NEN-EN-ISO 13485:2016 en

Medische hulpmiddelen - Kwaliteitsmanagementsystemen - Eisen voor reguleringsdoeleinden


Over deze norm

Status Definitief
Aantal pagina's 36
Commissie Medische hulpmiddelen - horizontale onderwerpen
Gepubliceerd op 01-03-2016
Taal Engels
NEN-EN-ISO 13485 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.


ICS-code 03.120.10
Nederlandse titel Medische hulpmiddelen - Kwaliteitsmanagementsystemen - Eisen voor reguleringsdoeleinden
Engelse titel Medical devices - Quality management systems - Requirements for regulatory purposes
Vervangen door
Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica



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