Historical
DS/EN ISO 13485:2016/AC:2016
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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 organizationÆs 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.
Content Provider
Danish Standards [ds]