Free matrix (PDF)

ISO 13485:2003 vs. ISO 13485:2016 Matrix

Compare the requirements of ISO 13485:2003 and ISO 13485:2016 side by side.

This matrix helps you:

  • Learn which changes to prepare for.
  • Identify similar parts of both revisions.
  • Understand how to transition to the new revision.

Prepared by Advisera experts to help you get started with ISO 13485.

ISO 13485:2003 vs. ISO 13485:2016 Matrix

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