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NEW QUESTION # 121
Scenario 3:
Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.
To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.
The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.
The audit team began by gathering information about Fin-Pro's understanding of ISO 9001 requirements.
While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.
The team also reviewed the organizational chart and job descriptions to confirm employee competence.
They observed the company's working environment (social, psychological, and physical conditions).
The audit team analyzed the evidence and prepared an audit report with findings and conclusions.
Which statement below represents the level of responsibility demonstrated by the audit team in scenario 3?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 19011:2018 requires auditors to conduct audits professionally and diligently.
Clause References:
* ISO 19011:2018, Clause 4.4 - Professional Care: Auditors must exercise due diligence in conducting audits.
* ISO 9001:2015, Clause 9.2 - Internal Audit: Requires objective and systematic audits to evaluate QMS effectiveness.
Why is the Correct Answer A?
* The audit team followed best practices by gathering verifiable audit evidence through interviews, document reviews, and observations.
* They ensured fair presentation of findings in the final audit report.
* They complied with ISO 9001 and ISO 19011 guidelines for audit procedures.
Why are the Other Options Incorrect?
* B (Ordinary negligence) # No evidence of negligence; the team followed structured audit processes.
* C (Gross negligence) # No indication that the auditors ignored important responsibilities.
* D (Willful misconduct) # The auditors acted professionally and did not intentionally disregard rules.
NEW QUESTION # 122
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD's top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
Based on scenario 4, conducting which of the activities below is NOT the responsibility of Anne?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires specific roles and responsibilities for audit leaders and certification bodies.
Clause References:
* ISO 19011:2018, Clause 5.5 - Conducting the Audit: Defines audit team leader responsibilities.
* ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning: Defines certification body responsibilities, including the certification agreement.
Why is the Correct Answer D?
* The certification agreement is signed between the certification body and the auditee (TD Advertising).
* Anne (audit team leader) does NOT have authority to sign the agreement-that is the responsibility of the certification body's management.
Why are the Other Options Incorrect?
* A (Establishing audit criteria and objectives) # Correct responsibility of the audit leader as per ISO 19011.
* B (Determining audit feasibility) # Audit leaders assess feasibility but do not sign agreements.
* C (Assigning responsibilities for the audit team) # This is part of the audit leader's role in planning audits.
NEW QUESTION # 123
Which of the following two documents does an auditor need to prepare and complete prior to the on-site audit?
Answer: C,D
Explanation:
According to ISO 19011:2018, clause 6.3, the audit plan is a document that provides the basis for agreement regarding the conduct of the audit. The audit plan should include the information listed in my previous response, such as the audit objectives, scope, criteria, schedule, team, methods, report, etc. The audit plan should be prepared and completed prior to the on-site audit, and should be communicated to the audit team and the auditee1.
According to ISO 19011:2018, clause 6.4.3, the checklist / prompts are documents that list the questions or topics that need to be covered during an audit. The checklist / prompts can help the auditor to collect and verify information relevant to the audit criteria, and to ensure the consistency and completeness of the audit.
The checklist / prompts should be prepared and completed prior to the on-site audit, and should be based on the audit plan and the audit scope and objectives1.
Therefore, the two documents that an auditor needs to prepare and complete prior to the on-site audit are B and D, as they are essential for planning and conducting the audit. The other options are not correct, as they are either prepared or completed after the on-site audit, or not required by the standard:
*A. Audit Report: The audit report is a document that provides a complete, accurate, concise, and clear record of the audit. The audit report should include the information listed in my previous response, such as the audit objectives, scope, criteria, findings, conclusions, etc. The audit report should be prepared and completed after the on-site audit, and should be distributed to the audit client and the auditee1.
*C. Procedures: Procedures are documents that specify the way activities are to be performed. Procedures may be part of the audit criteria, if they are part of the organization's management system, or part of the audit programme, if they are part of the certification body's or registrar's requirements. Procedures are not prepared or completed by the auditor prior to the on-site audit, but rather reviewed or followed by the auditor during the audit1.
*E. Risk Matrices: Risk matrices are tools that help to assess and prioritize the risks and opportunities associated with the audit programme or the audit. Risk matrices may be part of the audit programme management, if they are used to determine and evaluate the audit programme risks and opportunities, or part of the audit preparation, if they are used to determine and evaluate the audit risks and opportunities. Risk matrices are not prepared or completed by the auditor prior to the on-site audit, but rather used or updated by the auditor during the audit programme management or the audit preparation1.
*F. Findings: Findings are the results of the evaluation of the collected audit evidence against the audit criteria. Findings can indicate either conformity or nonconformity, as well as positive aspects or opportunities for improvement. Findings are not prepared or completed by the auditor prior to the on-site audit, but rather generated and recorded by the auditor during the audit activities1.
References: ISO 19011:2018(en), Guidelines for auditing management systems
NEW QUESTION # 124
In a third-party audit to ISO 9001, select two options of when the organisation is required to act in response to reported findings.
Answer: B,F
Explanation:
According to ISO 19011:2018, clause 6.6.2, a nonconformity is the non-fulfilment of a requirement. A nonconformity can be classified as either major or minor, depending on the nature and extent of the deviation from the audit criteria. A major nonconformity is a nonconformity that affects the ability or the integrity of the organization's management system to achieve the intended results. A minor nonconformity is a nonconformity that does not affect the ability or the integrity of the organization's management system to achieve the intended results, but is a deviation from the audit criteria1.
According to ISO/IEC 17021-1:2015, clause 9.4.9, the organization is required to analyze the cause and describe the specific correction and corrective actions taken, or planned to be taken, to eliminate detected nonconformities, within a defined time. The organization is also required to provide the certification body with records and evidence of the implementation and effectiveness of the correction and corrective actions taken.
The certification body will then verify the correction and corrective actions taken by the organization and decide on the certification status2.
Therefore, the two options of when the organization is required to act in response to reported findings are D and F, as they indicate the presence of nonconformities that need to be corrected and prevented from recurring.
The other options are not correct, as they do not require the organization to act in response to reported findings:
*A. A recommendation is given in the report: A recommendation is a suggestion for improvement that is not related to a nonconformity. A recommendation is not binding for the organization and does not affect the certification status. The organization may choose to accept or reject the recommendation, but it is not required to act on it.
*B. A finding of good practice is reported: A finding of good practice is a positive observation that indicates a strength or a best practice of the organization's management system. A finding of good practice is not related to a nonconformity and does not affect the certification status. The organization may choose to acknowledge or share the finding of good practice, but it is not required to act on it.
*C. An opportunity for improvement is raised: An opportunity for improvement is a potential area where the organization's management system can be enhanced or optimized. An opportunity for improvement is not related to a nonconformity and does not affect the certification status. The organization may choose to pursue or ignore the opportunity for improvement, but it is not required to act on it.
*E. A finding of conformity is reported: A finding of conformity is a confirmation that the organization's management system fulfils the audit criteria. A finding of conformity is not related to a nonconformity and does not affect the certification status. The organization may choose to celebrate or communicate the finding of conformity, but it is not required to act on it.
References: ISO 19011:2018(en), Guidelines for auditing management systems, ISO/IEC 17021-1:2015(en), Conformity assessment - Requirements for bodies providing audit and certification of management systems
- Part 1: Requirements
NEW QUESTION # 125
In the context of a third-party certification audit, match the roles with the following responsibilities:
Answer:
Explanation:
Explanation:
In the context of a third-party certification audit, match the roles with the following responsibilities:
Responsibilities:
Conduct the audit to the assigned area.= Auditors
Assist the auditors in identifying personnel to participate in the audit.= Guide Assign each team member's responsibility for the audit.= Audit team leader Respond to questions and provide evidence to the auditor.= Auditee According to ISO 19011:2018, clause 3, the definitions of the roles are as follows1:
Auditors: persons with the competence to conduct an audit
Guide: person appointed by the auditee to assist the audit team
Auditee: organization being audited
Audit team leader: member of an audit team appointed to manage the audit or an audit team Therefore, the roles can be matched to the responsibilities based on these definitions and the description of the audit process in clause 6 of the standard1.
References: ISO 19011:2018(en), Guidelines for auditing management systems
NEW QUESTION # 126
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