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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | PECB Certified ISO 9001:2015 Lead Auditor Examination |
| Exam Number: | ISO 9001 Lead Auditor Exam |
| Real Exam Qty: | 80 MCQs |
| Exam Price: | Varies by region (typically approx. USD 500–800) |
| Exam Duration: | 180 minutes |
| Related Certifications: | QMS ISO 9001:2015 Internal Auditor ISO 19011 Lead Auditor ISO 9001:2015 Foundation ISO 9001:2015 Lead Implementer |
| Available Languages: | Chinese, Portuguese, Spanish, German, English, French, Arabic |
| Passing Score: | 70% |
| Exam Format: | Closed-book exam, Scenario-based questions, Multiple Choice Questions |
| Certificate Validity Period: | 3 years (renewal required for certification validity) |
| Recommended Training: | ISO 9001:2015 QMS Training Resources PECB ISO 9001 Lead Auditor Training |
| Exam Registration: | PECB Official Certification Page PECB Exam Registration Portal |
| Sample Questions: | PECB ISO-9001-Lead-Auditor Sample Questions |
| Exam Way: | Online proctored or onsite exam (depending on PECB authorized providers) |
| Pre Condition: | Recommended: basic knowledge of ISO 9001:2015 or prior experience in quality management systems or auditing. |
| Official Syllabus URL: | https://pecb.com |
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質問 # 266
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 two statements that apply to the term
`nonconformity'.
正解：A、C
解説：
According to the ISO 9001:2015 standard, clause 10.2.1 defines nonconformity as the non-fulfilment of a requirement. A requirement can be related to the quality management system, the products and services, the customer expectations, or the applicable statutory and regulatory requirements. Nonconformities can be detected through various sources, such as audits, inspections, tests, customer complaints, or internal reviews.
Nonconformities must be addressed by taking appropriate actions to correct them and prevent their recurrence.
In this scenario, the auditee has shown several issues that indicate nonconformities in their quality management system. Two statements that apply to the term nonconformity are:
A: No quality objectives planned for the top management team: According to ISO 9001, clause 6.2.1, the organization must establish quality objectives at relevant functions, levels, and processes. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The top management team is responsible for providing leadership and direction for the quality management system and ensuring its alignment with the organization's purpose and context. Therefore, the absence of quality objectives for the top management team is a nonconformity as it violates the requirement of clause 6.2.1.
E: Quality improvements not aligning with the quality policy: According to ISO 9001, clause 5.2.1, the quality policy is a statement of the organization's intentions and direction regarding quality, as formally expressed by top management. The quality policy must provide a framework for setting quality objectives and be compatible with the context and strategic direction of the organization. The quality policy must also be communicated, understood, and applied within the organization. Therefore, if the quality improvements are not aligned with the quality policy, it is a nonconformity as it violates the requirement of clause 5.2.1.
質問 # 267
Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).
正解：
解説：
Explanation:
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According to the ISO 9000:2015 document, the seven quality management principles are:
Customer focus
Leadership
Engagement of people
Process approach
Improvement
Evidence-based decision making
Relationship management
For each principle, the document provides a statement, a rationale, key benefits, and actions you can take to apply the principle in your organization.
Based on the document, here is a possible way to match a potential benefit to each of the four quality management principles you mentioned:
Table
Quality management principle
Potential benefit
Customer focus
Increased revenue and market share
Engagement of people
Enhanced trust and collaboration throughout the organization
Improvement
Enhanced drive for innovation
Evidence-based decision making
Increased ability to demonstrate effectiveness of past actions
質問 # 268
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 the manufacture of our own brand products to one of our suppliers." You: "What were the reasons for making the change?" Auditee: "Our manufacturing section was a small operation, and we struggled to cope with fluctuations in demand. During busy periods, we found it hard to meet lead times, and in quiet periods, we had staff with little to do. This was having an impact on customer satisfaction, and meant we had to charge premium prices that made our product uncompetitive." You: "How did you go about the change?" In relation to the auditor's question about how the change was managed, the auditee mentions the steps listed below. The steps represent different elements of the Plan/Do/Check/Act cycle.
Select three steps which apply to the 'check' element of the cycle.
正解：A、B、G
解説：
The "Check" stage of the PDCA cycle is about monitoring, measuring, analysing and evaluating performance against objectives, requirements and planned activities.
B is correct because reviewing data at management review is part of evaluating QMS performance.
C is correct because monitoring customer feedback is checking whether customer needs and expectations are being met.
D is correct because monitoring supplier performance checks whether the outsourced manufacturing process is effective.
A, E, F and H are mainly "Plan/Do" activities. G may be a monitoring result, but the strongest three "Check" activities are B, C and D because they directly involve review, monitoring and evaluation of QMS performance.
質問 # 269
What is an advantage of group interviews?
正解：A
解説：
Comprehensive and Detailed In-Depth Explanation:
Group interviews allow auditors to gather more information in less time by:
Obtaining input from multiple participants simultaneously.
Encouraging discussions that might highlight inconsistencies.
Reducing the number of individual interviews needed.
While auditors strive for fairness, equal time for each interviewee is not guaranteed, and paying attention to each individual is more difficult in a group setting.
Reference:
ISO 19011:2018, Clause 6.4.6 (Conducting Interviews)
質問 # 270
In the context of a second-party audit, match the activity with the party responsible for conducting it.
正解：
解説：
Explanation:
Here is the correct matching of the activities with the responsible parties in the context of a second-party audit:
* Define the audit scope: Customer
* Develop the audit plan: Audit team leader
* Respond to the audit findings: External provider
* Conduct the audit: Audit team
This reflects the typical division of responsibilities in a second-party audit, where the customer (the party commissioning the audit) sets the scope, the audit team leader manages the planning, the external provider responds to findings, and the audit team carries out the audit.
質問 # 271
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