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Which of the following statements regarding the interested parties related to the AIMS is correct?
During the audit planning phase, what is the primary activity an auditor should focus on?
Did the audit team conduct their meetings in accordance with best practices? Refer to Scenario 7.
Scenario 7: TastyMade. headquartered in Hamburg, Germany, is an established company in the food manufacturing industry that applies Al technologies in its
operations. It has implemented an artificial intelligence management system AIMS based on ISO/IEC 42001 to further strengthen its Al management and ensure
compliance with international standards. As part of its commitment to excellence and continual improvement, TastyMade is undergoing an audit process to achieve
certification against ISO/IEC 42001.
In preparation for the audit, TastyMade collaborated closely with the audit team leader to develop a detailed audit plan. This plan encompassed objectives, criteria,
scope, and logistical arrangements for both on-site and remote audit activities. Recognizing the specialized nature of Al integration, a technical expert was brought in
to support the audit team and ensure comprehensive coverage of relevant aspects. Upon discussion with the audit team leader, it was mutually decided that not every
audit team member would need a guide throughout the audit process. At times, the TastyMade itself would assume the role of the guide, actively facilitating audit
activities.
A formal opening meeting was held with TastyMade's management to provide an overview of the audit process and set expectations. During this meeting, key
interested parties were briefed on the audit objectives and the methodologies that would be employed during the audit. Following the meeting, the audit team
proceeded with their work, collecting information and conducting tests to evaluate the effectiveness of TastyMade's AIMS.
Daily evening meetings were held to review progress, discuss encountered issues, and facilitate collaboration among audit team members. The audit team leader
adopted an open communication approach, encouraging all auditors to share their findings and challenges. The communication regarding the progress of the audit
was informal, allowing for a fluid exchange of information and updates among team members.
To verify adherence to some requirements of clause 4.1 Understanding the organization and its context, the audit team arbitrarily selected for analysis a representative
sample of Al management practices across different departments and functions within the company.
During the audit process, the technical expert uncovered certain technical and operational findings related to the integration and governance of Al systems.
Recognizing the significance of these findings, the expert promptly informed the audit team leader. Understanding the need for further clarification and direct
communication, the audit team leader authorized the technical expert to address the findings directly with the auditee. However, to ensure proper oversight, the expert
was supervised by one of the audit team members.
Throughout the audit, it became apparent that TastyMade promoted a culture of autonomy and decentralized decision-making in Al integration processes. Employees
were empowered to set goals, allocate responsibilities, and devise methodologies independently, with management providing guidance and support as needed. This
approach fostered innovation and agility within the company
Scenario 3 (continued):
ArBank is a financial institution located in Brussels, Belgium, which offers a diverse range of banking and investment services to its clients. To ensure the continual improvement of its operations, ArBank has implemented a quality management system QMS based
on ISO 9001 and an artificial intelligence management system AIMS based on the requirements of ISO/IEC 42001.
Audrey, an experienced auditor, led an internal audit focused on the AIMS within ArBank. She assessed the chatbots integrated into the bank's website and mobile app, analyzing communications using big data technology to identify potential noncompliance, fraud, or unethical conduct. Instead of relying solely on the information provided by the chatbots, Audrey sought out evidence that would either confirm or challenge the validity of the data, ensuring her conclusions were based on reliable and accurate information. Her review of selected chatbot interactions confirmed they met their intended purpose.
For the specific context of ArBank's operations, Audrey utilized an Al system to assess the efficiency of the bank's digital infrastructure, focusing on tasks critical to the Finance Department. This Al system was able to analyze the functionality of chatbots integrated into ArBank's website and mobile app to determine if it adheres to ISO/IEC 42001 requirements and internal policies governing customer service in the banking sector.
In addition, Audrey conducted a deeper assessment of the bank’s AIMS. Her evaluation included observing different stages of the AIMS life cycle, from development to deployment, to ensure that roles and responsibilities were clearly defined and aligned with ArBank’s operational goals. She also evaluated the tools used to monitor and measure the performance of the AIMS.
Audrey continued the audit process by auditing ArBank's outsourced operations. Upon checking the contractual agreements between the two parties, Audrey decided that there was no need to gather audit evidence regarding the contractual agreement. She reviewed the company's processes for monitoring the quality of outsourced operations, determined whether appropriate governance processes are in place with regard to the engagement of outsourced persons or organizations, and reviewed and evaluated the company's plans in case of expected or unexpected termination of the outsourcing agreement.
Based on the scenario above, answer the following question:
Question:
What big data technology did Audrey utilize? Refer to Scenario 3.
Scenario 4 (continued):
BioNovaPharm, a German biopharmaceutical company, has implemented an artificial intelligence management system AIMS based on ISO/IEC 42001 to optimize various aspects of drug discovery, including analyzing extensive biological data, identifying potential drug candidates, and streamlining clinical trial processes. After having the AIMS in place for over a year, the company contracted a certification 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 plan corresponded to the scope and complexity of the audit. The team employed a ranking system for detailed audit procedures, prioritizing those with the highest risk.
Once the stage 1 audit began, the audit team started reviewing the auditee's documented information. To assess whether BioNovaPharm complies with the legal and regulatory requirements related to incident communication, the audit team examined evidence provided by the company’s external legal office. The evidence confirmed that BioNovaPharm applies the requirements of the EU Al Act, which mandates 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 the observations of the audit team that could result in nonconformities during the on-site audit. However, the audit team leader, Emma, who was overseeing the audit activities, observed that John failed to document significant observations related to the lack of transparency in the 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:
Which of the following AI applications for auditing did the audit team employ?
Scenario 2: OptiFlow is a logistics company located in New Delhi, India. The company has enhanced its operational efficiency and customer service by integrating AI across various domains, including route optimization, inventory management, and customer support. Recognizing the importance of AI in its operations, OptiFlow decided to implement an Artificial Intelligence Management System (AIMS) based on ISO/IEC 42001 to oversee and optimize the use of AI technologies.
To address Clauses 4.1 and 4.2 of the standard, OptiFlow identified and analyzed internal and external issues and needs and expectations of interested parties. During this phase, it identified specific risks and opportunities related to AI deployment, considering the system's domain, application context, intended use, and internal and external environments. Central to this initiative was the establishment and maintenance of AI risk criteria, a foundational step that facilitated comprehensive AI risk assessments, effective risk treatment strategies, and precise evaluations of risk impacts. This implementation aimed to meet AIMS’s objectives, minimize adverse effects, and promote continuous improvement. OptiFlow also planned and integrated strategies to address risks and opportunities into AIMS’s processes and assessed their effectiveness.
OptiFlow set measurable AI objectives aligned with its AI policy across all organizational levels, ensuring they met applicable requirements and matched the company’s vision. The company placed strong emphasis on the monitoring and communication of these objectives, ensuring they were updated annually or as needed to reflect changes in technology, market demands, or internal processes. It also documented the objectives, making them accessible across the company.
To guarantee a structured and consistent AI risk assessment process, OptiFlow emphasized alignment with its AI policy and objectives. The process included ensuring consistency and comparability, identifying, analyzing, and evaluating AI risks.
OptiFlow prioritizes its AIMS by allocating the necessary resources for its comprehensive development and continuous enhancement. The company carefully defines the competencies needed for personnel affecting AI performance, ensuring a high level of expertise and innovation.
OptiFlow also manages effective internal and external communications about its AIMS, aligning with ISO/IEC 42001 requirements by maintaining and controlling all required documented information. This documentation is meticulously identified, described, and updated to ensure its relevance and accessibility. Through these strategic efforts, OptiFlow upholds a commitment to excellence and leadership in AI management practices.
To comply with Clause 9 of ISO/IEC 42001, the company determined what needs to be monitored and measured in the AIMS. It planned, established, implemented, and maintained an audit program, reviewed the AIMS at planned intervals, documented review results, and initiated a continuous feedback mechanism from all interested parties to identify areas of improvement and innovation within the AIMS
Which of OptiFlow’s implemented requirements is NOT included in Clause 9 (Performance Evaluation) of ISO/IEC 42001? Refer to Scenario 2.
According to the core element of 'Privacy and Security,’ what is essential when developing AI systems?
Scenario 1 (continued):
To ensure the integrity of the AI system, Future Horizon Academy has implemented measures to ensure that training data remain isolated from data that could lead to harmful or undesirable outcomes. The institution adds significant data elements as metadata, transforms the data into a format usable by the AI system, and uses data from one or more trusted sources.
Committed to standardization and continual improvement, Future Horizon Academy decided to implement an artificial intelligence management system (AIMS) based on ISO/IEC 42001 that would help the institution increase operational efficiency, resulting in improved processes.
After having the AIMS in place for a year, the institution decided to apply for a certification audit to get certified against ISO/IEC 42001. Prior to the certification audit, the institution conducted an internal audit and management review to ensure that the AIMS aligns with the institution’s own requirements and that the system is being maintained effectively.
Question:
Based on Scenario 1, which of the following processes regarding data did Future Horizon Academy NOT conduct?
An organization is undergoing a certification audit to evaluate its compliance with ISO/IEC 42001 and ISO/IEC 27001 for its AIMS and ISMS, respectively. What type of audit is the organization undergoing in this case?
During an audit, the auditor employed data analytic technology to identify anomalies and unusual patterns in the decision-making processes of an AI system used by a financial institution to approve or reject loan applications. Which data analytic technology did the auditor use?
Scenario 8 (continued):
Scenario 8:
Scenario 8: InnovateSoft, headquartered in Berlin, Germany, is a software development company known for its innovative solutions and commitment 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 the evidence, 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 inaccurately reflecting the efficiency of their software development processes. In response, the company provided new evidence and additional information to alter the audit conclusions for a couple of minor nonconformities identified. After thorough consideration, the audit team leader clarified that the new evidence did not significantly alter the core conclusions drawn for the nonconformities. Therefore, the certification 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 the audit team on resolving the identified nonconformities. The audit team leader offered solutions to address the issues, fostering a collaborative 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 audit evidence was based on a sample, acknowledging the inherent uncertainty. The method and time frame of reporting and grading findings were 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 corrective actions planned to address the detected nonconformities. However, the submission slightly exceeded the specified period of 45 days set by the certification body, arriving three days later. InnovateSoft explained this by attributing the delay to unexpected challenges encountered during the compilation of the action plans.
InnovateSoft’s corrective action plans described the detected issues and intended corrections but did not include the root causes.
Question:
Were InnovateSoft’s action plans drafted appropriately?
Scenario 2: OptiFlow is a logistics company located in New Delhi, India. The company has enhanced its operational efficiency and customer service by integrating AI across various domains, including route optimization, inventory management, and customer support. Recognizing the importance of AI in its operations, OptiFlow decided to implement an Artificial Intelligence Management System (AIMS) based on ISO/IEC 42001 to oversee and optimize the use of AI technologies.
To address Clauses 4.1 and 4.2 of the standard, OptiFlow identified and analyzed internal and external issues and needs and expectations of interested parties. During this phase, it identified specific risks and opportunities related to AI deployment, considering the system's domain, application context, intended use, and internal and external environments. Central to this initiative was the establishment and maintenance of AI risk criteria, a foundational step that facilitated comprehensive AI risk assessments, effective risk treatment strategies, and precise evaluations of risk impacts. This implementation aimed to meet AIMS’s objectives, minimize adverse effects, and promote continuous improvement. OptiFlow also planned and integrated strategies to address risks and opportunities into AIMS’s processes and assessed their effectiveness.
OptiFlow set measurable AI objectives aligned with its AI policy across all organizational levels, ensuring they met applicable requirements and matched the company’s vision. The company placed strong emphasis on the monitoring and communication of these objectives, ensuring they were updated annually or as needed to reflect changes in technology, market demands, or internal processes. It also documented the objectives, making them accessible across the company.
To guarantee a structured and consistent AI risk assessment process, OptiFlow emphasized alignment with its AI policy and objectives. The process included ensuring consistency and comparability, identifying, analyzing, and evaluating AI risks.
OptiFlow prioritizes its AIMS by allocating the necessary resources for its comprehensive development and continuous enhancement. The company carefully defines the competencies needed for personnel affecting AI performance, ensuring a high level of expertise and innovation.
OptiFlow also manages effective internal and external communications about its AIMS, aligning with ISO/IEC 42001 requirements by maintaining and controlling all required documented information. This documentation is meticulously identified, described, and updated to ensure its relevance and accessibility. Through these strategic efforts, OptiFlow upholds a commitment to excellence and leadership in AI management practices.
To comply with Clause 9 of ISO/IEC 42001, the company determined what needs to be monitored and measured in the AIMS. It planned, established, implemented, and maintained an audit program, reviewed the AIMS at planned intervals, documented review results, and initiated a continuous feedback mechanism from all interested parties to identify areas of improvement and innovation within the AIMS.
Which of the following requirements of Clause 6.1.2 AI risk assessment did OptiFlow NOT consider?
A retail company wants to implement a system that can predict customer buying behavior based on their browsing history and past purchases. Which AI concept would be most suitable for developing this predictive system?
Scenario 8 (continued):
Scenario 8:
Scenario 8: InnovateSoft, headquartered in Berlin, Germany, is a software development company known for its innovative solutions and commitment 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 the evidence, 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 inaccurately reflecting the efficiency of their software development processes. In response, the company provided new evidence and additional information to alter the audit conclusions for a couple of minor nonconformities identified. After thorough consideration, the audit team leader clarified that the new evidence did not significantly alter the core conclusions drawn for the nonconformities. Therefore, the certification 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 the audit team on resolving the identified nonconformities. The audit team leader offered solutions to address the issues, fostering a collaborative 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 audit evidence was based on a sample, acknowledging the inherent uncertainty. The method and time frame of reporting and grading findings were 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 corrective actions planned to address the detected nonconformities. However, the submission slightly exceeded the specified period of 45 days set by the certification body, arriving three days later. InnovateSoft explained this by attributing the delay to unexpected challenges encountered during the compilation of the action plans.
During the closing meeting, the audit team covered key topics including sampling uncertainty, timelines for corrections, and complaint/appeals procedures.
Question:
Based on Scenario 8, was the concluding meeting comprehensive in addressing all essential components of the audit?
Question:
A certification body is conducting surveillance audits for a company managing multiple sites, including a temporary construction site with a limited duration.
The audit team is considering whether the presence of this temporary site should influence the frequency of surveillance audits.
Can this factor necessitate an adjustment in the audit schedule?
The top management of Alterhealth initially rejected the selected audit team leader because they had audited the company in the past, and thus would not bring added value for the auditee. Is this acceptable?
Scenario 5: Alterhealth is a mid-sized technology firm based in Toronto. Canada. It develops Al systems for healthcare providers, focusing on improving patient care,
optimizing hospital workflows, and analyzing healthcare data for insights that can improve health outcomes. To ensure responsible and effective use of Al in its
operations, Alterhealth has implemented an artificial intelligence management system AIMS based on ISO/IEC 42001. After a year of having the AIMS in place, the
company decided to apply for a certification audit to obtain certification against ISO/IEC 42001.
The company contracted a certification body to conduct the audit, who assembled the audit team and appointed the audit team leader. The audit team leader had
conducted a certification audit at Alterhealth in the past. The top management of Alterhealth decided to reject the appointment of this auditor because they believed
that they would not receive added value from the audit. In response, the certification body appointed Jonathan, an independent auditor with no prior engagements with
Alterhealth, as the new audit team leader. Jonathan's introduction marked the beginning of a collaborative process aimed at evaluating the conformity of the AIMS to
ISO/IEC 42001 requirements.
The certification body determined the audit scope, which included only specific departments essential to the integration and application of Al, such as the Al Research,
Machine Learning Applications, and Al Ethics and Compliance Departments, and did not cover all of the departments covered by the AIMS scope. Meanwhile,
Alterhealth determined the audit time, setting the necessary time frame for planning and conducting a thorough and effective review to ensure all aspects of the AIMS
within the selected departments were meticulously reviewed.
Afterward, Jonathan received a detailed offer from the certification body, outlining his role and including information related to the audit, such as the audit's duration,
team members, their responsibilities, the limits to the audit engagement, and their salary compensation. With a clear mandate, Jonathan was tasked with a multitude
of responsibilities: defining the audit objectives and criteria, planning the audit process, identifying and addressing audit risks, managing communication with
Alterhealth, overseeing the audit team, and ensuring a smooth and conflict free execution.
With Jonathan's leadership and a well-defined audit framework in place, the certification audit proceeded with a structured and objective evaluation of Alterhealth's
AIMS.
What certification recommendation did the auditee receive?
Scenario 8: VeridicAI. based in San Francisco. USA, specializes in market research using Al technologies to analyze customer behavior. Founded in 2023, the company
employs natural language processing, machine learning, and predictive analytics to provide real time insights to a range of businesses. VeridicAI has implemented an
artificial intelligence management system AIMS based on ISO/IEC 42001 to manage its Al technologies effectively. The AIMS scope includes select departments within
the company, for which it has received a four-year certification against ISO/IEC 42001. Committed to transparency. VeridicAI publicly shares details of this certification.
As the certification nears its end, VeridicAI is preparing for an audit to renew its certification.
The audit process was led by Sharona, the audit team leader, who is a full-time employee of the certification body. Sharona and the audit team undertook all planned
audit activities. Afterward, they organized the closing meeting with VeridicAl’s management. During the meeting, Sharona and the team made a recap on audit
objectives and scope, presented the audit findings and conclusions, presented identified nonconformities, and organized a session for questions and answers for the
auditee.
VeridicAI received a conditional recommendation for certification, underscoring its compliance with the industry's standards. Sharona confirmed that the company met
the essential requirements but noted some identified minor nonconformities. In response, VeridicAI compiled and submitted a comprehensive action plan that
addresses all identified nonconformities within a designated timeframe. Because of the comprehensive action plan, Sharona did not see the need for an additional on-
site visit to verify the effectiveness of the action plan.
Sharona played an integral role in the certification decision process. Her thorough understanding of VeridicAI's operations, gained from the audit, guided the
certification body towards a well-informed certification decision.
Based on the scenario above, answer the following question:
Which activity conducted during the stage 2 audit does not follow best practices?
A global bank is currently evaluating the effectiveness of its AI management system controls through an AIMS audit. Which role is being played by this company?
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:
Based on Scenario 6, the auditor did not include the potential nonconformity of the Sales Department in the audit report. Is this acceptable?
While preparing for an AIMS audit, a technology company faced an issue with the auditor assigned by the certification body. The auditor lacked a security clearance, which is mandatory for accessing certain sensitive information involved in the audit due to the company's government contracts and proprietary technology. The company requested to replace the auditor with someone who meets the security requirements to ensure the audit can proceed without compromising sensitive information or violating government regulations. Is this acceptable?
Did the audit team leader thoroughly review all essential components before deciding to close the nonconformity? Refer to scenario 9.
Scenario 9: ImoAl, headquartered in California. USA, provides Al solutions for various industries such as finance, healthcare, retail, and manufacturing. Its clients
include major financial institutions seeking Al powered fraud detection systems, healthcare providers leveraging Al for diagnostics and patient care, retailers
optimizing supply chain management with Al forecasting, and manufacturers enhancing production efficiency through Al-driven automation.
ImoAl has recently undergone a certification audit to ensure that its artificial intelligence management system AIMS is in compliance with ISO/IEC 42001. During the
audit, a major nonconformity related to data security protocols was identified, requiring urgent resolution. ImoAl swiftly initiated corrective actions to address the
major nonconformity. The audit follow-up, in agreement with the auditee, was scheduled six weeks after the initial audit. As part of exploring alternatives to audit
follow-up, the audit team leader chose to verify the effectiveness of the actions taken by the auditee by scheduling a specific visit to ImoAI's premises.
The follow-up audit involved a thorough evaluation of the effectiveness of these actions. The audit team leader thoroughly examined the corrections, corrective actions,
and root cause analysis conducted by ImoAl to assess whether they adequately addressed the nonconformity identified during the initial audit.
In conjunction with the external audit follow-up, ImoAl engaged its internal auditing team to oversee the progress of corrective actions. The AIMS manager of ImoAl
updated Ms. Rebecca Hayes, the internal auditor, on the status of corrections and corrective actions prompted by the nonconformity identified during the external
audit. Subsequently, Ms. Hayes thoroughly reviewed these measures, analyzing the corrections, root causes, and effectiveness of the implemented actions.
Upon satisfactory validation of the action plans, ImoAl was recommended for certification.
Scenario 7:
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:
Which phase of the Stage 1 audit was NOT conducted by the audit team?
The certification body did not include all departments covered by the AIMS scope in the audit scope. Is this acceptable? Refer to Scenario 5.
Scenario 5: Alterhealth is a mid-sized technology firm based in Toronto. Canada. It develops Al systems for healthcare providers, focusing on improving patient care,
optimizing hospital workflows, and analyzing healthcare data for insights that can improve health outcomes. To ensure responsible and effective use of Al in its
operations, Alterhealth has implemented an artificial intelligence management system AIMS based on ISO/IEC 42001. After a year of having the AIMS in place, the
company decided to apply for a certification audit to obtain certification against ISO/IEC 42001.
The company contracted a certification body to conduct the audit, who assembled the audit team and appointed the audit team leader. The audit team leader had
conducted a certification audit at Alterhealth in the past. The top management of Alterhealth decided to reject the appointment of this auditor because they believed
that they would not receive added value from the audit. In response, the certification body appointed Jonathan, an independent auditor with no prior engagements with
Alterhealth, as the new audit team leader. Jonathan's introduction marked the beginning of a collaborative process aimed at evaluating the conformity of the AIMS to
ISO/IEC 42001 requirements.
The certification body determined the audit scope, which included only specific departments essential to the integration and application of Al, such as the Al Research,
Machine Learning Applications, and Al Ethics and Compliance Departments, and did not cover all of the departments covered by the AIMS scope. Meanwhile,
Alterhealth determined the audit time, setting the necessary time frame for planning and conducting a thorough and effective review to ensure all aspects of the AIMS
within the selected departments were meticulously reviewed.
Afterward, Jonathan received a detailed offer from the certification body, outlining his role and including information related to the audit, such as the audit's duration,
team members, their responsibilities, the limits to the audit engagement, and their salary compensation. With a clear mandate, Jonathan was tasked with a multitude
of responsibilities: defining the audit objectives and criteria, planning the audit process, identifying and addressing audit risks, managing communication with
Alterhealth, overseeing the audit team, and ensuring a smooth and conflict free execution.
With Jonathan's leadership and a well-defined audit framework in place, the certification audit proceeded with a structured and objective evaluation of Alterhealth's
AIMS.
What is one of the key objectives of conducting an audit according to ISO 19011?
What does the 'Human-Centered Design' core element prioritize in AI development?
Based on Scenario 5, which of the following should NOT be Jonathan's responsibility?
Scenario 5: Alterhealth is a mid-sized technology firm based in Toronto. Canada. It develops Al systems for healthcare providers, focusing on improving patient care,
optimizing hospital workflows, and analyzing healthcare data for insights that can improve health outcomes. To ensure responsible and effective use of Al in its
operations, Alterhealth has implemented an artificial intelligence management system AIMS based on ISO/IEC 42001. After a year of having the AIMS in place, the
company decided to apply for a certification audit to obtain certification against ISO/IEC 42001.
The company contracted a certification body to conduct the audit, who assembled the audit team and appointed the audit team leader. The audit team leader had
conducted a certification audit at Alterhealth in the past. The top management of Alterhealth decided to reject the appointment of this auditor because they believed
that they would not receive added value from the audit. In response, the certification body appointed Jonathan, an independent auditor with no prior engagements with
Alterhealth, as the new audit team leader. Jonathan's introduction marked the beginning of a collaborative process aimed at evaluating the conformity of the AIMS to
ISO/IEC 42001 requirements.
The certification body determined the audit scope, which included only specific departments essential to the integration and application of Al, such as the Al Research,
Machine Learning Applications, and Al Ethics and Compliance Departments, and did not cover all of the departments covered by the AIMS scope. Meanwhile,
Alterhealth determined the audit time, setting the necessary time frame for planning and conducting a thorough and effective review to ensure all aspects of the AIMS
within the selected departments were meticulously reviewed.
Afterward, Jonathan received a detailed offer from the certification body, outlining his role and including information related to the audit, such as the audit's duration,
team members, their responsibilities, the limits to the audit engagement, and their salary compensation. With a clear mandate, Jonathan was tasked with a multitude
of responsibilities: defining the audit objectives and criteria, planning the audit process, identifying and addressing audit risks, managing communication with
Alterhealth, overseeing the audit team, and ensuring a smooth and conflict free execution.
With Jonathan's leadership and a well-defined audit framework in place, the certification audit proceeded with a structured and objective evaluation of Alterhealth's
AIMS.
Question:
During an audit, the auditor employed data analytic technology to identify anomalies and unusual patterns in the decision-making processes of an AI system used by a financial institution to approve or reject loan applications. Which data analytic technology did the auditor use?
Scenario 4 (continued):
BioNovaPharm, a German biopharmaceutical company, has implemented an artificial intelligence management system AIMS based on ISO/IEC 42001 to optimize various aspects of drug discovery, including analyzing extensive biological data, identifying potential drug candidates, and streamlining clinical trial processes. After having the AIMS in place for over a year, the company contracted a certification 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 plan corresponded to the scope and complexity of the audit. The team employed a ranking system for detailed audit procedures, prioritizing those with the highest risk.
Once the stage 1 audit began, the audit team started reviewing the auditee's documented information. To assess whether BioNovaPharm complies with the legal and regulatory requirements related to incident communication, the audit team examined evidence provided by the company’s external legal office. The evidence confirmed that BioNovaPharm applies the requirements of the EU Al Act, which mandates 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 the observations of the audit team that could result in nonconformities during the on-site audit. However, the audit team leader, Emma, who was overseeing the audit activities, observed that John failed to document significant observations related to the lack of transparency in the 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:
Based on Scenario 4, is the decision of the top management representative not to provide the additional evidence requested by the audit team justifiable?
What is the main goal of the 'Transparency and Explainability' core element in AI?
Question:
During which phase of the certification process is confirmation of registration performed?
Question:
Which of the following standards emphasizes the importance of conducting AI system impact assessments to evaluate the potential effects on individuals and societies affected by the AI system?
Was the audit team leader’s decision regarding the handling of the technical expert's findings acceptable? Refer to Scenario 7.
Scenario 7: TastyMade. headquartered in Hamburg, Germany, is an established company in the food manufacturing industry that applies Al technologies in its
operations. It has implemented an artificial intelligence management system AIMS based on ISO/IEC 42001 to further strengthen its Al management and ensure
compliance with international standards. As part of its commitment to excellence and continual improvement, TastyMade is undergoing an audit process to achieve
certification against ISO/IEC 42001.
In preparation for the audit, TastyMade collaborated closely with the audit team leader to develop a detailed audit plan. This plan encompassed objectives, criteria,
scope, and logistical arrangements for both on-site and remote audit activities. Recognizing the specialized nature of Al integration, a technical expert was brought in
to support the audit team and ensure comprehensive coverage of relevant aspects. Upon discussion with the audit team leader, it was mutually decided that not every
audit team member would need a guide throughout the audit process. At times, the TastyMade itself would assume the role of the guide, actively facilitating audit
activities.
A formal opening meeting was held with TastyMade's management to provide an overview of the audit process and set expectations. During this meeting, key
interested parties were briefed on the audit objectives and the methodologies that would be employed during the audit. Following the meeting, the audit team
proceeded with their work, collecting information and conducting tests to evaluate the effectiveness of TastyMade's AIMS.
Daily evening meetings were held to review progress, discuss encountered issues, and facilitate collaboration among audit team members. The audit team leader
adopted an open communication approach, encouraging all auditors to share their findings and challenges. The communication regarding the progress of the audit
was informal, allowing for a fluid exchange of information and updates among team members.
To verify adherence to some requirements of clause 4.1 Understanding the organization and its context, the audit team arbitrarily selected for analysis a representative
sample of Al management practices across different departments and functions within the company.
During the audit process, the technical expert uncovered certain technical and operational findings related to the integration and governance of Al systems.
Recognizing the significance of these findings, the expert promptly informed the audit team leader. Understanding the need for further clarification and direct
communication, the audit team leader authorized the technical expert to address the findings directly with the auditee. However, to ensure proper oversight, the expert
was supervised by one of the audit team members.
Throughout the audit, it became apparent that TastyMade promoted a culture of autonomy and decentralized decision-making in Al integration processes. Employees
were empowered to set goals, allocate responsibilities, and devise methodologies independently, with management providing guidance and support as needed. This
approach fostered innovation and agility within the company
Scenario: NeuraGen, founded by a team of AI experts and data scientists, has gained attention for its advanced use of artificial intelligence. It specializes in developing personalized learning platforms powered by AI algorithms. MindMeld, its innovative product, is an educational platform that uses machine learning and stands out by learning from both labeled and unlabeled data during its training process. This approach allows MindMeld to use a wide range of educational content and personalize learning experiences with exceptional accuracy. Furthermore, MindMeld employs an advanced AI system capable of handling a wide variety of tasks, consistently delivering a satisfactory level of performance. This approach improves the effectiveness of educational materials and adapts to different learners' needs.
NeuraGen skillfully handles data management and AI system development, particularly for MindMeld. Initially, NeuraGen sources data from a diverse array of origins, examining patterns, relationships, trends, and anomalies. This data is then refined and formatted for compatibility with MindMeld, ensuring that any irrelevant or extraneous information is systematically eliminated. Following this, values are adjusted to a unified scale to facilitate mathematical comparability. A crucial step in this process is the rigorous removal of all personally identifiable information (PII) to protect individual privacy. Finally, the data is subjected to quality checks to assess its completeness, identify any potential bias, and evaluate other factors that could impact the platform's efficacy and reliability.
NeuraGen has implemented an advanced artificial intelligence management system (AIMS) based on ISO/IEC 42001 to support its efforts in AI-driven education. This system provides a framework for managing the life cycle of AI projects, ensuring that development and deployment are guided by ethical standards and best practices.
NeuraGen's top management is key to running the AIMS effectively. Applying an international standard that specifically provides guidance for the highest level of company leadership on governing the effective use of AI, they embed ethical principles such as fairness, transparency, and accountability directly into their strategic operations and decision-making processes.
While the company excels in ensuring fairness, transparency, reliability, safety, and privacy in its AI applications, actively preventing bias, fostering a clear understanding of AI decisions, guaranteeing system dependability, and protecting user data, it struggles to clearly define who is responsible for the development, deployment, and outcomes of its AI systems. Consequently, it becomes difficult to determine responsibility when issues arise, which undermines trust and accountability, both critical for the integrity and success of AI initiatives.
What type of machine learning does MindMeld utilize?
What should the auditor assess to verify the establishment of an internal audit program?
Scenario 5:
Scenario 5: Aizoia, located in Washington, DC, has revolutionized data analytics, software development, and consulting by using advanced 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 based on 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 leader despite 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 of seven 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 (whether physical or virtual), organizational units, and the activities for review. Once the scope, processes, methods, and team composition had been defined, the certification body provided the audit team leader with extensive information, including the audit objectives and documented 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 audit activities to be conducted. The team leader also received information needed for evaluating and addressing identified risks and opportunities 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 initial contact. The initial contact aimed to confirm the communication channels, establish the audit team's authority to conduct the audit, and summarize the audit's key aspects, such as objectives, scope, criteria, methods, and team composition. During this first meeting, Robert emphasized 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 or interpreters, were thoroughly planned. The meeting also addressed areas of interest or concern, preemptively resolving potential issues and 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-related data 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 governance practices, but there was no mutual decision to officially change the audit scope. Consequently. Robert decided to proceed with the audit based 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:
Robert did not receive an offer from the certification body prior to accepting the mandate. Is this acceptable?
In which step are the audit findings, including nonconformities, documented and reviewed?
Question:
What type of audit is conducted when a customer audits suppliers to make purchasing decisions?
Scenario 3 (continued):
ArBank is a financial institution located in Brussels, Belgium, which offers a diverse range of banking and investment services to its clients. To ensure the continual improvement of its operations, ArBank has implemented a quality management system QMS based
on ISO 9001 and an artificial intelligence management system AIMS based on the requirements of ISO/IEC 42001.
Audrey, an experienced auditor, led an internal audit focused on the AIMS within ArBank. She assessed the chatbots integrated into the bank's website and mobile app, analyzing communications using big data technology to identify potential noncompliance, fraud, or unethical conduct. Instead of relying solely on the information provided by the chatbots, Audrey sought out evidence that would either confirm or challenge the validity of the data, ensuring her conclusions were based on reliable and accurate information. Her review of selected chatbot interactions confirmed they met their intended purpose.
For the specific context of ArBank's operations, Audrey utilized an Al system to assess the efficiency of the bank's digital infrastructure, focusing on tasks critical to the Finance Department. This Al system was able to analyze the functionality of chatbots integrated into ArBank's website and mobile app to determine if it adheres to ISO/IEC 42001 requirements and internal policies governing customer service in the banking sector.
In addition, Audrey conducted a deeper assessment of the bank’s AIMS. Her evaluation included observing different stages of the AIMS life cycle, from development to deployment, to ensure that roles and responsibilities were clearly defined and aligned with ArBank’s operational goals. She also evaluated the tools used to monitor and measure the performance of the AIMS.
Audrey continued the audit process by auditing ArBank's outsourced operations. Upon checking the contractual agreements between the two parties, Audrey decided that there was no need to gather audit evidence regarding the contractual agreement. She reviewed the company's processes for monitoring the quality of outsourced operations, determined whether appropriate governance processes are in place with regard to the engagement of outsourced persons or organizations, and reviewed and evaluated the company's plans in case of expected or unexpected termination of the outsourcing agreement.
Based on the scenario above, answer the following question:
Question:
Based on Scenario 3, did Audrey perform a technical assessment during the audit?
A few months after an audit, the auditor returns to the company to verify that corrective actions have been effectively implemented and that the issues identified have been resolved. Which step of the management system audit process does this activity correspond to?
Question:
Which of the following competencies must at least one of the audit team members possess?
Scenario: NeuraGen, founded by a team of AI experts and data scientists, has gained attention for its advanced use of artificial intelligence. It specializes in developing personalized learning platforms powered by AI algorithms. MindMeld, its innovative product, is an educational platform that uses machine learning and stands out by learning from both labeled and unlabeled data during its training process. This approach allows MindMeld to use a wide range of educational content and personalize learning experiences with exceptional accuracy. Furthermore, MindMeld employs an advanced AI system capable of handling a wide variety of tasks, consistently delivering a satisfactory level of performance. This approach improves the effectiveness of educational materials and adapts to different learners' needs.
NeuraGen skillfully handles data management and AI system development, particularly for MindMeld. Initially, NeuraGen sources data from a diverse array of origins, examining patterns, relationships, trends, and anomalies. This data is then refined and formatted for compatibility with MindMeld, ensuring that any irrelevant or extraneous information is systematically eliminated. Following this, values are adjusted to a unified scale to facilitate mathematical comparability. A crucial step in this process is the rigorous removal of all personally identifiable information (PII) to protect individual privacy. Finally, the data is subjected to quality checks to assess its completeness, identify any potential bias, and evaluate other factors that could impact the platform's efficacy and reliability.
NeuraGen has implemented an advanced artificial intelligence management system (AIMS) based on ISO/IEC 42001 to support its efforts in AI-driven education. This system provides a framework for managing the life cycle of AI projects, ensuring that development and deployment are guided by ethical standards and best practices.
NeuraGen's top management is key to running the AIMS effectively. Applying an international standard that specifically provides guidance for the highest level of company leadership on governing the effective use of AI, they embed ethical principles such as fairness, transparency, and accountability directly into their strategic operations and decision-making processes.
While the company excels in ensuring fairness, transparency, reliability, safety, and privacy in its AI applications, actively preventing bias, fostering a clear understanding of AI decisions, guaranteeing system dependability, and protecting user data, it struggles to clearly define who is responsible for the development, deployment, and outcomes of its AI systems. Consequently, it becomes difficult to determine responsibility when issues arise, which undermines trust and accountability, both critical for the integrity and success of AI initiatives.
Based on Scenario 1, which of the following processes did NeuraGen NOT conduct regarding data?
Were VeridicAI’s action plans drafted appropriately? Refer to Scenario 8.
Scenario 8: VeridicAI. based in San Francisco. USA, specializes in market research using Al technologies to analyze customer behavior. Founded in 2023, the company
employs natural language processing, machine learning, and predictive analytics to provide real time insights to a range of businesses. VeridicAI has implemented an
artificial intelligence management system AIMS based on ISO/IEC 42001 to manage its Al technologies effectively. The AIMS scope includes select departments within
the company, for which it has received a four-year certification against ISO/IEC 42001. Committed to transparency. VeridicAI publicly shares details of this certification.
As the certification nears its end, VeridicAI is preparing for an audit to renew its certification.
The audit process was led by Sharona, the audit team leader, who is a full-time employee of the certification body. Sharona and the audit team undertook all planned
audit activities. Afterward, they organized the closing meeting with VeridicAl’s management. During the meeting, Sharona and the team made a recap on audit
objectives and scope, presented the audit findings and conclusions, presented identified nonconformities, and organized a session for questions and answers for the
auditee.
VeridicAI received a conditional recommendation for certification, underscoring its compliance with the industry's standards. Sharona confirmed that the company met
the essential requirements but noted some identified minor nonconformities. In response, VeridicAI compiled and submitted a comprehensive action plan that
addresses all identified nonconformities within a designated timeframe. Because of the comprehensive action plan, Sharona did not see the need for an additional on-
site visit to verify the effectiveness of the action plan.
Sharona played an integral role in the certification decision process. Her thorough understanding of VeridicAI's operations, gained from the audit, guided the
certification body towards a well-informed certification decision.
What type of audit evidence did Augustine gather when he collected management review records? Refer to scenario 3.
Scenario 3: Heala specializes in developing Al-driven solutions for the healthcare sector. With a keen focus on leveraging Al to revolutionize patient care, diagnostics,
and treatment planning, the company has implemented an artificial intelligence management system AIMS based on ISO/IEC 42001. After a year of having the AIMS in
place, the company decided to apply for a certification audit.
It contracted a local certification body, who established the audit team and assigned the audit team leader. Augustine, the designated audit team leader, has a wide
range of skills relevant to various auditing domains. His proficiency encompasses audit principles, processes, and methods, as well as standards for management
systems and additional references. Furthermore, he is knowledgeable about the Heala’s context and relevant statutory and regulatory requirements.
Augustine first gathered management review records, interested party feedback logs, and revision histories for Heala's AIMS. This crucial step laid the groundwork for
a deeper investigation, which included conducting comprehensive interviews with key personnel to understand how feedback from interested parties directly
influenced updates to the AIMS and its strategic direction. Augustine's thorough evaluation process aimed to verify Heala's commitment to integrating the needs and
expectations of interested parties, a critical requirement of ISO/IEC 42001.
Augustine also integrated a sophisticated Al tool to analyze large datasets for patterns and anomalies, and thus have a more informed and data driven audit process.
This Al solution, known for its ability to sift through vast amounts of data with unparalleled speed and accuracy, enabled Augustine to identify irregularities and trends
that would have been nearly impossible to detect through manual methods. The tool was also helpful in preparing hypotheses based on data.
During the audit. Augustine failed to fully consider Heala’s critical processes, expectations, the complexity of audit tasks, and necessary resources beforehand. This
oversight compromised the audit integrity and reliability, reflecting a significant deviation from the diligence and informed judgment expected of auditors.
TESTED 23 Oct 2025
