Quality is as important to us as it is to our customers and their patients
Our experienced team works with the customer regarding the technical specifications of each product. In alignment with ISO quality management standards, Span Link commits to our customers that all products are manufactured in compliance with all applicable technical specifications and regulatory requirements. Tours of our manufacturing facilities can be scheduled.
Span Link applies a risk-based approach to the control of the appropriate processes needed for the Quality Management System. We recognize the importance of data management and document control. Records are maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Our quality experts oversee a regular schedule of internal and external audits. The audit process contributes to continuous improvement of the Quality Management System.
Span Link works with the customer to:
- Determine criteria and methods needed to ensure the control of these processes are effective
- Ensure the availability of resources and information necessary to support the operation and monitoring of processes
- Implement actions to achieve planned results and maintain the effectiveness of these processes
- Monitor, measure and analyze processes
- Establish and maintain records needed to demonstrate conformance to the international standard ISO13485:2016 and compliance with applicable regulatory requirements
