This table maps all requirements of the ISO 13485:2016 (by section) to the relevant documents.
Note that the document names in the “Fulfilled in Document” column are based on the OpenRegulatory templates. You’ll probably have a different system for assigning document names, so feel free to rename them.
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 | Control of Documents | SOP Document and Record Control |
| 4.2.5 | Control of Records | SOP Document and Record Control |
| 5.1 | Management Obligations | Quality Management Manual SOP Management Review |
| 5.2 | Client Orientation | SOP Update of Regulations and KPIs |
| 5.3 | Quality Policies | Quality Management Manual SOP Management Review |
| 5.4 | QMS Planning and Quality Goals | Quality Management Manual and KPIs SOP Management Review |
| 5.5 | Responsibilities, Competencies and Communication | Quality Management Manual |
| 5.6 | Management Review | SOP Management Review |
| 6.1 | Allocation of Resources | SOP Management Review and KPIs |
| 6.2 | Staff Resources | SOP Human Resources Administration |
| 6.3 | Infrastructure | SOP Software Validation |
| 6.4 | Work Environment | – not applicable – |
| 6.4.2 | Control of Contamination | – not applicable – |
| 7.1 | Planning of Product Development | SOP Integrated Software Development |
| 7.2 | Customer-Oriented 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 | Control of Surveillance and Measurement | 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 | SOP Feedback Management |
| 8.2.2 | Complaint Processing | SOP Feedback Management SOP Corrective and Preventive Actions |
| 8.2.3 | Reporting to Authorities | SOP Incident Reporting |
| 8.2.4 | Internal Audit | SOP Internal Auditing |
| 8.2.5 | Surveillance and Measurement of Processes | SOP Management Review |
| 8.2.6 | Surveillance and Measurement of Products | SOP Post-Market Surveillance |
| 8.3 | Control of Nonconforming Products | SOP Corrective and Preventive Actions SOP Incident Reporting |
| 8.4 | 8.4 Data Analysis | SOP Management Review |
| 8.5 | 8.5 Improvement: Corrective and Preventive Action | SOP Corrective and Preventive Actions |
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