The full name of the ISO13485 standard is "Medical device-Quality management system-requirements for regulatory". The standard was formulated by the SCA/TC221 Medical Device Quality Management and General Requirements Standardization Technical Committee and is an independent standard based on ISO9001. The standard specifies the quality management system requirements for relevant organizations, but it is not a guide for the implementation of the ISO9001 standard in the medical device industry.

Since the standard was released in 1996, it has been widely implemented and applied all over the world. The ISO13485:2003 version of the standard was officially released on July 3, 2003. Different from the ISO9001 standard, ISO13485:2003 is a management standard applicable in a regulatory environment: from the name, it is clearly a quality management system requirement for regulations. Internationally, medical devices are not only general marketed commodities operating in a commercial environment, but also subject to the supervision and management of national and regional laws and regulations, such as the FDA in the United States, the MDD (European Union Medical Device Directive) in the European Union, and the Medical Device Directive in China. Regulations on the Supervision and Administration of Devices. Therefore, the standard must be constrained by law and operate in a regulatory environment. At the same time, the risk of medical device products must be fully considered, and risk management must be carried out in the entire process of medical device product realization. So in addition to special requirements, it can be said that ISO13485 is actually ISO9001 in the context of medical device regulations.

In 2016, the ISO13485 standard was revised again and officially released on March 1, 2016.

The United States, Canada and Europe generally take ISO 9001, EN 46001 or ISO 13485 as the requirements for quality assurance systems, and the establishment of medical device quality assurance systems is based on these standards. To enter the market of different countries in North America, Europe or Asia, medical devices should comply with the corresponding regulatory requirements.

The ISO13485 standard emphasizes regulatory requirements: the new standard emphasizes regulatory requirements, and many places do not overemphasize customer requirements. This is because customer satisfaction is not suitable as a regulatory goal for medical devices, which is consistent with the harmonization goal of management system regulations around the world.

According to the industry characteristics of medical devices, many professional regulations are made in the ISO13485 standard. In a word, the new ISO13485 standard is an independent standard. Although its chapter structure is the same as ISO9001, and some chapters are the same as ISO9001, the ISO13485 standard highlights the requirements of laws and regulations according to the characteristics of the medical device industry, and dilutes the customer Satisfied, some important requirements of ISO9001 have been deleted, so meeting the requirements of ISO13485 does not mean meeting the requirements of ISO 9001 at the same time.