ISO 13485:2016 Appreciation and Interpretation

You need this course if ...

  • You want an overview and an understanding of the intent and the requirements for ISO 13485:2016 Medical Devices quality management systems (QMS) 
  • You need to understand ISO 13485:2016 compatibility with other management systems
  • You want to convert from ISO 9001 to ISO 13485:2016
  • If you want to create a single quality management system that meets global regulations

You will learn …

  • The scope and application of the ISO 13485:2016 standard
  • The differences between ISO 13485:2003, EN ISO 13485:2012 and ISO 13485:2016
  • Essential definitions and terminology to help you interpret and apply ISO 13485:2016 requirements
  • The key requirements of ISO 13485:2016 and how they relate to each other to form a robust effective system
  • How ISO 13485 forms the basis of worldwide Medical Device Regulation with particular emphasis on Canadian Regulation CMDCAS
  • The relationship and differences between ISO 13485:2016 and ISO 9001:2015 requirements
  • The relationship between ISO 13485:2016 and the risk management standard ISO 14971

You will need …

  • No previous training

Your future development

Course length

  • One day
Start Date End Date Venue Book course
Emperors Palace, 64 Jones Road, Kempton Park, Johannesburg Book Now