ISO 13485 is an international standard for the blueprint, manufacture and allocation of medical devices. ISO 13485:2003 is the latest version by ISO, published in 24th July 2003. This standard is based on the ISO 9001:2008 process representation approach. ISO 13485 is process based approach which define, execute, and improve effectives of quality management coordination that they expected by customers and regulatory requirements. The main endeavor of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485:2003 is directly aligned to other management standards such as ISO 9001, ISO 14001 and OHSAS 18001 providing a great opportunity for integration and synergy with other quality systems.