EN ISO 9001:2015 - Quality management

EN ISO 9001:2015 sets out the criteria for a quality management system. This 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.

EN ISO 13485:2012 - Medical devices -- Quality management systems -- Requirements for regulatory purposes

EN ISO 13485:2012 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).

ECO PHYSICS is continuously audited and fulfills all requirements of the EN ISO 9001:2015 and the EN ISO 13485:2012 standards.