The Foster Quality Management system is registered to ISO 13485:2003.
ISO 13485:2003 specifies quality management systems requirements, pertaining to the sale of products and services for medical devices. The goal of ISO 13485:2003 is to esnure consistency among medical device regulatory requirements for qualtity management. Whereas ISO 9001 emphasizes continual improvement and customer satisfaction, ISO 13485 emphasizes maintaining effective processes while meeting regulatory requirements, customer requirements and managing risks.
Being certified to ISO 13485 does not fulfill the requirements regulators, including the FDA. However, the certification aligns an organization’s management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements, as well as many other regulatory requirements found throughout the world. As such, ISO 13485 provides a framework on which to build compliance to various regulatory and customer requirements.
ISO 13485 certification does not fulfill the requirements of ISO 9001, nor is it equivalent to or have the ability to take the place of any country-specific requirement for medical device manufacturers. Benefits can be achieved by being both 9001 and 13485 certified, because 9001 focuses on business aspects not found in 13485 that are essential for all business practices.
For more information on ISO-13485:2003, please visit: www.iso.org