21 CFR Part 820 – Quality System Regulation (QSR)

This topic is part of the SG Systems Global regulatory glossary series.

Updated October 2025 • FDA / QSR • Medical Devices

21 CFR Part 820 defines the Quality System Regulation (QSR) for medical device manufacturers. It establishes the framework for design, production, installation, and servicing controls to ensure devices consistently meet safety and performance requirements. It aligns closely with ISO 13485 and incorporates many of the same quality management principles.

“Part 820 ensures medical devices are designed and manufactured under a controlled system that prioritizes patient safety, performance, and traceability.”

1) What It Is

Part 820 requires device manufacturers to establish and maintain a formal Quality Management System (QMS) with documented processes for design, production, testing, and complaint handling. It encompasses management responsibility, design controls, document control, production and process validation, CAPA, and traceability requirements throughout the product lifecycle.

Scope & applicability. Applies to domestic and foreign manufacturers of finished medical devices intended for U.S. markets. Components and contract manufacturers may also be covered if their work affects device quality.

Core subparts and requirements:

• Subpart A – General Provisions. Defines scope, definitions, and quality policy obligations.
• Subpart B – Quality System Requirements. Requires a defined QMS, management review, internal audits, and trained personnel.
• Subpart C – Design Controls. Establishes structured design planning, verification, validation, risk management, and design history files (DHF).
• Subpart D – Document Controls. Procedures for document approval, revision, and retention.
• Subpart E – Purchasing Controls. Supplier evaluation, quality agreements, and incoming inspection verification.
• Subpart F – Identification and Traceability. Lot and component-level traceability from design through distribution.
• Subpart G – Production and Process Controls. Process validation, equipment qualification, environmental monitoring, and contamination control.
• Subpart H – Acceptance Activities. Inspections, tests, and approvals before release.
• Subpart I – Nonconforming Product. Procedures for segregation, review, and disposition of nonconforming material.
• Subpart J – Corrective and Preventive Action (CAPA). Systems for identifying, investigating, and resolving quality issues.
• Subpart M – Records. Device History Record (DHR), Device Master Record (DMR), and complaint files retention.

Authoritative references. Regulation text: 21 CFR Part 820 (eCFR). Related frameworks include ISO 13485, ICH Q10, and Part 11.

2) FAQ

Q1. What’s the purpose of the QSR?
To ensure medical devices are consistently designed and manufactured to meet quality, safety, and performance specifications.

Q2. How does Part 820 differ from ISO 13485?
Both share similar principles. ISO 13485 is international, while Part 820 is a U.S. regulatory requirement enforced by FDA inspections.

Q3. What are design controls?
Procedures that govern planning, design inputs/outputs, verification, validation, and risk management before production begins.

Q4. What records are required?
Device Master Record (DMR), Device History Record (DHR), and Design History File (DHF) documenting each product’s lifecycle.

Q5. How does CAPA fit in?
CAPA identifies root causes of nonconformances, implements corrective/preventive actions, and verifies their effectiveness.

Q6. Does Part 11 apply to device manufacturers?
Yes—Part 11 governs electronic record integrity and e-signatures in QSR systems such as DHR, CAPA, and complaint handling.

Q7. What is the FDA’s “QMSR” update?
The FDA is harmonizing Part 820 with ISO 13485 under the new Quality Management System Regulation (QMSR) expected to replace QSR in coming years.

Q8. Where can I read the rule?
Full text available at eCFR Part 820.

3) How It Relates to V5

V5 by SG Systems Global supports Part 820 and ISO 13485 compliance by integrating design, manufacturing, and quality processes into a unified digital environment with full traceability.

• Design & document control. Manage DHFs, DMRs, and revisions within controlled, validated environments using QMS tools.
• Manufacturing execution. MES enforces process validation, in-process checks, and e-signature controls.
• Device history records. Generate and archive eDHRs that capture each lot’s production and inspection data.
• CAPA integration. QMS tracks nonconformances, investigations, and effectiveness checks with audit trails.
• Supplier & calibration control. Manage equipment qualification and supplier status across lifecycle events using linked V5 Connect API.
• Regulatory readiness. All manufacturing, testing, and quality data are linked in inspection-ready electronic records compliant with Part 11.

End-to-end example. A medical device company uses QMS to manage design changes, MES to control assembly, and eDHR to document production. CAPA investigations feed back into design control—providing complete lifecycle traceability for audits and FDA inspections.

Primary References:
• FDA eCFR: 21 CFR Part 820
• ISO Alignment: ISO 13485
• Future Rule: ICH Q10 / QMSR Harmonization