One major distinction of ISO 13485 is that it is intended to also be required for regulatory purposes as well as a non-statutory requirement for a quality management system. Just like these other standards, ISO 13485 includes the entire ISO 9001 standard with additional requirements included in blue italics text. Like many other quality management system requirements for special purposes (such as IATF 16949 for automotive production and service parts and AS9100 for use by aviation, space and defense organizations), the ISO 13485 standard is based on the requirements of ISO 9001. ISO 13485 is the international standard requirement for a medical device quality management system. Note: This article was updated according to the ISO 13485:2016 revision.
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