ISO 13485 medical pills industryMedical Device Manufacturing Quality Management System - the ISO 13485 requirements.

ASR is an accredited ISO 13485 registrar so you can take your medical device manufacturing global.  ISO 13485 is a QMS standard, that was derived from the ISO 9000 quality management standard series. ISO 13485 reflects the ISO 9000 process-based model for a regulated medical device manufacturer.

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.

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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.

ISO 13485

What is ISO 13485?

ISO 13485 Medical Device Quality StandardsThis standard represents the quality and system requirements that medical device manufacturers must incorporate into their management systems.

Like any ISO certification, medical device manufacturers wanting 13485 certification must first learn the requirements of customers and any regulatory agencies, as well as how to implement an ISO 13485 quality management system.

ISO 13485:2015 – Moving to ISO 13485:2016

Standard writers for ISO 13485 released this medical device standard earlier this year using ISO 9001:2008 with its base of 8 sections, but it now appears it has been sent back for alignment with the new structure of ISO 9001:2015.

ISO 13485:2015 was rewritten using ISO 13485:2003 as they had started revision work prior to the introduction of the high level (10 sections) structure.  Revisions were made using the 2008 version of ISO 9001 plus added medical device language.  The plan was to adjust ISO 13485:2015 to the high level structure at some future date.   This rewritten 2015 standard was released in March 2016.  

Revision writers have returned to the drawing board with the possibility that a rewritten ISO 13485:2016 document could be released sometime this year.  Third party registrars may be able to start the ANAB accreditation process in late 2016.  Registration and upgrades to the 2016 version of ISO 13485 may begin in 2017.

ASR will continue to provide clients with updates regarding ISO 13485:2016.

Revised Medical Device Standard Released Soon

ISO 13485 medical pills industry factor 31Expect a first quarter release of ISO 13485 for medical device manufacturers. Voting on the Final Discussion version of ISO 13485 concluded December 29, 2015 and now the wait is on for the 2016 revision to be officially released.

ISO 13485 was last revised in 2003. The latest update of ISO 13485 is to the 2008 version of ISO 9001 NOT the 2015 version. Structurally, the updated ISO 13485 uses 8 sections rather than the 10 sections found in ISO 9001:2015.

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Automotive

  • IATF 16949
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  • BS 25999
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Medical Devices

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

Aerospace

  • AS9100
  • AS9110
  • AS9120
  • SAE Technical Standards

Environmental

  • ISO 14001
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