DS/EN ISO 13485:2016/AC:2016 ( Withdrawn )

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

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Harmonized under:
  • Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices

  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:


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
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
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
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.

Number of pages: 6

Published: 2017-01-18

Date of approval: 2017-01-06

Date of withdrawal: 2018-04-09

International relationships : EN ISO 13485:2016/AC:2016 IDT

ICS: 03.100.70 - Management systems 03.120.10 - Quality management and quality assurance 11.040.01 - Medical equipment in general

Item number: M313582




Danish committee