Applied StemCell has received certifications for two International Organization for Standardization (ISO) Quality Management Systems (QMS) on October 20, 2017, the ISO 9001:2015 and 13485:2016.
The ISO certification entails extensive documentation and creation of standard operating procedures (SOP) to ensure quality services and products, customer satisfaction, continued improvement in processes, quality and workflow, and conformity to customer and regulatory requirements. The certificate approves Applied StemCell located in Milpitas, California, providing gene-editing, stem cell, and reference standard products and services for life science research, preclinical, and clinical diagnostic global markets. In addition, we have also been awarded the ISO 13485 certification for consistently meeting customer and regulatory requirements for products and services related to medical devices, and specifically to our reference standard products.
“We are extremely proud of our team and their efforts to receive both the ISO 9001 and 13485 certifications. This new milestone reinforces Applied StemCell’s mission to offer high quality biotechnology services and products so that our customers can be assured that their expectations are met or exceeded,” stated Dr. Ruhong Jiang, CEO of Applied StemCell.