ISO 13485:2003 Certification

ISO 13485:2003 Certification

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This is an industry specific management standard specially developed for medial devices manufacturing industry. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.

Systemic Requirements
  • Establish a quality system for medical devices
  • Document your medical device quality system

Management Requirements
  • Support quality
  • Focus on customers
  • Establish a quality policy
  • Perform quality planning
  • Control your quality management system
  • Carry out management reviews

Resource Requirements
  • Provide quality resources
  • Provide quality personnel
  • Provide quality infrastructure
  • Provide quality environment

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.