# Common base Audit checklist for IEC62304 Class B products
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# This checklist is not a substitute for reading, understanding, and implementing the associated standard.
# The descriptive phrase following each keyword reference is intended only as a helpful mnemonic for locating
# and recalling the referenced section of the standard.
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include 62304_base_class_a
62304:5.1.5 Software Integration and Integration Testing Planning
62304:5.1.10 Supporting items to be controlled
62304:5.1.11 Software configuration item control before verification
62304:5.2.3 Include Risk Control Measures in Software Requirements
62304:5.3.1 Transform software requirements into an architecture
62304:5.3.2 Develop an architecture for the interfaces of software items
62304:5.3.3 Specify functional and performance requirements of SOUP item
62304:5.3.4 Specify system hardware and software required by SOUP item
62304:5.3.6.a Verify Software Architecture: risk control
62304:5.3.6.b Verify Software Architecture: interfaces
62304:5.3.6.c Verify Software Architecture: SOUP items
62304:5.4.1 Refine software architecture into software units
62304:5.5.2 Establish Software Unit Verification Process
62304:5.5.3 Software Unit Acceptance Criteria
62304:5.5.5 Software Unit Verification
62304:5.6.1 Integrate software units
62304:5.6.6 Conduct regression tests
62304:5.6.7.a Integration test record contents: document
62304:5.6.7.b Integration test record contents: retain
62304:5.6.7.c Integration test record contents: testor identity
62304:5.6.8 Use software problem resolution process
62304:5.7.2 Use software problem resolution process
62304:5.7.3.a Retest after changes: verify
62304:5.7.3.b Retest after changes: no side effects
62304:5.7.3.c Retest after changes: risk management
62304:5.7.4.a Verify software system testing: appropriate
62304:5.7.4.b Verify software system testing: trace to requirements
62304:5.7.4.c Verify software system testing: verified
62304:5.7.4.d Verify software system testing: all passed
62304:5.7.5.a Software system test record contents: results
62304:5.7.5.b Software system test record contents: repeatable
62304:5.7.5.c Software system test record contents: testor identity
62304:5.8.1 Ensure software verification is complete
62304:5.8.2 Document known residual anamolies
62304:5.8.3 Evaluate known residual anamolies
62304:5.8.5 Document how released software was created
62304:5.8.6 Ensure activites and tasks are complete
62304:5.8.7.a Archive software: product and configuration
62304:5.8.7.b Archive software: documentation
62304:5.8.8 Assure repeatability of software release
62304:6.2.3 Analyse change requests
62304:7.1.1 Identity of software items that could contribute to a hazardous situation
62304:7.1.2.a Identify potential causes of contribution to a hazardous situation: specification
62304:7.1.2.b Identify potential causes of contribution to a hazardous situation: defects
62304:7.1.2.c Identify potential causes of contribution to a hazardous situation: SOUP failure
62304:7.1.2.d Identify potential causes of contribution to a hazardous situation: Unpredictability
62304:7.1.2.e Identify potential causes of contribution to a hazardous situation: misuse
62304:7.1.3 Evaluate published SOUP Anamoly lists
62304:7.1.4 Document potential causes
62304:7.1.5 Document sequences of events
62304:7.2.1 Define risk control measures
62304:7.2.2.a Risk control measures implemented in software: requirements
62304:7.2.2.b Risk control measures implemented in software: classification
62304:7.2.2.c Risk control measures implemented in software: developmemnt
62304:7.3.1 Verify risk control measures
62304:7.3.3.a Document traceability: situation to item
62304:7.3.3.b Document traceability: item to cause
62304:7.3.3.c Document traceability: cause to measure
62304:7.3.3.d Document traceability: measure verification
62304:7.4.2 Analyze impact of software chanes on existing risk control measures
62304:7.4.3 Perform risk management activities based on analyses

