ISO 13485
ISO 13485 is the internationally recognized quality management system standard for organizations involved in medical devices. It helps organizations control processes consistently while meeting applicable customer and regulatory requirements.
What is ISO 13485?
ISO 13485 specifies quality management system requirements for organizations involved in the medical device life cycle. It provides a framework for controlling activities such as design and development, supplier management, production, process validation, complaint handling and corrective action.
As of July 2026, ISO 13485:2016 remains the current edition. ISO completed a systematic review in 2025 and confirmed that the 2016 edition remains current.
Who should use ISO 13485?
ISO 13485 can apply to medical device manufacturers as well as organizations that design, install, service, sterilize, store or distribute devices. It can also apply to suppliers and external parties whose products or services affect device quality.
The exact processes included in a company’s QMS depend on its role and activities. A contract manufacturer, software developer and legal manufacturer may therefore have different scopes while using the same standard.
Is ISO 13485 certification always required?
No. ISO itself does not perform certification, and ISO 13485 certification does not by itself authorize a medical device for sale. Certification is performed by an external certification body.
Some jurisdictions or commercial relationships require certification, while others use ISO 13485 as part of a broader regulatory framework. Manufacturers must evaluate the rules for each target market rather than assuming one certificate satisfies every requirement.
How does ISO 13485 relate to FDA QMSR?
The FDA Quality Management System Regulation incorporates ISO 13485:2016 by reference while retaining United States-specific legal requirements. The QMSR became effective on February 2, 2026.
A manufacturer subject to FDA requirements must comply with the regulation itself, not merely hold an ISO certificate. See Quality Management System Regulation and Pure Global’s FDA QMSR consulting page.
How does ISO 13485 relate to MDSAP?
The Medical Device Single Audit Program uses ISO 13485 as a foundational audit criterion together with jurisdiction-specific requirements from participating regulators. An MDSAP audit is therefore broader than a conventional ISO 13485 certification audit.
This relationship is particularly important for manufacturers entering Canada, Australia, Brazil, Japan or the United States.
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