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Quality management

Industry-leading products and services

Principles for quality management

  • Putting quality first

  • Being customer-centric

  • Striving for excellence

  • Innovating continuously

The principles
The quality management pyramid

We adopt a four-level pyramid for preparing a quality management document, to ensure that the document is manageable and executable.

  • Level-by-level management: Level 1 is the principle, the goal, and the manual for quality management. Level 2 is the procedural document. Level 3 lists protocols and requirements such as the management rules, the standard operating procedure (SOP), the inspection procedure, and the technical document. Level 4 provides forms and records.

  • Level-by-level training: We provide level-by-level training, to ensure the enforcement of the quality management system and the management of our labs.

  • Real-time & traceable: The content of the document can be increased along with the increase of our products and services, to ensure that our production processes are standard-based, effective, and traceable.

The certification of our quality management system

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    ISO 13485:2016

    This system is for the production of IVD reagents and complementary reagents used in  immunochemistry (or immunology).

    We adopt the standard for the production and validation of medical devices to dramatically increase the compatibility of our raw materials.

    2024

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    ISO 9001:2015

    This system is for the development and production of antigens, antibodies and their biomarkers used for IVD and research purposes.

    2024

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    ISO 14001:2015

    This system is also for the development and production of antigens, antibodies, and their biomarkers used for IVD and research purposes.

    2024

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    ISO 45001:2018

    This is an occupational health and safety (OH&S) management system.

    2024

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    The advanced certification for Authorized Economic Operators (AEOs)

    This is the advanced certification of China Customs for economic operators in recognition of their reputation and reliability.