ISO 13485:2003, based on the ISO 9001:2000 process model, suggests that the application and management of a system of processes is an effective way to ensure good quality management. All requirements of this International
Standard are specific to organizations providing medical devices, regardless of the type or size of the organization.
The standard strongly infers that clients should consider using ISO 9000:2000 to ensure understanding of the Process Model, definitions and other items of concern, too.

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