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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q94-Q99):
NEW QUESTION # 94
An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:
"The reject rate of 'finished' product of 9.7% needs improvement as it doesn't meet the stated objective of top management of 5%." Just before the Closing meeting of a third-party audit, the audit team leader is invited to a meeting with the Quality Manager. He tells the audit team leader that a member of the audit team was seen taking photographs of the factory on his phone during the day and wants him suspended from the Closing meeting with any nonconformities raised by him rescinded. The issue of photographs was not discussed during the opening meeting.
Select the three options for how the audit team leader might deal with this situation.
- A. Apologise for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting
- B. State that the auditor will take no further part in the audit and all his photographs will be deleted
- C. Advise the Quality Manager that he, as audit team leader, needs to speak to the auditor about the situation and he will report back to the Quality Manager once this is done
- D. Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered
- E. Advise the Quality Manager that the auditor will be reported to Head Office
- F. Delay the Closing meeting until the audit team leader has consulted his audit programme manager at Head Office
Answer: C,D,F
Explanation:
* This option reflects a balanced and professional approach. The audit team leader should first gather information directly from the involved auditor to understand the situation before making any decisions.
It demonstrates due diligence and fairness.
* This ensures that the situation is properly escalated and handled in accordance with the auditing body's procedures. Consulting the audit programme manager helps ensure consistency in handling such incidents.
* The nonconformity raised is based on objective evidence, independent of the incident with the photographs. ISO 9001 audits are evidence-based, and the validity of the findings should not be compromised by unrelated issues.
1. A. Advise the Quality Manager that he, as audit team leader, needs to speak to the auditor about the situation and he will report back to the Quality Manager once this is done:2. D. Delay the Closing meeting until the audit team leader has consulted his audit programme manager at Head Office:3. E. Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered:
* B. Advise the Quality Manager that the auditor will be reported to Head Office:
* Reporting the auditor directly without first investigating the situation is premature and unprofessional. It might escalate the issue unnecessarily.
* C. Apologize for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting:
* Deleting evidence without proper consultation could be seen as tampering or unprofessional conduct. It's essential to understand the context of the photographs first.
* F. State that the auditor will take no further part in the audit and all his photographs will be deleted:
* This is an extreme response without first investigating the situation. Taking unilateral action without gathering facts can damage the audit's integrity.
Why Not the Other Options:
NEW QUESTION # 95
You are leading a Stage 2 certification audit of a multi-site organisation and have received the audit schedule below; Head Office and Site 1 - Day 1 Site 2 (150 Km from HQ) - Days 2 and 3 During Day 1 of the audit, the dient informs you that the laboratory at Site 2 has been dosed for decontamination due to a serious outbreak of an infectious disease among workers. In Site 2, all other functions could be audited as planned.
As the audit team leader, what would you do?
Choose the best acceptable action you could take:
Ask the audit Programme Manager for direction.
Complete the audit on day 3 and report back to the certification body for a certification decision.
Continue the audit on days 2 and 3 and return later to audit the Site 2 laboratory.
Immediately cancel the audit since the audit plan cannot be completed.
Who has the responsibility for assigning work to the audit team?
- A. The certification body
- B. The audit team leader
- C. The auditee organisation
- D. The audit team member
Answer: B
Explanation:
In the context of ISO 9001:2015 audits, it is the audit team leader who holds the responsibility for assigning work to the audit team. According to ISO 19011:2018 (Guidelines for auditing management systems, which complements ISO 9001:2015), the audit team leader is responsible for the organization and direction of the audit, including assigning specific roles and responsibilities to audit team members. This includes preparation of the audit plan, leading the audit, and ensuring that each team member understands their tasks.
NEW QUESTION # 96
The Closing meeting of a second-party audit was planned for 6 pm with the general manager and the quality manager.
At 6 pm, when the audit team enters the meeting room, only the Quality Manager is present and walting for them.
The dialogue among them is as follows:
Auditor team leader: "Good evening, could you please inform the general manager that we are ready to start with the closing meeting?" Quality manager: "Good evening. I am sorry to inform you that the general manager will not be able to attend the meeting. He will try to participate virtually to make some closing remarks." Auditor team leader: "OK. We identified seven nonconformities - these are the reports. Could you please review them and sign them?" Quality manager: "OK. As you know, I reviewed them after yesterday's meeting and accept of all them, where shall I sign?" General manager (from speakers in the room and addressing the quality manager): "Hold on! Do not sign the two nonconformities related to ABC Bank! I have just checked, and we did not provide any services to ABC Bank during September! You can sign the remaining five nonconformities." How would you proceed with the audit? Select one.
- A. I will include the seven nonconformities in the report, considering that we identified objective evidence on which all these nonconformities are based
- B. I will review this issue at length with the audit team tonight and will phone you tomorrow to let you know our decision
- C. I withdraw the two nonconformities related to service to ABC and will present the report with the remaining five nonconformities
- D. I will discuss this issue with our corporate quality manager and will let you know what we will do
Answer: B
NEW QUESTION # 97
Select the word that best completes the sentence:
Answer:
Explanation:
Explanation:
According to the ISO - Management system standards page, the key benefits of an effective management system include improved operational effectiveness and efficiency, improved risk management and protection of people and the environment, and enhanced drive for innovation. The Integrated Use of Management System Standards (IUMSS) handbook also states that the purpose and objectives of management system standards are to help organizations improve their performance by specifying repeatable steps that organizations consciously implement to achieve their goals and objectives.
Therefore, the complete sentence is:
"The purpose of a management system standard is to improve the performance of an organisation."
NEW QUESTION # 98
Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?
- A. Consistently provide products that meet customers' requirements
- B. Enhanced customer satisfaction
- C. Decreased number of warranty claims
- D. Decreased number of management system nonconformities
- E. Increased profits
- F. Decreased number of nonconforming products in all stages of the manufacturing cycle
Answer: A,B
Explanation:
According to the ISO 9001:2015 document, the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015 are:
*the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;
*the enhancement of customer satisfaction.
These results are derived from the quality management principles of customer focus and process approach, which are the basis of the ISO 9000 family of standards1. Customer focus means understanding and meeting customer needs and expectations, as well as exceeding them when possible1. Process approach means managing activities as interrelated processes that function as a coherent system, which leads to consistent and predictable results1.
Therefore, the correct answer is C and F.
References: 2: ISO 9001:2015 - Quality management systems - Requirements 1: ISO - Quality management principles
NEW QUESTION # 99
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