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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.
• 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:

Similarities Differences Comparison of the two written standards And more…

Compare ISO 13485 to FDA QSR 820