Quality Management 

The only sustainable method to

Lower Total Cost of Ownership

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Quality Tips

Quality Impacts Total Cost of Ownership

Goal - Lower Total Cost of Ownership

Summit Imaging's

ISO 13485:2016 

Quality Mgmt System

  • Decrease equipment failure frequency

  • Increase equipment uptime

  • Uninterrupted patient care

  • Increase Clinical Engineering Efficiency

  • Increase revenue

Quality Tips

 

What healthcare facilities need to know

 

Quality Certifications

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WHY THIS IS IMPORTANT

  • ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) demonstrating an organization’s ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

  • Our QMS governing the repair of Ultrasound Parts and Transducers is ISO 13485:2016 certified resulting in higher quality and reliability.

  • Protect safety and performance of products

  • Contamination control

  • Product quality monitoring and improvement

  • Protect patients' health information

  • Low product failure rates

  • On-time delivery

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WHY THIS IS IMPORTANT

  • Restriction of Hazardous Substances

  • Protect environment from hazardous waste materials

  • Ensures repairs performed with proper materials

  • Preserves quality and performance of products

  • Conforms to  international standards required for foreign business

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WHY THIS IS IMPORTANT

  • Required for component level repairs

  • Ensures repairs performed with proper materials

  • Repairs are performed in-house

  • Control of quality

  • Tracebility of repairs performed on medical devices

  • Preserves quality and performance of parts repaired

  • Qualified repair technicians

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