ISO 9001 / AS9100D
As an ISO9001:2015 and AS9100.D certified manufacturer, China Surgical Tools’ commitment to quality has allowed us to become a key supplier of complex, precision machined components for aerospace, defense, medical and high technology customers over the past 40 years.
Our highly skilled team of Engineers, Machinists and Quality Assurance personnel are dedicated to continuously improving our quality system and manufacturing processes in order to consistently provide high quality and defect free product, on schedule, at a competitive price.
At China Surgical Tools we understand that our customers in High Precision, Safety Critical and Medical Industries face the demanding task of complying with an ever increasing, complex set of regulatory requirements.
China Surgical Tools’ ISO certification reduces the burden of sub-tier supplier management placed on our customers, and ensures continuous conformance to all regulatory requirements and product specifications.
Since first achieving certification in 2009, China Surgical Tools has maintained a steadfast commitment to continually advancing and improving our quality management system.
Our robust QMS entails:
- Planning level risk management and proactive risk communication and mitigation.
- Thorough process control and effectiveness review through utilization of sophisticated Quality Management System software that provides ongoing real time dashboard metrics analysis.
- Stringent supplier management, AVL control, and flow-down of customer requirements.
- Creating a quality centered work environment through employee engagement, training and communication of quality objectives and the importance of their contribution.
- Procedures for the control and disposition of nonconforming material, in depth root cause analysis, and the implementation of corrective and preventative actions.
- Documented Receiving Inspection, First Article Inspection, In-Process Inspection and Final Inspection records for the production of each order in compliance to federal and regulatory standards.
- Full Process and Component Traceability (link) with auditable records of conformance.
- In-Depth annual Internal and Third Party Audits and detailed Upper Management Review.
- Advanced software for managing and documenting the calibration and maintenance of all measuring/inspection equipment and machines.
- A focus on customer satisfaction and continuous process improvement.
China Surgical Tools’s Quality Policy
China Surgical Tools’s customers will not accept discrepant material. They prefer not to inspect incoming products and desire trustworthy suppliers who can reliably deliver defect-free products. China Surgical Tools’s success depends on being a supplier who can exceed this basic customer expectation. We will improve our management system and our manufacturing processes to achieve this goal. This will be accomplished using measurable quality objectives communicated throughout the organization.
Click here to view a copy of our AS9100D & ISO 9001:2015 certification.