Testing the interfaces between modules.
An IEC 62304 compliance checklist is typically structured around Clauses 5 through 9: Software Development Process (Clause 5): Define the development lifecycle, tools, and roles. Requirements Analysis: Iec 62304 Checklist Xls
| 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 | | Testing the interfaces between modules
35, 19.1, "Audit and internal review", Quality, "Plan and perform internal audits of software lifecycle processes", "Audit schedule, audit reports, corrective actions", "Findings closed within target", Not Started, QA Lead, , , Medium, "Audit and internal review"
| Clause | Activity / Work Product | Safety Class A | Safety Class B | Safety Class C | Evidence / Artifact | Status | Comments | |--------|------------------------|----------------|----------------|----------------|----------------------|--------|----------| | | Software development plan | Yes | Yes | Yes | Development plan document | | | | 4.4 | Software configuration management plan | Conditional | Yes | Yes | CM plan | | | | 5.1.1 | Software requirements specification | Yes | Yes | Yes | SRS document | | | | 5.1.2 | Analyze software requirements | Yes | Yes | Yes | Requirements review record | | | | 5.2.1 | Software architectural design | No | Yes | Yes | Architecture design doc | | | | 5.2.2 | Identify SOUP items | No | Yes | Yes | SOUP list & risk assessment | | | | 5.2.3 | Allocate requirements to software units | No | Yes | Yes | Traceability matrix | | | | 5.2.4 | Define interfaces | No | Yes | Yes | Interface specification | | | | 5.2.5 | Verify architecture | No | Yes | Yes | Architecture review report | | | | 5.3.1 | Software detailed design | No | Conditional | Yes | Detailed design doc | | | | 5.3.2 | Develop software units | No | Conditional | Yes | Code / models | | | | 5.3.3 | Verify detailed design & units | No | Conditional | Yes | Design/code reviews | | | | 5.4.1 | Software integration plan | No | Yes | Yes | Integration plan | | | | 5.4.2 | Integrate software units | No | Yes | Yes | Integration records | | | | 5.4.3 | Verify integration | No | Yes | Yes | Integration test report | | | | 5.5.1 | Software system test plan | Yes | Yes | Yes | System test plan | | | | 5.5.2 | Test software requirements | Yes | Yes | Yes | Test cases & results | | | | 5.5.3 | Document test results | Yes | Yes | Yes | Test report, issue log | | | | 5.6.1 | Prepare for software release | Yes | Yes | Yes | Release notes, version | | | | 5.6.2 | Deliver software | Yes | Yes | Yes | Delivery records | | | | 5.7.1 | Establish problem resolution process | Conditional | Yes | Yes | Issue tracking system | | | | 5.7.2 | Analyze & resolve problems | Conditional | Yes | Yes | Problem reports, change requests | | | | 5.7.3 | Track problems | Conditional | Yes | Yes | Problem resolution log | | | | 5.8 | Software configuration management | Conditional | Yes | Yes | Version control, baseline records | | | | 6 | Software maintenance process | Yes | Yes | Yes | Maintenance plan, change records | | | | 7 | Software risk management (see ISO 14971) | Yes | Yes | Yes | Risk management file | | | | 8 | Documentation (compliance evidence) | Yes | Yes | Yes | Document index, trace matrix | | | | Annex A | SOUP acceptance | No | Yes | Yes | SOUP validation report | | |
Analysis of software contributing to hazardous situations and risk control measures.