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ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes

active, Most Current
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Organization: ISO
Publication Date: 1 March 2016
Status: active
Page Count: 46
ICS Code (Quality management and quality assurance): 03.120.10
ICS Code (Medical equipment in general): 11.040.01
scope:

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.

Document History

ISO 13485
March 1, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
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...
August 1, 2009
Medical devices — Quality management systems — Requirements for regulatory purposes TECHNICAL CORRIGENDUM 1
General 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...
July 15, 2003
Medical devices - Quality management systems - Requirements for regulatory purposes
General 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...
December 15, 1996
Quality Systems - Medical Devices - Particular Requirements for the Application of ISO 9001
A description is not available for this item.

References

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