Which control in Annex A of ISO 42001:2023 focuses on the need for stakeholder engagement in AI system development?
Annex A -- Control A.5.2.2: Stakeholder Consultation explicitly requires organizations to consult with relevant stakeholders (such as users, impacted communities, regulators, etc.) during the development and operation of AI systems.
This control emphasizes the importance of engaging stakeholders to identify expectations, values, ethical concerns, and social impact risks associated with the AI system.
Stakeholder engagement supports transparency, ethical alignment, and social acceptability of AI solutions.
PECB Lead Auditor Guide -- Domain 2: ''Governance and Control Requirements for Ethical AI''
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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.
Based on Scenario 4, is the decision of the top management representative not to provide the additional evidence requested by the audit team justifiable?
Verbal evidence alone is considered less reliable.
ISO/IEC 42001 Clause 9.2.2 states that ''auditors shall corroborate interviews with documented information or other tangible evidence whenever possible.''
The ISO 19011:2018 Guidelines for Auditing Management Systems (adopted for auditing principles) Clause 6.5.6 also clearly specifies: ''Interview results should be verified with other forms of evidence because interviews alone are insufficient.''
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In which situations does an auditor have the right to decline the audit mandate?
Auditors have the right and responsibility to ensure that audits are conducted effectively. According to ISO 19011:2018 and ISO/IEC 17021-1:2015, if the audit time allocated is insufficient to conduct a comprehensive and thorough audit, the auditor may refuse or request modification of the assignment.
This helps maintain audit integrity, quality, and professional due care.
ISO/IEC 17021-1:2015, Clause 9.1.4 -- Audit duration
ISO 19011:2018, Clause 5.3.2 -- Audit planning responsibilities
PECB ISO/IEC 42001 Lead Auditor Guide -- Chapter: Auditor Rights and Responsibilities
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How does ISO 19011 recommend auditors select audit criteria?
Audit criteria should be selected according to the requirements of the management system standard (e.g., ISO/IEC 42001:2023) and the organization's objectives.
Per ISO 19011:2018 -- Clause 5.4.2, audit criteria must be defined based on standards, statutory requirements, internal policies, procedures, and contractual obligations relevant to the audit.
Random selection or convenience-based criteria are not acceptable in professional audit practice.
ISO/IEC 42001:2023 -- Clause 9.2.1 (Internal Audit planning)
PECB Lead Auditor Guide -- Domain 3: ''Defining Audit Criteria and Reference Documents''
[Fundamental Audit Concepts and Principles]
Auditors use the ______ as a benchmark to determine conformity.
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