Following rigorous review by the internationally renowned certification body SGS (SGS-CSTC Standards Technical Services Co., Ltd.), Tianjin Baikang Hexin Medical Laboratory Co., Ltd.—the independently operated clinical trial window under ProteinT—successfully obtained the ISO 9001:2015 Quality Management System certificate on July 13, 2023. The certification scope covers medical and pathological testing services in clinical cellular and molecular genetics.
Since its establishment, Baikang Hexin has taken the ISO 9001:2015 Quality Management System as its standard, continuously revising and improving system documents, optimizing workflows, and continuously enhancing the level and quality of ISO system management. During this certification audit, the expert panel conducted a comprehensive review of the laboratory's quality policy, quality objectives, organizational context, business processes, and risk response measures through interviews with relevant persons in charge, random sampling, review of records, and on-site inspection, and fully recognized its overall operation.
Quality management is the foundation of a company's development and growth. Obtaining the ISO 9001:2015 Quality Management System certificate marks that the Company has reached international standards in the integration of its various management systems, and that quality management has entered a new stage of being systematic, scientific, standardized, and institutionalized—of important value and significance for comprehensively and high-quality improving quality management work. ProteinT will continue to fully implement the requirements of the ISO 9001 quality management system standard, strictly enforce relevant rules and regulations, and apply the quality philosophy, basic principles, and systematic thinking it advocates to continuously improve the effectiveness of system operation and provide clinicians and patients with higher-quality products and services.
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About Tianjin Baikang Hexin Medical Laboratory Co., Ltd.
Tianjin Baikang Hexin Medical Laboratory Co., Ltd. is the independently operated clinical trial window under ProteinT. It is a national high-tech enterprise and a for-profit medical institution approved by the Health Commission, equipped with an Illumina NextSeq 500 sequencing system, Thermo Fisher Q-Exactive+/HF and AB SCIEX 4500 mass spectrometry systems, and a Bruker Avance III IVDr nuclear magnetic resonance spectrometer platform, with a total value of more than RMB 90 million. It has cumulatively served more than 100 tertiary hospitals and research institutions, with a sample volume of over 100,000 cases.
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About ISO 9001 Certification
The ISO 9001 quality management system is one of the most influential standards issued by the International Organization for Standardization (ISO). It is by far the most mature management system and standard in the world and is hailed as a "passport to the international market." ISO 9001 sets standards not only for the quality management system but also for the overall management system. It helps organizations of all kinds succeed through improved customer satisfaction, enhanced employee motivation, and continuous improvement.
