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ISO-IEC-42001-Lead-Auditor Latest Exam Vce - ISO-IEC-42001-Lead-Auditor Exam Study Guide
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PECB ISO-IEC-42001-Lead-Auditor Exam Syllabus Topics:
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PECB ISO/IEC 42001:2023Artificial Intelligence Management System Lead Auditor Exam Sample Questions (Q58-Q63):
NEW QUESTION # 58
Scenario 8 (continued):
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.
InnovateSoft's corrective action plans described the detected issues and intended corrections but did not include the root causes.
Question:
Were InnovateSoft's action plans drafted appropriately?
- A. Yes, the action plans were drafted appropriately
- B. No, because a general action plan was not submitted encompassing all nonconformities
- C. No, because they did not include the root causes of the detected nonconformities
Answer: C
Explanation:
A complete corrective action planmust include:
* Description of the nonconformity
* Root cause analysis
* Correction
* Corrective action
* ISO/IEC 17021-1:2015 Clause 9.4.9.2explicitly states:"The client shall analyze the cause of the nonconformity and describe the specific correction and corrective action taken."
* The absence ofroot cause analysisrenders the plan non-compliant.
Reference:ISO/IEC 17021-1:2015 Clause 9.4.9.2; Lead Auditor Training Manual - Module 9 ("Corrective Action Management").
NEW QUESTION # 59
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?
- A. Automated data validation
- B. Augmented audit interviews
- C. Augmented analysis
- D. Automated planning
Answer: A
Explanation:
The audit team used Automated Data Validation by using AI to gather and validate external digital data (e.
g., drug development information).
* ISO/IEC 42001 Clause 9.2.2 allows the use of automated methods to collect and validate information, provided that the reliability and integrity of such systems are ensured.
* The Lead Auditor Course Guide explains: "Automated data validation tools help auditors improve evidence collection efficiency by cross-referencing multiple datasets with minimal manual intervention." Reference: ISO/IEC 42001:2023 Clause 9.2.2; Lead Auditor Guide Module 5 ("Use of Automated Tools in Audits").
NEW QUESTION # 60
What type of audit evidence did Augustine gather when he collected management review records? Refer to scenario 3.
Scenario 3: Heala specializes in developing Al-driven solutions for the healthcare sector. With a keen focus on leveraging Al to revolutionize patient care, diagnostics, and treatment planning, the company has implemented an artificial intelligence management system AIMS based on ISO/IEC 42001. After a year of having the AIMS in place, the company decided to apply for a certification audit.
It contracted a local certification body, who established the audit team and assigned the audit team leader.
Augustine, the designated audit team leader, has a wide
range of skills relevant to various auditing domains. His proficiency encompasses audit principles, processes, and methods, as well as standards for management systems and additional references. Furthermore, he is knowledgeable about the Heala's context and relevant statutory and regulatory requirements.
Augustine first gathered management review records, interested party feedback logs, and revision histories for Heala's AIMS. This crucial step laid the groundwork for a deeper investigation, which included conducting comprehensive interviews with key personnel to understand how feedback from interested parties directly influenced updates to the AIMS and its strategic direction. Augustine's thorough evaluation process aimed to verify Heala's commitment to integrating the needs and expectations of interested parties, a critical requirement of ISO/IEC 42001.
Augustine also integrated a sophisticated Al tool to analyze large datasets for patterns and anomalies, and thus have a more informed and data driven audit process.
This Al solution, known for its ability to sift through vast amounts of data with unparalleled speed and accuracy, enabled Augustine to identify irregularities and trends that would have been nearly impossible to detect through manual methods. The tool was also helpful in preparing hypotheses based on data.
During the audit. Augustine failed to fully consider Heala's critical processes, expectations, the complexity of audit tasks, and necessary resources beforehand. This oversight compromised the audit integrity and reliability, reflecting a significant deviation from the diligence and informed judgment expected of auditors.
- A. Observational
- B. Documentary
- C. Mathematical
- D. Confirmative
Answer: B
Explanation:
Audit evidence can be classified into different types, including documentary, oral, observational, and physical. According to ISO 19011:2018 (Guidelines for Auditing Management Systems), which is referenced in ISO/IEC 42001:2023 for audit practice, "Documented information (such as policies, procedures, reports, records)" is considered documentary evidence.
In the scenario, Augustine collected:
Management review records
Feedback logs
Revision histories
All of these are written or electronic records and fall under documentary evidence.
Reference:
ISO 19011:2018, Clause 3.8 - Audit Evidence
ISO/IEC 42001:2023, Clause 9.2 - Internal audit evidence requirements
PECB ISO/IEC 42001 Lead Auditor Study Guide, Chapter: Types of audit evidence
NEW QUESTION # 61
What is the purpose of conducting an opening meeting in the audit process?
- A. To perform a root cause analysis
- B. To confirm the audit plan and address any issues
- C. To establish the audit criteria
- D. To discuss the audit findings
Answer: B
Explanation:
Theopening meetingis a critical step in the audit process where the audit team:
* Confirms the audit plan
* Clarifies thescope, objectives, and schedule
* Addresses any last-minute concerns or changes
* Establishes lines of communication and cooperation
As perISO 19011:2018 - Clause 6.4.3, the opening meeting ensures mutual understanding between the auditor(s) and the auditee, helping set expectations and reduce confusion during the audit.
Reference: ISO 19011:2018 - Clause 6.4.3 (Opening Meeting)
ISO/IEC 42001:2023 - Clause 9.2.2 (Audit implementation)
PECB Lead Auditor Guide - Domain 5: "Opening and Conducting the Audit"
NEW QUESTION # 62
Based on the scenario above, answer the following question:
Which activity conducted during the stage 2 audit does not follow best practices?
- A. Skipping the review of documented information related to the AIMS
- B. Conducting interviews with auditee personnel
- C. Conducting on-site activities
- D. Conducting the opening meeting with the auditee present
Answer: A
Explanation:
Even though some documented information was reviewed during Stage 1, ISO/IEC 17021-1:2015 (Clause
9.3.1.2.2) and ISO 19011:2018 (Clause 6.5.2) recommend that auditors should not entirely skip the review of documented information during the Stage 2 audit.
The Stage 2 audit is intended to evaluate the implementation and effectiveness of the management system, and this includes ensuring that documented information is not only available but also maintained, communicated, and used properly in operations.
Skipping this step may lead to overlooking changes made after Stage 1 or gaps not previously identified.
Reference:
ISO/IEC 17021-1:2015, Clause 9.3.1.2.2
ISO 19011:2018, Clause 6.5.2 - Conducting Document Review
PECB ISO/IEC 42001 Lead Auditor Study Guide - Stage 2 Audit Activities
NEW QUESTION # 63
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