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Documented Quality System
At Scion Cardio-Vascular, we conform to documented quality systems to produce quality products and services. Scion Cardio-Vascular conforms to ISO 13485:2003 and Quality System Regulation 21CFR820. Our quality system is documented in our Quality Manual:
- Standard operating procedures for documentation.
- Standard operating procedures for manufacturing.
- Standard operating procedures for raw materials.
- Standard operating procedures for nonconforming product and materials.
We partner with our customer to define our quality system to meet their needs, wants and satisfaction.
Quality Policy
Our mission at Scion Cardio-Vascular is to be recognized as a leading innovator and provider of medical devices.
As evidence of our commitment to quality, Scion will establish measurable goals aligned with our objectives and customers expectations, Scion will demonstrate compliance with applicable regulatory requirements, while continually measuring our ability to maintain and improve the effectiveness of our Quality Management System.