This table aligns the ISO 13485:2016 requirements by section with the corresponding documents.
The document titles listed in the “Fulfilled in Document” column are based on FdaToday templates. If you use a different system for naming documents, feel free to adjust these titles as needed.
ISO 13485:2016
| Section | Title | Document |
|---|---|---|
| 4.1 | General QMS Requirements | Quality Management Manual SOP Management Review SOP Purchasing SOP Software Validation |
| 4.2.1 | General Documentation Requirements | Quality Management Manual |
| 4.2.2 | Quality Management Manual | Quality Management Manual |
| 4.2.3 | Medical Device File | SOP Product Certification and Registration SOP Integrated Software Development |
| 4.2.4 | Document Control | SOP Document and Record Control |
| 4.2.5 | Records Control | SOP Document and Record Control |
| 5.1 | Management Responsibilities | Quality Management Manual SOP Management Review |
| 5.2 | Customer Focus | SOP Update of Regulations and KPIs |
| 5.3 | Quality Policy | Quality Management Manual SOP Management Review |
| 5.4 | QMS Planning and Objectives | Quality Management Manual and KPIs SOP Management Review |
| 5.5 | Roles, Responsibilities, and Communication | Quality Management Manual |
| 5.6 | Management Review | SOP Management Review |
| 6.1 | Resource Management | SOP Management Review and KPIs |
| 6.2 | Human Resources | SOP Human Resources Administration |
| 6.3 | Infrastructure | SOP Software Validation |
| 6.4 | Work Environment | - not applicable - |
| 6.4.2 | Contamination Control | - not applicable - |
| 7.1 | Product Development Planning | SOP Integrated Software Development |
| 7.2 | Customer-Related Processes | SOP Integrated Software Development SOP Feedback Management |
| 7.3 | Development | SOP Integrated Software Development SOP Product Certification and Registration SOP Change Management |
| 7.4 | Purchasing | SOP Purchasing |
| 7.5 | Production and Service Provision | SOP Integrated Software Development |
| 7.5.5 | Special Requirements for Sterile Medical Devices | - not applicable - |
| 7.5.9 | Traceability | SOP Product Certification and Registration |
| 7.6 | Monitoring and Measurement Control | SOP Post-Market Surveillance SOP Software Validation |
| 8.1 | General Measurement, Analysis, and Improvement | SOP Integrated Software Development SOP Internal Auditing SOP Management Review |
| 8.2.1 | Feedback Management | SOP Feedback Management |
| 8.2.2 | Complaint Handling | SOP Feedback Management SOP Corrective and Preventive Actions |
| 8.2.3 | Reporting to Authorities | SOP Incident Reporting |
| 8.2.4 | Internal Audits | SOP Internal Auditing |
| 8.2.5 | Process Surveillance and Measurement | SOP Management Review |
| 8.2.6 | Product Surveillance and Measurement | SOP Post-Market Surveillance |
| 8.3 | Nonconforming Product Control | SOP Corrective and Preventive Actions SOP Incident Reporting |
| 8.4 | Data Analysis | SOP Management Review |
| 8.5 | Corrective and Preventive Actions | SOP Corrective and Preventive Actions |