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.
Design Controls
| Part 820 Ref | ISO 13485 Clause | Requirement | Gaps | Details |
|---|---|---|---|---|
| §820.30(b) | 7.3.2 | Design and Development Planning | 5 | View → |
| §820.30(c) | 7.3.3 | Design and Development Inputs | 5 | View → |
| §820.30(e) | 7.3.5 | Design and Development Review | 5 | View → |
| §820.30(d) | 7.3.4 | Design Outputs | 5 | View → |
| §820.30(f) | 7.3.6 | Design Verification | 5 | View → |
| §820.30(g) | 7.3.7 | Design Validation | 5 | View → |
| §820.30(i) | 7.3.8 / 7.3.9 | Design Changes | 5 | View → |
| §820.30(h) | 7.3.9 | Design Transfer | 4 | View → |
| §820.30(j) | 7.3 | Design History File (DHF) | 5 | View → |
Management Responsibility
Measurement & Improvement
| Part 820 Ref | ISO 13485 Clause | Requirement | Gaps | Details |
|---|---|---|---|---|
| §820.90/820.198 | 8.5.2/8.5.3 | Corrective and Preventive Action (CAPA) | 5 | View → |
| §820.198 | 8.2.2 | Complaint Handling | 5 | View → |
| §820.180 (now inspectable) | 8.2.4 | Internal Audit | 5 | View → |
| §820.90 | 8.3 | Nonconforming Product | 5 | View → |
| §820.198 | 8.2.1 | Feedback / Post-Market Surveillance | 3 | View → |
| §820.198 | 8.2.3 | Regulatory Reporting | 5 | View → |
| §820.250 | 8.4 | Analysis of Data | 5 | View → |
Product Realization
Production Controls
| Part 820 Ref | ISO 13485 Clause | Requirement | Gaps | Details |
|---|---|---|---|---|
| §820.75 | 7.5.6 | Process Validation | 5 | View → |
| §820.45 | 7.5.1 | Labeling Controls | 5 | View → |
| §820.70 | 7.5.1 | Production Process Controls and Work Instructions | 5 | View → |
| §820.60 / 820.65 | 7.5.8 / 7.5.9 | Product Identification and Traceability | 5 | View → |
| §820.130 / 820.140 / 820.150 | 7.5.11 | Product Preservation — Handling, Packaging, and Storage | 5 | View → |
| §820.181 / 820.184 | 4.2.3 | Device Master Record (DMR) and Device History Record (DHR) | 5 | View → |
| §820.80 / 820.86 | 8.2.4 / 7.4.3 | Acceptance Activities — Receiving, In-Process, and Finished Device Release | 5 | View → |
Quality Management System
Quality System
Resource Management
Risk Management
| Part 820 Ref | ISO 13485 Clause | Requirement | Gaps | Details |
|---|---|---|---|---|
| §820.30(g) | 7.1 | Risk Management | 5 | View → |
Other standards
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