AI management system (AIMS) ISO-IEC-42001-Lead-Auditor Syllabus Exam Questions Answers

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 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:

Question:

Did the audit team consider all the necessary aspects when determining audit findings?

Which core element of AIMS is defined as: “Organizations are responsible for the development, deployment, and use of AI systems, and their potential impacts”?

Which control in Annex A emphasizes the importance of security measures in AI system operations?

Scenario 4 (continued):

BioNovaPharm, a German biopharmaceutical company, has implemented an artificial intelligence management system AIMSbased on ISO/IEC 42001 to optimize various aspects of drug discovery, including analyzing extensive biological data, identifying potentialdrug candidates, and streamlining clinical trial processes. After having the AIMS in place for over a year, the company contracted acertification body and is now undergoing an AIMS audit to obtain certification against ISO/IEC 42001.

Adopting a risk-based approach, the audit team focused on risk throughout their activities. The level of detail outlined in the audit plancorresponded to the scope and complexity of the audit. The team employed a ranking system for detailed audit procedures, prioritizingthose with the highest risk.

Once the stage 1 audit began, the audit team started reviewing the auditee's documented information. To assess whether BioNovaPharmcomplies with the legal and regulatory requirements related to incident communication, the audit team examined evidence provided bythe company’s external legal office. The evidence confirmed that BioNovaPharm applies the requirements of the EU Al Act, whichmandates that providers of high-risk Al systems report serious incidents to relevant authorities.

Following the completion of the stage 1 audit, John, an audit team member, documented the stage 1 audit outputs, including theobservations of the audit team that could result in nonconformities during the on-site audit. However, the audit team leader, Emma, whowas overseeing the audit activities, observed that John failed to document significant observations related to the lack of transparency inthe Al decision-making processes of BioNovaPharm. Considering that Emma observed John's lack of competence in undertaking some

audit activities, a disciplinary note was recorded for John.

Question:

What level of negligence did Emma observe regarding John’s audit documentation failures?