This two-day training 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.
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.
- Anyone involved in defining, planning, or implementing an ISO 13485:2016 based quality management system
- Management representatives
- Implementation team members
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.
- Training course notes
- Lunch and refreshments