ISO 10007:2017 - Quality Management - Configuration Management Lead Implementer Quiz 01 26Jul25 - Practice Quiz

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Consider a scenario where a Configuration Management Lead Implementer for a firm developing safety-critical medical devices discovers that a critical firmware update, intended for release next quarter, has been subtly altered by a developer without following the established change control procedures. This alteration, though seemingly minor, could potentially impact the device\'s diagnostic accuracy. What is the most immediate and critical action the Configuration Management Lead Implementer must take to uphold the principles of ISO 10007:2017 in this situation?

Formally document the unauthorized change and initiate the established deviation control process for impact assessment and disposition.

Immediately revert the firmware to the last approved baseline and conduct a root cause analysis of the developer's actions.

Inform senior management about the unauthorized modification and await their directive on how to proceed with the firmware.

Instruct the developer to correct the firmware according to the proper procedures before any further action is taken.

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