No extension for the ISO 13485 standard re-certification

Posted in ISO 13485

If you have not started the transition to the new ISO 13485 standard, it is time to prepare.


Currently, there are no plans by IAOB or ANAB (oversight bodies) to approve or grant waivers for organizations that do not transition by the planned deadlines.

  • March 1, 2019 - Only ISO 13485:2016 certificate is valid
  • September 15, 2018 - Only AS9100D or AS9120B certificates are valid
  • September 15, 2018 - Only ISO 9001:2015 and ISO 14001:2015 certificates are valid
  • September 15, 2018 - Only IATF16949:2016 certificate is valid
Organizations may recertify to the revised standard(s) at their recertification audit. If that is not possible, upgrade at surveillance, otherwise a special audit will be necessary.

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Automotive

  • IATF 16949
  • Intl. Automotive Task Force
  • BS 25999
  • OHSAS 18001

Medical Devices

  • ISO 13485
  • Product Safety
  • Device Recalls
  • Emergency Situations

Aerospace

  • AS9100
  • AS9110
  • AS9120
  • SAE Technical Standards

Environmental

  • ISO 14001
  • EPA Regulations
  • EMS Tools
  • Emergency Preparedness