Diagram of ISO 13485:2016 Implementation Process

Download a complimentary checklist (PDF)

This diagram outlines the steps for your ISO 13485:2016 implementation. This easy-to-follow format shows the process at a glance, allowing you to track every stage, including:

  • Establishing the project
  • Identifying customer and other requirements
  • Implementing support procedures
  • Conducting internal audits
  • Certification procedure
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