After the International Organization for Standardization launched the ISO9000 series of standards, combined with the characteristics of medical devices in 1996 formally released the ISO13485-1996 "Quality System-Medical Devices-ISO9001 The application of the special requirements of the ISO9001. Since the ISO9001 standard has been formally upgraded to ISO9001:2000 on December 15, 2000, the abolition of ISO9002, so ISO/TC210 in March 2003 formally released ISO13485: 2003. from the strengthening of China's quality management of medical devices, to ensure the safety and effectiveness of medical devices, and to safeguard the people's health needs. According to the principle of equivalent adoption, the State Administration of Medicine will transform ISO13485:2003 into YY/T0287-2003 "Medical Device Quality Management System Requirements for Regulations", which will replace the original YY/T0287-1996 "Quality System-Medical Devices-GB/T19001" and "ISO9001 Application Specific Requirements".
ISO13485:2003 was published on September 17, 2003 and implemented on April 1, 2004, and will replace ISO13485:1996 "Quality System - Medical Devices - GB/T19001 - ISO9001 Application Specific Requirements". The special requirements for the application of GB/T19001-ISO9001".
ISO13485 is a stand-alone standard for quality management systems in the medical device industry and is not a guide to the implementation of ISO9001 in the medical device industry, and the two are not compatible. As a result, it has become the only independent quality management system standard for the medical device industry other than ISO9001:2000. This is a very important standard for the medical device industry.
ISO13485:2003 is based on ISO9001:2000, and adopts the structure of ISO9001 chapters and articles, as well as their main contents. However, since medical devices are directly related to human life and health, China and other countries around the world have formulated more laws and regulations for them than for other products, and put forward more stringent control requirements in order to achieve the main purpose of making medical devices safe and effective. For this reason, ISO13485:2003 divides the content of ISO9001:2000 into chapters and articles that present requirements and informative chapters and articles. The standard divides the content of changes to ISO13485:2003 into three categories: the first category is the deletion or revision of substantive requirements by deletion or major modification. The second category is to make changes to chapters and articles that make requirements by adding provisions. The third category is to make changes to the chapter or article that sets forth the requirements by adding information or cropping in order to bring it into compliance with the requirements of the medical device regulations.
Features of the new ISO 13485 standard for quality management of medical devices:
1. ISO 13485:2003 is an independent standard based on ISO 9001:2000.
2. ISO13485:2003 is a management standard suitable for the regulatory environment.
3. ISO 13485:2003 requires significantly more documentation than ISO 9001:2000.
4. ISO 13485:2003 defines the scope of medical devices more clearly.
5. ISO13485:2003 is more specialized.
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ISO13488 / EN46002 is a quality system for medical devices. It indicates that the Division has established a quality system in the production of electronic medical devices.
ISO13485 is the most accepted standard among medical device manufacturers worldwide (e.g., US, Japan, Canada, EU). The standard includes industry-specific requirements and defines additional terms such as medical device, active medical device, active implant device, and sterile medical device.
ISO 13485 supports organizations that manufacture or use medical products and services by helping them to reduce unanticipated risks. The system seeks to enhance a company's reputation in the eyes of customers and authoritative organizations.
ISO13485:2003 has been officially promulgated and will cancel and replace ISO13485:1996 and ISO13488:1996 (the Chinese equivalents of the medical device industry standards YY/T0287:1996 and YY/T0288:1996). China's equivalent medical device industry standard YY/T0287:2003 "medical device quality management system for regulatory requirements" (instead of YY/T0287:1996), also on September 17, 2003 by the State Food and Drug Administration formally released, the standard since April 1, 2004 onwards.
ISO13485:2003 is a stand-alone standard that can be used independently of ISO9001:2000 for companies operating solely in the medical products industry.