- Foundation Module 1 - Introduction to ISO 13485
- Purpose, Benefits & Structure of ISO 13485 2016
- Key Terms & Definitions
- Principles of Quality Management
- Relationship with ISO 9001
- Key Revisions of ISO 13485
- Key Concepts (PDCA, Process Approach, Risk Management)
- Foundation Module 2 - Establishing a QMS
- QMS Processes
- QMS Documentation
- Document Control
- Record Control
- Foundation Module 3 - Management Responsibility
- Role of Top Management (Commitment, customer focus, quality policy, quality objectives, change control),
- Authority and Communication
- Management Review
- Foundation Module 4 - Resource Management
- Resource Planning
- Human Resources
- Work Environment and Contamination Control
- Foundation Module 5 - Product Realization, Part 1
- Planning of Product Realization & ISO 14971
- Customer related Processes
- Design & Development
- Foundation Module 6 - Product Realization, Part 2
- Production & Service Provision
- Control of Monitoring & Measuring Equipment
- Foundation Module 7 - Measurement, Analysis and Improvement
- Monitoring & Measurement (feedback, complaint handling, regulatory reporting & internal audit, process and product monitoring & measuring)
- Control of Non-Conforming Product
- Analysis of Data
- Improvement (CAPA)
On completion, successful Learners will have the knowledge needed to:
- Explain the purpose of a medical device quality management system, of medical device quality management systems standards, and the business benefits of improved performance given by an effectively implemented medical device quality management system
- Outline the structure and content of ISO 13485 and its relationship with ISO 9001 and IMDRF individual country regulatory documents
- Explain the specific quality management-related requirements of ISO 13485
In order to successfully complete this course, each Learner will need to:
- Complete the course modules and obtain 70% or higher in the final assessment (MCQ-based)
Upon registering for this course, each Learner will have 90-days of eLearning access to complete the course, including final assessment.
Recommended Prior Learning
It is recommended that each Learner should have the following prior knowledge before completing this course:
- The Plan, Do, Check, Act (PDCA) cycle
- The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.
- The fundamental concepts and commonly used quality management terms and definitions
It is recommended that each Learner should have a copy of ISO 13485 2016 (International Standard) to reference while completing this course. This is not provided by Comply Guru and without it, this course will be very challenging to complete successfully.
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well.
Click here to read the full technology requirements.
- Your Computer System and EquipmentYou are solely responsible for supplying all equipment, Internet access, and bandwidth needed to properly access and use the Course. Before paying for (or being provided with access to) any Course, You must confirm the compatibility of your computer system with the published computer specification for the applicable Course. COMPLY GURU shall have no responsibility or liability for Your inability to access the Course due to issues beyond COMPLY GURU’s control, including but not limited to the speed of Your modem – or other connection devices used, Your use of third-party security software or firewall/proxy servers, or the performance levels of Your internet service provider.
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