It Has Finally Arrived! The ISO 13485:2016 - What now?

9 March, 2016

With the publication of the international standard ISO 13485:2016 in March 2016, the latest EN ISO 13485:2016 was published as well. The European version is not a harmonized standard yet in relation to the Medical Devices Directives though. The German version - DIN EN ISO 13485 - will be published in the course of this year. The validity of the EN ISO 13485:2012 ends on 31st of March 2019. Commencing March 2016, companies have approximately three years left for their quality management system to be adapted with the new legislative requirements of EN ISO 13485:2016.

The main changes to EN ISO 13485:2016 are

  • Section 3 (Terms): new vocabulary is introduced, the section was revised
  • Section 7.3 (Design and Development): has been significantly extended
  • The risk management has been included throughout the processes of the quality management system
  • The implementation of the requirements of the medical device directives was taken into account at a greater extent
  • Additional requirements in relation to the activities of the verification and validation
  • Extended supplier monitoring processes
  • Increased focus on feedback mechanisms

Conclusion

The latest version of the EN ISO 13485 has not experienced a huge revolution in comparison to its predecessor. However, many requirements are more specified which should the user to get a better understanding of this standard.

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