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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | QMS ISO 9001:2015 Lead Auditor Exam |
| Exam Number: | ISO-9001-Lead-Auditor |
| Passing Score: | 70% (minimum 28/40 or 56/80 correct answers) |
| Exam Format: | Open-book, Multiple choice, Scenario-based, Multi-response |
| Exam Price: | $1000 USD |
| Real Exam Qty: | 40–80 |
| Related Certifications: | ISO 9001 Foundation ISO 9001 Auditor ISO 9001 Provisional Auditor |
| Available Languages: | French, Russian, Portuguese, English, Arabic, German, Spanish, Italian, Chinese |
| Exam Duration: | 180 (120 + 30 for non-native speakers) |
| Certificate Validity Period: | 3 years |
| 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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NEW QUESTION # 110
What does the application of the process approach in a QMS enable?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:ISO 9001:2015 promotes the process approach, which allows organizations to structure their activities into interrelated processes. This approach helps ensure that processes effectively achieve intended results.
Clause 0.3.1 (Process Approach) states that "The application of the process approach in a quality management system enables understanding and consistency in meeting requirements, considering processes in terms of added value, and achieving effective process performance." This aligns directly with option C, making it the correct answer. The other options are either partially correct or do not fully capture the purpose of the process approach:
* Option A (Improvement based on interested parties) is a benefit but does not define the main goal.
* Option B (Financial value) is not the primary focus of the process approach.
* Option D (Reduction of resource consumption) may be an indirect benefit but is not a core objective.
NEW QUESTION # 111
In the context of a third-party certification audit, it is very important to have effective communication. Which is not the responsibility of the audit team leader?
Answer: D
NEW QUESTION # 112
You have been just hired as the Internal Lead Auditor of a large organisation, responsible for internal audits.
Your first job is to analyse the answers to nonconformities included in the report of a recent internal audit to Top Management.
The report contained one nonconformity as follows:
There is no evidence of Top Management ensuring the availability of resources to operate the QMS, the establishment of objectives, the promotion of continual improvement, and the promoting of the process approach.
Which four of the following Top Management actions can be considered 'corrections to the nonconformity'?
Answer: A,E,F,G
NEW QUESTION # 113
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.
In scenario 3, the audit team required access to see the organizational chart and job descriptions to verify the employees' competence. Based on audit best practices, is this acceptable?
Answer: D
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires organizations to ensure competence of personnel whose work affects quality performance.
Clause References:
* Clause 7.2 - Competence: Organizations must determine, provide, and evaluate competence of employees performing work under the QMS.
* ISO 19011:2018, Clause 6.4.6 - Audit Evidence: Auditors should use a combination of document review, interviews, and observation to verify competence.
Why is the Correct Answer C?
* The organizational chart shows reporting structures and helps verify roles and responsibilities.
* Job descriptions outline required qualifications, skills, and competencies for each role.
* These documents provide objective audit evidence that personnel meet the required competencies for their positions.
Why are the Other Options Incorrect?
* A (Sufficient evidence) # Partially correct, but competence verification often requires multiple sources of evidence, including training records, certifications, and observations.
* B (Not relevant) # Incorrect because verifying competence is crucial for ensuring effective QMS implementation.
* D (Direct observation only) # Observation alone is insufficient; documentation and interviews are also required to confirm competence.
Reference:
ISO 9001:2015, Clause 7.2 - Competence
ISO 19011:2018, Clause 6.4.6 - Audit Evidence
NEW QUESTION # 114
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.
Answer:
Explanation:
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.
NEW QUESTION # 115
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