CROSSWALK
Part 820 → ISO 13485 Clause Crosswalk
Requirement-by-requirement mapping between FDA Part 820 and the QMSR ISO 13485 foundation — what changed, what maps directly, and where gaps appear.
Design Controls
| Legacy Part 820 Ref (pre-QMSR) | ISO 13485 Clause | Requirement | Common 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) | 7.3.9 | Design Changes | 5 | View → |
| §820.30(h) | 7.3.8 | Design Transfer | 4 | View → |
| §820.30(j) | 7.3 | Design History File (DHF) | 5 | View → |
Management Responsibility
Measurement & Improvement
| Legacy Part 820 Ref (pre-QMSR) | ISO 13485 Clause | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| §820.100 | 8.5.2, 8.5.3 | Corrective and Preventive Action (CAPA) | 5 | View → |
| §820.198 | 8.2.2 | Complaint Handling | 5 | View → |
| §820.180 | 8.2.4 | Internal Audit | 5 | View → |
| §820.90 | 8.3 | Nonconforming Product | 5 | View → |
| §N/A (no direct Part 820 equivalent; cf. §820.198 Complaint files) | 8.2.1 | Feedback / Post-Market Surveillance | 3 | View → |
| §21 CFR Part 803 (MDR) | 8.2.3 | Regulatory Reporting | 5 | View → |
| §820.250 | 8.4 | Analysis of Data | 5 | View → |
Product Realization
Production Controls
| Legacy Part 820 Ref (pre-QMSR) | ISO 13485 Clause | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| §820.75 | 7.5.6 | Process Validation | 5 | View → |
| §820.120 | 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 | 8.2.6, 7.4.3 | Acceptance Activities — Receiving, In-Process, and Finished Device Release | 5 | View → |
Production and Service Provision
| Legacy Part 820 Ref (pre-QMSR) | ISO 13485 Clause | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| §820.70(e) | 7.5.2 | Cleanliness of Product | 3 | View → |
| §820.170 | 7.5.3 | Installation Activities | 3 | View → |
| §820.200 | 7.5.4 | Servicing Activities | 3 | View → |
| §820.184 | 7.5.5 | Particular Requirements for Sterile Medical Devices | 3 | View → |
| §820.75 | 7.5.7 | Particular Requirements for Validation of Processes for Sterilization and Sterile Barrier Systems | 3 | View → |
| §no equivalent | 7.5.10 | Customer Property | 3 | View → |
Quality Management System
| Legacy Part 820 Ref (pre-QMSR) | ISO 13485 Clause | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| §820.40 | 4.2.4 | Document Control | 5 | View → |
| §820.181 | 4.2.3 | Medical Device File | 4 | View → |
| §820.186 | 4.2.1, 4.2.2 | Quality Manual | 5 | View → |
| §820.70(b) | 4.1.4 | Control of Changes to QMS Processes | 4 | View → |
| §820.70(i) | 4.1.6 | Validation of Computer Software Used in the QMS | 5 | View → |
Quality System
Resource Management
| Legacy Part 820 Ref (pre-QMSR) | ISO 13485 Clause | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| §820.25 | 6.2 | Human Resources / Training | 5 | View → |
| §820.70(g) | 6.3 | Infrastructure and Equipment Maintenance | 5 | View → |
| §820.70(c), 820.70(e) | 6.4 | Work Environment and Contamination Control | 5 | View → |
| §820.72 | 7.6 | Calibration — Control of Monitoring and Measuring Equipment | 5 | View → |
Other standards
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