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Compare ISO 9001 and ISO 13485

ISO 13485 differs from 9001 in several areas critical to the Medical Device industry:

  • From QMS Continuous Improvement to maintaining the effectiveness (since it must meet certain requirements as a medical device)
  • Focus on meeting regulatory requirements versus increasing customer satisfaction.
  • Additional documentation requirements (depending on product) including
    • Regulatory requirements
    • Health, cleanliness, sterilization
    • Risk management
    • Purchased material for traceability
    • Labeling and packaging
    • etc.
  • PDF Compare of the requirements of ISO 9001 and ISO 13485

Need help migrating from ISO 9001 to ISO 13485?

This tutorial Comparing ISO 9001 to 13485 compares ISO 13485 to ISO 9001, and outlines their:

ISO 13485 vs 13485
  • Similarities
  • Differences
  • Comparison of the two written standards
  • And more…

Compare ISO 13485 to FDA QSR 820

View ISO 9001 to ISO 13485 Products