The full name of the ISO 13485: 2003 standard is "Medical device-Quality management system-requirements for regulatory". The standard developed by the SCA / TC221 Medical Device Quality Management and General Requirements Standardization Technical Committee is based on the ISO 9001: 2000 independent standard. The standard specifies the quality management system requirements for the relevant organization, but is not a guideline for the implementation of the ISO 9001 standard in the medical device industry.
The standard since 1996, has been widely implemented around the world and applications, the new version of ISO13485 standard in July 3, 2003 officially released. In contrast to the ISO 9001: 2000 standard, ISO 13485: 2003 is a regulatory standard that applies to regulatory environments: it is clearly defined as a quality management system requirement for regulations. Medical equipment in the international market is not only the general merchandise in the commercial environment to run, it also subject to national and regional laws and regulations, such as the US FDA, the European Union MDD (European Medical Device Directive), China's "medical Equipment supervision and management regulations. " Therefore, the standard must be legally binding, in the regulatory environment to run, and must take full account of the risk of medical device products, medical products in the whole process of implementing risk management. So in addition to special requirements, it can be said that ISO13485 is actually a medical device under the regulatory environment of ISO9001.
The ISO 9001, EN 46001 or ISO 13485 quality assurance systems are widely used in the United States, Canada and Europe, and the quality assurance system for medical devices is based on these standards. Medical devices entering the market in North America, Europe, or Asia should comply with applicable regulatory requirements.
The standard since 1996, has been widely implemented around the world and applications, the new version of ISO13485 standard in July 3, 2003 officially released. In contrast to the ISO 9001: 2000 standard, ISO 13485: 2003 is a regulatory standard that applies to regulatory environments: it is clearly defined as a quality management system requirement for regulations. Medical equipment in the international market is not only the general merchandise in the commercial environment to run, it also subject to national and regional laws and regulations, such as the US FDA, the European Union MDD (European Medical Device Directive), China's "medical Equipment supervision and management regulations. " Therefore, the standard must be legally binding, in the regulatory environment to run, and must take full account of the risk of medical device products, medical products in the whole process of implementing risk management. So in addition to special requirements, it can be said that ISO13485 is actually a medical device under the regulatory environment of ISO9001.
The ISO 9001, EN 46001 or ISO 13485 quality assurance systems are widely used in the United States, Canada and Europe, and the quality assurance system for medical devices is based on these standards. Medical devices entering the market in North America, Europe, or Asia should comply with applicable regulatory requirements.
