21 CFR part 820: FDA Requirements for QM Systems

Especially in the FDA-regulated (but also ISO-regulated) environment, companies are obliged to comply with the quality specifications, requirements and regulations. The requirements for the quality management system (QMS) cover a wide variety of areas, including production and process controls, corrective and preventive measures, product development and management responsibility. The 21 CFR part 820 can be seen as a counterpart to ISO 13485. However, the FDA does not recognize ISO 13485 certification as evidence of compliance with CFR part 820.

Part A: General requirements
Part B: Quality system requirements
Part C: Development Steering
Part D: Document control
Part E: Procurement
Part F: Identification and traceability
Part G: Production and process control
Part H: Acceptance measures
Part I: Faulty products
Part J: Corrective and preventive actions
Part K: Labelling and packaging controls
Part L: Handling, storage, distribution and installation
Part M: Records
Part N: Maintenance
Part O: Statistical techniques

DHC VISION Compliance Matrix for 21 CFR part 820

Request AreaDescription Solutions and Products
Part B: QMS requirements
§ 820.20 Management Responsibility
The quality policy, organisation, management review, quality planning and quality system procedures shall be ensured.· Process and Quality Management
· SOP Management
· Change Management
Part B: QMS requirements
§ 820.22 Quality Audit
The system documentation and revision and change control procedures by which time-based system changes can be documented must be controlled.· Process and Quality Management
· SOP Management
· Change Management
· Auditmanagement
· Training und Learning Success Management
Part B: QMS requirements
§ 820.25 Employees
Manufacturers must ensure that they have sufficient adequately trained staff. There shall be a procedure for identifying training needs. All training should be documented.· Process and Quality Management
· SOP Management
· Training und Learning Success Management
Part D: Document control
§ 820.40 Document Control
Each manufacturer shall establish and maintain procedures for the control of all required documents. The procedures shall ensure document release, distribution and modification.· Process and Quality Management
· SOP Management
· Change Management
Part I: Faulty products
§ 820.90 Faulty products.
Manufacturers of medical devices must establish and maintain product control procedures for products that do not meet regulatory requirements. The disposition of the defective product must be documented.· Process and Quality Management
· SOP Management
· CAPA-Management
· Deviation Management
· Complaint Management
· Training und Learning Success Management
Part J: Corrective and preventive actions
§ 820,100 corrective and preventive actions.
The introduction and maintenance of non-conformity and corrective and preventive measures is necessary. Nonconformity should be investigated and documented. Corrective and preventive actions should be identified. Corrective actions must be validated and become valid.· Process and Quality Management
· SOP Management
· CAPA-Management
· Deviation Management
· Complaint Management
· Training und Learning Success Management
Part M: Records
§ 820.198 Reclamation protocols
Each manufacturer must maintain a complaint file. Procedures for receiving, reviewing and evaluating complaints shall be established and maintained by a formally notified Body.· Process and Quality Management
· SOP Management
· CAPA-Management
· Deviation Management
· Complaint Management
· Training und Learning Success Management