ISO 13485:2016



Medical devices can affect people’s health in profound ways, so making them requires more than good engineering. Organizations must also control how devices are designed, produced, stored, and supported, while meeting the rules that apply in the markets where they operate. ISO 13485:2016 provides an internationally recognized framework for managing these responsibilities through a quality management system.

Published by the International Organization for Standardization (ISO), ISO 13485:2016 is a standard for quality management systems (QMS) in the medical-device industry. A QMS is the connected set of policies, processes, responsibilities, and records an organization uses to ensure its work is planned and controlled.

The standard is intended for organizations involved in one or more stages of a medical device’s life cycle. This can include design and development, manufacturing, storage, distribution, installation, servicing, and related activities. It can also apply to suppliers and other organizations that provide products or services to medical-device companies.

ISO 13485 is not a product standard: it does not specify the exact design or performance requirements for every device. Instead, it describes how an organization should manage its processes so that it can consistently meet customer and applicable regulatory requirements. Those requirements vary by country and product, so organizations must identify which rules apply to their own activities.


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