ISO 13485:2016 – Transition Timeline

ISO 13485 was revised and released on March 1, 2016. The transition to the new revision of this standard will occur over a three-year period ending on March 1, 2019. This means all companies certified to ISO 13485:2003 will need to conduct an upgrade audit at their regular audit cycle (recertification or surveillance) prior to that date.

As ASR schedules your audits for 2017 and 2018 we will ask about your readiness and timing for the upgrade and a new contract will be issued reflecting the new standard and additional audit time for the upgrade audit.

This new version of ISO 13485 does not align with ISO 9001:2015 and maintains the structure of ISO 9001:2008 with increased emphasis on risk and regulatory requirements. The standard does contain Annexes correlating back to ISO 13485:2003 as well as ISO 9001:2015.

If you have any questions on this transition please contact Tom Droog at 888-891-9002 or This email address is being protected from spambots. You need JavaScript enabled to view it.

Learn more about how we work with our customers from their words (ASR Testimonials).

Transfer your certificate to ASR

We make it easy,
and affordable.

  1. Contact Us
  2. ASR Review
  3. Legal Documents / Approval
  4. Transfer
ASR-Referral-Button

News Delivered to Your Inbox

Standards of Interest:

Latest Poll

How do you train your employees?

Shadowing or Mentoring - 50%
Training Manual - 16.7%
Computer Based or Online Training - 33.3%
None - 0%

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