21 CFR 820.20: Management responsibility
Required executive management to set and communicate a quality policy, define organizational roles and resources, appoint a management representative, conduct documented periodic quality system reviews, and establish quality plans and procedures.
Part 820, Quality System Regulation · Subpart B, Quality System Requirements
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 820.20, from the 483s we hold.
Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals.Most used
Procedures for management review have not been adequately established.820.20(c)
Quality system procedures and instructions have not been established.820.20(e)
Cited over time
483s citing 820.20, by yearMost citations in 2024. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2024.
Recent 483s citing 820.20
- Seniorlife Technologies Inc · Bellevue, WashingtonQuality management system processes were not adequately managed… Feb 20, 2026
- ASEPTIKITS, LLC · North Salt Lake, UtahProcedures for management review have not been established… Dec 3, 2025
- Sterigenics UK Limited · —Procedures for management review have not been adequately established… Sep 25, 2025
- Sparsha Pharma Usa Inc · Oceanside, CaliforniaThe organizational structure has not been established and maintained to ensure that… Sep 4, 2025
- Coronado Aesthetics LLC · Dallas, TexasManagement with executive responsibility has not reviewed the suitability and… Aug 22, 2025
The regulation text
§ 820.20 Management responsibility. As published before it was replaced.
(a)Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.
(b)Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.
(1)Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
(2)Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.
(3)Management representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:
(i)Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and
(ii)Reporting on the performance of the quality system to management with executive responsibility for review.
(c)Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.
(d)Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.
(e)Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.
Questions
What does 21 CFR 820.20 require?
Required executive management to set and communicate a quality policy, define organizational roles and resources, appoint a management representative, conduct documented periodic quality system reviews, and establish quality plans and procedures.
How do FDA investigators word a 820.20 observation?
The most common opening is: “Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals.”
Which sections are cited alongside 820.20?
In the same 483s, investigators most often also cite 820.22 (Quality audit), 820.100 (Corrective and preventive action), 820.30 (Design controls), 820.198 (Complaint files).