What is ISO 13485 Compliance?

ISO 13485 Compliance Definition

ISO 13485 compliance is demonstrated when organizations can demonstrate that their quality management system (QMS) follows regulatory best practices throughout a product’s lifecycle from creation through service and delivery. The International Organization for Standardization (ISO) is a non-governmental organization that creates and publishes international standards to support innovation, quality, and challenges across the globe.

What is a ISO 13485 Compliance


Who needs ISO 13485 certification?

Any company involved in the design, development, manufacture, and/or distribution of medical devices requires ISO 13485 certification.

*Source: https://insights.pecb.com/iso-13485-certification/

What is the cost of ISO 13485 certification?

The cost of ISO 13485 certification will depend on the amount of time and resources that is required to implement the standard within your organization. The cost will also be impacted by the amount of employee training that is required and the duration of your audit. Additional expenses such as application fees and annual management fees may also impact your total cost.

*Source: https://www.nqa.com/en-us/resources/blog/july-2017/costs-of-third-party-certification

Is ISO 13485 a legal requirement?

Technically, ISO 13486 is not a legal requirement. You can create a QMS that suits your needs for your organization, so long as the processes of the QMS meet the legal and regulatory requirements for medical devices where you intend to manufacture and sell them. Even though ISO 13485 is not required for EU MDR compliance, the EU MDR regulation requires that you have a QMS in place, and the ISO 13485:2016 standard is the only QMS standard listed in the EU list of harmonized standards, so most companies will use the ISO 13485 requirements to implement their QMS.

While the ISO 13485 Medical Devices standard isn’t enforceable by law, many governments around the world, including in the UK, make it a legal requirement for organisations to comply with the Medical Devices Directive (MDD).


Do organizations need ISO 9001 if they have ISO 13485?

No. Medical device manufacturers only require ISO 13485 certification. ISO 13485 is specific to the medical device industry and incorporates the quality management system fundamentals of ISO 9001 with some additional requirements.

*Source: https://www.orielstat.com/blog/alignment-of-iso-9001-2015-and-iso-13485-2016/

ISO 13485 Guidelines

Manufacturers who have yet to address ISO 13485 should start assessing their quality management system (QMS) to determine whether there are any gaps to meet the ISO 13485 guidelines.

Read this blog to learn about ISO 13485 and what manufacturers need to do to meet compliance.