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ISO 13485 Fundamentals e-learning  

This is a self directed, self paced E-learning course.  You can pause the training and repeat sections as many times as you wish.  Cost: €199. Access is available for 30 days.   Need a quote for In-house Training? email us today 


This online training is designed specifically for those who are new to ISO 13485 or are scheduled to attend our accredited Internal / Lead Auditor training courses. 
This is an excellent opportunity to get an introduction to the ISO 13485:2016 standard, then proceed onto the Foundation course, followed by our accredited Internal / Lead Auditor training. 
Who should do this course? 
• Operational Staff involved in implementing and or maintaining the system. 
• Quality personnel 
• Management and Supervisors 
• Any responsible personnel involved in the design, development, implementation, and auditing of quality management systems 
This course aims to provide learners who have an existing basic knowledge of, or experience in, quality management in any Industry and in the context of the requirements of ISO 13485. 
Course Objectives: 
At the end of this e-learning training on ISO 13485 you will have a better understanding of: 
• The General requirements of the standards 
• Management responsibilities 
• Resource management 
• Product Realisation – Planning 
• Customer related Processes 
• Design and Development 
• Purchasing 
• Control of Production and Service Provision 
• Monitoring and Measuring 
• Improvement 
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