EN ISO 13485:2016

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

Publication date:   Apr 18, 2016

General information

60.60 Standard published   Mar 2, 2016

CEN/CENELEC

CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

European Norm

03.100.70   Management systems | 11.040.01   Medical equipment in general

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Scope

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.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting
90/385/EEC

Active implantable medical devices

Harmonized/Supporting
2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Harmonized/Supporting
2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Harmonized/Supporting

Life cycle

PREVIOUSLY

Replaces
CEN ISO/TR 14969:2005

Replaces
EN ISO 13485:2012

Replaces
EN ISO 13485:2012/AC:2012

NOW

PUBLISHED
EN ISO 13485:2016
60.60 Standard published
Mar 2, 2016

CORRIGENDA / AMENDMENTS

Amended by
EN ISO 13485:2016/A11:2021

Corrected by
EN ISO 13485:2016/AC:2018