Introduction
It is essential that personnel involved in the development, implementation and auditing of medical device quality management systems understand the ISO 13485 requirements.
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
Please Note:
If you have any specific questions after the fundamentals training, contact us on [email protected] and we will invite you to one of our free one-hour lunchtime consultations with an expert.