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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | PECB Certified ISO 9001 Lead Auditor |
| Exam Number: | ISO-9001-Lead-Auditor |
| Exam Format: | Open Book, Multiple Choice |
| Certificate Validity Period: | 3 Years |
| Exam Price: | USD 1000 |
| Available Languages: | English |
| Passing Score: | 70% |
| Exam Duration: | 180 minutes |
| Related Certifications: | PECB Certified ISO 9001 Lead Implementer PECB Master in Quality Management |
| Real Exam Qty: | 80 |
| 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 |
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質問 # 155
Will the auditee be subject to an audit follow-up if a minor nonconformity has been reported by the audit team leader in the audit conclusions?
正解：B
解説：
Comprehensive and Detailed In-Depth Explanation:According to ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions):
* Minor nonconformities do not require a follow-up audit but must be corrected before the next surveillance audit.
* Follow-up audits are required only for major nonconformities.
* The audit team should recommend corrective actions, not enforce immediate follow-ups for minor nonconformities.
Thus, A is the correct answer.
質問 # 156
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The
organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years. The organisation uses a software programme called SWIFT, which is used to record sales, plan production, purchase supplies, print despatch notes, track new product development, perform traceability exercises, carry out mass balance checks, raise invoices, create budgets, and support financial control.
You are nearing the end of the audit and you are reviewing your audit notes. You notice a recurring trend concerning the SWIFT database as shown below:
You ask the Quality Manager to explain how the SWIFT database is controlled. You learn that the Operations Director is responsible for determining and progressing SWIFT software updates. You decide to meet the Operations Director (OD).
You: "Good afternoon."
OD: "Good afternoon."
You: "What responsibility do you have concerning the SWIFT database?"
OD: "I maintain it. If anyone wishes to propose an update to the database, they send me an email with details of their proposal. I then either process the database update myself, or I send the request to the consultant who designed the database 20 years ago. The necessary software changes are made, and the amended software is immediately released to users." You: "Would you explain how the software amendments are controlled?" OD: "Of course. I personally update every computer myself." You: "Do you inform the database users of the changes?" OD: "No I don't. They find out for themselves by using the software, or they come to see me if they have any questions." You: "How do you ensure that the database users use the latest version?" OD: "That's easy, I update every computer myself." You: "During the audit, I noted there were several versions of SWIFT in use (you refer to your audit notes)." OD: "I know. That's because some versions work better than others, and depending on user needs and experiences, we allow users to revert to using an earlier version if they find it works better for them." Based on the scenario, which two of the following statements are true? There is evidence of nonconformity with a requirement defined in ...
正解：D、E
解説：
Based on the scenario provided, there is evidence of nonconformity with the requirements defined in:
C). Clause 7.5.1 Documented information - General: The scenario indicates that there is no formal process for informing users about updates to the SWIFT database, which suggests a lack of control over documented information. This could lead to users being unaware of important changes and not using the latest version of the software, which is required by the quality management system1.
E). Clause 7.5.3 Control of documented information: The Operations Director's approach to updating the SWIFT database and the lack of communication to users about these updates indicate that the documented information is not adequately controlled. Allowing users to revert to earlier versions of the software at their discretion further suggests that the organization does not have a proper mechanism in place to ensure the integrity and suitability of documented information2.
These clauses are part of the ISO 9001:2015 standard, which requires organizations to have a systematic approach to controlling and managing documented information as part of their quality management system.
The scenario described shows a casual approach to managing critical software updates, which could affect the organization's ability to consistently meet customer and regulatory requirements.
質問 # 157
Scenario 3:
Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.
To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.
The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.
The audit team began by gathering information about Fin-Pro's understanding of ISO 9001 requirements.
While reviewing documented information, they noticed missing records of training and awareness sessions.
They conducted employee interviews to verify attendance.
The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the company's working environment (social, psychological, and physical conditions).
The audit team analyzed the evidence and prepared an audit report with findings and conclusions.
ACB sent the audit objectives to the audit team after an agreement was reached. Is this acceptable?
正解：B
解説：
Comprehensive and Detailed In-Depth Explanation:
Clause References:
ISO 19011:2018 (Guidelines for Auditing Management Systems), Clause 5.3 - Establishing the Audit Objectives ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning Why is the Correct Answer C?
Audit objectives must be clearly defined in the audit offer to ensure that the scope, criteria, and purpose are agreed upon in advance.
ISO/IEC 17021-1:2015 (which governs certification bodies) requires that audit objectives be established before the audit begins to ensure transparency and effectiveness.
Sending audit objectives after an agreement has been reached could lead to misalignment between the auditee' s expectations and the audit's purpose.
Why are the Other Options Incorrect?
A (Audit objectives should be known only after agreement) # Incorrect because objectives must be pre- defined in the audit offer.
B (Only the auditee should know the objectives) # Incorrect because both the auditor and auditee must align on objectives.
D (Approval from the lead auditor is sufficient) # Incorrect because audit planning follows formal procedures defined by ISO/IEC 17021-1.
Reference:
ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning
ISO 19011:2018, Clause 5.3 - Establishing the Audit Objectives
質問 # 158
The following list gives examples of records that may be evidence of how an organisation has fulfilled the requirements of clause 8.4 of ISO 9001. Match the records to the appropriate requirement of clause 8.4.
正解：
解説：
Explanation:
The following table shows the possible matching of the records to the requirements of clause 8.4:
Table
Requirements
Records
Define product requirements
Product specification
Criteria for selection
List of requirements to be met by the external provider
Evaluation of potential external provider
External provider questionnaire
External provider selection
Approved external provider list
Communicate requirements
Purchase order
Monitoring of performance
External provider delivery times and quality issues
Comprehensive and Detailed Explanation: = According to clause 8.4 of ISO 9001:2015, the organization should ensure that externally provided processes, products, and services conform to the specified requirements. To do so, the organization should:
Define the product requirements that are relevant for the external provision, such as specifications, drawings, standards, codes, etc. These should be documented and communicated to the external provider. A record of the product specification can be used as evidence of this requirement.
Establish the criteria for the selection, evaluation, and re-evaluation of external providers, based on their ability to provide processes, products, and services in accordance with the requirements. The criteria should be documented and applied consistently. A record of the list of requirements to be met by the external provider can be used as evidence of this requirement.
Evaluate the potential external providers before selecting them, using the established criteria. The evaluation methods may include questionnaires, audits, references, samples, etc. The results of the evaluation should be documented and reviewed. A record of the external provider questionnaire can be used as evidence of this requirement.
Select the external providers that have demonstrated their competence and conformity to the requirements.
The selection should be based on the evaluation results and the organization's needs. The selection should be documented and approved. A record of the approved external provider list can be used as evidence of this requirement.
Communicate the requirements for the processes, products, and services to be provided by the external provider, including the verification and validation activities, the acceptance criteria, the documentation requirements, the changes control, etc. The communication methods may include purchase orders, contracts, agreements, etc. The communication should be clear, complete, and timely. A record of the purchase order can be used as evidence of this requirement.
Monitor the performance and conformity of the external provider, using the established criteria and methods.
The monitoring methods may include inspections, tests, audits, feedback, complaints, etc. The monitoring results should be documented and analyzed. A record of the external provider delivery times and quality issues can be used as evidence of this requirement.
References: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Scope], Mastering the Scope of ISO 9001 Quality Management Systems
質問 # 159
What is an advantage of group interviews?
正解：B
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 # 160
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