Scenario 2:
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, analyzevast amounts of data for insights, improve recruitment and talent management strategies, and personalize employee experiences, thecompany 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 frameworkfor 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 thepolicy, 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, theyensured that these individuals were responsible for overseeing the AIMS, reporting its performance to the top management, andfacilitating 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 Alperformance.
The company also planned, implemented, and monitored processes to meet AIMS requirements. Additionally, it set clear criteria andimplemented 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 theintegrity and accuracy of documentation, the company adopted version control practices. Each document update was tracked using aversioning system, with clear records of what was modified, who made the changes, and when the updates occurred. Access to makechanges was restricted to authorized personnel, and any proposed modifications required approval from the designated managementteam before being implemented.
Moreover, considering past experiences where the company encountered unforeseen risks, Empsy HR Solutions established acomprehensive Al risk assessment process. This process involved identifying, analyzing, and evaluating Al risks to determine if it isnecessary to implement additional controls than those specified in Annex A. The company also referred to Annex B for guidance onimplementing controls and, ultimately, produced a Statement of Applicability SoA. The SoA contained the necessary controls, including allthe 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'srequirements and ISO/IEC 42001. It defined the audit objectives, criteria, and scope for each audit, selected auditors, and ensuredobjectivity 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:
Did Empsy HR Solutions meet all ISO/IEC 42001 requirements regarding the AI policy?
Question:
Which of the following does NOT represent the purpose of managing and maintaining auditprogram records?
Question:
Which of the following does NOT constitute an appropriate technology requirement for virtualaudits between the auditee and audit team?
Scenario 4:
BioNovaPharm, a German biopharmaceutical company, has implemented an artificial intelligence management system AIMSbased on ISO/IEC 42001 to optimize various aspects of drug discovery, including analyzing extensive biological data, identifying potentialdrug candidates, and streamlining clinical trial processes. After having the AIMS in place for over a year, the company contracted acertification body and is now undergoing an AIMS audit to obtain certification against ISO/IEC 42001.
Adopting a risk-based approach, the audit team focused on risk throughout their activities. The level of detail outlined in the audit plancorresponded to the scope and complexity of the audit. The team employed a ranking system for detailed audit procedures, prioritizingthose with the highest risk.
Once the stage 1 audit began, the audit team started reviewing the auditee's documented information. To assess whether BioNovaPharmcomplies with the legal and regulatory requirements related to incident communication, the audit team examined evidence provided bythe company’s external legal office. The evidence confirmed that BioNovaPharm applies the requirements of the EU Al Act, whichmandates that providers of high-risk Al systems report serious incidents to relevant authorities.
Following the completion of the stage 1 audit, John, an audit team member, documented the stage 1 audit outputs, including theobservations of the audit team that could result in nonconformities during the on-site audit. However, the audit team leader, Emma, whowas overseeing the audit activities, observed that John failed to document significant observations related to the lack oftransparency inthe Al decision-making processes of BioNovaPharm. Considering that Emma observed John's lack of competence in undertaking some
audit activities, a disciplinary note was recorded for John.
Question:
What type of evidence did the audit team obtain to assess BioNovaPharm's compliance with legal and regulatory incident reporting requirements?