Quality Control

Aim of our quality control Laboratory that entered with its construction of factory is to manufacture produce and supply the highest quality kit for prevent and diagnosis of diseases.

The manufacturing cycle of our diagnostic kit starts from the preparation of raw materials (recombinant antigen, monoclonal/polyclonal antibody for tracer or conjugate) up to each kit component (microplates and tubes, coated with antigens or antibodies and liquid reagents) and final packaging with delivery of the finished product.

Our quality control department, pays special attention, not only to all the raw materials before they go into production, but also to the finished product line, before preceeding to sales. Before they are introduced into the market, all kits undergo rigorous testing for quality control.

Finally, we will do our best for our product to be more accurate and prompt than any other product.

Raw Material QC

Material Inspection and Traceability
  • Warehousing of Raw Materials
  • Coating Material
  • Standard Material
  • Tracer Material and etc...

Half Finished Product QC

Solutions, Tube, Plate QC
  • Coated Tube, Plate Test (Reappearance of Tube, Plate)
  • Fuctions Test of Solutions

Packaging QC

Finished Products
  • Packaging Inspections
  • Test for Final Release

Trace QC

Combination QC
  • Assay test (combination of Tracer, Tube, Standard)

Quality Policy

The Quality policy of Shin Jin Medics Inc. is to identify and meet the needs and expectations of its customers and the requirements of international quality system, ISO9001:1996, ISO13485, Directive 98/97/EC. All employees must do this in an effective and efficient manner, and to achieve, maintain, and improve everall organizational performance and capabilities. Quialiy Guideline is to provide quality and service to meet the needs and expectiations of its customers in an effective and efficient manner as a specialized company based on the strategic focus of customer satisfaction, Superiority, and Specialization in the field of the In Vitro Diagnostic Devices.