:2016 and Medical Devices QMS
- Understand the purpose, scope, and structure of ISO 13485:2016.
- Explain the importance of quality management systems in the medical device industry.
- Quality Management System (QMS) Requirements in ISO 13485:2016
- Apply ISO 13485:2016 QMS requirements within medical device organizations.
- Evaluate organizational compliance with international QMS standards.
- Risk Management and Compliance in Medical Device Manufacturing
- Identify, assess, and mitigate risks in medical device manufacturing.
- Ensure compliance with global regulatory frameworks and standards.
- Internal Auditing in Medical Device QMS
- Plan, conduct, and document internal audits in line with ISO 19011 guidelines.
- Develop auditing skills to identify non-conformities and recommend corrective actions.
- Document and Record Control in Compliance with ISO 13485:2016
- Implement effective documentation and record control systems.
- Ensure traceability and regulatory compliance through proper record-keeping.
- Maintaining Regulatory Compliance and Continuous Improvement in Medical Devices
- Promote continuous improvement culture within medical device organizations.
- Maintain compliance with evolving international medical device regulations.
Entry Requirements
- A minimum of Level 3 qualification in quality management, healthcare, or related fields.
- Secondary/high school graduates with relevant work experience in medical devices may also apply.
- Professionals already working in medical device manufacturing, auditing, or regulatory compliance are encouraged.
- Good command of English (IELTS 5.0 or equivalent) is required for international learners.
- Minimum age requirement: 18 years.
Course Benefits
- Gain a globally recognized qualification in medical device quality management.
- Enhance your knowledge of ISO 13485:2016 standards and auditing practices.
- Improve career prospects in auditing, quality assurance, and regulatory compliance.
- Learn practical auditing techniques aligned with international best practices.
- Boost employability in medical device companies, healthcare sectors, and regulatory authorities.
Why Choose This Course?
- Industry-recognized qualification in line with global medical device standards.
- Designed by experts with extensive experience in quality and compliance auditing.
- Provides both theoretical knowledge and hands-on auditing skills.
- Flexible learning suitable for working professionals.
- Opens doors to international career opportunities in medical devices and healthcare.
Who Can Enroll in This Course?
- Quality assurance professionals in the medical device sector.
- Internal auditors and compliance officers.
- Healthcare professionals seeking knowledge of regulatory compliance.
- Fresh graduates aiming for a career in medical device quality management.
- Professionals transitioning into the medical device or healthcare industry.
Future Progression
After completing this qualification, learners can progress to:
- LICQual ISO 13485:2016 Lead Auditor Course
- Advanced diplomas in Quality Management and Regulatory Compliance.
- Senior roles such as Quality Manager, Compliance Specialist, or Lead Auditor.
- Further higher-level qualifications in ISO standards, risk management, and healthcare quality systems.
