ISO 13485 Transition Deadline March 2019

Medical device manufacturers certified to ISO 13485:2003 will need to transition to a revised ISO 13485 by March 2019. The updated standard, released in March 2016, was written based on ISO 9001:2008 not the 2015 version of ISO 9001.

Transition audits to ISO 13485:2016 begin as certification bodies update their accreditation and auditors complete training.

Contact ASR if there are questions concerning the transition process to the newly revised ISO 13485.

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