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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | QMS ISO 9001:2015 Lead Auditor Exam |
| Exam Number: | ISO-9001-Lead-Auditor |
| Exam Duration: | 180 (120 + 30 for non-native speakers) |
| Related Certifications: | ISO 9001 Auditor ISO 9001 Provisional Auditor ISO 9001 Foundation |
| Exam Price: | $1000 USD |
| Available Languages: | French, Russian, Italian, Arabic, Spanish, Chinese, English, German, Portuguese |
| Certificate Validity Period: | 3 years |
| Exam Format: | Multi-response, Open-book, Scenario-based, Multiple choice |
| 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 |
>> ISO-9001-Lead-Auditor最新日本語版参考書 <<
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質問 # 32
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:
Based on Scenario 7, the team worked together to draft the final audit report. Is this acceptable?
正解：B
解説：
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 6.4.9 (Audit Conclusions & Reporting):
* One consolidated audit report should be drafted based on all team members' findings.
* Each auditor does not draft separate reports (B) unless explicitly required.
Thus, A is the correct answer.
Reference:
ISO 19011:2018, Clause 6.4.9 (Audit Conclusions & Reporting)
質問 # 33
During an ISO 9001 audit of an electric cable manufacturer, you are reviewing the customer file for XYZ Construction in the Sales Department. This contract specifies that the installation configuration of the cable runs should meet national fire safety standards for Category A.
You discover that the customer later agreed to the approval of a less stringent Category B configuration instead.
The organization has the following quality policy document displayed in the reception area.
"This organization is committed to providing electric cables to customers' requirements, in accordance with statutory regulations for their use. Continual improvement is a permanent objective of the organization. This policy shall be communicated to all employees and, where required, to all interested parties." Referring to the scenario, select the two options for which the organization is meeting its policy commitments.
正解：B、F
質問 # 34
Select the words that best complete the sentence:
正解：
解説：
Explanation:
According to the ISO 19011:2018 document, the audit plan should provide the basis for agreement regarding the conduct and scheduling of the audit activities. The amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives1. The scope of the audit refers to the extent and boundaries of the audit, such as the audit criteria, the audit objectives, the organizational and functional units, and the processes to be audited1. The complexity of the audit refers to the degree of difficulty or intricacy of the audit, such as the number and diversity of the auditees, the audit criteria, the audit methods, and the audit team composition2. The risk of not achieving the audit objectives refers to the possibility that the audit may fail to provide reliable and sufficient audit evidence to support the audit conclusions and report1.
Therefore, the complete sentence is:
In the context of a third-party audit, the amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives.
References: 1: ISO 19011:2018 - Guidelines for auditing management systems 2: Audit Complexity - an overview | ScienceDirect Topics
質問 # 35
What are the criteria for reviewing documented information?
正解：C
解説：
Comprehensive and Detailed In-Depth Explanation:According to ISO 9001:2015, Clause 7.5.2 (Creating and Updating Documented Information), the criteria for reviewing documented information include:
* Content - The accuracy and relevance of the information.
* Format - Ensuring readability and proper structuring (e.g., language, versioning).
* Procedure for managing documented information - Ensuring control, access, and updates.
Other options, such as internal audit reports and client feedback, are important for overall QMS evaluation but are not the main criteria for reviewing documented information.
質問 # 36
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：A、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 # 37
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