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DIN EN ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

active
Organization: DIN
Publication Date: 1 August 2016
Status: active
Page Count: 71
ICS Code (Medical equipment in general): 11.040.01
ICS Code (Management systems): 03.100.70
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

November 1, 2019
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
A description is not available for this item.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) , Corrigendum to DIN EN ISO 13485:2016-08
A description is not available for this item.
DIN EN ISO 13485
August 1, 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...
May 1, 2015
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2015); German and English version prEN ISO 13485:2015
A description is not available for this item.
November 1, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009) (includes Corrigendum :2012)
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...
January 1, 2010
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009) (includes Corrigendum AC:2009)
A description is not available for this item.
October 1, 2007
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) (includes Corrigendum AC:2007)
A description is not available for this item.
November 1, 2003
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
A description is not available for this item.
February 1, 2001
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (Revision of EN 46001:1996) (ISO 13485:1996); English version of DIN EN ISO 13485
A description is not available for this item.

References

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