Online ISO 13485:2016 Foundation Course | CQI, IRCA & Exemplar Global Certified
New! Online ISO 13485:2016 Foundation Course!
Eoin provides an overview on this new, exciting online course including what this self-paced course will cover and who will benefit most from completing it!Watch Video
Module 0 - Course Introduction (Online & Self-Paced)
In this module, an introduction to the course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & how to successfully complete the course.
Module 1 - Introduction to ISO 13485:2016 (Online & Self-Paced)
- 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)
Module 2 - Establishing a QMS (Online & Self-Paced)
- QMS Processes
- QMS Documentation
- Document Control
- Record Control
Module 3 - Management Responsibility (Online & Self-Paced)
- Role of Top Management (Commitment, customer focus, quality policy, quality objectives, change control),
- Authority and Communication
- Management Review
Module 4 - Resource Management (Online & Self-Paced)
- Resource Planning
- Human Resources
- Work Environment and Contamination Control
Module 5 - Product Realization, Part 1 (Online & Self-Paced)
- Planning of Product Realization & ISO 14971
- Customer related Processes
- Design & Development
Module 6 - Product Realization, Part 2 (Online & Self-Paced)
- Production & Service Provision
- Control of Monitoring & Measuring Equipment
Module 7 - Measurement, Analysis and Improvement (Online & Self-Paced)
- Monitoring & Measurement (feedback, complaint handling, regulatory reporting & internal audit, process and product monitoring & measuring)
- Control of Non-Conforming Product
- Analysis of Data
- Improvement (CAPA)
I really enjoyed this self-paced course. I observed many benefits including flexible schedule customised learning variation of information delivery types. It allowed me to progress at my own schedule go through the same learning content multiple times and that allowed me to really immerse my self in the content without any side distractions. I was also contacted by the trainer to see if I have any questions or queries. All my questions were answered immediately in detail with some examples. I dont think I would be getting such clarification in a classroom training.
Average Rating 75 global ratings
The course was well structured and gave me a better understanding of the requirements for ISO 13485 compliance.
I have heard of people receiving similar trainings in the past from different companies but that involved going to a fancy hotel to listen to a person speak for 6-8 hours having your meal and being back with zero to less information backed up in the mind.With this course the information is available 247365 and easy to access on the go. I would highly recommend this training to anyone looking to be an auditor in any industry. I feel a lot closer to being an actual auditor and can easily understand the expectations in an audit from both parties.