ISTQB Certified Tester Advanced Level – Test Manager (CTAL-TM) — Question 5

You are working as a test manager in the medical domain leading a team of system testers. You are currently working on a major release of the product which gives customers many new features and resolves a number of problem reports from previous releases.
Since the system is in the medical domain and therefore in the safety critical area, testing needs to be rigorous and evidence is required that the system has been adequately tested. Identify THREE measures that would typically be part of the test approach in this domain and which are not always applicable in other domains! 1 credit

Answer options

• A. High level of documentation
• B. Failure Mode and Effect Analysis (FMEA) sessions
• C. Traceability to requirements
• D. Non-functional testing
• E. Master test planning
• F. Test design techniques
• G. Reviews

Correct answer: A, B, C

Explanation

The correct measures include a high level of documentation, Failure Mode and Effect Analysis (FMEA) sessions, and traceability to requirements, all essential for ensuring safety and compliance in the medical domain. Non-functional testing, master test planning, test design techniques, and reviews are important but are often more broadly applicable and not unique to safety-critical environments.