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?
Which of the following competencies must at least one of the audit team members have?
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?
Was the involvement of Ms. Rebecca Hayes, the internal auditor, necessary for the audit at ImoAI? 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 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 software development company values collaborative decision-making. The CEO often gathers input from employees but retains final decision authority.
Which type of leadership does the CEO most closely embody?
Scenario 4: Finalogic leads the application of artificial intelligence in the financial services sector, which is used to improve risk assessment, fraud detection, and customer service. The company has implemented an artificial intelligence management system (AIMS) based on ISO/IEC 42001 to ensure operational quality, ethical AI use, regulatory compliance, and transparency, allowing for consistent oversight and structured governance.
This month, Finalogic is undergoing an audit to obtain certification against ISO/IEC 42001, a critical step in demonstrating its commitment to responsible AI. To evaluate Finalogic's conformity to the audit criteria, the audit team adopted a comprehensive, evidence-based approach. The gathered evidence ranged from analyses of unquantifiable information to analyses of samples related to determining the audit criteria—including internal reports generated by Finalogic's own AI system—which assert successful integration and compliance with the standard.
Additionally, presentations by the company’s AI team during the audit highlighted the system’s success in customer service enhancements and fraud detection, emphasizing improved efficiency, decision-making accuracy, and user trust. An evaluation report prepared by an independent third-party firm specializing in AI systems also provided an objective review of Finalogic's AIMS. It assessed the system's effectiveness, bias, and compliance through a thorough examination.
During the audit, the audit team applied the same level of effort and utilized the same techniques across all audit areas, regardless of their risk level. This strategy ensured a consistent and thorough evaluation of the AIMS, uncovering any latent weaknesses or inefficiencies that might otherwise go unnoticed.
Despite Finalogic's advanced AIMS and adherence to ISO/IEC 42001 for ethical AI practices, there remains a risk of AI algorithms inadvertently perpetuating bias or making inaccurate predictions due to unforeseen flaws in training data or algorithmic models. This could lead to unfair loan rejections or approvals, potentially causing financial losses or damaging the company’s reputation for fairness and accuracy in its financial services. By acknowledging these risks, Finalogic remains committed to refining its AI governance, implementing bias mitigation strategies, and enhancing transparency to uphold its reputation as a leader in AI-driven financial services.
What type of audit is Finalogic undergoing?
Which phase involves the collection of objective evidence through interviews, observations, and examination of documents?
Which core element focuses on ensuring that the creators and operators of AI systems are responsible for the outcomes and impacts of those systems?
Question:
A multinational technology corporation has initiated an audit process to assess compliance with ISO/IEC 42001. The audit team drafted an audit schedule after the initiation of the audit.
Which aspect of the audit schedule prepared by the audit team is NOT correct?
In the functional view of an AI system, what role does the processing component play?
What should the auditor assess to verify the establishment of an internal audit program?
Question:
What is a significant drawback of using judgment-based sampling in audits?
What did the audit team use to assess the implementation of AI-related controls, verify compliance with established procedures, and identify any gaps in adherence to the AIMS requirements? Refer to Scenario 6
Scenario 1:
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:
Which of the following AI principles has Future Horizon Academy applied?
During a certification audit, the audit team reviewed the defined roles and responsibilities within the auditee and conducted interviews with key personnel. They also evaluated whether the roles and responsibilities were aligned with the AI policy and objectives, examined reporting mechanisms for concerns, and reviewed the reporting frequency and response time for AI-related matters. The implementation of which control of ISO/IEC 42001 is being verified in this case?
According to the core element of 'Privacy and Security,’ what is essential when developing AI systems?
Which of the following does NOT represent the purpose of managing and maintaining audit program records?
Question:
Can ISO/IEC 42001 be integrated into an integrated management system (IMS) with ISO/IEC 27001 and ISO 9001?
A software development company is well-known for its innovative practices and collaborative work environment. The CEO, Alex, has fostered a work culture where team input is highly valued in shaping the company’s strategic direction. Alex often organizes brainstorming sessions and workshops, inviting employees from various departments to share their insights and suggestions on new projects, company policies, and workflow improvements. While Alex ensures that every team member feels heard and valued, the final decisions on project directions, key company policies, and strategic initiatives rest with Alex. Which type of leadership does Alex most closely embody?
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?
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, which of the following AI technologies did Audrey employ to assess the efficiency of the bank's digital infrastructure?
Scenario 2 (continued):
Empsy HR Solutions is a human resources consulting company that provides innovative HR solutions to diverse industries. Recognizing the significant impact of artificial intelligence Al in HR processes, including its ability to automate repetitive tasks, analyze vast amounts of data for insights, improve recruitment and talent management strategies, and personalize employee experiences, the company has initiated the implementation of an artificial intelligence management system AIMS based on ISO/IEC 42001.
Initially, the top management established an Al policy that was aligned with the company's objectives. The Al policy provided a framework for defining Al objectives, a commitment to meeting relevant requirements, and a dedication to continually improve the AIMS. However, it
did not refer to other organizational policies, although some were relevant to the AIMS. Afterward, the top management documented the policy, communicated it internally, and made it accessible to interested parties.
The top management designated specific individuals to ensure that the AIMS meets the standard's requirements. Additionally, they ensured that these individuals were responsible for overseeing the AIMS, reporting its performance to the top management, and facilitating continual improvement. Moreover, in its awareness sessions, the company focused exclusively on ensuring that all personnel
were informed about the Al policy, emphasizing their role in ensuring the effectiveness of the AIMS and the benefits of enhanced Al performance.
The company also planned, implemented, and monitored processes to meet AIMS requirements. Additionally, it set clear criteria and implemented controls based on them, ensuring effective operation, alignment with organizational objectives, and continual improvement. Empsy HR Solutions decided to implement strict measures to control changes to documented information within the AIMS. To ensure the integrity and accuracy of documentation, the company adopted version control practices. Each document update was tracked using a versioning system, with clear records of what was modified, who made the changes, and when the updates occurred. Access to make changes was restricted to authorized personnel, and any proposed modifications required approval from the designated management team before being implemented.
Moreover, considering past experiences where the company encountered unforeseen risks, Empsy HR Solutions established a comprehensive Al risk assessment process. This process involved identifying, analyzing, and evaluating Al risks to determine if it is necessary to implement additional controls than those specified in Annex A. The company also referred to Annex B for guidance on implementing controls and, ultimately, produced a Statement of Applicability So A. The SoA contained the necessary controls, including all the controls of Annex A and justifications for their inclusion or exclusion.
Lastly. Empsy HR Solutions decided to establish an internal audit program to ensure the AIMS conforms to both the company's requirements and ISO/IEC 42001. It defined the audit objectives, criteria, and scope for each audit, selected auditors, and ensured objectivity and impartiality during the audit process. The results of the first audit were documented and reported only to the top
management of the company.
Question:
Based on Scenario 2, was the awareness session conducted in accordance with the requirements of Clause 7.3 Awareness of ISO/IEC 42001?
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?
During which phase of the certification process is confirmation of registration performed?
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
Which control in Annex A emphasizes the importance of security measures in AI system operations?
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.
Question:
Was the audit team leader’s attitude appropriate regarding the new evidence provided by the company?
Question:
During a combined audit, if an auditor identifies a finding linked to one criterion, should they consider its potential impact on corresponding or related criteria of other management systems?
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?
What is the main goal of the 'Transparency and Explainability' core element in AI?
Based on the scenario above, answer the following question:
Which activity conducted during the stage 2 audit does not follow best practices?
Question:
During which phase of the certification process is confirmation of registration performed?
Jonathan received an offer from the certification body including detailed information related to the audit. What other information should have been included in the audit offer? 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.
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 functionality, what type of AI system did Future Horizon Academy establish?
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:
Which clause did the audit team evaluate when assessing the appropriateness of the “AIMS Insight Strategy” procedure?
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.
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?
A financial institution uses an AI system to approve loan applications. Recently, there have been complaints that the system disproportionately denies loans to applicants from certain minority groups. Which core element should the institution prioritize to address these complaints?
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.
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:
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, does the level of detail in the audit plan adequately reflect all aspects recommended for a comprehensive risk-based approach to planning?
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:
Based on Scenario 5, did the certification body take the necessary steps to assure the overall competence of the audit team?
In which step are the audit findings, including nonconformities, documented and reviewed?
After an AIMS audit, the auditee made the required corrections and implemented corrective actions. However, it did not notify the auditor that led the audit regarding the completion status of the corrections and corrective actions since the auditee had been recommended for certification under the condition that corrective actions be submitted without a prior visit. Is this acceptable?
Which control in Annex A of ISO 42001:2023 focuses on the need for stakeholder engagement in AI system development?
Scenario 2 (continued):
Empsy HR Solutions is a human resources consulting company that provides innovative HR solutions to diverse industries. Recognizing the significant impact of artificial intelligence Al in HR processes, including its ability to automate repetitive tasks, analyze vast amounts of data for insights, improve recruitment and talent management strategies, and personalize employee experiences, the company has initiated the implementation of an artificial intelligence management system AIMS based on ISO/IEC 42001.
Initially, the top management established an Al policy that was aligned with the company's objectives. The Al policy provided a framework for defining Al objectives, a commitment to meeting relevant requirements, and a dedication to continually improve the AIMS. However, it
did not refer to other organizational policies, although some were relevant to the AIMS. Afterward, the top management documented the policy, communicated it internally, and made it accessible to interested parties.
The top management designated specific individuals to ensure that the AIMS meets the standard's requirements. Additionally, they ensured that these individuals were responsible for overseeing the AIMS, reporting its performance to the top management, and facilitating continual improvement. Moreover, in its awareness sessions, the company focused exclusively on ensuring that all personnel
were informed about the Al policy, emphasizing their role in ensuring the effectiveness of the AIMS and the benefits of enhanced Al performance.
The company also planned, implemented, and monitored processes to meet AIMS requirements. Additionally, it set clear criteria and implemented controls based on them, ensuring effective operation, alignment with organizational objectives, and continual improvement. Empsy HR Solutions decided to implement strict measures to control changes to documented information within the AIMS. To ensure the integrity and accuracy of documentation, the company adopted version control practices. Each document update was tracked using a versioning system, with clear records of what was modified, who made the changes, and when the updates occurred. Access to make changes was restricted to authorized personnel, and any proposed modifications required approval from the designated management team before being implemented.
Moreover, considering past experiences where the company encountered unforeseen risks, Empsy HR Solutions established a comprehensive Al risk assessment process. This process involved identifying, analyzing, and evaluating Al risks to determine if it is necessary to implement additional controls than those specified in Annex A. The company also referred to Annex B for guidance on implementing controls and, ultimately, produced a Statement of Applicability So A. The SoA contained the necessary controls, including all the controls of Annex A and justifications for their inclusion or exclusion.
Lastly. Empsy HR Solutions decided to establish an internal audit program to ensure the AIMS conforms to both the company's requirements and ISO/IEC 42001. It defined the audit objectives, criteria, and scope for each audit, selected auditors, and ensured objectivity and impartiality during the audit process. The results of the first audit were documented and reported only to the top
management of the company.
Question:
According to Scenario 2, were the risks addressed in accordance with the ISO/IEC 42001 requirements?
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:
Prior to the certification audit, the institution conducted an internal audit and management review. Is this acceptable?
A certification body is conducting surveillance audits for a company that manages 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?
Based on Scenario 7, what sampling method was used to assess TastyMade's adherence to some requirements of Clause 4.1 Understanding the organization and its context?
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
TESTED 18 Aug 2025
