Medical Devices Quality Management
Understanding medical device quality management starts with the right foundation. The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Foundation Course delivers a comprehensive introduction to the international standard that defines quality in healthcare manufacturing. This ISO 13485 foundation training online breaks down the regulatory framework into accessible segments, helping learners navigate design controls, risk management protocols, and documentation requirements without feeling overwhelmed.
Unlike advanced auditor programs, this entry-level ISO 13485 certification focuses on building confidence with the standard’s core structure. Learners explore quality management principles, corrective action processes, and record-keeping essentials through practical examples drawn from real medical device environments.
As a recognized ISO 13485 foundation qualification, this LICQual Medical Devices QMS Foundation course bridges the gap between theoretical requirements and workplace application. Every learner completes the program with a clear roadmap of how quality systems operate, what auditors look for, and how daily decisions impact compliance.
Course Overview
Qualification Title
LICQual ISO 13485:2016 Medical Devices Quality Management Systems Foundation Course
Total Units
6
Total Credits
40
GLH
120
Qualification #
LICQ2201343
Qualification Specification
To enroll in the LICQual ISO 13485:2016 Medical Devices Quality Management Systems Foundation Course applicants must meet the following criteria:
|
Qualification# |
Unit Title |
Credits |
GLH |
|---|---|---|---|
|
LICQ2201343-1 |
Introduction to ISO 13485:2016 and Quality Management Principles |
8 |
24 |
|
LICQ2201343-2 |
Understanding the Structure and Core Clauses (Clauses 4-6) |
8 |
24 |
|
LICQ2201343-3 |
Deep Dive into Product Realisation (Clause 7) |
6 |
18 |
|
LICQ2201343-4 |
Risk Management Throughout the Product Lifecycle |
6 |
18 |
|
LICQ2201343-5 |
Measurement, Analysis, and Improvement (Clause 8) |
6 |
18 |
|
LICQ2201343-6 |
Pathway to Certification and Maintaining Compliance |
6 |
18 |
By the end of this course, Applicants will be able to:
Introduction to ISO 13485:2016 and Quality Management Principles
- Understand the historical development and international recognition of the ISO 13485 standard within the medical device sector.
- Define the core concept of a Quality Management System (QMS) and its role in ensuring product safety and consistency.
- Identify the fundamental quality management principles underpinning the ISO 13485 framework.
- Explain the Plan-Do-Check-Act (PDCA) cycle and how it applies to process improvement in healthcare manufacturing.
- Recognize the regulatory significance of ISO 13485:2016 for global market access and compliance.
Understanding the Structure and Core Clauses (Clauses 4-6)
- Distinguish between the general requirements and the specific documentation requirements outlined in Clause 4.
- Outline the responsibilities of management regarding quality policy, objectives, and communication as per Clause 5.
- Identify the key resource requirements, including infrastructure and work environment, mandated by Clause 6.
- Describe the hierarchy of documentation, from the quality manual to records, and their interrelationships.
- Recognize the importance of ensuring personnel competence through training and awareness programs.
Deep Dive into Product Realisation (Clause 7)
- Trace the sequence of processes involved in planning medical device realization.
- Explain the critical stages and controls required within design and development procedures.
- Identify the key requirements for evaluating and selecting suppliers and managing purchased product.
- Describe the controls necessary for production, including validation, identification, and traceability.
- Understand the importance of preserving product conformity during internal processing and delivery.
Risk Management Throughout the Product Lifecycle
- Define the concept of risk management and its mandatory integration within the ISO 13485 framework.
- Identify the general process for conducting risk analysis, evaluation, and control throughout the device lifecycle.
- Explain how risk management principles apply specifically to design and development activities.
- Recognize the relationship between risk management and post-production activities like complaint handling.
- Understand the requirement for maintaining documented information as evidence of risk management activities.
Measurement, Analysis, and Improvement (Clause 8)
- Identify the methods used to monitor, measure, and analyze the effectiveness of the QMS.
- Describe the purpose and key stages of conducting an internal audit program.
- Explain the process for handling customer feedback, including complaints, as a source of improvement.
- Understand the procedure for controlling and addressing non-conforming products.
- Differentiate between corrective and preventive actions and their role in driving continual improvement.
Pathway to Certification and Maintaining Compliance
- Outline the typical stages involved in achieving third-party certification to ISO 13485:2016.
- Understand the purpose and structure of a certification audit, from stage one to stage two.
- Describe the management review process and its input and output requirements.
- Recognize the ongoing activities required to maintain certification and address non-conformities.
- Identify the linkages between ISO 13485 and other relevant regulatory frameworks and standards.
This course is ideal for:
- Quality assurance professionals seeking to formalize their understanding of international medical device standards.
- Regulatory affairs associates looking to understand the quality system requirements behind compliance submissions.
- Production and manufacturing supervisors responsible for maintaining quality during device production.
- Entry-level quality department staff wanting to build a career foundation in medical device compliance.
- Recent graduates in biomedical engineering or life sciences aiming to enter the regulated medical device industry.
- Internal process owners whose daily work activities directly impact product quality and safety.
- Document control specialists needing deeper insight into why documentation structure matters for audits.
- Healthcare professionals transitioning from clinical roles into medical device industry positions.
- Supplier quality personnel managing relationships with medical device manufacturers.
- Technical support and service engineers working with medical equipment requiring quality system knowledge.
- Sales and marketing professionals in medical device companies seeking credibility through quality awareness.
- Startup founders and entrepreneurs developing medical devices who must understand compliance fundamentals.
- Compliance officers expanding their expertise into the medical device regulatory landscape.
- Purchasing and procurement staff involved in sourcing materials for medical device production.
- Anyone involved in medical device development or manufacturing who needs to understand how their role fits within a formal quality management system.
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.
