The medical device industry operates under some of the strictest regulatory frameworks in the world—and for good reason. Patient safety, product reliability, and regulatory compliance are non-negotiable. To meet these demands, organizations rely on ISO 13485:2016, the internationally recognized standard for medical devices quality management systems (QMS).
The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Auditor qualification is designed to give professionals the skills and expertise needed to audit, assess, and improve QMS in line with this vital standard.
Why ISO 13485:2016 Matters
ISO 13485:2016 sets out the requirements for a QMS specific to medical devices, ensuring safety and effectiveness throughout the product lifecycle—from design and development to production, distribution, and post-market monitoring.
Compliance with this standard helps organizations to:
- Demonstrate commitment to patient safety and quality.
- Streamline operations and reduce risks.
- Improve product reliability and customer satisfaction.
- Meet regulatory requirements across global markets.
What You’ll Learn
This course provides a comprehensive understanding of ISO 13485:2016 and equips learners with the tools to lead audits effectively. Key areas include:
- Regulatory requirements and quality management principles for medical devices.
- Risk management strategies across product design and manufacturing.
- Leadership and management responsibilities in QMS.
- Resource management for quality assurance.
- Product realization and design control processes.
- Techniques for measurement, analysis, and continuous improvement.
By the end of the program, you’ll be ready to conduct and lead audits that ensure medical device organizations meet international quality and safety standards.
Qualification Structure
The program consists of 6 units, worth 40 credits with 120 Guided Learning Hours (GLH):
| Unit Ref | Unit Title | Credits | GLH |
|---|---|---|---|
| LICQ2200107-1 | Introduction to ISO 13485:2016 | 8 | 24 |
| LICQ2200107-2 | Quality Management Principles and Requirements | 8 | 24 |
| LICQ2200107-3 | Management Responsibility and Leadership | 6 | 18 |
| LICQ2200107-4 | Resource Management | 6 | 18 |
| LICQ2200107-5 | Product Realization and Design Control | 6 | 18 |
| LICQ2200107-6 | Measurement, Analysis, and Improvement | 6 | 18 |
Entry Requirements
To enroll, candidates should meet the following criteria:
- Age: Minimum 16 years.
- Education: High school diploma or equivalent. A background in healthcare, engineering, biomedical sciences, or quality management is highly recommended.
- Experience: At least 2 years of professional experience in medical device manufacturing or a related field is preferred. Knowledge of QMS in regulated environments is beneficial.
- Language: Proficiency in technical English, with strong reading, writing, and comprehension skills.
Who Should Enroll?
This qualification is ideal for:
- Quality managers, compliance officers, and regulatory affairs professionals in the medical device industry.
- Internal and external auditors aiming to specialize in ISO 13485:2016.
- Medical device manufacturing professionals in design, production, and quality assurance.
- Consultants and advisors supporting medical device companies in achieving certification.
- Healthcare and engineering professionals looking to transition into quality management.
- Organizations seeking to upskill staff to ensure compliance and product safety.
Why Choose LICQual ISO 13485:2016 Lead Auditor?
- Gain an internationally recognized qualification.
- Develop advanced auditing skills tailored to the medical device industry.
- Enhance career prospects in regulatory compliance, quality management, and auditing.
- Help organizations achieve certification, improve efficiency, and ensure patient safety.
Lead the Future of Medical Device Quality
By completing the LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Auditor course, you’ll not only strengthen your career but also contribute to safer, more effective medical devices worldwide. This certification equips you to drive compliance, promote continuous improvement, and safeguard patient health in a highly regulated industry.
