International Standard
ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
Reference number
ISO 13485:2016
Edition 3
International Standard
Read sample
ISO 13485:2016
Published (Edition 3, 2016)
This standard was last reviewed and confirmed in 2020. Therefore this version remains current.

ISO 13485:2016

ISO 13485:2016
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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.

In bundle

ISO 13485:2016 + ISO 13485:2016 - Medical devices - A practical guide + ISO 14971:2019 + ISO/TR 24971:2019
ISO 13485:2016 ISO 13485:2016 59752 173 ISO 13485:2016 - Medical devices - A practical guide ISO 13485:2016 - Medical devices - A practical guide pub100484 96 ISO 14971:2019 ISO 14971:2019 72704 173 ISO/TR 24971:2020 ISO/TR 24971:2020 72704 216
Medical devices - the basics

This bundle combines essential ISO standards to provide a robust framework for quality management and risk management in the medical device industry.

  • ISO 13485:2016
  • ISO 13485:2016 A practical guide
  • ISO 14971:2019
  • ISO/TR 24971:2020

General information

  •  : Published
     : 2016-03
    : International Standard confirmed [90.93]
  •  : 3
     : 36
  • ISO/TC 210
  • RSS updates

Life cycle

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