InSphero Certified for ISO 9001:2015
InSphero demonstrates commitment to customer satisfaction, superior quality, and continuous improvement by adhering to new ISO 9001:2015 standards.
Schlieren, Switzerland – January 3, 2018 InSphero AG, the leading supplier of assay-ready 3D cell culture models for accelerating drug discovery and development, today announced that it has achieved ISO 9001:2015 certification. This quality assurance milestone reaffirms InSphero’s commitment to customer satisfaction, superior quality and continuous improvement of its quality management system for microtissue production and contract services. InSphero was previously ISO 9001:2008 certified.
ISO 9001 is a quality management system standard developed by the International Organization for Standardization, an association of governmental and nongovernmental organizations from many countries. The ISO 9001 standard is utilized to certify quality management systems that focus on continuous improvement, customer satisfaction and the active involvement of both management and employees in a process based approach. To earn this certification from DQS, InSphero passed an audit during which each step of our quality management processes across all departments was reviewed.
“We are honoured to have received this level of recognition and I am extremely pleased with the performance everyone at InSphero has shown throughout the process of achieving ISO 9001:2015 certification,” said Dr. Marion Bavand, InSphero Head of Quality Assurance. “Beyond the hard work, and time required to become certified, this accomplishment shows just how much each of our employees cares about the quality of what we do. We will continue to do everything we can to provide reliable, robust, physiologically relevant models and services for all of our customers.”
Dr. Frank Junker
Chief Business Officer
Phone +41 44 5150490
Dr. Marion Bavand
Head of Quality Assurance
Phone +41 44 5150490
InSphero sets the standard for in vitro testing of novel drugs in the pharmaceutical and biotechnology industry with comprehensive solutions that provide greater confidence in decision making. Its robust and highly physiologically relevant suite of 3D InSight™ Microtissues and Services are used by major pharmaceutical companies worldwide to increase efficiency in drug discovery and safety testing. InSphero patent-pending technologies and methods enable large-scale, reproducible production of scaffold-free 3D microtissues driven solely by cellular self-assembly. The company specializes in delivering assay-ready and custom 3D models derived from liver, pancreas, and tumor tissues, to provide unrivalled biological insight into liver toxicology, metabolic diseases (e.g., diabetes and liver diseases), and oncology (with a focus on immuno-oncology). All InSphero microtissues are thoroughly validated to ensure the highest quality, certified for use in a variety of assays, and shipped globally to customers in a patented, easy-to-use spheroid-optimized platform, ready for research. Field application scientists and research staff with expertise in working with 3D models help ensure efficient integration and onsite training as needed. For customers who prefer an outsourcing strategy with fast turnaround, InSphero also offers contract research services utilizing their 3D microtissue models.
InSphero 3D InSight™ solutions drive significant findings in peer-reviewed journals, through collaborative projects such as EU-ToxRisk and HeCaToS, and have gained validation in the world’s largest government institutions and pharmaceutical, chemical and cosmetics companies.
Founded in 2009, the privately held company is headquartered in Schlieren, Switzerland with subsidiaries in the United States (Brunswick, ME) and Waldshut, Germany. It has been recognized for its scientific and commercial achievements with a number of national and international awards.
Image caption: InSphero has implemented and maintains a quality management system that was verified to fulfill the requirements of the ISO 9001:2015 standard.