ISO 13485:2003 is stanadard that specifies the need for a complete quality management system for manufacture of medical devices. Under this standardization a organization specifies a requirement for a quality management system by the organizations that offer medical devices as well as related products to show that they possess the ability to consistently meet customer requirements .Its primary objective  is to facilitate systematic medical device regulatory requirements for quality management systems.

 

ISO 13485:2003 Specifications :

  • Identify and develop a quality management system for medical devices .
  • Utilize the quality systems and control processes for medical devices .
  • Monitor and maintain quality management system for medical devices.

 

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.

If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.

The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.