21 CFR 820.186: Quality system record
Required manufacturers to maintain a quality system record containing or pointing to procedures and activity documentation not specific to any one device type, such as management responsibility records, prepared and approved under document controls.
Part 820, Quality System Regulation · Subpart M, Records
Most device 483s cite the Quality System Regulation in force before February 2, 2026, when the QMSR replaced it. Those sections are marked Former.
How FDA words it
The opening lines investigators use most when they cite 820.186, from the 483s we hold.
The quality system record has not been adequately maintained.Most used
Recent 483s citing 820.186
- GLAND PHARMA LIMITED · Hyderabad, Telangana, IndiaThe quality system record has not been adequately maintained… Aug 26, 2023
- Helio USA Inc · San Jose, CaliforniaThe quality system record has not been adequately maintained… Jul 6, 2016
- Helio USA Inc. · San Jose, CaliforniaThe quality system record has not been adequately maintained… May 12, 2015
- Masimo Corporation · Irvine, CaliforniaProcedures for receiving, reviewing, and evaluating complaints by a formally… Oct 3, 2013
The regulation text
§ 820.186 Quality system record. As published before it was replaced.
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.
Questions
What does 21 CFR 820.186 require?
Required manufacturers to maintain a quality system record containing or pointing to procedures and activity documentation not specific to any one device type, such as management responsibility records, prepared and approved under document controls.
How do FDA investigators word a 820.186 observation?
The most common opening is: “The quality system record has not been adequately maintained.”
Which sections are cited alongside 820.186?
In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.198 (Complaint files), 820.30 (Design controls), 820.150 (Storage).