NF EN ISO 13485

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

72 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 - 01/08/2022

International kinship

ISO 13485:2016

European kinship

EN ISO 13485:2016
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.

Replaced standards (1)
NF EN ISO 13485
September 2012
Standard Cancelled
Medical devices - Quality management systems - Requirements for regulatory purposes

Le présent document énonce les exigences relatives au système de management de la qualité lorsqu'un organisme doit dé montrer son aptitude à fournir régulièrement des dispositifs médicaux et des services associés conformes aux exigences des clients et aux exigences réglementaires applicables aux dispositifs médicaux et aux services associés. Le présent document a été élaboré dans le cadre d'un mandat donné au CEN par la Commission européenne et l'Association européenne de libre-échange et vient à l'appui des exigences relatives au système qualité des Directives UE relatives aux dispositifs médicaux.

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Système de management de la qualité
  • 5 Responsabilité de la direction
  • 6 Management des ressources
  • 7 Réalisation du produit
  • 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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