Human Cell Technology Company Medicyte Awarded ISO 9001 Certification
As announced today, its quality management system was certified in December 2011 to meet the criteria of the globally recognized standard DIN ISO 9001:2008, supervised by the TÜV. The certification was performed in order to meet the strict quality requirements of customers in the pharmaceutical, chemical and cosmetic industries. It underlines Medicyte's consistency and continuous endeavours to improve the quality of products and customer service. The certificate covers both the controlled and scalable production and sales process of human quasi-primary cell products. This is especially important for the supply of human cells, such as hepatocytes and keratinocytes, for ADME/Tox testing, which should be consistently of high quality.
"We have always had a strict total quality system, but the additional structure of the DIN ISO 9001 registration has helped us to improve and standardize our internal daily tasks and thus our customers' satisfaction with our products and services. Becoming an ISO-certified company is a natural extension of our quality commitment. Customers can feel confident relying on our compliance for quality standards of our products and services because they are aware that we follow internationally accepted standards," said Nadja Hartmann, Medicyte's Total Quality Manager.
About quality management system DIN ISO 9001:2008
DIN ISO 9001:2008, an internationally accepted quality management certification system, helps thousands of companies worldwide to manage their processes to become more efficient and cost-effective. Certified companies must be able to demonstrate to the satisfaction of an independent third-party auditor an ability to consistently provide products that meet customer and regulatory requirements. ISO 9001 has existed for almost 20 years. In 2008, the standard was revised, placing more emphasis on continuous improvement and customer satisfaction.
Medicyte is a cell technology company specializing in the controlled and scalable production of human primary cells. Medicyte's patented vericyte® and upcyte® technologies allow controlled proliferation of primary cells without losing their typical properties. This enables improved and new cell products with consistent quality and industrial scalability e.g. for production processes, pharmacological R&D (ADMET, HTS etc.), basic research, and clinical applications.