NF EN ISO 13485
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NF EN ISO 13485
April 2016
Standard
Current
Medical devices - Quality management systems - Requirements for regulatory purposes
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.
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Main informations
Collections
National standards and national normative documents
Thematics
Management et performance
Publication date
April 2016
Number of pages
87 p.
Reference
NF EN ISO 13485
ICS Codes
03.100.70 Management systems
03.120.10 Quality management and quality assurance
11.040.01 Medical equipment in general
Classification index
S99-101
Print number
3 - août 2022
International kinship
ISO 13485:2016
European kinship
EN ISO 13485:2016
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Sumary
Medical devices - Quality management systems - Requirements for regulatory purposes
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.
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Replaced standards
(1)
NF EN ISO 13485
September 2012
Standard
Cancelled
Medical devices - Quality management systems - Requirements for regulatory purposes
Table of contents
- Avant-propos
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1 Domaine d'application
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2 Références normatives
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3 Termes et définitions
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4 Système de management de la qualité
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5 Responsabilité de la direction
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6 Management des ressources
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7 Réalisation du produit
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8 Mesurage, analyse et amélioration
- Annexe
- Annexe A (informative) Comparaison entre le contenu de l'ISO 13485:2003 et celui de l'ISO 13485:2016
- Annexe B (informative) Correspondances entre l'ISO 13485:2016 et l'ISO 9001:2015
- Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive européenne 90/385/CEE (telle que modifiée)
- Annexe ZB (informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive européenne 93/42/CEE (telle que modifiée)
- Annexe ZC (informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive européenne 98/79/CE
- Bibliographie
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The Requirements department helps you quickly locate within the normative text:
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- non-essential but useful clauses to know, such as permissions and recommendations.
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