Training – Auditor Transition ISO 13485

ISO 13485:2016 – Auditor Transition (1 day)

Course Overview

This Auditor Transition course is conducted over 1 day, giving delegates the benefit of understanding the transition process from ISO 13485:2012 to ISO 13485:2016.

This is a great way for the delegates to develop their knowledge to understand the changes in ISO 13485:2016 and how to apply them when using auditing skills and techniques.

Course Benefits

By attending and completing this course, successful delegates will:-

  • Benefit from a highly interactive course with extensive use of team-based exercises, which is both challenging and stimulating
  • Understand the changes with ISO 13485:2016 and be able to apply them in practice
  • Gain a key understanding of management systems and the transition processes involved

Tutors have extensive quality management systems design and improvement experience.  They are qualified and experienced auditors with extensive practical management experience across a wide range of business sectors.

Course Objectives

  • To be able to identify the key changes in ISO 13485:2016;
  • To understand the relation between ISO 13485:2016 and ISO 9001:2015;
  • To have a clear understanding about the transition process from ISO 13485:2012 to ISO 13485:2016.
  • To be able to interpret MD9:2015 Specifics and an introduction to the principles of ISO 14971:2007.

Course content

  • Key changes in ISO 13485:2016
  • Auditing skills/techniques
  • Relation between ISO 13485:2016 and ISO 9001:2015
  • Transition process from ISO 13485:2012 to ISO 13485:2016


09.00 – 17:00


All successful participants will be issued with a certificate on behalf of QA International (Training) Limited.

Who should attend

This training programme is specifically designed for delegates who are involved with an ISO 13485:2016 Quality Management System transition.

This course will also be relevant for those who are involved in auditing an ISO 13485:2003 quality management system and will be auditing ISO 13485:2016.

Course price

The fee includes course materials, delegate notes, lunch and refreshments. It does not include a copy of ISO 13485:2016 which you will need for the course.

Fee: £395.

To enquire about this training course, please complete the course enquiry form.  This form can also be used to enquire about holding this course at your premises.

For other enquiries about training, please contact us by telephone on 01325 384272 or email us at


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