At Karos Health we are committed to providing our partners and customers with the highest quality products in compliance with ISO standards, national health authorities’ requirements and industry standards. We believe that operational excellence comes from process innovation that directly contributes to product quality. To fulfill our quality objectives we have implemented a Quality Management System in accordance to ISO 13485:2003 and the Canadian Medical Device Conformity Assessment System (CMDCAS).
ISO 13485 represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. It focuses on risk management activities during product development, and guides specific requirements for verification of effectiveness of corrective and preventive actions. It demonstrates a commitment from management for quality throughout the product development life-cycle and the product’s lifespan with customers.
Karos’ certified Quality Management System by Intertek is practical but comprehensive and is supported by the following principles:
- On-going dialog with our customers, prospects, and partners to understand their needs
- Ensuring that team members are knowledgeable about our capabilities in order to design effective products for our customers
- Ensuring compliance with regulatory requirements in target markets
- Effective monitoring and control of product development and customer support processes
- Continually reviewing and maintaining the effectiveness of our quality management system
- Active participation of team members in quality improvement activities through teamwork and focused task groups
- Achieve and maintain a level of quality which enhances our reputation with our customers and target markets
Ultimately the effectiveness of our Quality Management System is measured by our ability to successfully deliver products that meet our customer’s specific requirements and market needs.