Quality system record

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Sec. 820.186 Quality system record.

    Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including, but not limited to, the records required by Sec. 820.20. Each manufacturer shall ensure that the QSR is prepared and approved in accordance with Sec. 820.40.


For correct application of this information, see NOTE on Contents page