Saturday, 6 August 2011


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.
  • 9001&13485 Compare of the requirements of ISO 9001 and 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


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