QMS auditors holding the current ISO 13485:2003 scope must demonstrate transition training in order to update their scope to ISO 13485:2016. If this is not completed, the ISO 13485 scope will be removed in February 2019.

Current Exemplar Global certified QMS auditors have two options after they have completed ISO 13485 transition training:

  • Update their ISO 13485:2003 scope
  • Transition their certification to include the Medical Device scheme

Transition training/assessment for ISO 13485:2016 can be completed by:

  • Completing the Exemplar Global College ISO 13485:2016 Transition Assessment
  • Attending an ISO 13485:2016 course from an Exemplar Global-certified training provider
  • Completing an ISO 13485:2016 course from an accredited certification body

IMPORTANT: Medical device auditors must transition to ISO 13485:2016 by February 2019. Once you have completed ONE of the above items, you must email your certificate of completion to certification@exemplarglobal.org.