ISO 13485:2003, based on the ISO 9001:2008 System Implementation 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 9001:2008 to ensure understanding of the Process Model, definitions and other items of concern, too.
The benefits of an ISO 13485:2003 System Implementation compliant quality management system to the many of companies worldwide include:
Improved communications, morale and job satisfaction – staff understand what is expected of them and each other.
ACASCERT consists of full-time trainers and certification having huge international experience and exposure in ISO 13485 Consulting, implementation and training.