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.

This International Standard can also be used by suppliers or external parties that provide product, including quality management system related services to such organizations.

The scope of ISO13485:2016 has been expanded to include all stakeholders in the medical device industry. (ex. Manufacturers, importers, & distributors)

ISO 13485:2016 Requires the application of a risk based approach to the control of the appropriate processes needed for the quality management system.

ISO13485:2016 emphasizes organizations that meet all applicable regulatory requirements.

Benefits of ISO 13485

  • Enhances recognition and financial benefits of an organization
  • Helps an organization meet legal, regulatory, contractual and marketing requirements
  • Has a lot in common with the Food and Drug Administration’s (FDA) QSR standards
  • Enables an organization to align or integrate its own quality management system with related management system requirements.
  • Decreases production time which leads to faster cycle times
  • Leads to less waste and fewer customer returns
  • Puts great emphasis on customer focus which leads to higher customer satisfaction

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