Medical Devices Quality Management Systems
The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor course equips learners with the essential expertise to perform internal audits in compliance with ISO 13485:2016 standards. Learners will gain a thorough understanding of the ISO 13485:2016 framework, including its key requirements for establishing, implementing, and maintaining effective quality management systems in the medical device sector.
Through this course, learners will explore the critical role of internal audits in ensuring regulatory compliance, product safety, and operational efficiency. Learners will acquire practical skills to plan, execute, and report internal audits, as well as to identify non-conformities and opportunities for improvement within the quality management system.
By completing the program, learners will be proficient in conducting comprehensive internal audits that support continuous improvement, enhance compliance with regulatory standards, and strengthen overall quality management practices in medical device manufacturing and services. This course ensures learners are fully prepared to contribute effectively to organizational quality objectives.
Course Overview
Qualification Title
LICQual ISO 13485:2016 Medical Devices Quality Management Systems
Total Units
6
Total Credits
40
GLH
120
Qualification #
LICQ2200120
Qualification Specification
To enroll in the LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor, applicants must meet the following criteria:
|
Qualification# |
Unit Title |
Credits |
GLH |
|---|---|---|---|
|
LICQ2200120-1 |
Introduction to ISO 13485:2016 and Medical Devices Quality Management Systems |
8 |
24 |
|
LICQ2200120-2 |
Quality Management System (QMS) Requirements in ISO 13485:2016 |
8 |
24 |
|
LICQ2200120-3 |
Risk Management and Compliance in Medical Device Manufacturing |
6 |
18 |
|
LICQ2200120-4 |
Internal Auditing in Medical Device Quality Management Systems |
6 |
18 |
|
LICQ2200120-5 |
Document and Record Control in Compliance with ISO 13485:2016 |
6 |
18 |
|
LICQ2200120-6 |
Maintaining Regulatory Compliance and Continuous Improvement in Medical Devices |
6 |
18 |
By the end of this course, learners will be able to:
Introduction to ISO 13485:2016 and Medical Devices Quality Management Systems
- 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
- 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
- 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
- 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
- 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
- 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.
This diploma is ideal for:
Assessment and Verification
All units within this qualification are subject to internal assessment by the approved centre and external verification by LICQual. The qualification follows a criterion-referenced assessment approach, ensuring that learners meet all specified learning outcomes.
To achieve a ‘Pass’ in any unit, learners must provide valid, sufficient, and authentic evidence demonstrating their attainment of all learning outcomes and compliance with the prescribed assessment criteria. The Assessor is responsible for evaluating the evidence and determining whether the learner has successfully met the required standards.
Assessors must maintain a clear and comprehensive audit trail, documenting the basis for their assessment decisions to ensure transparency, consistency, and compliance with quality assurance requirements.
