Quality management systems
Quality management systems describe all measures and actions of a company, which serves to achieve fixed requirements of products and services. Documented and established QM-Systems conduct to the implementation of regulatory requirements, like for example Medical Devices Directive 93/42/EEC or obligatory, generally international accepted norm.
Harmonized medical device regulatory requirements for quality management systems are facilitate by the ISO 13485 standard.
This international standard enables an organization to adapt the existing management systems into the new established quality management system so the requirements of this international standard are met.
All requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization.
More information on ISO 13485 are enclosed at our website under ISO 13485 section.