For those who work on medical devices, it determines the specific requirements required by the quality system and the quality management system requirements that any organization operating in the medical device industry must meet. This is a management standard that can be applied by organizations that subcontract medical device manufacturing and provide medical device distribution and technical service. La presente Norma specifica i requisiti per i sistemi di gestione per la qualità che permettono ad una organizzazione di dimostrare la sua capacità di fornire dispositivi medici e relativi servizi che siano conformi ai requisiti dei clienti e ai requisiti regolamentari applicabili. The ISO 13485:2016 standard is an international standard based on ISO 9001:2015 standard, which includes special requirements for Medical Devices. ISO 13485 Standard is the Quality Management System standard in the Medical Sector. ISO certificate It is a document that proves that the enterprises operating in different sectors of the service area offer services in accordance with a certain standard and that they have competence in their fields. Founded in 1947, the Swiss city of Geneva is the center of this organization. 'ISO It is an abbreviated form of the Inter-Country Standards Organization.
