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SO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. It is a process approach model based on the widely accepted ISO 9001 Standard.

The objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system. Consequently ISO 13485:2003 provides a sound platform for compliance to national regulatory requirements including EU CE Mark Medical Device Directives and FDA Quality System regulation.

Benefits

The implementation of this standard benefits the organization with

  1. Meet regulatory requirements
  2. Demonstrate that you produce safer and more effective medical devices
  3. Increased Efficiency
  4. Cost Savings
  5. More Effective Risk Management and Quality Assurance
  6. Improved ability to respond to Customer Requirements
  7. Meet customer expectations
  8. Help monitor the effectiveness of your supply chain