Introducing ISO 13485 Clause by Clause

This two day course explores the requirements of the ISO 13485:2016 Quality Management System standard, clause by clause, and provides a clear understanding of the key principles of the standards as well as the steps needed to implement ISO 13485:2016 within your organisation.

The course will help you:

  • Understand the scope and purpose of ISO 13485:2016
  • Understand the structure of ISO 13485 and its relationship with other standards and regulations
  • Understand the intent and requirements of ISO 13485:2016, clause by clause breakdown of the Standard
  • Understand the key differences between ISO 13485:2016 and ISO 9001:2015
  • Understand the requirements for ISO 13485 certification

This is an interactive course developed and delivered by our experienced Medical Device Certification team.

Throughout the course, you will have the opportunity to ask questions of our team as well as discuss ideas with other delegates, helping you better understand the next steps in your engagement with ISO 13485:2016

At the end of the course you will:

  • Have a clear understanding of the core principals and requirements of the standard
  • Understand the next steps you need to take towards ISO 13485:2016 certification
  • Understand how you and your organisation can better meet regulatory requirements
  • Discover opportunities to improve existing processes and quality management systems
  • Understand the next steps in developing safe and effective medical devices

The training will be delivered either in person or on-line (see the current dates below).

Next Course dates

Dates Duration Location Type Cost (per person ex VAT)
22-23 March 2023 2 Days On-line Virtual Full
24-25 April 2023 2 Days Eurofins York Bristol Lab In Person Full
15-16 May 2023 2 Days Eurofins York Castleford Lab In Person Full
12-13 June 2023 2 Days Eurofins York Castleford Lab In Person Full
26-27 June 2023 2 Days Eurofins E&E CML Ellesmere Port In Person £1250
3-4 July 2023 2 Days On-line Virtual £1100

If you would like more information or wish to book this course please call 0330 430 3456, complete the form below or email quoting course code T011.