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To well control the product quality, we manage and organize the production in full compliance with the ISO13485 and the Good Manufacturing Practices. We focus on all aspects that may influence the product quality, and consistently follow the strict craft discipline.
Strict Purchase Management of the Raw Materials
We adopt the systematic management for the raw materials. Only the materials that have been inspected to be qualified can be put into storage or can be used. Additionally, we regularly evaluate the quality of raw materials.
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 production.
Highly Skilled and Experienced Staff
40% of the staff are the technicians. 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.
Standardized Quality Management
We arrange the production in line with the ISO-13485 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.
Good Production and Storage Environment.
We carry out such processes as cleaning and initial packing for the disposable sterile medical instruments and surgical instruments. Good storage conditions are available. The stockroom are rationally arranged. They are separately used for the raw materials, semi filed and finished products, etc.