Quality Assurance

Quality Assurance

Minkang people have firmly established the quality tenet of "survival by quality, reputation by service, benefit by management, and glory by education". The company has established a quality system in strict accordance with ISO9001, ISO13485, Medical Device Production Quality Management Code and the MDR directive of the European Union, and has passed the certification of the certification bodies recognized by the European Union and SFDA. In August 2011, it became a model enterprise of medical device collection in Hunan Province, It passed the examination and acceptance of the medical device production quality management standard organized by the State Food and Drug Administration at one time. The company's product quality testing center has 350 ㎡, 20 full-time inspectors with certificates, 1215 sets of various testing equipment and instruments, and more than 20 middle and senior technicians.

In terms of quality control: strictly control the incoming inspection. Each batch of raw materials or outsourced materials must be inspected in accordance with the Incoming Inspection Specification, and all unqualified materials will be rejected. Strictly control the quality of semi-finished products in the production process in accordance with the Process Inspection Specification, establish the quality concept that the next process is the customer's quality, and ensure that unqualified parts or semi-finished products never flow into the next process; The products must be inspected in strict accordance with the Finished Product Delivery Inspection Specification before leaving the factory. Only after all items are tested to be qualified and signed by the person in charge of quality can they leave the factory and be delivered.