Quality Management
The only sustainable method to
Lower Total Cost of Ownership
Quality Tips
Quality Impacts Total Cost of Ownership
Goal - Lower Total Cost of Ownership
Summit Imaging's
ISO 13485:2016
Quality Mgmt System
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Decrease equipment failure frequency
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Increase equipment uptime
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Uninterrupted patient care
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Increase Clinical Engineering Efficiency
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Increase revenue
Quality Tips
What healthcare facilities need to know
Quality Certifications
WHY THIS IS IMPORTANT
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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.
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Our QMS governing the repair of Ultrasound Parts and Transducers is ISO 13485:2016 certified resulting in higher quality and reliability.
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Protect safety and performance of products
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Contamination control
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Product quality monitoring and improvement
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Protect patients' health information
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Low product failure rates
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On-time delivery
WHY THIS IS IMPORTANT
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Restriction of Hazardous Substances
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Protect environment from hazardous waste materials
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Ensures repairs performed with proper materials
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Preserves quality and performance of products
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Conforms to international standards required for foreign business
WHY THIS IS IMPORTANT
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Required for component level repairs
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Ensures repairs performed with proper materials
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Repairs are performed in-house
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Control of quality
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Tracebility of repairs performed on medical devices
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Preserves quality and performance of parts repaired
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Qualified repair technicians