Medical devices: the new updated ISO 13485 standard

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The new version of ISO 13485 has been published. This standard establishes specific guidelines for quality management systems in the medical device industry.

On 1 March, ISO published a new version of ISO 13485, which establishes specific guidelines for quality management systems in the medical device industry. This new standard supersedes the 2003 and 2012 versions.
The publication of the new version marks the start of a three-year transition phase: from 1 March 2018, all audits conducted to check conformity with the standard must be based on the new 2016 version. Any certificates based on the 2003 version will only be valid until 28 February 2019.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. “Such organizations can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device,” states ISO.

No additional audit duration

Note that the updated standard does not feature the HLS structure (High Level Structure), meaning the standard format for drafting new ISO management system standards. The structure of this standard is actually based on ISO 9001:2008 (and not 2015), since the revision process was launched a long time ago. However, there is nothing to prevent organizations from maintaining dual ISO 9001:2015 and ISO 13485:2016 certification, since their requirements are not contradictory. “Migrating from one version to the other does not mean a longer audit. Nevertheless, we can provide specific pre-audit surveys and focus meetings based on the 2016 version during a 2003 audit,” adds Benoît Phuez, Product Manager at AFNOR Certification.

The updated standard does not entail any major modifications to customers’ quality systems. A list of modifications is available in the appendix of the new ISO 13485 standard, including:

  • Harmonization of regulatory requirements
  • Risk management throughout the quality management system
  • Clarification of requirements for design, validation and verification activities
  • Reinforcement of supplier control processes
  • Clarification of requirements for validating software
  • Details for managing customer feedback


Find out more on ISO 13485  
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