Iec 62304 Checklist Xls

Iec 62304 Checklist Xls Review

| Clause | Requirement | Class A | Class B | Class C | Status | Evidence / Artifact | Date | | :--- | :--- | :---: | :---: | :---: | :--- | :--- | :--- | | | Software development plan | ✔ | ✔ | ✔ | | Plan document | | | 5.1.1 | Define software requirements | ✔ | ✔ | ✔ | | SRS document | | | 5.1.2 | Analyze software requirements for risk | ✘ | ✔ | ✔ | | Risk assessment | | | 5.1.3 | Define architecture | ✘ | ✔ | ✔ | | Architecture design | | | 5.1.4 | Detailed design (units) | ✘ | ✘ | ✔ | | Detailed design spec | | | 5.1.5 | Implement units | ✔ | ✔ | ✔ | | Code / components | | | 5.1.6 | Verify units (unit testing) | ✘ | ✔ | ✔ | | Unit test report | | | 5.1.7 | Integrate software | ✔ | ✔ | ✔ | | Integration plan | | | 5.1.8 | Verify integration | ✘ | ✔ | ✔ | | Integration test | | | 5.1.9 | System testing | ✔ | ✔ | ✔ | | System test report | | | 5.2 | Maintenance process | ✔ | ✔ | ✔ | | Maintenance plan | | | 5.3 | Problem resolution | ✔ | ✔ | ✔ | | Issue tracking log | | | 5.4 | Configuration management | ✔ | ✔ | ✔ | | CM plan / tool | | | 5.5 | Change control | ✔ | ✔ | ✔ | | Change request log | |

of the checklist (e.g., Clause 5: Development). Explain SOUP management in more detail for your XLS. Compare requirements between Class B and Class C. Iec 62304 Checklist Xls

| Process Area | Clause | Requirement Name | Class A | Class B | Class C | | :--- | :--- | :--- | :--- | :--- | :--- | | | 4.1 | Software Development Plan | Required | Required | Required | | Documentation | 5.1 | Software Requirements Specification (SRS) | Required | Required | Required | | Architecture | 5.2 | Software Architectural Design | Required | Required | Required | | Architecture | 5.3 | Software Detailed Design | Not Required | Required | Required | | Implementation | 5.4 | Implementation (Source Code) | Required | Required | Required | | V&V | 5.5 | Unit Testing | Not Required | Required | Required | | V&V | 5.6 | Integration Testing | Required | Required | Required | | V&V | 5.7 | System Testing | Required | Required | Required | | Release | 5.8 | Software Release | Required | Required | Required | | Maintenance | 6.1 | Maintenance Plan | Required | Required | Required | | Config Mgmt | 8.1 | Configuration Management Plan | Required | Required | Required | | Clause | Requirement | Class A |

A useful checklist should cover the following primary and supporting lifecycle processes defined by the standard: | Process Area | Clause | Requirement Name

Iec 62304 Checklist Xls