Leading Chinese Stem Cell Therapy Provider Awarded Three ISO9001 Certifications for Stem Cell Technology Quality Management System
TAIZHOU, China, April 2 /PRNewswire-Asia/ — Beike Biotechnology Co. Ltd., one of the world’s leading biotechnology companies focusing on adult stem cell therapies, has been awarded ISO9001 certification by the International Organization for Standardization (“ISO”). This internationally recognized designation signifies Beike has established a Quality Management System (QMS) that complies with ISO9001 standards. To be certified to these standards, Beike’s stem cell preparation laboratory was recently assessed by auditors of the China Quality Certification Centre (CQC) and joins Beike’s Jiangsu Province Stem Cell Bank and processing laboratory as the latest Beike facility to achieve the ISO9001 recognition. The Jiangsu Province Stem Cell Bank and Regenerative Medicine Base was the first comprehensive storage facility to receive authentications for both banking and cell processing systems.
Dr. Sean Hu, Chairman and CEO of Beike Biotech, commented, “The implementation of our comprehensive Quality Management System and its certification by the China Quality Certification Centre and the International Organization for Standardization, highlights Beike’s commitment to quality and safety. To our knowledge, only a small percentage of biotech companies in the world have established Quality Management Systems conforming to ISO standards and subsequently obtained certification.
Since its inception in 2005, Beike has been focused on establishing rigorous quality control systems and specifications for stem cell industrialization. Early adoption of the Association of Blood Banks (AABB) and Foundation for the Accreditation of Cellular Therapy (FACT) standards and strict attention to quality processes led to the subsequent development of the firm’s current ISO9001 certified QMS. These extensive preparations and the commitment of Beike’s senior management through each step of the ISO certification process substantiate Beike’s dedication to provide safe and effective stem cell therapies.
“This certification assures our partners performing clinical trials and the patients receiving our stem cells, that Beike’s stem cell preparation laboratories and stem cell banks function at the highest worldwide quality standards,” continued Dr. Hu. “The fact that we are the first comprehensive stem cell organization in China to achieve this certification reinforces our relentless quest to deliver the best quality stem cell technologies to the world.”
Located in China’s Medical City, Beike’s ISO certified stem cell bank is well positioned for its role as an international leader in life-changing stem cell technologies. Qian Ling, Director of the Management Committee of China Medical City, noted, “We are pleased to hear of Beike’s recent ISO9001 accreditation. This is an outstanding achievement. The ISO quality standard is recognized around the world and will help solidify China Medical City as one of the primary hubs for stem cell technology research.”
About The International Organization for Standardization
The International Organization for Standardization (ISO) (www.iso.org) is the world’s largest developer and publisher of International Standards. It is comprised of national standards bodies from 159 countries that promote high quality standards for all company processes. To meet ISO 9000 certification requirements for Quality Management Systems, companies must establish a well-tuned system of interacting processes that ensures consistent quality of the company’s products; their capacity to optimally meet customer requirements; and their fulfillment of all applicable regulatory requirements.