DNS/ISO 13485: 2016


Status: Public comments
Start date: 20240718
End date: 20240916

This International Standard specifies requirements for a quality management system where an  organization needs to demonstrate its ability to provide medical devices and related services that  consistently meet customer and applicable regulatory requirements. Such organizations can be involved  in one or more stages of the life-cycle, including design and development, production, storage and  distribution, installation, or servicing of a medical device and design and development or provision of  associated activities (e.g. technical support). This International Standard can also be used by suppliers  or external parties that provide product, including quality management system-related services to such  organizations. 

Requirements of this International Standard are applicable to organizations regardless of their size  and regardless of their type except where explicitly stated. Wherever requirements are specified as  applying to medical devices, the requirements apply equally to associated services as supplied by the  organization. 

The processes required by this International Standard that are applicable to the organization, but  are not performed by the organization, are the responsibility of the organization and are accounted  for in the organization’s quality management system by monitoring, maintaining, and controlling the  processes. 

If applicable 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 regulatory  requirements can provide alternative approaches that are to be addressed in the quality management  system. It is the responsibility of the organization to ensure that claims of conformity to this  International Standard reflect any exclusion of design and development controls. 

If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable due to the  activities undertaken by the organization or the nature of the medical device for which the quality  management system is applied, the organization does not need to include such a requirement in its  quality management system. For any clause that is determined to be not applicable, the organization  records the justification as described in 4.2.2

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