Industry-leading products and services
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We adopt an industry-leading quality management system for IVD raw materials.
We are the first ISO 9001:2015-certified Chinese IVD company.
We are among a small number of IVD raw material manufacturers certified by the ISO13485: 2016 system for the medical device industry.
We adopt an industry-leading quality management system for IVD raw materials.
We are the first ISO 9001:2015-certified Chinese IVD company.
We are among a small number of IVD raw material manufacturers certified by the ISO13485: 2016 system for the medical device industry.
We adopt a quality management principle that follows high standards and strict requirements. We are committed to providing industry-leading products and services.
High quality standards -
We are rigorous in selecting suppliers, adopting high standards for them, strictly controlling production processes, and strictly following operational rules and QA standards.
We adopt high standards for every detailed aspect, striving to create a great experience for customers.
We are constantly optimizing our quality management system, to improve quality and productivity.
We are rigorous in selecting suppliers, adopting high standards for them, strictly controlling production processes, and strictly following operational rules and QA standards.
We adopt high standards for every detailed aspect, striving to create a great experience for customers.
We are constantly optimizing our quality management system, to improve quality and productivity.
We adopt strict quality control throughout our operations from product design and development to the purchase of raw materials, the manufacturing and delivery of products.
Strict quality control -
Listening to customers.
Preventing & solving problems for them.
Proactively upgrading products & services.
Listening to customers.
Preventing & solving problems for them.
Proactively upgrading products & services.
Our technical support team addresses every request from our customers promptly and provides professional solutions for them.
Prompt response to customers
Principles for quality management
Putting quality first
Being customer-centric
Striving for excellence
Innovating continuously
We adopt a four-level pyramid for preparing a quality management document, to ensure that the document is manageable and executable.
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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.
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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.
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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.