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R&D Certification and Status

Based on accurate quality control and thorough analysis,
It contributes to the improvement of public health by producing and supplying high-quality diagnostic reagent products

Accurate quality control and thorough analysis

Today, the medical environment is rapidly changing, and the need for quality management is increasing due to the Ministry of Health and Welfare's annual comprehensive adult disease screening, medical institution service evaluation to induce competition, and hospital standardization test as an educational hospital.

To listen to and meet the changing needs of patients and to continue to improve and improve the service of the entire testing system beyond the reliability of the old simple statistical data test results, new theories and practical techniques should be sought. In this reality, the company aims to contribute to improving public health by producing and supplying high-quality diagnostic reagent products based on accurate quality management and thorough analysis using TQM.

Quality Control

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 proceeding 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.

  • Step 1 Raw Material QC

    Material Inspection and Traceability

    • Warehousing of Raw Materials
    • Coating Material
    • Standard Material
    • Tracer Material and etc.
  • Step 2 Half Finished Product QC

    Solutions, Tube, Plate QC

    • Characteristic test after production of basic undiluted solution
    • Product undiluted solution QC
    • Characteristic inspection
    • Civilianity, specificity, and reproducibility evaluation of products to be shipped
  • Step 3 Packaging QC

    Finished Products

    • Packaging Inspections & Test for Final Release
  • Step 4 Combination 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 the 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 overall organizational performance and capabilities. Quality Guideline is to provide quality and service to meet the needs and expectations 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.

  • Technology Innovation Small and Medium Enterprise (Inno-biz) Certificate

  • Certificate of Compliance with In vitro Diagnostic Medical Device Manufacturing and Quality Control Standards

  • Venture Enterprise Confirmation

  • EC Certificae

  • ISO 13485 Certificate

  • IVD NOTIFICATION Certificate

  • E.A.R(COVID-19) Certificate

  • E.A.R Certificate