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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | QMS ISO 9001:2015 Lead Auditor Exam |
| Exam Number: | ISO-9001-Lead-Auditor |
| Exam Price: | $1000 USD |
| Exam Format: | Scenario-based, Open-book, Multiple choice, Multi-response |
| Certificate Validity Period: | 3 years |
| Available Languages: | English, Arabic, Portuguese, Chinese, French, Spanish, German, Russian, Italian |
| Exam Duration: | 180 (120 + 30 for non-native speakers) |
| Related Certifications: | ISO 9001 Foundation ISO 9001 Auditor ISO 9001 Provisional Auditor |
| Passing Score: | 70% (minimum 28/40 or 56/80 correct answers) |
| Real Exam Qty: | 40–80 |
| Recommended Training: | PECB ISO 9001 Lead Auditor Training Course |
| Exam Registration: | PECB Official Registration |
| Sample Questions: | PECB ISO-9001-Lead-Auditor Sample Questions |
| Exam Way: | Online proctored via PECB Exams app or paper-based at authorized test centers |
| Pre Condition: | Recommended: ISO 9001 Foundation knowledge or certification; no mandatory prerequisites, but experience in quality management is advised |
| Official Syllabus URL: | https://pecb.com/en/education-and-certification-for-individuals/iso-9001/iso-9001-lead-auditor |
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質問 # 14
How much time is usually spent on the Stage 1 audit?
正解：C
解説：
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)
質問 # 15
Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.
Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled.
The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.
The top management, in cooperation with Sean, assigned 10 more employees to the audit team.
Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.
Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.
Based on the scenario above, answer the following question:
Ten employees of POLKA were part of the audit team that conducted the internal audit. Is this acceptable?
正解：C
解説：
Comprehensive and Detailed In-Depth Explanation:According to ISO 9001:2015, Clause 9.2 (Internal Audit):
* Internal audits are conducted by employees of the company who are trained as auditors.
* External auditors are not mandatory unless required by the organization.
Thus, A is the correct answer.
質問 # 16
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization manufactures cosmetics for major retailers.
You are interviewing the Manufacturing Manager (MM).
You: "I would like to begin by looking at the cleaning controls."
MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside." Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.
正解：
解説：
Explanation:
Nonconformity report
ISO 9001 Clause Number: 8.5.4 Nature of problem: Cleaning and sanitising records are not available for every batch. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "The organization shall implement planned arrangements, at appropriate stages, to verify that the product requirements have been met." Evidence: 40 cleaning records are available for 63 batches.
質問 # 17
Takitup is a small fabrication company that manufactures steel fencing, stairs and platforms for the construction sector. It has been certified to ISO 9001 for some time and has appointed a new Quality Manager. The audit plan during a surveillance audit is to cover the company's improvement actions and the auditor asks to see the most recent management review meeting minutes.
Which two of the options would be relevant points for the auditor's checklist for the audit?
正解：E、F
解説：
ISO 9001:2015 requires top management to review the quality management system at planned intervals to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organisation. The auditor's focus, especially during a surveillance audit covering improvement actions, must therefore be on evidence that management review is being carried out correctly and that it results in QMS-related decisions and changes.
Relevant ISO 9001 clauses include:
* Clause 9.3.1 - Management review (General)Top management shall review the organisation's quality management system at planned intervals.
* Clause 9.3.3 - Management review outputsThe outputs of management review shall include decisions and actions related to opportunities for improvement and any need for changes to the QMS.
Explanation of the correct options:
A). The date of the most recent management review meeting
This is directly relevant because ISO 9001 requires management reviews to occur at planned intervals. The auditor must confirm that the review has taken place and that it is current, especially during a surveillance audit.
E). Changes made to the quality system by the new Quality Manager
This is directly linked to management review outputs and improvement actions. Since a new Quality Manager has been appointed, the auditor must verify whether changes to the QMS were reviewed, approved, and monitored through management review in line with Clauses 9.3.3 and 10.3.
Explanation of why the other options are not relevant:
* B: Workforce redundancies are a human resources or business decision unless they directly affect QMS effectiveness, which is not indicated here.
* C: Increased profitability is a business outcome, not a required management review input or output under ISO 9001.
* D: Pension scheme improvements are unrelated to QMS performance or improvement.
* F: A bonus scheme may relate to productivity, but unless it directly affects QMS objectives or process performance reviewed in management review, it is not a required checklist item.
ISO-aligned conclusion:
For an audit focusing on improvement actions and management review, the auditor's checklist should confirm:
* That management review has been conducted as required, and
* That QMS-related changes and improvements (especially under a new Quality Manager) are being reviewed and controlled.
質問 # 18
What must the auditor consider in order to mitigate audit risks and obtain reasonable assurance?
正解：C
解説：
Comprehensive and Detailed In-Depth Explanation:
Auditors must focus on key processes that impact QMS effectiveness to ensure audit risks are minimized.
Clause References:
ISO 19011:2018, Clause 6.3 - Managing Audit Risk: Auditors should prioritize critical processes to obtain reasonable assurance.
Why is the Correct Answer A?
Some processes are critical (e.g., production quality, customer complaints handling).
If these material processes fail, the QMS could collapse.
Why are the Other Options Incorrect?
B (Needs of internal parties) # Important, but not the primary focus for reducing audit risk.
C (Previous audit results) # Useful for improvement but does not directly reduce current audit risks.
D (Financial risks) # ISO 9001 focuses on quality risks, not financial risks.
Reference:
ISO 19011:2018, Clause 6.3 - Managing Audit Risk
質問 # 19
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