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We believe quality assurance is the key to win good reputation. So we take product quality as the orientation of our work. In order to assure the stable product quality, we:
- Keep the sustained and effective operation of quality management system in accordance with the requirements of ISO13485, QSR21 CFR Part 820.
- Audit the manufacturing facilities strictly in accordance with quality management system before project starts.
- Only choose the manufacturing facilities which has passed our strict audit for cooperation.
- Develop inspection criteria on the basis of applicable international standards for the products' destination market. - Before the production, verify the key and special processes of products, such as injection, extrusion,blowing, package sealing, sterilization, etc., to assure the stable quality during the mass production of products.
- Conduct quality tracking during the production process of products.
- Conduct full inspection to every batch of products in line with associated specifications before final release. - Assure each batch of products have traceable production and test records.
- Conduct annual quality system aduit on suppliers and list those passed the annual audit into the qualified supplier list.
- Establish a strong and experienced QA-QC team.
D-Tec commits itself to provide quality, safe and effective medical devices for customers.