What is ISO 13485?

ISO 13485:2016 is the latest, and most current version of ISO 13485, updated from 2003 (learn about the differences here). This standard specifies requirements for a quality management system (QMS) centered around the medical device system, focusing on the needs of customers and applicable regulatory requirements.

There are many different stages of medical device development from design and development to distribution and servicing, and this standard was developed to be used in organizations no matter what their role in the life-cycle.

ISO 13845:2016 can also be used by suppliers and external parties that are involved with providing medical device products.

ISO 13485 (and variations such as DIN EN ISO 13485) is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices. While it remains a stand-alone document, ISO 13485 is based on ISO 9001 with some additional clauses as well as the removal of some requirements.

ISO 13485 / DIN EN ISO 13485 2012 requires more attention to regulatory requirements and the exception of 9001’s requirement of continuous improvement. ISO 13485 only asks for the QMS to be implemented and maintained.For more information on ISO 13485 please see our tutorial: Basics of ISO 13485 which covers:

intro to 13485 tutorial

Basics of ISO 13485

To learn more about the Medical Device terminology, please view: ISO 13485 Definitions which covers the various classifications of medical devices across the globe.

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Who is ISO 13845:2016 for? 

ISO 13845:2016 is beneficial for many organizations, and can be used by suppliers and external parties that are involved with providing medical device products.

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.

When will 13485:2003 be updated?

The latest version is ISO 13485:2016. This version aligns with ISO 9001:2008 (Yes, 2008, not 2015). Meaning that 13485 does not follow the high level structure of the latest version of 9001.

TC 176 is currently requesting user feedback for the next version of ISO 9001 (for example, one of the areas being studied for inclusion is risk management). This will reflect on the new version of ISO 1348

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