Medical Technology
The primary goal of the DIN EN ISO 13485 is the facilitation of the harmonization of applicable for medical devices regulations quality management systems. The primary goal of the DIN EN ISO 13485 is the facilitation of the harmonization of applicable for medical devices regulations quality management systems. This international standard DIN EN ISO 13485 requirements for a quality management system determines if an organization has its ability to provide medical devices and related services to demonstrate that constantly meet customer requirements and regulatory requirements applicable to medical devices and related services. As a result contains the DIN EN ISO 13485 some special requirements on medical devices and some of the requirements of the DIN EN ISO excludes 9001, are not suitable as requirements for legal purposes. Due to these exclusions, organisations whose quality management systems of this international standard match, can not Compliance with DIN EN ISO 9001 claim, except if its quality management system with all the requirements of DIN EN ISO 9001 is in conformity. All requirements of DIN EN ISO 13485 are specific to organizations, the medical supply available, regardless of type and size of organization. If regulatory requirements permit exclusions of steering measures to design and development, this can be used as a justification for their exclusion from the quality management system. These provisions may provide alternative arrangements must be included in the quality management system.
Tags: health, medicine & surgery