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    ISO-13485-blog

    Tag: “ISO 13485”

    List of mandatory documents required by ISO 13485:2016
    The new ISO 13485 is based on ISO 9001:2008, which means that the requirements for documentation are based on the...
    The new ISO 13485 is based on ISO 9001:2008, which means that the requirements for documentation are based on the requirements of the previous version of ISO 9001, with the addition of documents specific to...