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

Scenario 7 (continued):

Scenario 7: ICure, headquartered in Bratislava, is a medical institution known for its use of the latest technologies in medical practices. It has 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 holistic management 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 1 audit 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 were documented 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 stage 2 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, paying special 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 documented information. Essential processes related to Al model training, validation, and deployment were not documented accurately, hindering effective control and management of these critical activities. This issue was recorded as a minor nonconformity, signaling a need for enhanced 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, the audit team conducted a Stage 2 audit after a considerable time from Stage 1. Is this recommended?

Samuel reviewed and approved the audit plan. Is this acceptable? Refer to Scenario 6.

Scenario 6: AfrinovAl, based in Nairobi, Kenya, develops Al tools to improve agriculture in Africa. The company uses Al to address challenges faced by African farmers,

offering tools for analyzing satellite images to monitor crop health, predicting pest and disease outbreaks, and automating irrigation to use water more efficiently.

AfrinovAl has implemented an artificial intelligence management system AIMS based on ISO/IEC 42001, reflecting its commitment to ethical and effective

management practices in its Al solutions.

AfrinovAl is undergoing a certification audit to obtain certification against ISO/IEC 42001. Samuel, an expert in Al technologies and management systems, is heading

the audit team. Before initiating the audit process, Samuel reviewed and approved the audit plan, which served as a basis for the agreement between the certification

body and the auditee.

During the stage 1 audit, the audit team focused on a detailed evaluation of AfrinovAI's documented information, critically assessing both their format and content.

Samuel held a meeting with his team to prepare for the stage 2 audit. During this meeting, responsibilities were allocated among team members, assigning specific

processes, functions, sites, areas, or activities based on each auditor's expertise and the audit requirements. He also assigned auditing roles to technical experts to

leverage their specialized knowledge in specific areas.

In the stage 2 audit, Samuel and his team held an opening meeting during which Samuel explained how the audit activities will be undertaken. AfrinovAI's also

participated in the meeting. Afterward, the audit team conducted on-site activities to closely inspect the physical locations of the audited processes. The interviewed

individuals from the auditee's personnel regarding the AIMS and observed some of the operations of the auditee. They also used sampling and technical verification to

assess the implementation of Al-related controls, verify compliance with established procedures, and identify any gaps in adherence to the AIMS requirements. They

skipped the review of documented information related to the AIMS since some documents had already been reviewed during the stage 1 audit. This comprehensive

approach ensured a thorough evaluation of AfrinovAI's AIMS against the ISO/IEC 42001.

Scenario 6 (continued):

Scenario 6: HappilyAI is a pioneering enterprise dedicated to developing and deploying artificial intelligence Al solutions tailored to enhance 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 and innovation, 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 groundwork for the extensive on-site activities of the stage 1 audit. This initial phase was marked by a comprehensive documentation review. The audit scope encompassed a critical review of HappilyAI's core departments, including Research and Development (R&D), Customer Service, 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 audit activities. The meeting set a collaborative tone for the subsequent phases, where the team engaged in information collection, executed audit 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 to ensure a comprehensive and representative data collection by drawing samples from each segment. Furthermore, the team employed observation 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 these tools effectively identify and respond to errors or anomalies. However, a notable challenge emerged as the team encountered a lack of access to documented information that describes how tasks about AIMS are executed. In addition to this, the team identified a potential nonconformity within the Sales Department. They decided not to record this as a nonconformity in the audit report but only communicated 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 audit team. Recognized for their specialized knowledge and expertise in artificial intelligence and its applications, these technical experts are tasked 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:

During the stage 2 audit, the certification body and the company assigned the roles of technical experts. Is this acceptable?

The process to assess the potential consequences for individuals or groups of individuals, or both, and societies that can result from the AI system throughout its life cycle is known as: