The medical device industry is highly regulated, and quality management is critical to ensure safety, efficacy, and compliance. The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Implementer course provides organisations with the knowledge and skills required to implement, manage, and improve a quality management system (QMS) specific to the medical device sector. This internationally recognised standard sets out the criteria for a comprehensive QMS, helping businesses ensure that their products are safe and meet regulatory requirements.
ISO 13485:2016 is the international standard for quality management systems in the medical device industry. The standard specifies the requirements for a QMS where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
The LICQual ISO 13485:2016 Lead Implementer course provides a comprehensive understanding of the ISO 13485 standard, detailing the key processes and requirements necessary for successful implementation. This course offers practical insights into how to develop and implement a QMS in line with regulatory standards, enhance customer satisfaction, and ensure continual improvement. Upon completion, participants will be equipped with the tools to lead the implementation and maintenance of a robust QMS in their organisation.
In the medical device industry, quality is non-negotiable. ISO 13485:2016 provides a structured approach to ensuring that all aspects of the product lifecycle meet the highest standards of quality and regulatory compliance. The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Implementer course equips professionals with the knowledge and tools required to successfully implement and maintain a quality management system that ensures product safety, meets customer expectations, and complies with regulatory requirements. By enrolling in this course, organisations can enhance their ability to deliver high-quality medical devices and gain a competitive edge in a rapidly evolving industry.
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:
- A basic understanding of quality management systems (QMS).
- Prior knowledge of ISO 9001:2015 or any other ISO-based management systems is advantageous but not mandatory.
- Familiarity with the medical device industry and regulatory frameworks will be beneficial.
- No specific academic qualifications are required, though individuals with experience in quality assurance, regulatory affairs, or medical device manufacturing may find the course more relevant.
|
Qualification# |
Unit Title |
Credits |
GLH |
|---|---|---|---|
|
LICQ2200133-1 |
Introduction to ISO 13485: Purpose, Scope, and Structure |
6 |
20 |
|
LICQ2200133-2 |
Management Requirements |
6 |
20 |
|
LICQ2200133-3 |
Risk Management |
6 |
20 |
|
LICQ2200133-4 |
Design and Development |
6 |
20 |
|
LICQ2200133-5 LICQ2200133-6 |
Production and Service Provision Post-Market Surveillance |
8 8 |
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.
