PECB Updated ISO-IEC-42001-Lead-Auditor Exam Questions and Answers by aras

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 Alsystems 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:

Which clause did the audit team evaluate when assessing the appropriateness of the “AIMS Insight Strategy” procedure?

Scenario 6 (continued):

Scenario 6: HappilyAI is a pioneering enterprise dedicated to developing and deploying artificial intelligence Al solutions tailored toenhance customer service experiences across various industries. The company offers innovative products like virtual assistants,predictive analytics tools, and personalized customer interaction platforms. As part of its commitment to operational excellence andinnovation, HappilyAI has implemented a robust Al management system AIMS to oversee its Al operations effectively. Currently.HappilyAI is undergoing a comprehensive audit process of its AIMS to evaluate its compliance with ISO/IEC 42001.

Under the leadership of Jess, the audit team began the audit process with meticulous planning and coordination, setting the groundworkfor the extensive on-site activities of the stage 1 audit. This initial phase was marked by a comprehensive documentation review. Theaudit scope encompassed a critical review of HappilyAI's core departments, including Research and Development (R&D), CustomerService, and Data Security, aiming to assess the conformity of HappilyAI's AIMS to the requirements of ISO/IEC 42001.

Afterward, Jess and the team conducted a formal opening meeting with HappilyAI to introduce the audit team and outline the auditactivities. The meeting set a collaborative tone for the subsequentphases, where the team engaged in information collection, executedaudit tests, identified findings, and prepared draft nonconformity reports while maintaining a strict quality review process.

In gathering evidence, the audit team employed a sampling method, which involved dividing the population into homogeneous groups toensure a comprehensive and representative data collection by drawing samples from each segment. Furthermore, the team employedobservation to deepen their understanding of the Al management processes. They verified the availability of essential documentation,including Al-related policies, and evaluated the communication channels established for reporting incidents.

Additionally, they scrutinized specific monitoring tools designed to track the performance of data acquisition processes, ensuring thesetools effectively identify and respond to errors or anomalies. However, a notable challenge emerged as the team encountered a lack ofaccess to documented information that describes how tasks about AIMS are executed. In addition to this, the team identified a potentialnonconformity within the Sales Department. They decided not to record this as a nonconformity in the audit report but onlycommunicated it to the HappilyAI's representatives.

During the stage 2 audit, the certification body, in collaboration with HappilyAI, assigned the roles of technical experts within the auditteam. Recognized for their specialized knowledge and expertise in artificial intelligence and its applications, these technical experts aretasked with the thorough assessment of the AIMS framework to ensure its alignment with industry standards and best practices,focusing on areas such as data ethics, algorithmic transparency, and Al system security.

Question:

Which observation types did the audit team use to enhance their understanding of the AI management processes?

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?

Scenario 5 (continued):

Scenario 5: Aizoia, located in Washington, DC, has revolutionized data analytics, software development, and consulting by usingadvanced Al algorithms. Central to its success is an Al platform adept at deciphering complex datasets for enhanced insights. To ensure

that its Al systems operate effectively and responsibly, Aizoia has established an artificial intelligence management system AIMS basedon ISO/IEC 42001 and is now undergoing a certification audit to verify the AIMS’s effectiveness and compliance with ISO/IEC 42001.

Robert, one of the certification body's full-time employees with extensive experience in auditing, was appointed as the audit team leaderdespite not receiving an official offer for the role. Understanding the critical importance of assembling an audit team with diverse skills

and knowledge, the certification body selected competent individuals to form the audit team. The certification body appointed a team ofseven members to conduct the audit after considering the specific conditions of the audit mission and the required competencies.

Initially, the certification body, in cooperation with Aizoia, defined the extent and boundaries of the audit, specifying the sites (whetherphysical or virtual), organizational units, and the activities for review. Once the scope, processes, methods, and team composition hadbeen defined, thecertification body provided the audit team leader with extensive information, including the audit objectives anddocumented details on the scope, processes, methods, and team compositions.

Additionally, the certification body shared contact details of the auditee, including locations, time frames, and the duration of the auditactivities to be conducted. The team leader also received information needed for evaluating and addressing identified risks andopportunities for the achievement of the audit objectives.

Before starting the audit, Robert wrote an engagement letter, introducing himself to Aizoia and outlining plans for scheduling initialcontact. The initial contact aimed to confirm thecommunication channels, establish the audit team's authority to conduct the audit, andsummarize the audit's key aspects, such as objectives, scope, criteria, methods, and team composition. During this first meeting, Robertemphasized the need for access to essential information that would help to conduct the audit.

Moreover, audit logistics, such as scheduling, access, health and safety arrangements, observer attendance, and the need for guides orinterpreters, were thoroughly planned. The meeting also addressed areas of interest or concern, preemptively resolving potential issuesand finalizing any matters related to the audit team composition.

As the audit progressed, Robert recognized the complexity of Aizoia’s operations, leading him to conclude that a review of its Al-relateddata governance practices was essential for compliance with ISO/IEC 42001. He discussed this need with Aizoia's management,proposing an expanded audit scope. After careful consideration, they agreed to conduct a thorough review of the Al data governancepractices, but there was no mutual decision to officially change the audit scope. Consequently. Robert decided to proceed with the auditbased on the original scope, adhering to the initial audit plan, and documented the conversation and decision accordingly.

Based on the scenario above, answer the following question:

Question:

According to Scenario 5, was Robert's decision to proceed with the audit without changing its scope appropriate?