ISO 13485 Foundation Training
ISO 13485 Foundation Training is for anyone looking to gain a comprehensive understanding of the core requirements of ISO 13485 and this highly interactive course can be completed anytime, anywhere (24/7).
Course Overview
ISO 13485 Foundation Training
Our industry-leading Online Training is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
Available Formats:
eLearning
On completion of this course, 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
A summary of learning topics within this course include:
- Purpose, Benefits & Structure of ISO 13485
- Key Terms & Definitions
- Principles of Quality Management
- Relationship with ISO 9001
- Key Concepts (PDCA, Process Approach, Risk Management)
- QMS Processes
- QMS Documentation
- Document Control
- Record Control
- Role of Top Management (Commitment, customer focus, quality policy, quality objectives, change control)
- Responsibility
- Authority and Communication
- Management Review
- Resource Planning
- Purpose, Benefits & Structure of ISO 13485
- Key Terms & Definitions
- Principles of Quality Management
- Relationship with ISO 9001
- Key Concepts (PDCA, Process Approach, Risk Management)
- QMS Processes
- QMS Documentation
- Document Control
- Record Control
- Role of Top Management (Commitment, customer focus, quality policy, quality objectives, change control)
- Responsibility
- Authority and Communication
- Management Review
- Resource Planning
This course is targeted at:
- Quality Managers
- Quality Professionals/Technicians
- Quality Engineers
- Procurement Personnel
- Financial Personnel
- Document Controllers
- Internal Auditors
- Owner Managers
- Implementation Members
CQI & IRCA certify this course (No. 2327). Upon successful completion, each Learner shall receive a digital Certificate of Completion within 1 business day.
Exemplar Global also certify this course under the Recognized Training Provider scheme. Learners will receive dual accreditation where both logos will appear on their digital Certificate of Completion.
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
Fluency in written and spoken English
- For participants whose first language is not English, we recommend a minimum English language competency of IELTS 5.5 (or equivalent) for successful completion of the program. This is not assessed by Comply Guru in advance & each participant must self-assess their competency.
Copy of ISO 13485 (International Standard)
- 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 challenging to complete successfully.
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) within the 90-day course license
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. Read the full technology requirements here.
Why Choose Comply Guru
About Our ISO 13485 Foundation Training
Learn about how our Accredited ISO 13485 Training is leading the industry for innovation & learning effectiveness
Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.5
Average Rating
479 global ratings
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A thorough and straightforward explanation of the standard
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It was very helpful.
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Alot of information to take in but all information is relevant. I believe this course has given me better understanding of ISO 13485.
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My experience with the ISO 13485 foundation course was excellent. The course content was well-structured and the platform user friendly. This course really enhanced my understanding of the material by providing extra information and examples.
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This is a very helpful course to understand ISO 13485 and be more confident in dealing with all the processes required in the QMS. Well structured course with plenty of additional information on the ISO.
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