[Training] Introduction to ISO 13485 Clause by Clause

This 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

The course is aimed at anyone involved in the implementation of ISO 13485:2016, including:

  • New staff within organisations already certified to ISO 13485
  • Anyone new to ISO 13485
  • Organisations looking to move from ISO 9001 to ISO 13485
  • Manufacturers looking at entering the Medical Device market

For manufacturers who have already implemented ISO 13485, this course is ideal as a refresher for those with knowledge of the standard and for anyone with experience with ISO 9001 but who is now looking to better understand how the two standards interact.

It is also ideal for:

  • Senior Management
  • Quality & Regulatory Managers
  • Internal & External Auditors
  • Consultants

Next Course dates

22nd – 23rd March 2023

Cost: £1100 + VAT per delegate

This course will be hosted online via GoToMeeting.

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