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About This Item
Full Description
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.
Document History
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NS-EN ISO 13485:2016
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)- Most Recent
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NS-EN ISO 13485:2012/AC:2012
Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)- Historical Version
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NS-EN ISO 13485:2012
Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)- Historical Version
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NS-EN ISO 13485:2003/AC:2009
Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)- Historical Version
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NS-EN ISO 13485:2003/AC:2007
Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)- Historical Version
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SN-CEN ISO/TR 14969:2005
Medical devices — Quality management systems — Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)- Historical Version
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NS-EN ISO 13485:2003
Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)- Historical Version
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NS-EN ISO 13485:2000
Quality systems — Medical devices — Particular requirements for the application of EN ISO 9001 (ISO 13485:1996)- Historical Version
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NS-EN ISO 13488:2000
Quality systems — Medical devices — Particular requirements for the application of EN ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996)- Historical Version
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NS-EN 46003:1999
Quality systems — Medical devices — Particular requirements for the application of EN ISO 9003- Historical Version
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NS-EN 46001:1996
Quality systems — Medical devices — Particular requirements for the application of EN ISO 9001- Historical Version
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NS-EN 46002:1996
Quality systems — Medical devices — Particular requirements for the application of EN ISO 9002- Historical Version
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NS-EN 46001:1993
Quality systems — Medical devices — Particular requirements for the application of EN 29001- Historical Version
Amendments, rulings, supplements, and errata
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NS-EN ISO 13485:2016/AC:2018
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) -
NS-EN ISO 13485:2016/A11:2021
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) -
NS-EN ISO 13485:2016/AC:2016
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)