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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q140-Q145):NEW QUESTION # 140
At the end of a second-party audit, the audit team enters the meeting room to hold the closing meeting; only two people are present and waiting for them: the Health and Safety supervisor and the Administrative Officer.
Neither has participated in the audit. However, the team had previously agreed with the auditee Quality Manager on two nonconformities identified during the audit (NC1 and NC2).
They said:
Health and Safety Supervisor: "Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and the other two managers have had to leave urgently to attend to the emergency." The Administration Officer: "Concerning 'nonconformity 2', the General Manager left a message asking us to tell you that he does not accept it and requests you not to include it in the audit report. Here is a note in which he explains why." Which one of the following would be your preferred answer (as team leader) to the General Manager's request?
- A. OK. I will get in contact with my company tomorrow to ask for instructions on what to do with this non-conformity.
- B. OK. Please, let me review the message. I will try to see if I can change the text of the nonconformity if necessary. Let's take a 10-minute break, as I would like to discuss this issue with the audit team.
- C. Please tell him that this nonconformity has been previously accepted by the quality manager during the audit and will stand. I will include it in the report, along with the concern of the General Manager about it.
- D. Please tell him that I will phone him in two days and will discuss the issue. Could you please give me his mobile phone number?
Answer: B
NEW QUESTION # 141
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME's QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME' s operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of
45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
According to scenario 5, Li Na conducted group interviews with departmental managers and top management by herself. Is this in accordance with audit best practices?
- A. No, two auditors should be present in case of group interviews.
- B. Yes, only the audit team leader should conduct group interviews.
- C. Yes, the auditee's top management is always interviewed by the audit team leader only.
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 6.4.6 (Conducting Interviews), group interviews should be conducted with at least two auditors to ensure objectivity and accuracy.
* This prevents bias or misinterpretation of responses.
* It allows for cross-validation of information.
* It ensures that the audit results remain objective and impartial.
Since Li Na conducted the group interviews alone, she did not follow audit best practices. The correct approach would have been to have another auditor present during the interviews.
Reference:
ISO 19011:2018, Clause 6.4.6 (Conducting Interviews)
NEW QUESTION # 142
How much time is usually spent on the Stage 1 audit?
- A. 20% of the total audit time
- B. 30% of the total audit time
- C. 40% of the total audit time
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 17021-1:2015 (Conformity Assessment - Requirements for Certification Bodies), Clause
9.3.1.2, the Stage 1 Audit typically consumes around 30% of the total audit time.
This time is allocated to:
Reviewing documented information.
Assessing the readiness for Stage 2.
Identifying potential nonconformities.
A 20% allocation (Answer A) is too low, and 40% (Answer C) is excessive, as the majority of the audit should be spent on Stage 2 (on-site verification).
Reference:
ISO 17021-1:2015, Clause 9.3.1.2 (Determination of Audit Time)
NEW QUESTION # 143
What is a horizontal audit?
- A. In-depth investigation of one process across various departments in the organization
- B. In-depth investigation of all the processes in major functional areas of the organization
- C. In-depth investigation of all the processes in a specific department or organizational unit
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:A horizontal audit examines one process across multiple departments to assess consistency.
Thus, A is the correct answer.
NEW QUESTION # 144
You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.
Answer:
Explanation:
A screenshot of a computer AI-generated content may be incorrect.

Comprehensive and Detailed In-Depth Explanation:
Clause 8.3.2 e) - Internal Resource Needs elays due to staff shortages highlight a lack of internal resources, directly relating to this clause that requires internal resource planning for design and development.
Clause 8.3.6 - Design and Development Changes:Ongoing formulation changes due to feedback need to be documented and reviewed. This clause requires retention of documented information on changes.
Clause 8.3.5 - Design and Development Outputs:Customer approvals for formulations are outputs of the design process and must be retained as documented information, as per this clause.
Clause 8.3.4 d) - Design and Development Controls:Consumer trials are a validation activity. This clause ensures such trials are conducted to confirm that resulting products meet defined requirements.
Clause 8.3.2 e) - External Resource Needs:Shelf-life tests done by an external lab are part of the external resources needed for development and are referenced here.
NEW QUESTION # 145
......
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