Medical Devices | ISO 13485

The ISO 13485 standard specifies the requirements of a Quality Management System in organizations that need to demonstrate to their consumers their ability to comply with regulations relating to medical devices and related services. 

The new ISO 13485:2016 standard, in force since March 24, 2016 and available in the Italian version since October 26, 2016, has as its main objective to facilitate the harmonization of medical devices with the regulations of the Quality Management System. 
Consequently, the standard provides for some specific requirements for medical devices, excluding other requirements contained in the ISO 9001:2015 standard, which are not suitable. 

By means of these exclusions, organizations that have a Quality Management System in accordance with the international standard ISO 13485 cannot assert their compliance with the standard ISO 9001:2015, unless their Quality Management System complies with all of its requirements. 

If these requirements allow the exclusion of design and development controls, this can be used as a justification for their exclusion from the Quality Management System. 

These requirements may provide alternative provisions that can be addressed to the Quality Management System. 

It is the responsability of the organization to ensure that compliance with ISO 13485 also highlights the exclusions of designn and development controls. 

Through certification by an independent thid-party body, the company provides credibility of its commitments to its customers and stakeholders. 


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