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NEW QUESTION # 150
Which two of the following should be included in an audit plan?
Answer: A,D
Explanation:
According to ISO 19011:2018, clause 6.3.2, an audit plan should include the following information:
The audit objectives, scope, and criteria
The audit team members and their roles and responsibilities
The audit schedule, including the sequence and timings of audit activities, such as opening meeting, document review, interviews, observations, closing meeting, etc.
The expected time and duration of each audit activity and location
The name and contact details of the auditee's representative and other relevant parties The allocation of appropriate resources to support the audit activities The audit methods and techniques to be used, such as interviews, observations, sampling, etc.
The audit documents and records to be prepared and retained
The audit language and communication methods
The audit risks and opportunities and how to address them
The audit follow-up arrangements, if applicable
Therefore, the correct answer is D and F, as they are essential elements of an audit plan. The other options are either irrelevant or optional for an audit plan. References:
ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.3.2 ISO 19011: Guidelines for Auditing Management Systems | ASQ, section "Making audit arrangements" ISO 19011 Management Systems Audit Checklist | Process Street, task 6.3.2
NEW QUESTION # 151
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.
What type of evidence has been collected by the ACB's audit team, as presented in scenario 3?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Audit evidence includes information collected through different methods to assess compliance with ISO
9001:2015 requirements.
Clause References:
* ISO 19011:2018, Clause 6.4.6 - Audit Evidence: Audit evidence must be objective, verifiable, and based on facts.
* ISO 9001:2015, Clause 9.1.1 - Monitoring, Measurement, Analysis, and Evaluation: Requires organizations to collect and analyze data from multiple sources to verify effectiveness.
Types of Audit Evidence Collected in Scenario 3:
* Verbal Evidence - Employee interviews regarding training and awareness sessions.
* Documentary Evidence - Organizational charts, job descriptions, training records.
* Physical Evidence - Workplace observations to assess working conditions.
Why is the Correct Answer B?
* The audit team used a combination of verbal (interviews), documentary (records), and physical (site observations) evidence.
* This triangulation approach enhances audit reliability and ensures compliance verification.
Why are the Other Options Incorrect?
* A (Confirmative evidence) # Not a formal audit term in ISO 9001 or ISO 19011.
* C (Analytical evidence) # Incorrect, as analysis was not a primary method used.
* D (Qualitative evidence only) # Incorrect because the audit involved both qualitative (interviews) and quantitative (documents, physical) evidence.
NEW QUESTION # 152
You are a member of the audit team of a second-party audit of an organisation with 625 employees. The audit procedure recommends using sampling criteria which requires the review of the documented competence for
25 personnel. The audit team leader developed an audit plan allocating one hour to audit the Human Resources department (from 11:30 am to 12:30 pm). She told you that she could not allocate any additional time.
What would you do?
Answer: B
Explanation:
In this scenario, the time allocated by the audit team leader for the Human Resources audit is fixed, and as an auditor, you must work within that constraint. Although the sampling criteria suggests reviewing 25 personnel files, it is acceptable to adjust the sample size based on time and resource limitations. ISO 9001:2015 emphasizes risk-based thinking and practical resource management (Clause 7.1), so it is reasonable to review a smaller sample if the time is insufficient.
Option B is a pragmatic approach, allowing you to focus on quality over quantity by reviewing as many cases as time allows without compromising the audit schedule.
Options like extending the audit (A, C, D) are impractical in a structured audit environment, especially for second-party audits where maintaining the agreed schedule is important.
NEW QUESTION # 153
Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.
A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.
In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.
Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.
Based on the scenario above, answer the following question:
Scenario 6 indicates that although the top management did not agree with the audit findings, the audit team began preparing the audit report. Is this acceptable?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 6.4.11 (Closing Meeting):
* The audit team must proceed with the audit report, even if the auditee disagrees with findings.
* Disagreements do not invalidate audit results.
* The auditee has the right to file a complaint or appeal, but this is handled after the audit report is submitted.
Thus, the audit team acted correctly by proceeding with the audit report despite top management's disagreement.
Reference:
ISO 19011:2018, Clause 6.4.11 (Closing Meeting & Handling Disputes)
NEW QUESTION # 154
The following actions need to be carried out during a third-party audit planning stage. Which two actions correspond to the individual(s) managing the audit program before the involvement of the audit team leader'
Answer: A,D
Explanation:
In ISO 9001:2015, the responsibility for managing the audit program lies with those overseeing the entire audit process rather than the Audit Team Leader. During the planning stage, before involving the Audit Team Leader, key actions for managing the audit program include:
1. Providing the Resources Needed: According to clause 7.1 (Resources), the audit program manager must ensure that the necessary resources are in place to conduct the audit effectively. This encompasses logistical support, personnel, and other required resources for the audit to proceed smoothly.
2. Reviewing Reports of Previous Audits: As per clause 9.2.2 (Internal Audit), it is essential to consider the results of previous audits to plan effectively for the upcoming audit. This helps identify areas that require particular attention, ensuring continuity and focusing on recurring issues or improvements since the last audit.
These actions ensure that the audit is thoroughly prepared and that there is continuity and focus on any areas that might need closer inspection. The other options, such as preparing the audit plan, assigning responsibilities, preparing checklists, and selecting the audit team members, generally fall under the duties of the Audit Team Leader once they are appointed and engaged in the planning process.
NEW QUESTION # 155
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