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>> ISO-9001-Lead-Auditor考古題介紹 <<
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問題 #258
What should the auditor document during the Stage 1 audit?
答案：C
解題說明：
Comprehensive and Detailed In-Depth Explanation:
Stage 1 Audit (ISO 9001:2015, Clause 9.2.2) is a documentation review to assess the readiness for a Stage 2 Audit. The auditor must document:
Observations that could lead to nonconformities, ensuring they are addressed before Stage 2.
Areas needing improvement, such as missing documented information or unclear process definitions.
While understanding the auditee's main processes is important, documenting interviews is not a requirement at Stage 1.
Reference:
ISO 9001:2015, Clause 9.2.2 (Internal Audit Reporting)
問題 #259
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.
After reviewing the documented information, Li Na claimed that it was not necessary to report the minor nonconformities that were identified; instead, they would be discussed in the next audit phase. Is this acceptable?
答案：C
解題說明：
Comprehensive and Detailed In-Depth Explanation:As per ISO 9001:2015, Clause 10.2 (Nonconformity and Corrective Action), all identified nonconformities, including minor ones, must be documented and communicated to the auditee.
Minor nonconformities can lead to major issues if left unaddressed. The auditor must inform the organization before moving to the next audit phase so that corrective actions can be taken. Clause 9.2.2 (Internal Audit) states that audit findings should be reported without undue delay.
Since Li Na did not report the minor nonconformities immediately, her decision was incorrect. Minor nonconformities should always be documented and communicated before proceeding to the next phase.
問題 #260
You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory equipment and furniture.
You: "I'd like to look at how you manage change in the organisation. What changes have you made as a business, say, over the last 12 months?" Auditee: "We have made some strategic changes, the main one being that we no longer manufacture our own products in house." You: "That sounds like quite a significant change. What has been the impact of that?" Auditee: "We now mainly sell other manufacturers' products, under their brand names, and have outsourced manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging time." This scenario presents a number of audit trails to different ISO 9001 requirements.
Which three of the following requirements would be relevant audit trails for this scenario?
答案：B,E,G
解題說明：
B: Control of externally provided processes, products, and services: This is relevant because the organization has outsourced the manufacture of its own brand products to a supplier. According to ISO 9001, the organization must ensure that externally provided processes remain within the control of its quality management system.
C: Design and development of products and services: Even though the organization no longer manufactures in- house, it still needs to control the design and development of its products, especially since they are now being produced by an external provider.
F: Organisation roles and responsibilities: The change in strategy has led to a significant reduction in staff, which would have an impact on the roles and responsibilities within the organization. It is important to audit how these changes have been managed and communicated within the organization to ensure continued effectiveness of the quality management system.
These audit trails are aligned with the requirements of ISO 9001:2015, which emphasizes the importance of controlling externally provided processes and products, managing design and development, and clearly defining roles and responsibilities within the quality management system.
問題 #261
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oil and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. You, as one of the auditors, find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised the release of the anodes to avoid late delivery as penalties would be Imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
At the Closing meeting, the audit team leader presents the findings of the audit and comes to the above nonconformity. The Quality Manager produces the test report for Project DK, which shows an acceptable galvanic efficiency, and presents an email from the customer confirming acceptance of the anodes. He asks that the nonconformity be withdrawn.
Which two of the following responses by the audit team leader would be acceptable?
答案：A,C
問題 #262
(In the context of a third-party certification audit, please identify the four management responsibilities of the audit team leader in managing the audit and the audit team:)
答案：A,E,F,G
解題說明：
The responsibilities of an Audit Team Leader in a third-party certification audit are defined primarily in ISO
19011:2018 and reinforced by ISO/IEC 17021-1 for certification audits.
The Audit Team Leader is responsible for managing the audit process, coordinating the audit team, and maintaining communication with the auditee.
Correct Responsibilities
A). Holding the audit team meeting
The Audit Team Leader is responsible for:
* Organising and leading audit team meetings.
* Ensuring auditors understand their assignments.
* Reviewing findings and audit conclusions.
* Preparing the team for opening and closing meetings.
Therefore, this is a responsibility of the Audit Team Leader.
B). Adopting a risk-based approach to planning the audit
ISO 19011 promotes the use of a risk-based approach when:
* Developing the audit programme.
* Planning audit activities.
* Allocating resources and audit time.
* Determining audit priorities.
The Audit Team Leader applies this approach when preparing and managing the audit.
Therefore, this is a responsibility of the Audit Team Leader.
D). Chairing the audit opening and audit closing meeting
The Audit Team Leader normally:
* Conducts the opening meeting.
* Explains audit objectives, scope and methods.
* Conducts the closing meeting.
* Presents audit conclusions and findings.
Therefore, this is a responsibility of the Audit Team Leader.
F). Establishing contact with the auditee
Before and during the audit, the Audit Team Leader:
* Establishes communication channels.
* Confirms audit arrangements.
* Coordinates schedules and logistics.
* Clarifies audit activities.
Therefore, this is a responsibility of the Audit Team Leader.
Why the Other Options Are Incorrect
C). Issuing the management system certificate
Certification decisions and certificate issuance are the responsibility of the Certification Body , not the Audit Team Leader.
ISO/IEC 17021 requires certification decisions to be made independently of the audit team.
E). Auditing top management
The Audit Team Leader may audit top management, but this is not a management responsibility of leading the audit team . It is simply an audit assignment that could be performed by any competent auditor.
G). Selecting the audit team
Selection of auditors is normally the responsibility of the:
* Audit Programme Manager,
* Certification Body,
* Individual(s) managing the audit programme.
Not the Audit Team Leader.
H). Preparing the audit nonconformity reports
Each auditor normally prepares and documents their own findings and nonconformities. The Audit Team Leader reviews, coordinates, and approves them, but does not necessarily prepare all nonconformity reports.
Therefore, this is not considered one of the key management responsibilities listed.
ISO-Aligned Summary
Option
Audit Team Leader Responsibility?
Holding the audit team meeting
Yes
Adopting a risk-based approach to planning the audit
Yes
Issuing the management system certificate
No
Chairing the audit opening and audit closing meeting
Yes
Auditing top management
No
Establishing contact with the auditee
Yes
Selecting the audit team
No
Preparing the audit nonconformity reports
No
問題 #263
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ISO-9001-Lead-Auditor考試證照: https://www.vcesoft.com/ISO-9001-Lead-Auditor-pdf.html
P.S. VCESoft在Google Drive上分享了免費的2026 PECB ISO-9001-Lead-Auditor考試題庫：https://drive.google.com/open?id=1S8GE7hgul61vUE3tLbyMfCbm3Fg9TCZd