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Implementing ISO 13485:2016 Training Course This two-day course has been designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2016. The course introduces the concepts needed to understand, develop, and implement a quality management system. Who should attend? Anyone involved in defining, planning, or implementing an ISO 13485:2016 based quality management system Management representatives Implementation team members “While quality has always been our number one priority, we now have a more systematic approach to the way it is managed.” What will I learn? On completion of this training, participants will be able to: Define a ISO 13485:2016 QMS Identify the steps for defining, planning, organizing and scheduling necessary activities Implement an effective quality management system Conduct a base line review of an organization’s current position with regard to ISO 13485:2016. How will I benefit? Understand how to implement a QMS as required by medical device directives Plan the implementation of ISO13485:2016 within your organization Take the first steps towards ISO 13485:2016 certification Identify how you can better meet regulatory requirements Find ways to increase efficiency and add value through quality management Monitor supply chains to achieve continuous improvement. What's included? You will gain 16 CPD points on completing the course Certificate Training course notes Lunch and refreshments