Quality Management System – ISO 9001 : 2008 and TickIT
All Tessella managed projects are carried out under our ISO 9001 : 2008 and TickIT certified Quality Management System. This has been developed over several years to minimize unnecessary bureaucracy while maintaining the essential control over quality.
Building on the solid foundation of our quality system, we have the proven ability to deliver systems that meet the requirements of external frameworks or regulatory bodies. These include PRINCE 2, Output Based Specification (OBS), GxP, 21 CFR Part 11 and Medical Device standards (e.g. 510(k), PMA submissions, IEC 60601).
“It was such a pleasure to visit such a mature software development house and to find the standards up to the very best in the software industry of today. The quality system is not only sound in its aim of ensuring that quality is built into software from the moment of its inception, it is also being effectively implemented and monitored. We can therefore be confident that such software is validatable as understood by today’s pharmaceutical industry and regulatory authorities. … Your firm is one of the best I have reviewed and is an example to the industry.”
Howard Garston Smith,
QA Auditor/Consultant, Pfizer International