Medical Device Supplier Quality Management

Improve Visibility and Collaboration Throughout Your Supply Chain

For medical device manufacturers, having visibility into the critical supply chain processes, starting with the raw material suppliers and vendors through point-of-sale is a major factor to success.  Producing poor products or wrong products that require repair or replacement erodes customer sentiment and impacts customer satisfaction levels negatively.

Sparta Supplier Quality Management

Sparta offers supplier scorecards, supplier qualification best practices, approved supplier list (ASL), and tracking systems for supplier non-conformances and resulting CAPA.  Supplier qualification and vendor tracking increases the efficiency of supplier and vendor selection. It tracks and manages the qualification and approval process for new potential vendors and parts while avoiding redundant evaluations. Vendor records can be made available throughout the enterprise. Supplier qualification is further enhanced by audit management capabilities and reporting that help extend quality and compliance processes to partners.  

Addressing Nonconformance and Risk in Real-time

Sparta helps to ensure that supplier non-conformances are addressed and appropriate actions are taken by tracking and managing all reported instances, subsequent investigations, and any resulting CAPAs in a timely and thorough manner. Efficiency gains are achieved through effective workflow progression and appropriate risk management. 
 
Supplier scorecards offer a real-time view into the health of a supply chain. These scorecards pull information from QMS processes and activities such as new supplier qualification, incoming inspections, non-conformance, SCARs, supplier actions, and audit results. They can also integrate to your ERP data on quantity delivered and on-time delivery statistics. This helps highlight areas of risk in your supply chain so you can make appropriate supplier development, supply usage, and spend decisions. 

Benefits of SQM for Medical Device Manufacturers

  • Facilitates compliance with 21 CFR parts 11, 803 and 820; EN 46001 and 46002; GMP #40 and #63 ordinances and other international standards, including EU GMP Annex 11.
  • Ensures compliance with medical industry and government regulations and ISO 9001, 13485, 13488, 14001, 14791
  • Reduces risks of medical device and healthcare product deviations and other quality incidents by ensuring supplier and vendor non-conformances are addressed before using materials in product.
  • Increases supplier selection efficiency by eliminating redundant supplier evaluations across departments using a standardized, centralized supplier evaluation process.

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