The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor course is an intensive, internationally recognized training program designed for professionals who wish to develop the skills and knowledge necessary to perform internal audits of medical device organizations based on the ISO 13485:2016 standard. This course equips participants with the tools needed to evaluate a medical device organization’s quality management system (QMS), ensure compliance with regulatory requirements, and drive continual improvement across all aspects of medical device manufacturing and development.
ISO 13485:2016 is the internationally recognized standard for quality management systems specifically for the medical device industry. It ensures that organizations in this sector maintain consistent product quality, meet regulatory requirements, and enhance customer satisfaction. LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor course focuses on equipping professionals with the expertise to assess and audit processes that affect product safety, compliance, and performance, while ensuring that the medical device manufacturer remains in line with global regulatory standards.
Throughout this course, participants will gain in-depth knowledge of ISO 13485:2016, including its requirements for documentation, risk management, design control, product realization, and post-market surveillance. Emphasis is placed on how to conduct effective audits, from planning and preparing audit activities to reporting findings and implementing corrective actions. Practical audit scenarios and case studies provide hands-on learning that enables participants to directly apply audit principles to real-world medical device manufacturing environments.
The LICQual ISO 13485:2016 Internal Auditor course is suitable for a wide range of professionals involved in the design, production, and regulatory compliance of medical devices. This includes internal auditors, quality managers, regulatory affairs specialists, product development teams, and anyone involved in maintaining, improving, or evaluating the effectiveness of medical device quality management systems.
By the end of the LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor, participants will be able to confidently conduct internal audits that assess the effectiveness of a QMS, identify nonconformities, and recommend corrective and preventive actions. The training will also help organizations maintain or achieve ISO 13485:2016 certification, demonstrating their commitment to high-quality medical device production and compliance with international regulatory frameworks.
Upon successful completion of the course, participants will receive a LICQual ISO 13485:2016 Internal Auditor Certificate, a globally recognized qualification that enhances professional credibility and provides career advancement opportunities. Whether you are looking to enter the medical device industry, improve your organization’s compliance, or take on a more advanced auditing role, this course provides the expertise required to support quality assurance and regulatory efforts in the medical device sector.
The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor course is essential for those who want to ensure that their organization operates in compliance with global standards, improves product quality, and ultimately contributes to better patient safety and healthcare outcomes.
The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor course is designed to equip professionals with the knowledge and practical skills necessary to conduct internal audits in compliance with ISO 13485:2016, the global standard for medical device quality management systems (QMS). This comprehensive training program is ideal for individuals seeking to ensure their organization meets the stringent requirements for product quality, regulatory compliance, and continuous improvement in the medical device industry.
ISO 13485:2016 provides a framework for medical device manufacturers to ensure the safety, reliability, and regulatory compliance of their products. LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor focuses on equipping participants with the skills to audit the key processes of a QMS, assess conformity to the ISO 13485:2016 standard, and identify opportunities for improving quality management practices. Through expert-led instruction, interactive exercises, and real-world case studies, participants will gain a deep understanding of how to perform internal audits and identify areas of noncompliance that could impact product quality and patient safety.
Key topics covered in the course include risk management, design control, supplier management, regulatory requirements, post-market surveillance, and how to assess the effectiveness of the QMS. Emphasis is placed on the importance of documentation, traceability, and continual improvement to meet the evolving demands of both regulatory authorities and customers.
LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor is ideal for internal auditors, quality managers, compliance officers, regulatory affairs professionals, and anyone involved in medical device manufacturing, quality control, and regulatory compliance. It is especially beneficial for organizations seeking ISO 13485:2016 certification or wishing to maintain their existing certification, ensuring compliance with global standards for the medical device industry.
Upon completion of the course, participants will have the skills and confidence to conduct thorough internal audits, evaluate their organization’s QMS against ISO 13485:2016, and drive continual improvement within their organization. This course is also a stepping stone for career advancement, providing professionals with a globally recognized qualification that enhances their expertise and credibility in the medical device industry.
The LICQual ISO 13485:2016 Internal Auditor Certificate awarded at the end of the course validates the participant’s ability to conduct audits that contribute to the ongoing quality, safety, and regulatory compliance of medical devices. It is a valuable credential that opens up career opportunities in the highly regulated and rapidly growing medical device sector.
The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor qualification consists of 6 mandatory units required for completion.
Mandatory Units
| Unit# | Unit Title |
| 1 | Introduction to ISO 13485:2016 and Medical Devices Quality Management Systems |
| 2 | Quality Management System (QMS) Requirements in ISO 13485:2016 |
| 3 | Risk Management and Compliance in Medical Device Manufacturing |
| 4 | Internal Auditing in Medical Device Quality Management Systems |
| 5 | Document and Record Control in Compliance with ISO 13485:2016 |
| 6 | Maintaining Regulatory Compliance and Continuous Improvement in Medical Devices |
The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor course is designed for professionals involved in ensuring the quality, safety, and compliance of medical device operations. It is ideal for those seeking to develop the skills necessary to conduct internal audits in line with the ISO 13485:2016 standard, which governs quality management systems in the medical device industry.
Target Audience Includes:
- Internal Auditors: Professionals responsible for auditing the quality management systems (QMS) within medical device companies. This course is perfect for internal auditors who want to deepen their knowledge of ISO 13485:2016 and enhance their auditing skills.
- Quality Assurance Managers: Individuals overseeing quality control and quality assurance processes in medical device organizations. The course provides the knowledge needed to evaluate and improve the QMS through effective internal audits.
- Regulatory Affairs Specialists: Professionals responsible for ensuring that their organization meets all regulatory requirements for medical devices. This course helps them understand the auditing process and how ISO 13485:2016 fits within global regulatory frameworks.
- Compliance Managers: Individuals tasked with ensuring organizational adherence to regulatory and quality standards. The course helps compliance professionals understand how to audit for conformity with ISO 13485:2016 and address potential gaps.
- Medical Device Manufacturers: Anyone involved in the design, production, or manufacturing of medical devices. This course teaches how to audit critical processes within the QMS to ensure product quality, regulatory compliance, and patient safety.
- Product Development Engineers: Engineers who are involved in the development and lifecycle management of medical devices. By understanding ISO 13485:2016 auditing practices, they can ensure that their product development processes are compliant and effective.
- Consultants: Quality management consultants who support medical device organizations in achieving and maintaining ISO 13485:2016 certification. The course enables consultants to offer auditing services with confidence.
- Professionals Looking to Advance Their Career: Individuals seeking to enhance their qualifications and career prospects in the medical device industry. Completing this course and obtaining certification as an internal auditor opens up opportunities for higher-level positions in quality management and auditing.
This course is ideal for professionals who want to ensure their organization complies with the high standards set forth by ISO 13485:2016. Whether you’re working in a large multinational corporation or a smaller medical device company, this course equips you with the essential skills to perform internal audits, identify nonconformities, and drive continuous improvement in your organization’s quality management system.
Upon completing this Course students will be able to:
Introduction to ISO 13485:2016 and Medical Devices Quality Management Systems
Upon completion of this unit, learners will be able to:
- Understand the fundamental principles and objectives of ISO 13485:2016 and its significance in the medical device industry.
- Identify the structure and scope of the standard and its key requirements.
- Explain the relationship between ISO 13485:2016 and other quality management standards in the context of medical device manufacturing and regulatory compliance.
- Recognize the importance of maintaining a robust Quality Management System (QMS) to ensure product safety, efficacy, and compliance with global regulations.
Quality Management System (QMS) Requirements in ISO 13485:2016
Upon completion of this unit, learners will be able to:
- Demonstrate knowledge of the key requirements for establishing, implementing, and maintaining a QMS according to ISO 13485:2016.
- Understand the roles and responsibilities of management in ensuring QMS effectiveness.
- Implement processes for document control, resource management, and product realization in compliance with ISO 13485:2016.
- Develop and align organizational processes to the ISO 13485 standard to ensure consistent product quality and regulatory compliance.
Risk Management and Compliance in Medical Device Manufacturing
Upon completion of this unit, learners will be able to:
- Apply risk management principles and techniques to the medical device lifecycle, from design to post-market activities.
- Understand the process of identifying, assessing, and mitigating risks in accordance with ISO 13485:2016.
- Integrate risk management practices into the overall QMS to ensure compliance and patient safety.
- Demonstrate the ability to manage risk throughout product development and manufacturing processes to meet regulatory requirements.
Internal Auditing in Medical Device Quality Management Systems
Upon completion of this unit, learners will be able to:
- Conduct effective internal audits based on ISO 13485:2016, ensuring compliance with QMS standards.
- Plan, execute, and report on audits to assess system performance and identify areas for improvement.
- Identify non-conformities and recommend corrective actions to ensure continuous quality improvement.
- Understand the role of internal audits in maintaining a robust and compliant QMS and fostering a culture of continual improvement.
Document and Record Control in Compliance with ISO 13485:2016
Upon completion of this unit, learners will be able to:
- Implement document and record control procedures to ensure accuracy, traceability, and compliance with ISO 13485:2016.
- Understand the lifecycle of documents and records within the QMS, including creation, approval, distribution, and retention.
- Ensure all medical device documentation meets regulatory standards and can be easily accessed and tracked for audits and compliance purposes.
- Maintain effective document control to support quality assurance and product traceability throughout the medical device lifecycle.
Maintaining Regulatory Compliance and Continuous Improvement in Medical Devices
Upon completion of this unit, learners will be able to:
- Understand the importance of maintaining ongoing regulatory compliance in the medical device industry.
- Apply continuous improvement practices to enhance the performance of QMS and product quality.
- Utilize performance metrics and audit findings to drive corrective and preventive actions (CAPA) and ensure sustained compliance.
- Implement strategies for monitoring and evaluating QMS performance, ensuring continual alignment with regulatory requirements and industry best practices.
