To well control the product quality, we manage and organize the production in full compliance with the ISO13485:2003 and the Good Manufacturing Practices. We focus on all aspects that may influence the product quality, and consistently follow the strict craft discipline.
1. Strict Purchase Management of the Raw Materials
We adopt the systematic management for the raw materials. When purchasing the important raw materials, we merely choose the qualified manufacturers as our suppliers. Only the materials that have been inspected to be qualified can be put into storage or can be used. Additionally, we regularly evaluate the performance of the suppliers. And the underperformers will be timely abandoned.
2. Control and Inspection of Outsourcing Manufactured Parts
A Quality Assurance Agreement has been signed between the manufacturer and our company. We will inspect the outsourcing manufactured parts, and only the qualified ones that can be put into the warehouse.
3. Advanced Equipment
Those machines will be treated with the regular maintenance. Most of them are high precision machines with high degree of automation. There are more than 200 sets of machines, including DMG five axis processing centers, CHIRON four axis processing centers, Japanese STAR or Switzerland CNC automatic lathes, etc. Besides that, we also have a complete set of inspection and measuring equipment.
4. Highly Skilled and Experienced Staff
40% of the staff are the technicians who have college degrees or above. The operators and inspectors, who are responsible for the special or critical production processes, will receive the pre-service training. They must take the appointment with certificates. Moreover, regular on-the-job training will be conducted for them.
5. Standardized Quality Management
We arrange the production in line with the SFDA Good Manufacturing Practice. The control of the critical production process and special process has been strengthened. The records about the production and inspections will be made, which allows for the traceability.
6. Good Production and Storage Environment.
The fully equipped factory is capacious, clean, and bright. It is built with a 1500 square meters clean room, which has the cleanness of Grade 100,000. In this clean room, we carry out such processes as cleaning and initial packing for the disposable sterile medical devices and orthopedic implants. Good storage conditions are available. The warehouses are rationally arranged. They are separately used for the raw materials, hardware, finished products, etc.
7. Clients Visit
Through visiting clients, we can know their requirements. We will timely analyze and handle the feedback information, and take the relevant steps. The steps will be tracked in time as well.