What is ISO 13485?

ISO 13485 Definition

International Organization for Standardization defines ISO 13485 for companies involved in the design, production, installation, and servicing of medical devices and related services. This standard specifies requirements for a quality management system. ISO 13485 can also be used by internal and external parties, such as certification bodies, to help with auditing processes. ISO 13485 compliance occurs when impacted organizations can demonstrate that their quality management system (QMS) follows regulatory best practices throughout a product’s lifecycle from creation through service and delivery of medical devices that are safe and effective for their intended purpose. ISO 13485:2016 was published in March of 2016 and is the latest version of ISO 13485 as of March 25, 2021.

What is ISO 13485


What is the purpose of ISO 13485?

ISO 13485 is intended to help medical device companies consistently produce safe and effective products. It also provides guidelines for risk management to help organizations avoid product recalls.

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Who can apply for ISO 13485 certification?

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

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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.


What is the ISO 13485 certification?

ISO 13485 certification denotes that a company has established an ISO 13485 quality management system and has met all the standard’s requirements. ISO 13485 assesses if your quality management system is acceptable and effective, with a focus on medical device safety and efficacy.

*Source: https://13485store.com

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