On October 16, 2025, Shanghai Lishan Biopharmaceutical Co., Ltd. officially obtained the GB/T 19001-2016/ISO 9001:2015 quality management system certification issued by the international authoritative certification body BCC.

The Road to Building the ISO9001 Quality Management System in Lishan Biotech

ISO9001 is the globally recognized and most mature quality management system framework, published by the International Organization for Standardization (ISO) and widely adopted by various organizations around the world. This system is based on "quality" and rooted in "quality", committed to continuously improving product and service levels through systematic and standardized management. Obtaining ISO9001 certification is not only a powerful manifestation of a company's pursuit of excellence, but also an important cornerstone for achieving sustained, stable, and healthy development.

The introduction and implementation of ISO9001 system by Lishan Biotech is a key strategic deployment, which not only helps to comprehensively improve operational and management efficiency, but also lays a solid foundation for the company's long-term development. Since the start of system construction at the end of 2024, Lishan Biotechnology has gradually established a complete closed loop of "preparation construction audit certification improvement". The key nodes and core work are as follows:

1.Preparation period (November 2024 December 2024)

Organize and train first

System deployment: Establish a cross departmental quality team, develop detailed implementation plans, and accurately decompose various tasks into specific positions.

Full participation: Conduct multiple rounds of specialized training to ensure that all employees have a deep understanding of the standards and firmly establish a sense of standardization.

2.Construction period (December 2024- May 2025)

Process reshaping and document implementation

System solidification: Strictly following the ISO standard of "write what you do, write what you do, and record what you do", the system has compiled 158 quality management documents, including quality manuals, procedure files, work instructions, and record forms.

Rules to follow: The standards are fully solidified into daily operations through a document system, ensuring that every operation has a basis and rules to follow.

3.Internal audit period (2025.8)

Initial system testing with significant results

Internal Audit: Organized a team of internal auditors to conduct a 5-day full process audit, and made improvements to the system operation by drawing lessons from it. The overall compliance rate of the audit reached 98%, with only one general non conformance and one observation identified.

Quick response: The relevant responsible departments responded quickly, completed the rectification within the specified time, and successfully passed the verification.

4.External audit certification period (2025.9)

Authoritative certification, successfully passed

On site certification: Professional evaluation teachers dispatched by the third-party New Century Inspection and Certification Co., Ltd. will conduct a 2-day certification audit on site.

Highly affirmed: The certification audit team conducted a systematic and meticulous review of the planning, implementation, inspection, and improvement aspects of Lishan Biological's management system through business inspections, data reviews, and on-site interviews. The final audit result was excellent, with no serious non conformities and only one general non conformity. The audit team highly affirmed the achievements of Lishan Biotechnology in the operation of the system.

5.Continuous improvement period

Starting from the end, pursuing excellence

Starting from the end: The successful passing of ISO9001 certification marks that the quality management system of Lishan Biotechnology has reached international authoritative standards in terms of standardization and effectiveness. But this is not the end, but the starting point of a new journey of quality.

Pursuing excellence: In the future, Lishan Biotechnology will continue to deepen its system from two aspects based on a three-year quality plan: firstly, dynamically optimize existing processes and continuously improve details in daily operations; Secondly, promote the deep integration of the system with "AI+biomedicine", empower quality control with technological innovation, and ensure that research and development and production are always synchronized with international advanced standards.

Special thanks to all employees for their hard work! In the future, we will spare no effort to develop innovative drugs and provide more customers with reliable products!

About Kiwa BCC

Kiwa BCC, established in 1994, is one of the first domestic certification bodies approved by the Certification and Accreditation Administration of China (CNCA). It has been accredited by the China National Accreditation Service for Conformity Assessment (CNAS), the United Kingdom Accreditation Service for Conformity Assessment (UKAS) for medical device quality management systems, and the ANSI National Accreditation Board (ANAB) for quality, environmental, and occupational health and safety management systems. BCC has accumulated over 30 years of professional experience and practical cases in the fields of management system certification, product certification, service certification, second party audit, and training services. We have provided professional and efficient technical services for the quality improvement and sustainable development of over 100000 customers, conveying social trust.

About Lishan Biotech

Always focusing on innovative drug research and development, breaking through the century old problem of gut microbiota colonization with globally unique Swarming technology, and building a golden triangle system of "efficient discovery of strains+stable colonization of strains+clinical precision access group". Committed to developing innovative therapies based on microbiota for the treatment of inflammatory bowel disease, immune-mediated therapy for non-small cell lung cancer and renal cell carcinoma. Lishan utilizes globally leading drug targets and mechanisms of action to meet high-value unmet clinical needs with First in class or Best in class therapies, providing safe and reliable drug products for patients worldwide.