Question:
Who is responsible for reviewing the corrections, identified causes, and corrective actions of the auditee?
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
Question:
Based on ISO/IEC 42001, which of the following is NOT one of the factors that an organization must consider when determining the risks and opportunities related to an AI system?
Scenario 4 (continued):
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 of transparency 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:
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 8:
Scenario 8: InnovateSoft, headquartered in Berlin, Germany, is a software development company known for its innovative solutions andcommitment 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 theevidence, 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 inaccuratelyreflecting the efficiency of their software development processes. In response, the company provided new evidence and additionalinformation to alter the audit conclusions for a couple of minor nonconformities identified. After thorough consideration, the audit teamleader clarified that the new evidence did not significantly alter the core conclusions drawn for the nonconformities. Therefore, thecertification 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 theaudit team on resolving the identified nonconformities. The audit team leader offered solutions to address the issues, fostering acollaborative 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 auditevidence was based on a sample, acknowledging the inherent uncertainty. The method and time frame of reporting and grading findingswere 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 correctiveactions planned to address the detected nonconformities. However, the submission slightly exceeded the specified period of 45 days setby the certification body, arriving three days later.
InnovateSoft explained this by attributing the delay to unexpected challengesencountered during the compilation of the action plans.
Question:
Was the audit team leader's attitude appropriate regarding the new evidence provided by the company?
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