Our quality system leverages the ISO 9001:2008 (Quality manage systems — requirements) and ISO/TS 16949:2009 (Quality management systems — Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations) expertise of our affiliate The Phoenix Group. We are currently in the process of integrating the requirements of ISO 13485 (Medical devices — Quality management systems — Requirements for regulatory purposes).We expect to receive certification to ISO 13485:2003 mid-year 2013.
The ISO/TS16949:2009 is an ISO technical specification aiming to the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.
ISO 9001:2008 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact ISO 9001:2008 is implemented by over one million companies and organizations in over 170 countries. The standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement.