Title 21: Food and Drugs
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/ PART 820 - QUALITY SYSTEM REGULATION
/ Subpart M - Records / § 820.186 Quality system record.
§ 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 § 820.20. Each manufacturer shall ensure that the QSR is prepared and approved in accordance with § 820.40.