The full name of ISO13485:2003 standard is "Medical device-Quality management system-requirements for regulatory" (Medical device-Quality management system-requirements for regulatory). The standard was developed by SCA/TC221 Technical Committee for Standardization of Quality Management and General Requirements for Medical Devices, and is an independent standard based on ISO9001:2000. The standard specifies quality management system requirements for relevant organizations, but is not a guide to the implementation of the ISO9001 standard in the medical device industry.
Since its release in 1996, the standard has been widely implemented and used around the world, and a new version of the ISO 13485 standard was released on July 3, 2003, officially. Unlike the ISO9001:2000 standard, ISO13485:2003 is a management standard for use in a regulatory environment: from its name it is clear that it is a quality management system requirement for regulatory use. Medical devices in the international are not only general listed commodities operating in a commercial environment, it is also subject to the supervision and management of national and regional laws and regulations, such as the U.S. FDA, the European Union's MDD (European Union Medical Devices Directive), China's "Regulations for the Supervision and Administration of Medical Devices". Therefore, the standard must be bound by law and operate in a regulatory environment, and at the same time, it must give full consideration to the risks of medical device products and require risk management in the whole process of medical device product realization. Therefore, in addition to the specialized requirements, it can be said that ISO13485 is actually ISO9001 in the medical device regulatory environment.
The United States, Canada and Europe generally to ISO 9001,, EN 46001 or ISO 13485 as the requirements of the quality assurance system, the establishment of the medical device quality assurance system are 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.
An internal audit, sometimes referred to as a first-party audit, is conducted by or on behalf of the organization to verify that the organization's management system continues to meet the specified requirements and is functioning. It provides information for effective management review and corrective and preventive action, and its purpose is to confirm that the organization's management system is operating effectively and can be used as the basis for the organization's declaration of self-conformity. In many cases, particularly in small organizations, it can be performed by personnel who have no responsibility for the activities being audited to confirm independence.