During the audit, experts from Huaguang Organization conducted a comprehensive evaluation of Dukang's organizational structure, personnel allocation, technological capabilities, production environment, archival records, training management, equipment and facilities, and gave high praise. Li Bin, General Manager of Dukang Medical, stated: "Dukang always adheres to the concept that 'quality is the lifeline of the enterprise' and integrates 'innovation-driven, craftsmanship quality' into every aspect of the enterprise's quality system".
From cranial nerve rehabilitation to psychiatric rehabilitation, from pediatric rehabilitation to traditional Chinese medicine rehabilitation, home-based rehabilitation, and critical care rehabilitation, every product from Dukang is based on rigorous quality standards. We are committed to providing customers with excellent rehabilitation equipment and comprehensive solutions, continuously pursuing the vision of "Dedicated to Brain Disease Rehabilitation, Empowering Healthy China". We hope that this audit will facilitate the continuous improvement of the quality, work quality control, and management of Dukang Center.
What is ISO9001
ISO9001 is a quality management system established by the International Organization for Standardization. It is currently internationally recognized as the most mature standardized quality system, with the most stringent requirements, the most refined management, and the most comprehensive risk control. More than 750,000 organizations in 161 countries/regions worldwide are using this framework, making it the most widely used international standard globally.
What is ISO13485
ISO13485 is called "Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes" in Chinese. As medical devices are special products used to save lives, prevent and treat diseases, it is insufficient to regulate them solely according to the general requirements of the ISO9000 standard. Therefore, the ISO organization promulgated the ISO13485:1996 version of the standard (YY/T0287 and YY/T0288), which sets specific requirements for the quality management systems of medical device manufacturers and has played a significant role in promoting the quality of medical devices to be safe and effective. In the United States, Canada, and Europe, ISO9001 or ISO13485 are commonly used as the requirements for quality assurance systems, and the establishment of medical device quality assurance systems is based on these standards.
Dukang Medical firmly believes that adhering to high-quality development is the cornerstone of corporate growth and the guarantee of customer trust. We will take this audit as an opportunity to continuously improve our management system, persistently innovate and upgrade, provide customers with higher-quality rehabilitation medical products and services, and contribute Dukang's strength to promoting the development of the rehabilitation industry!
