Test item: ISO13485 medical device quality management system

The current new version of ISO13485 is the 2016 version, which is called "Medical Device Quality Management System" in Chinese. Because medical devices are special products that save lives, heal the wounded, prevent and treat diseases, it is not enough to standardize only in accordance with the general requirements of the ISO9000 standard. Therefore, the ISO organization issued ISO13485 : The 1996 version of the standard (YY/T0287 and YY/T0288) puts forward special requirements for the quality management system of medical device manufacturers, which has played a very good role in promoting the quality of medical devices to achieve safety and effectiveness.

The full name of the ISO13485:2003 standard is "Medical device-Quality management system-requirements for regulatory." This 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 2000. The standard specifies the quality management system requirements for related organizations, but it is not a guideline for the implementation of the ISO9001 standard in the medical device industry. Food safety management system

Since the standard was released in 1996, it has been widely implemented and applied all over the world. The new version of ISO13485 was officially released on July 3, 2003. Different from the ISO9001: 2000 standard, ISO13485: 2003 is a management standard applicable to the regulatory environment: from the name, it is clear that it is a quality management system requirement for regulations. Internationally, medical devices are not only general listed products operating in a commercial environment, they are also subject to the supervision and management of national and regional laws and regulations, such as the US FDA, the EU’s MDD (EU Medical Device Directive), and China’s "Medical Device Directive". Regulations on the Supervision and Administration of Devices. Therefore, the standard must be bound by law and operate in a regulatory environment. At the same time, the risks of medical device products must be fully considered, and risk management must be carried out in the entire process of medical device products. Therefore, in addition to the special requirements, it can be said that ISO13485 is actually ISO9001 under the environment of medical device regulations.

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

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