Medical Devices Quality Management Systems
Welcome to the LICQual ISO 13485:2016 Medical Devices Quality Management Systems course, designed to equip the learner with advanced knowledge of quality management in the medical devices sector. Aligned with the globally recognised ISO 13485:2016 standard, this course enables the learner to understand and implement systems that ensure medical devices meet regulatory requirements and customer expectations.
The learner explores quality management throughout the product lifecycle, from design and development to production, distribution, and post-market surveillance. The course covers regulatory compliance, risk management, process control, documentation, and reporting, equipping the learner to assess and improve organisational quality systems.
Through practical examples and case studies, the learner develops skills to reduce errors, enhance product reliability, and drive continuous improvement. By completing this course, the learner is prepared to implement ISO 13485:2016 effectively, ensuring medical device safety, regulatory compliance, operational efficiency, and the ability to contribute to organisational excellence and patient safety in the global medical device market.
Course Overview
Qualification Title
LICQual ISO 13485:2016 Medical Devices Quality Management Systems
Total Units
6
Total Credits
40
GLH
120
Qualification #
LICQ2200107
Qualification Specification
To enrol in the LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Auditor, applicants must meet the following criteria:
|
Qualification# |
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 |
By the end of this course, learners will be able to:
Introduction to ISO 13485:2016
- Understand the structure, purpose, and key components of ISO 13485:2016 and its significance in the medical device industry.
- Identify the regulatory requirements that ISO 13485:2016 addresses and its role in ensuring the safety and effectiveness of medical devices.
- Recognize the benefits of implementing ISO 13485:2016 for medical device manufacturers and their stakeholders.
- Distinguish between ISO 13485:2016 and other quality management standards, such as ISO 9001.
Quality Management Principles and Requirements
- Explain the core principles of quality management and their application within the medical device industry.
- Identify the key requirements of ISO 13485:2016, including document control, corrective actions, and internal audits.
- Evaluate the effectiveness of quality management systems in improving the safety and quality of medical devices.
- Assess the implementation of risk management processes within the scope of ISO 13485:2016.
Management Responsibility and Leadership
- Understand the responsibilities of management in establishing, maintaining, and improving the quality management system (QMS) under ISO 13485:2016.
- Analyze the role of leadership in fostering a culture of quality, continuous improvement, and regulatory compliance.
- Assess the involvement of top management in defining policies, goals, and objectives aligned with the standard.
- Evaluate the effectiveness of management reviews and communication strategies within a medical device organization.
Resource Management
- Identify the resources required for an effective QMS in a medical device manufacturing environment.
- Assess the adequacy of human resources, infrastructure, and work environment in supporting ISO 13485:2016 compliance.
- Evaluate the need for specialized training, qualification, and competence in ensuring the successful implementation of the QMS.
- Recommend resource improvements to optimize the performance of the quality management system.
Product Realization and Design Control
- Understand the processes involved in product realization and design control under ISO 13485:2016.
- Assess the design and development stages of medical devices, ensuring that they meet regulatory and quality standards.
- Evaluate product realization procedures, including planning, risk assessment, validation, and verification.
- Ensure that design control processes contribute to the continuous improvement of medical devices.
Measurement, Analysis, and Improvement
- Understand the importance of measurement, analysis, and continuous improvement in maintaining ISO 13485:2016 compliance.
- Identify key performance indicators (KPIs) and other metrics used to assess the effectiveness of the QMS.
- Evaluate data collection methods, analysis techniques, and reporting systems to monitor and improve product quality.
- Develop strategies for implementing corrective actions, conducting internal audits, and driving continuous improvement within a medical device organization.
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.
