We recognize that as a Specification Developer and Complaint File Establishment of medical devices we have a special responsibility to produce products that consistently meet or exceed our customers’ expectations for safety and efficacy. We recognize that Aparata Medical’s success cannot be achieved unless our products meet this goal.
We recognize that achieving this goal requires:
1. Management’s commitment to the quality system
2. A framework for establishing and reviewing quality objectives
3. An environment that encourages employee input, participation and initiative to achieve continuous quality improvements
4. Listening to our customers to ensure satisfaction and provide the seeds for the next generation of products
5. Being committed to our quality system and objectives, complying with regulatory requirements, and maintaining the effectiveness of the quality management system
6. Deliver the highest quality product and respond to feedback and concerns in a timely manner to our customers
1. Conduct annual internal audits of the quality system from an external reputable source to detect areas of improvement and non-compliance
2. Maintain involvement from management in decision processes for developed products and quality initiatives at a minimum annually
3. Prioritize innovation by shepherding in new improvements and products to the Aparata Medical product pipeline while maintaining the current portfolio
4. Generate feedback and involvement from all Aparata Medical employees, such as quality system improvements or driving new product initiatives
5. Create action able and obtainable product timelines and projections and stay on schedule and within budget
6. Allocate sufficient resources to continuously improve Aparata Medical’s capabilities and bandwidth to create the highest quality products
7. Produce brand awareness, reputation and distinction through marketing and networking activities
8. Achieve training timeliness and effectiveness from Aparata Medical employees and contractors
