ISO 13485, known in Chinese as "Medical Device Quality Management System," is essential due to the critical nature of medical devices in saving lives, treating diseases, and preventing illness. Standard ISO 9000's general requirements are insufficient for such specialized products. Therefore, the ISO organization issued the ISO 13485:1996 standard (YY/T0287 and YY/T0288), which outlines specific requirements for the quality management systems of medical device manufacturers, significantly promoting the safety and effectiveness of medical devices.

The name itself clearly indicates that it pertains to quality management system requirements under regulations. Medical devices are not only general commercial products operating in an international business environment; they are also subject to supervision and regulation by national and regional laws and regulations, such as the FDA in the United States, the MDD (Medical Device Directive) in the EU, and China's "Regulations for the Supervision and Administration of Medical Devices." Therefore, this standard must be legally bound and operated within a regulatory environment, while also fully considering the risks associated with medical device products, necessitating risk management throughout the entire process of medical device product realization. Thus, besides specific requirements, ISO 13485 can be said to be essentially ISO 9001 within the regulatory context of medical device laws.

As of November 2017, the implemented version is ISO 13485:2016 "Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes," with both name and content having been modified.

The United States, Canada, and Europe generally require ISO 9001, EN 46001, or ISO 13485 as quality assurance system standards. Establishing a medical device quality assurance system is based on these standards. To enter the markets of North America, Europe, or various Asian countries, medical devices must comply with the respective regulatory requirements.