ISO 13485, the latest version of the medical device quality system standard, was released in July 2003. It replaces both 1996 versions of ISO 13485 and ISO 13488, both of which became obsolete in July 2006. ISO 13485:2003 is structurally based on the widely recognized ISO 9001:2000 standard. However, some key differences in specific requirements limit the application of ISO 13485:2003 as a substitute for other quality management system standards.
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