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 §820.20. Each manufacturer shall ensure that the QSR is prepared and approved in accordance with § 820.40.
21 C.F.R. § 820.186