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 Area Description 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