Our Quality System - Elements
- Quality Manual
- Standard Operating Procedures
- Reference material
The ISO 13485 quality system standard is applied in all production related activities and process operations. The quality system describes the flow of the processes so that everything related to customer service, the reliability and efficiency of operations, and environmental protection is defined to meet the requirements of the standard.
We employ Corrective Action and Preventive Action (CAPA) which is a fundamental management tool that is used in every quality system. The company has strong belief that this simple step by step process for completing and documenting corrective or preventive actions results in complete, well documented investigation and solution that will satisfy regulatory requirements and form the basis for an effective continuous improvement plan for the company. The ability to correct existing problems or implementing controls to prevent potential problems is essential for continued customer satisfaction and efficient business practice.