The new ISO 13485:2016

The world’s most popular standard for medical device quality management has been revised for the first time since 2003. It has been published on 2016-02-25 and will become applicable as soon as the Certification houses, also known as “Registrars” will be accredited/qualified to certify the Quality Management Systems of medical devices and IVD companies.

Some of the new features of this new edition are:
  • The new edition is applicable across the whole supply chain and seeks to address the entire lifecycle of a medical device
  • More focus and alignment of global regulatory requirements
  • Inclusion of risk management and risk based decision making throughout the quality management system
  • Strengthening of supplier control processes
  • More stringent & clearer requirements for software validation for different applications
As with other standards there is a three year transition period to allow manufacturers to move from their current ISO 13485: 2003 (EN-ISO 13485: 2012) certification to the ISO 13485: 2016 one.

As always Qarad is ready to help you to plan for such a transition in the most effective possible way.


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