Important notice regarding the matrix – it refers to the current FDA QSR 21CFR 820 and not to one to come.
| FDA-QSR-21CFR-820 | ISO 13485 |
| § 820.1 – Scope. | 1 Scope |
| 820.5 Quality System | 4.1.1 Quality management system, General requirements |
| 820.20(a) Quality Policy | 5.3 Quality Policy 5.4.1 Quality Objectives |
| 820.20(b) Organization | 5.5.1 Responsibility and Authority |
| 820.20(b)(1) Responsibility and Authority | 5.5.1 Responsibility and Authority |
| 820.20(b)(2) Resources | 6.1 Provision of Resources |
| 820.20(b)(3) Management Representative | 5.5.2 Management Representative |
| 820.20(c) Management Review | 5.6 Management Review 5.6.1 General 5.6.2 Review Input 5.6.3 Review Output |
| 820.20(d) Quality Planning | 5.4.2 Quality Management System Planning |
| 820.20(e) Quality System Procedures | 4.2 Documentation Requirements 4.2.1 General 4.2.2 Quality Manual |
| 820.22 Quality Audit | 8.2.4 Internal Audit |
| 820.25(a) Personnel, General | 6.1 Provision of Resources 6.2 Human Resources |
| 820.25(b) Personnel, Training | 6.2 Human Resources 6.4.1(b) Work Environment |
| 820.30(a) Design Controls, General | 7.3.1 General |
| 820.30(b) Design and Development Planning | 7.3.2 Design and development planning |
| 820.30(c) Design Input | 7.3.3 Design and development inputs |
| 820.30(d) Design Output | 7.3.4 Design and development outputs |
| 820.30(e) Design Review | 7.3.5 Design and development review |
| 820.30(f) Design Verification | 7.3.6 Design and development verification |
| 820.30(g) Design Validation | 7.3.7 Design and development validation |
| 820.30(h) Design Transfer | 7.3.8 Design and development transfer |
| 820.30(i) Design Changes | 7.3.9 Control of design and development changes |
| 820.30(j) Design History File | 7.3.10 Design and development files |
| 820.40 Document Controls | 4.2.4 Control of documents 4.2.5 Control of records |
| 820.40(a) Document approval and distribution | 4.2.4 Control of documents 4.2.5 Control of records |
| 820.40(b) Document Changes | 4.2.4 Control of documents |
| 820.50 Purchasing Controls | 4.1.5 QMS General Requirements 7.4.1 Purchasing process |
| 820.50(a) Evaluation of Suppliers, Contractors, and Consultants |
7.4.1 Purchasing process |
| 820.50(b) Purchasing Data | 7.4.2 Purchasing information |
| 820.60 Identification | 7.5.8 Identification |
| 820.65 Traceability | 7.5.9 Traceability 7.5.9.1 General |
| 820.70(a) Production and Process Controls, General |
7.5.1 Control of Production and Service Provision |
| 820.70(b) Production and Process Changes | 4.1.4 Quality Management System |
| 820.70(c) Environmental Control | 6.4.1 Work environment |
| 820.70(d) Personnel | 6.4.1 Work environment |
| 820.70(e) Contamination Control | 6.4.2 Contamination control |
| 820.70(f) Buildings | 6.3 Infrastructure |
| 820.70(g) Equipment | 6.3 Infrastructure 7.5.1 Control of production and service provision |
| 820.70(h) Manufacturing Material | 7.5.2 Cleanliness of Product |
| 820.70(i) Automated Processes | 4.1.6 QMS General Requirements 7.5.6 Validation of processes for production and service provision 7.6 Control of monitoring and measuring equipment |
| 820.72(a) Control of Inspection, Measuring, and Test Equipment |
7.6 Control of monitoring and measuring equipment |
| 820.72(b) Calibration | 7.6 Control of monitoring and measuring equipment |
| 820.75(a) Process Validation | 7.5.6 Validation of processes for production and service provision 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems |
| 820.75(b) Process Validation | 8.2.5 Monitoring and measurement of processes |
| 820.75(c) Process Validation | 4.1.4 QMS General Requirements 7.5.6 Validation of processes for production and service provision 8.2.5 Monitoring and measurement of processes |
| 820.80(a) Receiving, in-process, and finished device acceptance, General |
7.1 Planning of product realization 8.2.6 Monitoring and measurement of product |
| 820.80(b) Receiving Acceptance Activities | 7.4.3 Verification of purchased product |
| 820.80(c) In-Process Acceptance Activities | 7.5.10 Customer property 8.2.6 Monitoring and measurement of product |
| 820.80(d) Final Acceptance Activities | 7.5.10 Customer property 8.2.6 Monitoring and measurement of product |
| 820.80(e) Acceptance Records | 4.2.5 Control of records 7.1 Planning of product realization 8.2.6 Monitoring and measurement of product |
| 820.86 Acceptance status | 7.5.8 Identification |
| 820.90(a) Control of Nonconforming Product | 8.3 Control of nonconforming product 8.3.1 General |
| 820.90(b) Nonconformity Review and Disposition | 8.3.2 Actions in response to nonconforming product detected before delivery 8.3.3 Actions in response to nonconforming product detected after delivery 8.3.4 Rework |
| 820.100(a) Corrective and Preventive Action | 8.4 Analysis of data 8.5 Improvement 8.5.1 General 8.5.2 Corrective Action 8.5.3 Preventive Action |
| 820.100(b) Corrective and Preventive Action | 8.5.2 Corrective Action 8.5.3 Preventive Action |
| 820.120 Device Labeling | 7.5.1 Control of production and service provision |
| 820.120(a) Label Integrity | 7.5.1 Control of production and service provision 7.5.11 Preservation of product |
| 820.120(b) Labeling Inspection | 7.4.3 Verification of purchased product 7.5.1 Control of production and service provision 8.2.6 Monitoring and measurement of product |
| 820.120(c) Labeling Storage | 6.4.1 Work environment 7.5.1 Control of production and service provision |
| 820.120(d) Labeling Operations | 7.5.1 Control of production and service provision 4.2.3 Medical device file |
| 820.120(e) Control Number | 7.5.8 Identification 7.5.9.2 Particular requirements for implantable medical devices |
| 820.130 Device Packaging | 7.3 Design and development 7.5.1 Control of production and service provision 7.5.11 Preservation of product |
| 820.140 Handling | 7.5.11 Preservation of product |
| 820.150(a) Storage | 7.5.11 Preservation of product |
| 820.150(b) Storage | No ISO 13485:2016 standard specific requirement. |
| 820.160(a) Distribution | 7.2.1 Determination of requirements related to product 7.2.2 Review of requirements related to product 7.5.1 Control of production and service provision |
| 820.160(b) Distribution | 7.5.9.2 Particular requirements for implantable medical devices |
| 820.170(a) Installation | 7.5.3 Installation activities |
| 820.170(b) Installation | 7.5.3 Installation activities |
| 820.180 General Requirements | 4.2.5 Control of records |
| 820.180(a) Confidentiality | 4.2.5 Control of records |
| 820.180(b) Record Retention Period | 4.2.4 Control of documents 4.2.5 Control of records |
| 820.180(c) Exceptions | No ISO 13485:2016 standard specific requirement. |
| 820.181 Device Master Record | 4.2.3 Medical device file |
| 820.184 Device History Record | 7.5.1 Control of production and service provision |
| 820.186 Quality System Record | 4.2.5 Control of records |
| 820.198(a) Complaint Files | 8.2.2 Complaint handling |
| 820.198(b) Complaint Files | 8.2.2 Complaint handling |
| 820.198(c) Complaint Files | 8.2.2 Complaint handling |
| 820.198(d) Complaint Files | 8.2.3 Reporting to regulatory authorities |
| 820.198(e) Complaint Files | 8.2.2 Complaint handling 7.2.3 Communication |
| 820.198(f) Complaint Files | 8.2.2 Complaint handling |
| 820.198(g) Complaint Files | 8.2.2 Complaint handling |
| 820.200(a) Servicing | 7.5.4 Servicing activities |
| 820.200(b) Servicing | 7.5.4 Servicing activities 8.1 Measurement, analysis, and improvement, General |
| 820.200(d) Servicing | 7.5.4 Servicing activities |
| 820.200(e) Servicing | 7.5.4 Servicing activities |
| 820.250(a) Statistical Techniques | 8.1 Measurement, analysis and improvement, General |
| 820.250(b) Statistical Techniques | 7.5.6 Validation of processes for production and service provision 8.1 Measurement, analysis and improvement, General |
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