# Common base Audit checklist for IEC62304 Class A 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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62304:4.1 Quality Management System
62304:4.2 Risk Management
62304:4.3.a Software safety classification: system class
# 62304:4.3.b Software safety classification: risk control (dropped by AMD1)
62304:4.3.c Software safety classification: risk documentation
62304:4.3.d Software safety classification: decomposition
62304:4.3.e Software safety classification: sub classes
62304:4.3.f Software safety classification: use highest class
62304:4.3.g Software safety classification: class c default
62304:5.1.1.a Software Development Plan: Processes
62304:5.1.1.b Software Development Plan: Deliverables
62304:5.1.1.c Software Development Plan: Traceability
62304:5.1.1.d Software Development Plan: Configuration and change management
62304:5.1.1.e Software Development Plan: Problem resolution
62304:5.1.2 Keep Software Development Plan Updated
62304:5.1.3.a Software Development Plan Reference to System Design and Development: inputs
62304:5.1.3.b Software Development Plan Reference to System Design and Development: procedures
62304:5.1.6.a Software Verification Planning: deliverables requiring verification
62304:5.1.6.b Software Verification Planning: verification tasks
62304:5.1.6.c Software Verification Planning: milestones
62304:5.1.6.d Software Verification Planning: acceptance criteria
62304:5.1.7 Software Risk Management Planning
62304:5.1.8.a Documentation Planning: title
62304:5.1.8.b Documentation Planning: purpose
62304:5.1.9.a Software Configuration Management Planning: controlled items
62304:5.1.9.b Software Configuration Management Planning: activities and tasks
62304:5.1.9.c Software Configuration Management Planning: organizations responsible
62304:5.1.9.d Software Configuration Management Planning: relationships
62304:5.1.9.e Software Configuration Management Planning: configuration control
62304:5.1.9.f Software Configuration Management Planning: resolution process
62304:5.2.1 Define and document software requirements from system requirements
62304:5.2.2.a Software Requirements Content: functional and capability
62304:5.2.2.b Software Requirements Content: inputs and outputs
62304:5.2.2.c Software Requirements Content: interfaces
62304:5.2.2.d Software Requirements Content: alarms, warnings, and operator messages
62304:5.2.2.e Software Requirements Content: security
62304:5.2.2.g Software Requirements Content: data and database
62304:5.2.2.h Software Requirements Content: installation and acceptance
62304:5.2.2.i Software Requirements Content: methods of operation and maintenance
62304:5.2.2.k Software Requirements Content: user maintenance
62304:5.2.2.l Software Requirements Content: regulatory requirements
62304:5.2.4 Re-evaluate Medical Device Risk Analysis
62304:5.2.5 Update System Requirements
62304:5.2.6.a Verify Software Requirements: implemented
62304:5.2.6.b Verify Software Requirements: non-contradictory
62304:5.2.6.c Verify Software Requirements: non-ambiguous
62304:5.2.6.d Verify Software Requirements: testable
62304:5.2.6.e Verify Software Requirements: unique
62304:5.2.6.f Verify Software Requirements: traceable
62304:5.5.1 Implement Each Software Unit
62304:5.8.4 Document released versions
62304:6.1.a Establish Software Maintenance Plan: procedures
62304:6.1.b Establish Software Maintenance Plan: criteria
62304:6.1.c Establish Software Maintenance Plan: risk management process
62304:6.1.d Establish Software Maintenance Plan: resolution process
62304:6.1.e Establish Software Maintenance Plan: configuration
62304:6.1.f Establish Software Maintenance Plan: evaluate and implement
62304:6.2.1.1 Monitor feedback
62304:6.2.1.2 Document and evaluate feedback
62304:6.2.1.3 Evaluate problem report's affects on safety
62304:6.2.2 Use software problem resolution process
62304:6.2.4 Change request approval
62304:6.2.5.a Communicate to users and regulators: problems
62304:6.2.5.b Communicate to users and regulators: changes
62304:6.3.1 Use established process to implement modification
62304:6.3.2 Re-release modified software system
62304:7.4.1.a Analyze changes to medical device software with respect to safety: additional causes
62304:7.4.1.b Analyze changes to medical device software with respect to safety: additional measures
62304:8.1.1 Establish means to identify configuration items
62304:8.1.2.a Identify SOUP: title
62304:8.1.2.b Identify SOUP: manufacturer
62304:8.1.2.c Identify SOUP: unique SOUP designator
62304:8.1.3 Identify system configuration documentation
62304:8.2.1 Approve change requests
62304:8.2.2 Implement changes
62304:8.2.3 Verify changes
62304:8.2.4.a Provide means for traceablity of change: change request
62304:8.2.4.b Provide means for traceablity of change: problem report
62304:8.2.4.c Provide means for traceablity of change: approval of change request
62304:8.3 Configuration Status Accounting
62304:9.2.a Investigate the problem: investigate
62304:9.2.b Investigate the problem: evaluate
62304:9.2.c Investigate the problem: document
62304:9.2.d Investigate the problem: change request
62304:9.3 Advise relevant parties
62304:9.4 Use change control process
62304:9.5 Maintain records
62304:9.6 Analyse problems for trends
62304:9.7.a Verify software problem resolution: closed
62304:9.7.b Verify software problem resolution: adverse trends reversed
62304:9.7.c Verify software problem resolution: implemented
62304:9.7.d Verify software problem resolution: whether new problems
62304:9.8.a Test documentation contents: results
62304:9.8.b Test documentation contents: anamolies
62304:9.8.c Test documentation contents: version
62304:9.8.d Test documentation contents: test configuration
62304:9.8.e Test documentation contents: test tools
62304:9.8.f Test documentation contents: date tested
62304:9.8.g Test documentation contents: testor identity
