TS Quality Assurance & Compliance Standards 2 — Questions and Answers
Question 1: Which ISO standard specifically addresses software testing processes and provides guidelines for test documentation?
- ISO 9001
- ISO/IEC 29119 (Correct answer)
- ISO 27001
- ISO 14001
Correct answer: ISO/IEC 29119
ISO/IEC 29119 is the international standard specifically for software testing, covering processes, documentation, and techniques.
Question 2: In a compliance audit, what is the primary purpose of a traceability matrix?
- To track defect resolution timelines
- To map requirements to test cases ensuring full coverage (Correct answer)
- To document test execution results
- To schedule regression test cycles
Correct answer: To map requirements to test cases ensuring full coverage
A traceability matrix links requirements to test cases, ensuring every requirement is tested and providing evidence of coverage for compliance audits.
Question 3: When applying the V-Model in a regulated industry, which activity must occur before system integration testing begins?
- Unit testing completion (Correct answer)
- Acceptance test planning
- Regression test execution
- Performance baseline establishment
Correct answer: Unit testing completion
The V-Model requires unit testing to complete successfully before proceeding to integration testing, ensuring lower-level defects are resolved first.
Question 4: A test specialist discovers that a critical defect was closed without proper root cause analysis. Which QA process was violated?
- Test closure reporting
- Defect lifecycle management (Correct answer)
- Entry criteria validation
- Risk-based test prioritization
Correct answer: Defect lifecycle management
Defect lifecycle management requires root cause analysis before closing critical defects to prevent recurrence and maintain quality records.
Question 5: Under FDA 21 CFR Part 11, which requirement applies to electronic records used in quality systems?
- Records must be printed and signed manually
- Electronic signatures must be equivalent to handwritten signatures (Correct answer)
- Only paper records are acceptable for compliance
- Electronic records require dual encryption only
Correct answer: Electronic signatures must be equivalent to handwritten signatures
FDA 21 CFR Part 11 requires that electronic signatures used in regulated environments be legally equivalent to traditional handwritten signatures.
Question 6: What distinguishes verification from validation in the context of QA compliance?
- Verification checks the product meets user needs; validation checks specifications
- Verification ensures the product is built right; validation ensures the right product is built (Correct answer)
- Verification is performed by developers; validation by testers only
- Verification applies to hardware; validation applies to software
Correct answer: Verification ensures the product is built right; validation ensures the right product is built
Verification confirms the product conforms to its specifications (built right), while validation confirms it meets the actual user needs (right product built).
Question 7: In an Agile QA context, which artifact serves as the primary compliance evidence for a completed sprint?
- Sprint velocity chart
- Definition of Done checklist and acceptance test results (Correct answer)
- Product backlog refinement notes
- Daily standup meeting minutes
Correct answer: Definition of Done checklist and acceptance test results
The Definition of Done checklist combined with passing acceptance test results provides auditable compliance evidence that sprint work meets quality standards.
TS Quality Assurance & Compliance Standards 2
Which ISO standard specifically addresses software testing processes and provides guidelines for test documentation?