TS Quality Assurance & Compliance Standards 2

Question 1

Which ISO standard specifically addresses software testing processes and provides guidelines for test documentation?

Accepted Answer

ISO/IEC 29119

Answer

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?

Accepted Answer

To map requirements to test cases ensuring full coverage

Answer

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?

Accepted Answer

Unit testing completion

Answer

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?

Accepted Answer

Defect lifecycle management

Answer

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?

Accepted Answer

Electronic signatures must be equivalent to handwritten signatures

Answer

FDA 21 CFR Part 11 requires that electronic signatures used in regulated environments be legally equivalent to traditional handwritten signatures.

(TS) Test Specialist Certification Practice Test

(TS) Test Specialist Certification Practice Test

TS Quality Assurance & Compliance Standards 2