ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer and regulatory requirements. One of the main objectives of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. It includes many of the elements of ISO 9001 but excludes some aspects not appropriate as regulatory requirements. ISO 13485:2003 is applicable to all medical device manufacturers, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls, or if “product realization” (Clause 7) is not applicable, these can be excluded from the quality management system. However, organizations claiming conformity with ISO 13485:2003 must reflect these exclusions. The processes required by ISO 13485:2003, which are applicable to the medical device(s) but are outsourced, must be accounted for in the organization's quality management system. ISO 13485:2003 is used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.
This conference looks at the requirements of ISO 13485:2003 and some practical aspects of setting up a quality system for medical device manufacturers.
Implementing a Quality Management System: ISO 13485 is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Thursday, October 15, 2009. For more details or to register, please visit our site at www.fxconferences.com
