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ISO 13485 – Change in the Medical Device Standard

Medical Device Standard Updated – The ISO 13485 Change (2016)

The ISO 13485 changes appeared in 2016 with the update to the Standard. There are now some differences in the approach for implementation of this Standard. With the ongoing reviewing and updating of all the Management Standards, it is interesting to note that ISO 13485 is an exception. In particular there are some significant departures from ISO 9001.

Notable differences in emphasis

When we look at these differences there are some clear points. Specifically,

  • ISO 13485 is a harmonised standard in the EU. Certification is needed as part of achieving CE Mark or UKCA Logo for medical devices.
  • The ISO 13485 change follows the previous Standard (and ISO 9001: 2008) Index layout. This is in-spite of ISO specifying that all new or revised Management Standards in 2013 would comply to the new Annex SL format as used in ISO 9001: 2015 and ISO 14001: 2015
  • All the ISO 9001-derived management Standards had the core requirement of complying with Customer Expectations. ISO 13485, the emphasis has changed to Regulatory compliance.
  • Risk has been extended throughout the Standard.
  • Compliance is the core requirement, unlike ISO 9001, where Improvement is more important.

The ISO 13485 change has a critical impact in the medical devices industry because of the potential for human harm and associated higher risk levels.

I sometimes wish that people would put a little more emphasis upon the observance of the law than they do upon its enforcement.

~ Calvin Coolidge

Medical devices compliAnce – change is good…

Of course, this change of emphasis should not unduly worry the company management. In the Medical Devices industries this has been a consistent theme in the history of the industry anyway. So, this change of emphasis reflects the greater regulatory control which the industry works within. On the other hand, it make your sensitivity to the risks and possible regulatory responses more overt for your management process. That is a good thing, as it helps your management focus to be right at the heart of a well organised response to regulation.

CHARTER4 can help with ISO 13485 change

As a company we have a clear focus on the core needs of ISO Standards. The change of emphasis in this case is a worthwhile endeavour. We have a range of strategies ready to help you make changes to your system that will develop your business at the same time. Remember, we aim to help you improve, not just comply.

If you have concerns over the changes, or seek advice with respect to your ISO Project, CHARTER4 is able to help. In fact, we can help you implement a new ISO Standards Project as well as give you advice on an existing Certification or Management System. If you would like to know more about how we can help you, please click on one of the buttons below. We would be pleased to advise you and help your business move forward.

Certification with Charter 4 – the Business Benefits
  • Improve, rather than just comply.
  • Full service and ongoing support to compliment your resources.
  • Build on your Processes & Systems (no standard templates).
  • Help defining your Best Practice.
  • Certification by independent UKAS accredited Assessors.
  • 100% Success & guaranteed support until Certification.
  • Help to get Government Grant (when available).
  • Flexible support to complement your resources.
CHARTER4 – Partners you with the experience and insight to help you grow using management Standards. We will help you improve your business, rather than just comply with the Standards.
Charter4 - We partner with you to help you grow using management Standards. [Article Name: The Biggest Mistakes with ISO 9001]