Exam ISO-IEC-42001-Lead-Auditor Topic 1 Question 108 Discussion
Actual exam question for PECB's ISO-IEC-42001-Lead-Auditor exam
Question #: 108
Topic #: 1
Question #: 108
Topic #: 1
Scenario 7 (continued):
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. Following these 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 whendetermining 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:
Question:
Based on Scenario 7, for which of the following ISO/IEC 42001 clauses was the minor nonconformity issued?
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. Following these 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 whendetermining 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:
Question:
Based on Scenario 7, for which of the following ISO/IEC 42001 clauses was the minor nonconformity issued?
Suggested Answer: C Vote an answer
The issue was thatessential AIMS processes (model training, validation, and deployment) were not properly documented- this falls under:
* ISO/IEC 42001:2023 Clause 7.5, which requires that "the organization shall ensure documented information is available, adequate, and properly controlled."
* The nonconformity was not about communication or awareness, but thelack of documentation, which is a direct violation of Clause 7.5.
Reference:ISO/IEC 42001:2023 Clause 7.5; Lead Auditor Manual Section 5 ("Document Control Requirements").
* ISO/IEC 42001:2023 Clause 7.5, which requires that "the organization shall ensure documented information is available, adequate, and properly controlled."
* The nonconformity was not about communication or awareness, but thelack of documentation, which is a direct violation of Clause 7.5.
Reference:ISO/IEC 42001:2023 Clause 7.5; Lead Auditor Manual Section 5 ("Document Control Requirements").
by Glenn at Jul 25, 2026, 05:46 AM
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