ISO-IEC-42001-LEAD-AUDITOR practice question 13 of 25
[Conducting an ISO/IEC 42001 Audit] Scenario 7: Scenario 7: ICure, headquartered in Bratislava, is a medical institution known for its use of the…
Choose your answer, then check it against the explanation.
[Conducting an ISO/IEC 42001 Audit]
Scenario 7:
Scenario 7: ICure, headquartered in Bratislava, is a medical institution known for its use of the latest
technologies in medical practices. Ithas introduced groundbreaking Al-driven diagnostics and
treatment planning tools that have fundamentally transformed patient care.
ICure has integrated a robust artificial intelligence management system AIMS to manage its Al
systems effectively. This holisticmanagement framework ensures that ICure's Al applications are not
only developed but also deployed and maintained to adhere to the
highest industry standards, thereby enhancing efficiency and reliability.
ICure has initiated a comprehensive auditing process to validate its AIMS's effectiveness in alignment
with ISO/IEC 42001. The stage 1audit involved an on-site evaluation by the audit team. The team
evaluated the site-specific conditions, interacted with ICure's personnel,
observed the deployed technologies, and reviewed the operations that support the AIMS.
Followingthese observations, the findings weredocumented and communicated to ICure. setting the
stage for subsequent actions.
Unforeseen delays and resource allocation issues introduced a significant gap between the
completion of stage 1 and the onset of stage2 audits. This interval, while unplanned, provided an
opportunity for reflection and preparation for upcoming challenges.
After four months, the audit team initiated the stage 2 audit. They evaluated AIMS's compliance with
ISO/IEC 42001 requirements, payingspecial attention to the complexity of processes and their
documentation. It was during this phase that a critical observation was made:
ICure had not fully considered the complexity of its processes and their interactions when
determining the extent of documentedinformation. Essential processes related to Al model training,
validation, and deployment were not documented accurately, hinderingeffective control and
management of these critical activities. This issue was recorded as a minor nonconformity, signaling
a need forenhanced control and management of these vital activities.
Simultaneously, the auditor evaluated the appropriateness and effectiveness of the "AIMS Insight
Strategy," a procedure developed by
ICure to determine the AIMS internal and external challenges. This examination identified specific
areas for improvement, particularly in
the way stakeholder input was integrated into the system. It highlighted how this could significantly
enhance the contribution of relevant
parties in strengthening the system's resilience and effectiveness.
The audit team determined the audit findings by taking into consideration the requirements of ICure,
the previous audit records and
conclusions, the accuracy, sufficiency, and appropriateness of evidence, the extent to which planned
audit activities are realized and
planned results achieved, the sample size, and the categorization of the audit findings. The audit
team decided to first record all the
requirements met; then they proceeded to record the nonconformities.
Based on the scenario above, answer the following question:
Which phase of the Stage 1 audit was NOT conducted by the audit team?
Question 13 of 25
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