Master PECB ISO-IEC-42001-Lead-Auditor Exam with Reliable Practice Questions

[Conducting an ISO/IEC 42001 Audit]

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:

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

[Fundamental Principles and Concepts of an AI Management System]

A company develops an AI-based health monitoring system that provides insights and recommendations to users. However, users have reported that they do not understand how the system arrives at its recommendations. Which core element should the company enhance to improve user trust and understanding?

[Fundamental Principles and Concepts of an AI Management System]

A social media platform wants to automatically detect and remove inappropriate content from images and videos uploaded by users. Which AI concept is most appropriate for this task?

[Closing an ISO/IEC 42001 Audit]

Scenario 8 (continued):

Scenario 8:

Scenario 8: InnovateSoft, headquartered in Berlin, Germany, is a software development company known for its innovative solutions andcommitment to excellence. It specializes in custom software solutions, development, design, testing, maintenance, and consulting,covering both mobile apps and web development. Recently, the company underwent an audit to evaluate the effectiveness and

compliance of its artificial intelligence management system AIMS against ISO/IEC 42001.

The audit team engaged with the auditee to discuss their findings and observations during the audit's final phases. After evaluating theevidence, the audit team presented their audit findings to InnovateSoft, highlighting the identified nonconformities.

Upon receiving the audit findings, InnovateSoft accepted the conclusions but expressed concerns about some findings inaccuratelyreflecting the efficiency of their software development processes. In response, the company provided new evidence and additionalinformation to alter the audit conclusions for a couple of minor nonconformities identified. After thorough consideration, the audit teamleader clarified that the new evidence did not significantly alter the core conclusions drawn for the nonconformities. Therefore, thecertification body issued a certification recommendation conditional upon the filing of corrective action plans without a prior visit.

InnovateSoft accepted the decision of the certification body. The top management of the company also sought suggestions from theaudit team on resolving the identified nonconformities. The audit team leader offered solutions to address the issues, fostering acollaborative effort between the auditors and InnovateSoft.During the closing meeting, the audit team covered key topics to enhance transparency. They clarified to InnovateSoft that the auditevidence was based on a sample, acknowledging the inherent uncertainty. The method and time frame of reporting and grading findingswere discussed to provide a structured overview of nonconformities. The certification body's process for handling nonconformities,including potential consequences, guided InnovateSoft on corrective actions. The time frame for presenting a plan for correction was

communicated, emphasizing urgency. Insights into the certification body's post-audit activities were provided, ensuring ongoing support.

Lastly, the audit team briefed InnovateSoft on complaint and appeal handling.

InnovateSoft submitted the action plans for each nonconformity separately, describing only the detected issues and the correctiveactions planned to address the detected nonconformities. However, the submission slightly exceeded the specified period of 45 days setby the certification body, arriving three days later. InnovateSoft explained this by attributing the delay to unexpected challengesencountered during the compilation of the action plans.

InnovateSoft submitted corrective action plans for nonconformities three days past the certification body's deadline of 45 days.

Based on Scenario 8, is InnovateSoft eligible for certification?

[AI Management System Requirements]

ReePharm, a pharmaceutical company, has decided to incorporate its AI risk management into the information security management system (ISMS) to identify and address risks related to the procurement, manufacturing, and distribution of pharmaceutical products. Is this decision appropriate?