ISO 13485:2016 Requirements

This one day course has been designed to provide an insight into the use of ISO 13485 as the basis for a quality management system implemented by medical device manufacturers.

Time will be spent during the course reviewing requirements of ISO 13485 and making comparisons to ISO 9001 and the FDA’s Quality System Regulation. In addition to this, participants will also gain an awareness of the relationship between ISO 13485 and ISO 14971, Application of Risk Management to Medical Devices.


Who should attend?

  • Senior Management
  • Quality Managers
  • Regulatory Affairs Managers
  • Internal and external Auditors
  • Anyone involved with the implementation of the standard

What will I learn?

On completion of this training, participants will be able to:

  • Compare the requirements between ISO 13485 and ISO 9001
  • Interpret the clauses of ISO 13485 using ISO 14969
  • Recognize the role and responsibilities of management in ISO 13485
  • Recognize the relationship between ISO 13485 and ISO 14971
  • Compare the requirements between ISO 13485 and FDA’s Quality System Regulation
  • Appreciate the use of ISO 13485 as the basis of Medical Device Regulations worldwide.

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
  • Develop safe and effective medical devices
  • Motivate employees through CPD.

What is included?

  • You will gain 8 CPD points on completing the course
  • Training course notes
  • Lunch
  • Refreshments
  • An internationally recognized BSI Training Academy certificate 
Book your place
    For pricing, availability and any further information, please contact us at Tel: 3149 3326.