NS-EN ISO 13485:2016

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Status: Alert Withdrawn
Norwegian title: Medisinsk utstyr — Systemer for kvalitetsstyring — Krav for å oppfylle regelverk (ISO 13485:2016)
English title: Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2016)
Item type: Standard
Language: Engelsk
Edition: 2016-03 (2016-06-01)
Supersedes: CEN ISO/TR 14969:2005 Check Published
NS-EN ISO 13485:2012 Alert Withdrawn
NS-EN ISO 13485:2012/AC:2012 Alert Withdrawn
NS-EN ISO 13485:2012 Alert Withdrawn
Superseded by: NS-EN ISO 13485:2016+AC:2016 Alert Withdrawn
Number of pages: 72
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Included in: NS ICS 03.120
NS ICS 03.120.10
NS ICS 03
NS ICS 03.100
NS ICS 11
NS ICS 11.040
NS ICS 11.040.01
Scope: ISO 13485:2016 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). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of ISO 13485:2016 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 ISO 13485:2016 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 ISO 13485:2016 reflect any exclusion of design and development controls. If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 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.
Committee: SN/K 113
Adopted: 2016-06-01
Withdrawn: 2017-03-01
ICS: 03.100.70 - Ledelsessystemer
03.120.10 - Kvalitetsledelse og kvalitetssikring
11.040.01 - Medisinsk utstyr generelt