Bally Ribbon Mills is proud to announce its certification to ISO 13485. For over 50 years, Bally Ribbon Mills has been supplying the highest quality medical products to its customers. Now we can certify those products to this rigorous international standard that governs the design and manufacture of medical devices and ensures that Bally Ribbon Mills:
- manufactures products in a controlled work environment to ensure product safety
- focuses on risk management activities and design control activities during product development
- follows specific requirements for inspection and traceability for implantable devices
- follows specific requirements for verification of the effectiveness of corrective and preventive actions
Our facility includes advanced weaving systems, yarn preparation, and inspection areas for the production of fabric to the most stringent requirements. Environmental sampling, data collection, storage, and alarms ensure complete environmental monitoring and redundancies.
Quality efforts also include an emphasis on continuous improvement and defect prevention. Tools include but are not limited to Management and Feasibility Reviews, AS9102 First Articles, FMEA’s, Control Plans, IQ-OQ-PQ’s, Process/Product Validation and Lean/Six Sigma best practices.
Visit our Medical page for more information and to download our ISO 13485 certification for your records.