CROSSWALK

Part 820 → ISO 13485 Clause Crosswalk

A complete requirement-by-requirement mapping between the old FDA Quality System Regulation and the QMSR's ISO 13485 foundation. See what changed, what maps directly, and where the gaps tend to appear.

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Design Controls

Part 820 Ref	ISO 13485 Clause	Requirement	Details
§820.30(b)	ISO 13485 7.3.2	Design and Development Planning	View →
§820.30(c)	ISO 13485 7.3.3	Design and Development Inputs	View →
§820.30(e)	ISO 13485 7.3.5	Design and Development Review	View →
§820.30(d)	ISO 13485 7.3.4	Design Outputs	View →
§820.30(f)	ISO 13485 7.3.6	Design Verification	View →
§820.30(g)	ISO 13485 7.3.7	Design Validation	View →
§820.30(i)	ISO 13485 7.3.8 / 7.3.9	Design Changes	View →
§820.30(h)	ISO 13485 7.3.9	Design Transfer	View →
§820.30(j)	ISO 13485 7.3	Design History File (DHF)	View →

Management Responsibility

Part 820 Ref	ISO 13485 Clause	Requirement	Details
§820.20	ISO 13485 5.6	Management Review	View →
§820.20	ISO 13485 5.3	Quality Policy	View →

Measurement & Improvement

Part 820 Ref	ISO 13485 Clause	Requirement	Details
§820.90/820.198	ISO 13485 8.5.2/8.5.3	Corrective and Preventive Action (CAPA)	View →
§820.198	ISO 13485 8.2.2	Complaint Handling	View →
§820.180 (now inspectable)	ISO 13485 8.2.4	Internal Audit	View →
§820.90	ISO 13485 8.3	Nonconforming Product	View →
§820.198	ISO 13485 8.2.1	Feedback / Post-Market Surveillance	View →
§820.198	ISO 13485 8.2.3	Regulatory Reporting	View →
§820.250	ISO 13485 8.4	Analysis of Data	View →

Product Realization

Part 820 Ref	ISO 13485 Clause	Requirement	Details
§820.50	ISO 13485 7.4	Supplier Management	View →
§820.20(d)	ISO 13485 7.1	Product Realization Planning and Quality Plan	View →
§820.198 / 820.100	ISO 13485 7.2	Customer Requirements and Communication	View →

Production Controls

Part 820 Ref	ISO 13485 Clause	Requirement	Details
§820.75	ISO 13485 7.5.6	Process Validation	View →
§820.45	ISO 13485 7.5.1	Labeling Controls	View →
§820.70	ISO 13485 7.5.1	Production Process Controls and Work Instructions	View →
§820.60 / 820.65	ISO 13485 7.5.8 / 7.5.9	Product Identification and Traceability	View →
§820.130 / 820.140 / 820.150	ISO 13485 7.5.11	Product Preservation — Handling, Packaging, and Storage	View →
§820.181 / 820.184	ISO 13485 4.2.3	Device Master Record (DMR) and Device History Record (DHR)	View →
§820.80 / 820.86	ISO 13485 8.2.4 / 7.4.3	Acceptance Activities — Receiving, In-Process, and Finished Device Release	View →

Quality Management System

Part 820 Ref	ISO 13485 Clause	Requirement	Details
§820.40	ISO 13485 4.2.4	Document Control	View →
§820.186	ISO 13485 4.2.1 / 4.2.2	Quality Manual	View →

Quality System

Part 820 Ref	ISO 13485 Clause	Requirement	Details
§820.35	ISO 13485 4.2.5	Records Control	View →
§820.184	ISO 13485 4.2.3 / 4.2.5	Control of Records	View →

Resource Management

Part 820 Ref	ISO 13485 Clause	Requirement	Details
§820.25	ISO 13485 6.2	Human Resources / Training	View →
§820.70(g)	ISO 13485 6.3	Infrastructure and Equipment Maintenance	View →
§820.70(c)(d)	ISO 13485 6.4	Work Environment and Contamination Control	View →
§820.72	ISO 13485 7.6	Calibration — Control of Monitoring and Measuring Equipment	View →

Risk Management

Part 820 Ref	ISO 13485 Clause	Requirement	Details
§820.30(g)	ISO 13485 7.1	Risk Management	View →

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