Online ISO 13485 Foundation Training | CQI & IRCA Certified
Online ISO 13485 Foundation Training (CQI & IRCA Certified) is ideal for anyone who wants to understand the underlying principles and requirements of the international standard, ISO 13485 (2016). This course has been designed for Quality Professionals.
Why Choose eLearning for ISO 13485 Foundation Training?
Our 8hr eLearning course 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.
Course Format & Content Breakdown
This ISO 13485 Foundation Training course is available via eLearning (24/7) offering you the most convenient & flexible way to learn online, anytime, anywhere. It is important to note that the exact time it takes to complete the eLearning modules will vary based on current knowledge, experience, and learning style.
During the eLearning modules, each Learner will cover the following:
- 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)
- Authority and Communication
- Management Review
- Resource Planning
- Human Resources
- Work Environment and Contamination Control
- Planning of Product Realization & ISO 14971
- Customer related Processes
- Design & Development
- Production & Service Provision
- Control of Monitoring & Measuring Equipment
- 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 of this Online ISO 13485 Foundation Training, 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
It is recommended that each Learner should have the following prior knowledge before completing this course: Management Systems
- 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.
Assessment & Certification
ISO 13485 Foundation Training Assessment Methodology
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
ISO 13485 Foundation Training Certification
This course is certified by CQI & IRCA (No. 2327). Successful completion will entitle each Learner to receive a digital Certificate of Completion.
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 full technology requirements
Terms & Conditions
In registering for this course, each Learner and/or Customer expressly acknowledges that they have read, fully understood and agreed to be bound by all of Comply Guru’s terms & conditions, including additional licensing agreement. The terms & conditions & licensing agreement can be read here.
Reviews & Ratings
459 global ratings
I believe this course helped me understand the foundations of ISO 13485 and the objectives were very well defined.
This was a great introductory course for ISO 13485:2016. It added a lot of information on what each section really means and requires. I found it hugely helpful how it showed which sections go together for certain areas of quality, verses just going in order and stating the standards verbatim. I also enjoyed all of the scenarios and examples.
The course was well designed and thorough. It addressed all needed topics very well, and did not leave me with any significant questions. The additional resources were also very useful.
The course is well designed and on successful completion leads to a very thorough understanding of the requirements of ISO 13485. This is very benefical for quality professionals who want to ensure that their companies quality management system remains compliant.
Excellent content and I enjoyed the narration
The Comply Guru course is well organized. The interactivity is a good feature.
I failed the end exam twice both times achieving 65%. I expected the second exam to be the same exam as the first one but almost all questions were different . I had to study the whole course again to ensure that I passed. (95%). Great course
It is very good course and well explain and easy to understand.
Would highly recommend this course as it cover all aspects of being a support auditor on internal audits. John the trainer was fantastic and made me feel as ease when i answered any questions he might ask me. Didnt feel overwhelmed with the information that was being presented.
As a process engineer i found the course very helpful and will most definitely help me throughout my career. Excellent