April 27, 2009
The Allied Group received dual certification under the International Organization for Standardization (ISO) quality systems standards, for ISO 13485:2003 and ISO 9001:2008.
We are committed to providing our customers with world-class printing and contract kitting and fulfillment services to the medical device and life sciences industries. The achievement of these ISO certifications will communicate the significant progress we have made toward that goal.
The ISO 13485:2003 standard is specifically designed to certify medical device manufacturers and their key suppliers. This standard defines 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 specifications and regulatory requirements. ISO 9001:2008 is the most recent update of the widely recognized ISO 9001 standard. While not specific to medical device manufacturing, ISO 9001 is intended to enhance customer satisfaction through the effective application of a quality management system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
Click here to learn more about Allied's ISO Certification