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 does the 'Human-Centered Design' core element prioritize in AI development?
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 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.
Scenario 9 (continued):
Scenario 9: Securisai, located in Tallinn. Estonia, specializes in the development of automated cybersecurity solutions that utilize AI systems. The company recently implemented an artificial intelligence management system AIMS in accordance with ISO/IEC 42001. In doing so, the company aimed to manage its Al-driven systems’ capabilities to detect and mitigate cyber threats more efficiently and ethically. As part of its commitment to upholding the highest standards of Al use and management, Securisai underwent a certification audit to demonstrate compliance with ISO/IEC 42001.
The audit process comprised two main stages: the initial or stage 1 audit focused on reviewing Securisai's documentation, policies, and procedures related to its AIMS. This review laid the groundwork for the stage 2 audit, which involved a comprehensive, on-site evaluation
of the actual implementation and effectiveness of the AIMS within Securisai's operations. The goal was to observe the AIMS in operation, ensuring that it not only existed on paper but was effectively integrated into the company's daily activities and cybersecurity strategies.
After the audit, Roger, Securisai's internal auditor, addressed the action plans devised to rectify nonconformities identified during the certification audit. He developed a long term strategy, highlighting key AIMS processes for triennial audits. Roger's internal audits play a
key role in advancing Securisai's goals by employing a systematic and disciplined method to assess and boost the efficiency of risk
management, governance processes, and strategic decision-making. Roger reported his findings directly to Securisai's top management.
Following the successful rectification of nonconformities, Securisai was officially certified against ISO/IEC 42001.
Recently, the company decided to transfer its ISO/IEC 42001 certification registration from one certification body to another despite being initially bound by a long-term agreement with the current certification body. This decision was motivated by the desire to partner with a certification body that offers deeper insights and expertise in the rapidly evolving field of artificial intelligence in cybersecurity.
To ensure a smooth transition and uphold its certification status, Securisai is diligently compiling the required documentation for submission to the new certification body. This includes a formal request, the most recent audit report underscoring its adherence to ISO/IEC 42001, the latest corrective action plan that highlights its continuous efforts toward improvement, and a copy of its current valid certification registration.
A year following Securisai's initial certification audit, a subsequent audit was carried out by the certification body on its AIMS. The
purpose of this audit was to assess compliance with ISO/IEC 42001 and verify the ongoing improvement of the AIMS. The audit team
concluded that Securisai's AIMS consistently meets the requirements set by ISO/IEC 42001.
Roger followed up on action plans after the external audit at Securisai, but he was directly involved in strategic decision-making processes, potentially affecting his audit objectivity.
Question:
Based on Scenario 9, which principle of internal auditing did Roger violate?
Question:
ReePharm, a pharmaceutical company, has decided to incorporate its AI risk management into the information security management system (ISMS) to identify and address risks related to the procurement, manufacturing, and distribution of pharmaceutical products. Is this decision appropriate?
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?
TESTED 18 Aug 2025
