5/22/2023 0 Comments Iso 13485 vs iso 9001Like 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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