Medical Devices Quality Management
In the highly regulated medical device industry, maintaining quality and compliance is critical for safety and efficacy. The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Implementer course empowers learners with the skills and expertise needed to implement, manage, and improve a quality management system (QMS) specific to the medical device sector. This internationally recognised standard ensures that medical devices consistently meet regulatory requirements and customer expectations.
ISO 13485:2016 provides a robust framework for laboratories, manufacturers, and healthcare organisations to demonstrate compliance, control risks, and maintain product quality. Through this course, learners gain in-depth knowledge of regulatory requirements, documentation practices, process management, risk assessment, and continuous improvement strategies essential for a successful QMS.
The LICQual ISO 13485:2016 Lead Implementer course combines theoretical knowledge with practical guidance, enabling learners to lead the development, implementation, and monitoring of a compliant QMS. By completing this course, learners will be fully equipped to enhance organisational efficiency, ensure product safety, and build regulatory confidence. This qualification positions learners as experts capable of driving quality improvements, achieving compliance, and ensuring excellence across all stages of the medical device lifecycle.
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.