Keyto Obtains ISO 13485:2016 Certification

Recently, Keyto Fluid successfully passed the ISO 13485 medical device quality management system audit and met the ISO 13485:2016 medical device management system standards within the design and production scope of fluid control components and medical devices.


ISO 13485 is the most authoritative international standard for quality management systems designed for the medical device industry, developed by the International Organization for Standardization (ISO).


Through this six-month comprehensive system audit, we have strengthened the standardization and training of keyto in various aspects, including research and development, production, procurement, quality, sales, and safety laws and regulations. Striving for excellence, identifying and filling gaps, and achieving the ultimate control of the company's product lifecycle risk management process means that our self-developed high-end component series product quality management has reached a higher level.


At the beginning of its establishment, the company consistently adhered to the quality policy of "striving for excellence and meeting customer needs" and maintained the same frequency with customers. Since the ISO 13485 audit kickoff meeting of the company, the internal implementation of the principle of "everyone has responsibilities, everything is tracked, the process is supervised, and defects are improved" has received strong support and cooperation from various departments, forming a department head as the main driving force to drive the participation and training of all employees in the company.


After the training, a third-party on-site audit was conducted. The audit team conducted a comprehensive, meticulous, and strict inspection of our company's quality system through data verification, on-site verification, personnel questioning, and providing practical evidence. The audit team put forward many valuable suggestions during the on-site audit process. Finally, it emphasized the need for the company to translate laws and regulations into internal requirements to strictly implement and establish a document system that complies with medical devices. At the same time, the audit team also highly recognized and fully affirmed the company's current quality control measures.


In the future, our company will strictly follow the ISO 13485:2016 quality management system standard requirements and continuously improve our quality management system and technical level based on refined management. To provide global customers with higher quality products and liquid solution services, constantly creating value for customers and society.