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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | PECB Certified ISO 9001 Lead Auditor |
| Exam Number: | ISO-9001-Lead-Auditor |
| Exam Price: | USD 1000 |
| Available Languages: | English |
| Related Certifications: | PECB Master in Quality Management PECB Certified ISO 9001 Lead Implementer |
| Exam Duration: | 180 minutes |
| Passing Score: | 70% |
| Certificate Validity Period: | 3 Years |
| Real Exam Qty: | 80 |
| Exam Format: | Multiple Choice, Open Book |
| Sample Questions: | PECB ISO-9001-Lead-Auditor Sample Questions |
| Exam Way: | Online (PECB Exams application) or Paper-based (at training centers) |
| Pre Condition: | None (Recommended: Training course and experience in Quality Management) |
| Official Syllabus URL: | https://pecb.com/en/education-and-certification-for-individuals/iso-9001-lead-auditor |
>> PECB ISO-9001-Lead-Auditor日本語版 <<
ISO-9001-Lead-Auditor試験の準備中に常に楽観的な心を持ち続けている場合、ISO-9001-Lead-Auditor試験に合格し、関連するISO-9001-Lead-Auditor認定を取得することは非常に簡単だと深く信じています。近い将来。もちろん、楽観的な心を保つ方法は多くの人が答えるのが非常に難しい質問であることも知っています。私たちに知られているように、意志があるところには方法があります。この分野の専門家であるため、ISO-9001-Lead-Auditor試験問題の助けを借りて素晴らしい結果が得られると信じています。
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質問 # 51
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 # 52
What must the auditor consider in order to mitigate audit risks and obtain reasonable assurance?
正解：A
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.
質問 # 53
Consultancy ABC, which is a subsidiary of a certification body called ABC-CERT, provided consultancy services regarding the implementation of a QMS based on ISO 9001 to an organization.
Considering this, can ABC-CERT provide certification services to the organization which obtained consultancy services from Consultancy ABC?
正解：A
解説：
Comprehensive and Detailed In-Depth Explanation:
Certification bodies must remain independent and impartial. If a certification body (ABC-CERT) provides consulting services to an organization through its subsidiary (Consultancy ABC), it cannot later certify the same organization.
Clause References:
* ISO/IEC 17021-1:2015, Clause 5.2.5 - Impartiality Requirements:
* A certification body must not certify an organization to which it has provided consultancy services.
* ISO/IEC 17021-1:2015, Clause 5.2.6:
* Subsidiaries of certification bodies must not provide consulting services to prevent conflicts of interest.
Why is the Correct Answer C?
* Certifying a client after providing consultancy creates a conflict of interest and violates ISO/IEC
17021-1:2015 impartiality rules.
* The certification body (ABC-CERT) and consultancy firm (Consultancy ABC) are related entities
, making it impossible to remain objective and independent.
Why are the Other Options Incorrect?
* A (Waiting two years) # ISO does not specify a time frame; the issue is impartiality, not just time.
* B (Signing an agreement to ensure objectivity) # Conflicts of interest cannot be resolved through an agreement; independence is required.
質問 # 54
Match the following potential audit client options to the type of audit.
正解：
解説：
Explanation:
First-party Management System audit # All members of an audited organisation Second-party Management System audit # Interested parties of an organisation According to ISO 19011:2018 (Guidelines for Auditing Management Systems) and as reinforced in ISO
9001 Lead Auditor training materials, audit types are defined as:
* First-party audit - conducted by the organization itself, or on its behalf (internal audit).# The audit client is all members of the audited organisation, because the audit is internal, involving all functional areas under the organization's control.
* Second-party audit - conducted by a customer or other person on behalf of a customer (external but not by a certification body).# The audit client includes interested parties of an organisation, such as customers who want to verify if their suppliers meet contractual or regulatory requirements.
These definitions are directly aligned with ISO 19011:2018, Clause 3.13 - Types of audits.
Why Other Options Are Incorrect:
* Certification body / Accreditation body # These relate to third-party audits, not first or second.
* Top management / Functions of an audited organisation # Refer to auditees or audit participants, not the audit client itself.
References:
ISO 19011:2018 Clause 3.13 - Types of audits
ISO 9001:2015 Clause 9.2 - Internal audit
ISO Definitions for First-party, Second-party, and Third-party audits
質問 # 55
You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements.
The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.
You are interviewing the Training Manager (TM).
You: " What quality objectives apply to the training process? "
TM: " One of the quality objectives we aim for is a 90% minimum exam pass rate for all open training courses. " You: " How do you measure this objective? " The Training Manager shows you a record on her computer and you see the following:
Which two of the following statements are true?
正解：A、C
解説：
In this scenario, the organization has set a quality objective of achieving a 90% minimum exam pass rate for all courses. The auditor's task is to assess whether this objective is being monitored effectively and if appropriate actions are taken when the objective is not met.
B). You would determine how the exam pass rate figures were analysed: ISO 9001:2015, particularly Clause
9.1 (Monitoring, measurement, analysis, and evaluation), requires organizations to evaluate performance data.
The auditor should verify how the organization analyses the pass rate data to ensure trends are identified, and corrective actions are planned based on this analysis.
D). You would determine what corrective action was being taken to address the low pass rates: When performance falls short of the objective, as seen with Course 4 (where the pass rate is below 90% in all months), Clause 10.2 (Nonconformity and corrective action) requires organizations to take corrective actions to address issues. The auditor would need to check if corrective actions have been initiated to address consistently low pass rates.
Statements A, C, E, and F do not directly address the monitoring and corrective action required under ISO
9001:2015 in this context.
質問 # 56
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