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    ISO-13485-blog

    Tag: “QMS”

    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...
    Infographic: What’s new in the 2016 revision of ISO 13485
    To get a better overview of the relationship between ISO 9001 and ISO 13485, see this article: ISO 9001 vs....
    To get a better overview of the relationship between ISO 9001 and ISO 13485, see this article: ISO 9001 vs. ISO 13485.   The new 2016 revision of ISO 13485, the leading international standard for...