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Benefits of ISO 13485

ISO 13485 is recognized by the Global Harmonization Task Force (GHTF) and has become the model QMS standard for the medical industry. ISO 13485 certification provides:

• Global Recognition - ISO 13485 Standard is recognized in major markets around the world
  • United States of America
  • Europe
  • Canada
  • Japan
  • Australia
• Meet legal and regulatory or contractual requirements complaince
• Although not fully harmonized, an ISO 13485 Quality Management System (QMS) is very close to the Food and Drug Administration’s (FDA) QSR standards. (Compare 13485 and FDA QSR)
• Improved product safety

Like ISO 9001, a solid QMS provides:

• Increased Efficiency
• Cost Savings
• More Effective Risk Management
• Increased likelihood of meeting Customer Requirements

"Benefits and Costs of ISO 13485" PowerPoint Presentation

Contains: Outline: Objectives Importance of Standards ISO Summary Getting Organized Implementing Change Benefits Costs A Business Decision

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