ISO 13485 Medical Devices Quality Management System (QMS) Foundation

Highlights of the course:

Our ISO 13485 one day foundation course gives a thorough introduction to Medical Device Quality Management System (QMS), together with the requirements for a MS-QMS implementation. It is also highly beneficial for those needing to fully understand or implement MS-QMS within their organization. It can be used as a foundation for those wishing to go on to complete certified quality.


Learning Objectives:

  • To provide an understanding of what a Medical Devise Quality Management System is and how it can help a business
  • The business benefits of improved performance as a result of a medical devise quality management system
  • To help you understand the tools required to meet the requirements
  • The structure and content of ISO 13485 and its relationship with other standards
  • Learn to interpret and apply the key concepts and principles of the standard to existing processes within your organization.
  • To understand the implementation of a ISO 13485 in accordance with other related standards.

Course Agenda:

  • Introduction to the ISO 13485 & its family
  • Introduction to management systems and the process approach
  • Fundamental principles
  • Implementation phases & framework
  • Continual improvement of Quality
  • Process and Conducting of ISO 13485 certification audit
  • Certification Exam




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