Hycells Biotechnology Obtains ISO 9001:2015 Quality Management System Certification
Release Date:
2023-06-13 13:15
On June 8, 2023, Shanghai Hycells Biotechnology Co., Ltd. officially obtained the GB/T 19001-2016/ISO 9001:2015 Quality Management System Certification, marking a new milestone in the company’s standardized, regulated, and scientifically managed quality assurance practices.

The ISO 9000 series of standards was developed on the basis of summarizing the quality management practices and experiences of economically advanced countries worldwide. A series of national standards with universality and guiding significance has been formulated. The establishment, improvement, and effective operation of a quality management system require the organization to define the system’s objectives and to identify the processes and resources necessary to achieve those objectives. A quality management system is the core of an organization’s effective quality management activities. In the face of a complex external environment and ever-changing customer requirements, the effective operation of a quality management system requires systematic planning, continuous control, and ongoing improvement of processes, the linkages, combinations, and interactions among them, as well as the acquisition, utilization, and integration of resources—all aimed at meeting the expectations of interested parties and achieving the objectives of the system.
The team at Shanghai Hycells Biotechnology Co., Ltd. has been deeply engaged in the fields of cell therapy and gene therapy for many years. Backed by a highly skilled R&D team and a robust commercial support function, the company relentlessly pursues innovation and excellence. While continuously optimizing product performance, it ensures reliable quality and stable supply, thereby empowering its partners in the biopharmaceutical sector to achieve rapid and sustainable growth. Hycells Biotechnology will continue to refine its quality management system, systematically and effectively advance the scientific and standardized operation of its therapeutic delivery platform, integrate quality standards into every aspect of its operational processes, and further enhance its core competitiveness—working hand-in-hand to contribute to China’s research community and the CGT industry.
About Hycells Biology
Shanghai Hycells Biotechnology Co., Ltd. is an innovative biotech company with many years of deep expertise in cell and gene therapy, primarily providing products and services in these fields. The company’s core business encompasses the collection and application of human immune cells, along with supporting biological reagents. Adhering to the core values of talent-driven excellence, quality first, and innovation as the foundation, the company leverages technological innovation to continuously enhance the quality of clinical bio-sample collection, processing, and application, thereby setting new industry standards for domestic substitution and laying a solid foundation for the development and global advancement of China’s innovative pharmaceuticals.
Hotline: 021-36696819
Email: info@hys-bio.com
Official website: www.hys-bio.com
Address: Room 503, Building 2, No. 999 Jiangyue Road, Minhang District, Shanghai

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