21 CFR 820.186 - Quality system record.

Regulations last checked for updates: Mar 13, 2025

Title 21 - Food and Drugs last revised: Feb 25, 2025

View all text of Subpart M [§ 820.180 - § 820.198]

§ 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.

authority: 21 U.S.C. 351,352,360,360c,360d,360e,360h,360i,360j,360l,371,374,381,383; 42 U.S.C. 216,262,263a,264

source: 61 FR 52654, Oct. 7, 1996, unless otherwise noted.

cite as: 21 CFR 820.186