21 C.F.R. § 820.186 Quality system record.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 820—QUALITY SYSTEM REGULATION
Subpart M—Records
§ 820.186 Quality system record.
