Medical Devices Quality Management
The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Implementer course is designed to develop the specialist knowledge and practical skills required to implement, manage, and improve a medical device Quality Management System (QMS). In the highly regulated medical device sector, effective quality management is essential for supporting product safety, regulatory compliance, consistent performance, and customer requirements. The course introduces learners to ISO 13485:2016 and its application within organisations involved in the medical device industry.
Learners develop an in-depth understanding of key areas including regulatory requirements, QMS documentation, process management, risk assessment, quality controls, and continual improvement. ISO 13485:2016 provides a structured framework that supports laboratories, medical device manufacturers, and healthcare organisations in demonstrating compliance, managing quality-related risks, and maintaining effective processes. Through the course, learners explore how these requirements can be integrated into organisational operations and applied throughout relevant stages of the medical device lifecycle.
Through a combination of theoretical learning and practical guidance, the LICQual ISO 13485:2016 Lead Implementer course prepares learners to support and lead the development, implementation, and monitoring of a compliant medical device QMS. On completion, learners can apply their knowledge to strengthen quality processes, improve organisational efficiency, support product safety, and enhance regulatory confidence. The qualification also supports professional development for individuals seeking to contribute to quality management, regulatory compliance, and continuous improvement within the medical device sector.
Course Overview
Qualification Title
LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Implementer
Total Units
6
Total Credits
40
GLH
120
Qualification #
LICQ2200133
Qualification Specification
To enrol in the LICQual ISO 26000:2010 Social Responsibility Lead Implementer course, applicants should meet the following criteria:
- Age Requirement: Applicants must be at least 16 years old.
- Educational Background: A basic understanding of quality management systems (QMS) is required.
- Experience: Prior knowledge of ISO 9001:2015 or any other ISO-based management systems is advantageous but not mandatory.
- English Language Proficiency: Applicants should have a sufficient level of English language proficiency.
|
Qualification# |
Unit Title |
Credits |
GLH |
|---|---|---|---|
|
LICQ2200133-1 |
Introduction to ISO 13485: Purpose, Scope, and Structure |
8 |
24 |
|
LICQ2200133-2 |
Management Requirements |
8 |
24 |
|
LICQ2200133-3 |
Risk Management |
6 |
20 |
|
LICQ2200133-4 |
Design and Development |
6 |
20 |
|
LICQ2200133-5 LICQ2200133-6 |
Production and Service Provision Post-Market Surveillance |
6 6 |
20 20 |
By the end of this course, learners will be able to:
Introduction to ISO 13485: Purpose, Scope, and Structure
- Understand the purpose and benefits of implementing ISO 13485 in medical device organizations.
- Identify the structure and key clauses of the ISO 13485 standard.
- Comprehend the scope of the standard and how it applies to the medical device manufacturing industry.
Management Requirements
- Recognize the management responsibilities as outlined in ISO 13485.
- Understand the organizational structure and its role in maintaining an effective QMS.
- Develop an understanding of documentation, record-keeping, and resource management required for ISO 13485 compliance.
Risk Management
- Understand the principles of risk management in the context of medical device manufacturing.
- Implement risk assessment, risk control, and risk communication processes as per ISO 14971.
- Develop risk management strategies for design, production, and post-market activities.
Design and Development
- Learn to establish and manage the design and development processes for medical devices.
- Understand the requirements for design inputs and outputs, as well as the need for verification and validation.
- Gain insight into managing design changes and ensuring compliance with ISO 13485 during product development.
Production and Service Provision
- Understand the processes involved in the production and service provision of medical devices.
- Learn how to control production processes, validate processes, and handle nonconforming products.
- Develop strategies for ensuring that products meet quality and regulatory standards throughout the production cycle.
Post-Market Surveillance
- Learn how to implement post-market surveillance processes to monitor medical device performance after release.
- Develop a process for complaint handling, vigilance reporting, and corrective actions.
- Understand the importance of continuous improvement in response to post-market feedback and regulatory requirements.
This diploma is ideal for:
- Quality Managers: Responsible for overseeing quality assurance and quality control functions within medical device manufacturing organizations, seeking to implement and maintain ISO 13485-compliant quality management systems.
- Regulatory Affairs Managers: Ensuring compliance with regulatory requirements for medical devices, including European Medical Device Regulation (MDR) and U.S. Food and Drug Administration (FDA) Quality System Regulation (QSR).
- Product Development Managers: Overseeing the design and development of medical devices, seeking to establish processes that meet regulatory requirements and ensure product safety and effectiveness.
- Manufacturing Managers: Managing production and service provision processes within medical device manufacturing organizations, seeking to ensure product quality, reliability, and compliance with ISO 13485 requirements.
- Quality Assurance Officers: Ensuring compliance with ISO 13485 requirements, conducting internal audits, and facilitating management reviews to improve organizational effectiveness and customer satisfaction.
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.