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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q49-Q54):

NEW QUESTION # 49
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.
Which stages of the audit were performed?

A. Audit follow-up and stage 1 audit.
B. Stage 2 audit and surveillance audit.
C. Stage 1 and stage 2 audit.

Answer: C

Explanation:
Comprehensive and Detailed In-Depth Explanation:
Understanding Audit Stages Based on ISO/IEC 17021-1:2015
ISO certification audits consist of two main stages:
* Stage 1 Audit (Readiness Review)
* The organization's documented information is reviewed to assess readiness for Stage 2.
* This ensures that the QMS is developed, implemented, and prepared for full assessment.
* Stage 2 Audit (On-Site Evaluation)
* Auditors assess process implementation and effectiveness through interviews, observations, and evidence collection.
* The audit team verifies if the organization meets ISO 9001 requirements in practice.
Why is the Correct Answer B?
* The audit team reviewed ME's documents, which is a Stage 1 activity.
* The audit team performed interviews, sampling, and on-site verification, which is a Stage 2 activity.
* There was no mention of an audit follow-up or a surveillance audit, which occur post-certification.
Why are the Other Options Incorrect?
* A (Audit follow-up and Stage 1 Audit) # Follow-up audits occur after certification, which was not the case here.
* C (Stage 2 Audit and Surveillance Audit) # Surveillance audits are post-certification audits and were not conducted yet.
Reference:
ISO/IEC 17021-1:2015, Clause 9.3.1 - Initial Certification Audit (Stage 1 & 2)

NEW QUESTION # 50
The procedures of an organisation require that all purchase orders have to be signed by the Purchasing Manager, or, in her absence, by the Production Manager. During an audit carried out in November 2020, an auditor determined that during three weeks in February 2020, the purchase orders were not signed. You raise a nonconformance under Clause 8.4.3 of ISO 9001:2015.
Which one of the following answers would you accept as a 'correction' from the Purchasing Manager?

A. All products related to those purchase orders have already been successfully used during the first quarter of 2020, therefore there is no need for correction. We will only take corrective action.
B. During those weeks, as I was on holiday, the production manager should have signed those purchase orders. As a correction to this particular nonconformity, I will ask him to sign them.
C. I do not accept the nonconformity. Anything I may ask my employees to do will be seen as another piece of evidence that complying with ISO 9001 requirements is a bureaucratic valueless burden.
D. I will sign all the purchase orders now. It will take some time to print them since they are on a backup disk, but I will get them done before the end of the audit.

Answer: D

Explanation:
Comprehensive and Detailed Explanation From Exact Extract:
# Correct Option D - "I will sign all the purchase orders now."
This response represents an immediate correction in accordance with ISO 9001:2015 Clause 8.4.3 - Information for external providers, which requires control over procurement documentation. The absence of required authorisation (signature) is a nonconformity in executing the organization's purchasing procedure.
Clause 8.4.3 specifically mandates that the organization:
"Shall communicate to external providers its requirements for:
a) the processes, products and services to be provided;
b) the approval of:
* products and services;
* methods, processes, and equipment;
* the release of products and services."
The purchase order process includes documented approval, which in this case was defined internally as a signature by the Purchasing or Production Manager. Signing the documents retroactively, while not ideal, is a correction to bring the documentation back into compliance and resolve the immediate issue.
# Why Other Options Are Incorrect:
* A. "No correction needed": Dismissing the nonconformity based on product performance fails to address the lack of documented control, violating Clause 8.4.3 and internal procedures.
* B. "I will ask the Production Manager to sign them now": This option shows intention but lacks immediacy and ownership. Also, backdating signatures without traceability can be ethically questionable.
* C. "I do not accept the nonconformity": This reflects noncompliance and a poor quality culture, contradicting ISO 9001's Clause 5.1.1 (Leadership commitment).
References:
ISO 9001:2015 Clause 8.4.3 - Information for external providers
ISO 9001:2015 Clause 5.1.1 - Leadership and commitment
ISO 9001:2015 Clause 10.2.1 - Correction vs. corrective action

NEW QUESTION # 51
Select the words that best complete the sentence:

Answer:

Explanation:

Explanation:
According to the ISO 19011:2018 document, the audit plan should provide the basis for agreement regarding the conduct and scheduling of the audit activities. The amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives1. The scope of the audit refers to the extent and boundaries of the audit, such as the audit criteria, the audit objectives, the organizational and functional units, and the processes to be audited1. The complexity of the audit refers to the degree of difficulty or intricacy of the audit, such as the number and diversity of the auditees, the audit criteria, the audit methods, and the audit team composition2. The risk of not achieving the audit objectives refers to the possibility that the audit may fail to provide reliable and sufficient audit evidence to support the audit conclusions and report1.
Therefore, the complete sentence is:
In the context of a third-party audit, the amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives.
References: 1: ISO 19011:2018 - Guidelines for auditing management systems 2: Audit Complexity - an overview | ScienceDirect Topics

NEW QUESTION # 52
XYZ Corporation is an organisation that employs 100 people. As audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality objectives have been set for every employee in the organisation except top management.
The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost. He asks for your opinion on whether this is the correct method of setting objectives.
Three months after Stage 1, you return to XYZ Corporation to conduct a Stage 2 certification audit as Audit Team Leader with one other auditor. You find that the Quality Manager has cancelled the previous quality objectives for all employees and replaced them with a single objective for himself. This states that "The Quality Manager will drive multiple improvements in the QMS in the next year". The Quality Manager indicates that this gives him the authority to issue instructions to department managers when quality improvement is needed. He says that this approach has the full backing of senior management. He shows you the latest Quality Improvement Request that was included in the last management review.

After further auditing, the issues below were found. Select three statements that apply to the term 'audit trail'

A. Limited knowledge of the content of Quality Improvement Requests by departmental staff.
B. Quality improvements not aligning with the quality policy.
C. Top management claim not to be aware of the improvement request (QI/12/20/HR-3) initiated by the Quality Manager.
D. Evaluation of the results of the improvement action not always documented by the Quality Manager.
E. The single quality objective set for the organisation by the Quality Manager.
F. Decisions on improvement action timescales not involving departmental managers.

Answer: A,D,F

Explanation:
Based on the scenario and the concept of an 'audit trail' within the context of ISO 9001, the three statements that apply would likely be:
A: Decisions on improvement action timescales not involving departmental managers. This indicates a lack of involvement and communication with those responsible for implementing the improvements, which is a key part of an effective audit trail1.
B: Evaluation of the results of the improvement action not always documented by the Quality Manager.
Proper documentation is essential for an audit trail, as it provides evidence that actions have been evaluated and are effective1.
C: Limited knowledge of the content of Quality Improvement Requests by departmental staff. An audit trail should ensure that all relevant parties are aware of and understand the actions being taken, which is not the case here1.
These points suggest issues with the communication, documentation, and involvement of relevant personnel in the quality management system processes, which are crucial for maintaining an effective audit trail and, by extension, a robust quality management system.

NEW QUESTION # 53
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 withdraw the two nonconformities related to service to ABC and will present the report with the remaining five nonconformities
B. I will include the seven nonconformities in the report, considering that we identified objective evidence on which all these nonconformities are based
C. I will review this issue at length with the audit team tonight and will phone you tomorrow to let you know our decision
D. I will discuss this issue with our corporate quality manager and will let you know what we will do

Answer: C

NEW QUESTION # 54
......

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