Implementing ISO 13485 Medical Device Quality Management System

This course shows you how to put in place a quality management system in line with ISO 13485, paving the way to accreditation. ISO 13485 is a clear mark of your dedication and commitment to quality and applies to every aspect of medical devices from design to development, production and servicing.

You will learn step by step how to plan, develop and implement a quality management system


Who should attend?

  • Anyone involved in defining, planning, or implementing an ISO 13485 based quality management system
  • Management representatives
  • Implementation team members

This training course is HRDF approved under the SBL scheme

What will I learn?

  • Describe the fundamentals of quality management systems
  • Explain the purpose, structure and requirements of ISO 13485
  • Apply a process of implementing a quality management system that meets the requirements of ISO 13485
  • Prepare for ISO 13485 certification

How will I benefit?

  • Take the first steps towards ISO 13485 certification
  • Understand how you can better meet customer and regulatory requirements
  • Find ways to increase efficiency and cost savings through quality management
  • Monitor supply chains to achieve continuous improvement

What does the fee cover?

  • Training course notes
  • Lunch
  • Refreshments
  • Loan copy of the standard (to be returned after the course)
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