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.

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