May 23, 2016

The new ISO 13485:2016 standard has been published in March 2016

The ISO 13485 standard “Quality management systems. Requirements for regulatory purposes”  is used globally by medical device manufacturers as a regulatory pathway to bring their medical devices onto some of largest worlds markets – Europe, Australia, Japan,  Canada, South Korea and Brazil, etc.

This standard provides the quality system architecture to demonstrate their compliance to strict regulatory requirements in these regions   ISO_english_logo_icon.svg

Transition period                            

During the transition (co-existence) period, ISO 13485:2016 will co-exist with ISO13485:2003.

The transition period will last until February, 2019, at which point the 2003 version will be withdrawn

Some of the key changes to ISO 13485 include:

  • Inclusion of risk management across all process activities
  • Additional requirements for design activities
  • Additional requirements for process validation and verification activities
  • Improvement in supplier control processes using a risk-based approach
  • Increased emphasis on feedback methodologies
  • Explicit requirements for quality system software
  • For outsourced processes control based on risk and ability to meet specifications and requirements
  • Detailed requirements in Technical file
  • Management Review frequency determination

If you would like to learn about all these updates and changes be sure to book a place on our 1 day course scheduled for 10th October 2016

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