Hand drawing of Quality Management Diagram

Transitioning Your Quality System – ISO13485:2016

ISO 13485:2016 was released earlier this year and, to remain certified, companies will have to transition by 2019.  These next few years will be quite interesting in the device world between this release, the EU in vitro diagnostic and medical device regulations coming, updates to other standards expected, and the continuous flow of new guidance documents.

The basic tenets of 13485 did not change.  The update does provide better alignment with the US FDA regulation, 21 CFR 820 in that there is now an explicit requirement for a design and development file, a Medical Device File, and an explicit Design Transfer process.

There are a few “themes” to be aware of:

  • Wider scope for validation of non-product software used in implementation of the QMS,
  • Expectations for documented and qualified infrastructure and work environment,
  • Increased emphasis on using (where appropriate) justified statistical techniques,
  • Recognition of growing “inter-connectedness” of devices and requirements to perform Verification & Validation (V&V) in the intended use configuration and environment (connected to or interfacing with other devices, as intended),
  • Increased controls for purchasing and management of suppliers, especially for outsourced processes, and
  • A general shift towards use of risk management to appropriately scope the level of controls.

The ISO folks published “Annex SL” in 2015, which was intended to be the standard framework for Management System Standards.  ISO 9001 adopted this framework in the 2015 release but the 13485 committee chose to not align.  Some of the aspects of Risk Based Thinking were adopted, but not to the extent of what’s in 9001:2015.  All this poses some challenges to companies holding certifications to both standards but they are not insurmountable.

In total, aligning with the 13485:2016 update should be approached as being beneficial to companies.  Change is often painful but this particular change provides an opportunity for overall improvement.

Contact a Realtime expert for help with this change or navigation through the compliance pathway, including 21CFR 820, IEC 60601-1, ISO 14971, IEC 62304, IEC 62366, and numerous others.

About Us

The Realtime Group has deep Medical Product Development experience, including standards compliance to ISO 13485.  We have a shared passion for time-to-market and product compliance. Visit us at www.TheRealtimeGroup.com or call us at 972-985-9100 to see how we can help you with your product development and testing!

Don Hurd, VP of Quality and Validation Services