Huaren Medical has strong R & D strength and a complete set of scientific and effective management methods, in line with the enterprise spirit of "fine technology, strong quality, carry health", adhering to the service concept of "customer problems are our subjects", with high enthusiasm, scientific methods and careful and meticulous working attitude to ensure the quality of products.
In accordance with the ISO9001:2008 quality assurance and quality management standards issued by the International Organization for Standardization, the company has established a quality management system in combination with the actual situation of the company, and has passed the ISO9001:2008 quality management system certification. At the same time, the production of our products meets the new GMP standards, and the production and quality management process can achieve the purpose of "anti-pollution, anti-confusion, anti-error and anti-cross-contamination", and take "quality * life" as the company's quality concept.
Implement a three-level quality management system, namely team level, workshop level and company level quality management. The company has an independent quality management organization, namely the quality management department, which is responsible for company-level quality management. The proportion of quality management department personnel in the total number of the company is not less than 10%, all of them have college degree or above, major in medicine, biology, polymer materials and chemistry and chemical engineering; All personnel have undergone GMP, pharmaceutical packaging materials, medical equipment and microbiology knowledge training and passed the assessment to work, which can meet the needs of the company's product quality assurance. The quality management department has on-site QA personnel to control all aspects that affect product quality in the production process to ensure that product quality meets the requirements of quality standards; At the same time, there are special personnel responsible for verification, deviation management, change management, non-conforming product management, corrective and preventive measures management, complaint handling, etc., strictly in accordance with the new version of GMP standards to ensure the normal operation of the system; QC personnel are responsible for sampling and inspecting each batch of products and issuing inspection reports. All products of the company are built with quality standards higher than the national standard to ensure that the product quality is not lower than the requirements of the national standard. The company's inspection equipment is complete and regularly calibrated, which can fully meet the needs of product inspection. The final release of the product is the responsibility of a special person, who has professional knowledge of pharmaceutical packaging materials and medical devices and is appointed by the general manager to ensure that the released products meet the requirements of quality standards.
The quality management system covers a series of links such as R&D, procurement, production, warehousing and sales to ensure that the listed products can meet the needs of customers and the market.