Good News | Shenzhen Cell Valley Achieves ISO 9001:2015 Quality Management System Certification

On July 11, 2025, following a rigorous audit by the globally recognized certification body SGS, Shenzhen Cell Valley Biomedicine Co., Ltd. was officially awarded the ISO 9001:2015 Quality Management System Certificate. The certification covers the production and technical services for both genetically modified and non-genetically modified cells.

Issued by the International Organization for Standardization (ISO), the ISO 9001 standard is one of the world’s most authoritative management frameworks. It employs a systematic approach to enforce strict protocols across all stages of R&D, production, and service delivery, ensuring that products and services consistently meet customer expectations and align with international best practices.

Since its founding in 2021, Shenzhen Cell Valley has been driven by a mission to overcome critical bottlenecks in Cell and Gene Therapy (CGT). The company has built a comprehensive CRO/CDMO service ecosystem spanning from basic research to clinical application. To guarantee that product quality consistently meets regulatory standards and client requirements, Shenzhen Cell Valley fully integrated the ISO 9001 framework. This involved systematically optimizing workflows across R&D, manufacturing, testing, logistics, and after-sales support. The company also instituted regular internal audits and management reviews, while bolstering risk control and operational efficiency through continuous training and the recruitment of top-tier talent, including PhDs and Masters. On July 11, an SGS expert panel conducted a thorough on-site assessment—reviewing documentation, interviewing staff, tracing records, and observing operations—to uate the company’s quality policy, objective attainment, and end-to-end process controls. The panel unanimously approved the certification on the first attempt.

This achievement underscores that Shenzhen Cell Valley’s quality management system meets internationally advanced standards, laying a robust foundation for global market expansion and strengthening client confidence.