ISO Quality Certifications

iso quality certificates Nowadays quality standardization is of preferential importance to customers, providers and many other stake holders. This is why Andromedical policy is to maintain quality in any way possible.

Being certified by the British Standards Institution (BSI) and acknowledged as complying with the ISO Standardization, Andromedical is proud to be the only medical company in the sector, with ISO 9001:2008 and ISO 13485:2003.

ISO 9001:2008 - Is intended for use in any organization which designs, develops, manufactures, installs and/or services any product or provides any form of service. It provides a number of requirements which an organization needs to fulfill if it is to achieve customer satisfaction through consistent products and services which meet customer expectations. It includes a requirement for the continual improvement of the Quality Management System, for which ISO 9004:2000 provides many guidelines.

ISO 13485:2003 - Standard, published in 2003 that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. While it remains a stand-alone document, ISO 13485:2003 is generally harmonized with ISO 9001.