ISO13485 is called "Medical device Quality Management System - Requirements for regulations", as the name suggests, the standard is a set of quality management system dedicated to the medical device industry, is a programmatic document of global medical device quality management. The ISO13485 standard is based on ISO9001:1994 and is developed and published by ISO/TC 210. ISO13485 along with the ISO9001 standard continuous upgrading has also experienced the evolution of EN46000, ISO13488 and so on, the International Organization for Standardization in March 2003 officially issued ISO13485:2003 new standards, the new standard for the medical device industry regulations to do a specific description. Therefore, it can be said that ISO13485:2003 is applicable to the management standard in the regulatory environment, ISO/TR 14969:2004 is the specific implementation guide of ISO13485:2003.
ISO13485 standard in the preparation process, its standard structure refers to the ISO9001 eight chapters, the structure of the four processes, but ISO13485 focuses on the legal and regulatory requirements of medical devices, and downplays the "continuous improvement" and "customer satisfaction", so it can be seen that the ISO13485 standard is an independent standard. Meeting the requirements of ISO13485 does not mean that the requirements of ISO9001 are met at the same time, because the ISO13485 standard has deleted some core requirements of ISO9001.
At present, ISO13485 has been directly adopted or equivalent by most countries or regions as the quality management norms of the domestic medical device industry. The European Union has directly adopted ISO13485 as the harmonized standard for its three medical device directives (MDD 93/42/EEC, IVDD 98/79/EC, AIMDD 90/385/EEC), and the United States has not directly adopted ISO13485. However, experts involved in the development of the ISO13485 standard in the United States have confirmed that their QSR820 system is generally consistent with the requirements of ISO13485, so an organization that has passed the ISO13485 review will also easily meet and satisfy the requirements of the QSR820 system. China's Food and Drug Administration is to convert ISO13485 into YY/T0287, which is equivalent to adopting China's medical device quality management system. The current EU certification version is EN IS013485:2012+AC:2012.
The ISO International Organization for Standardization (ISO) officially released the new version of ISO13485:2016 on March 1, 2016.
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