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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | QMS ISO 9001:2015 Lead Auditor Exam |
| Exam Number: | ISO-9001-Lead-Auditor |
| Real Exam Qty: | 40–80 |
| Exam Duration: | 180 (120 + 30 for non-native speakers) |
| Exam Price: | $1000 USD |
| Exam Format: | Multiple choice, Multi-response, Scenario-based, Open-book |
| Available Languages: | German, English, Russian, Portuguese, Chinese, Arabic, French, Italian, Spanish |
| Passing Score: | 70% (minimum 28/40 or 56/80 correct answers) |
| Related Certifications: | ISO 9001 Auditor ISO 9001 Provisional Auditor ISO 9001 Foundation |
| 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 # 252
What does the application of the process approach in a QMS enable?
Answer: B
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.
Reference:
ISO 9001:2015, Clause 0.3.1 - Process Approach
ISO 9001:2015, Clause 4.4 - QMS and its Processes
NEW QUESTION # 253
What are the objectives of the Stage 2 audit?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
The Stage 2 audit (ISO 17021-1:2015, Clause 9.3.1.3) is conducted to:
* Verify whether the QMS is effectively implemented and operational.
* Ensure compliance with ISO 9001 requirements in actual practice.
* Identify nonconformities that may impact certification.
Reviewing documented information (Answer B) is part of Stage 1, and gathering scope information (Answer C) is done before the certification audit.
Reference:
ISO 17021-1:2015, Clause 9.3.1.3 (Stage 2 Audit)
NEW QUESTION # 254
ABC is a car washing company with 25 stations in the city. A national taxi chain (CAR XX) decided to audit ABC's ISO 9001 management system.
You, as CAR XX audit team leader, are interviewing the ABC Quality Manager (QM) at their central office.
You: "How do you measure customer satisfaction?"
QM: "When we give the keys back to the owners, we always ask them two questions about their needs and expectations, and once per month, we discuss a summary of the answers to those questions and the complaints we receive in a box located in the waiting room." You: "Did you take any action based on these responses?" QM: "We installed cameras to monitor the process and a coffee machine in the waiting room. These actions reduced the complaints by 90%." Based on the scenario, select which three statements are true:
Answer: A,F,G
Explanation:
Relevant ISO 9001 Requirements
Clause 9.1.2 - Customer Satisfaction
The organisation shall monitor customers' perceptions of the degree to which their needs and expectations have been fulfilled.
Clause 10.3 - Continual Improvement
The organisation shall continually improve the suitability, adequacy and effectiveness of the quality management system.
Why C is Correct
C). ABC monitors the improvements it makes.
The Quality Manager stated:
"These actions reduced the complaints by 90%."
This demonstrates that ABC monitored the effectiveness of the actions taken by comparing complaint levels before and after implementation.
This aligns with:
* Clause 9.1 (Monitoring and measurement)
* Clause 10.3 (Improvement)
Why F is Correct
F). ABC takes actions to improve customer satisfaction.
ABC analysed customer feedback and complaints and then implemented:
* Cameras to monitor the process.
* A coffee machine in the waiting room.
These are actions taken in response to customer feedback with the objective of improving customer satisfaction.
This aligns with:
* Clause 9.1.2 Customer Satisfaction
* Clause 10.3 Continual Improvement
Why H is Correct
H). ABC obtains customer feedback.
The Quality Manager stated:
"We always ask them two questions about their needs and expectations."
and
"We discuss a summary of the answers and the complaints."
This is direct evidence that customer feedback is obtained.
This aligns with:
* Clause 9.1.2 Customer Satisfaction
Why the Other Options Are Incorrect
A). ABC trains its employees in customer care.
No evidence of training is provided.
B). ABC records the answers to the questions asked when customers get the car back.
The scenario mentions a summary is discussed monthly, but does not state that all answers are recorded.
D). ABC reviews the feedback every day.
The scenario states feedback is reviewed once per month , not daily.
E). ABC documents all customer feedback.
No evidence is provided that all feedback is documented.
G). ABC responds to customer expectations.
While actions were taken, the scenario does not provide sufficient objective evidence that customer expectations themselves were specifically addressed or fulfilled.
ISO-Aligned Conclusion
The scenario provides objective evidence that ABC:
* Obtains customer feedback,
* Takes actions based on that feedback,
* Monitors the effectiveness of those actions.
Therefore, the three correct statements are:
C). ABC monitors the improvements it makes.
F). ABC takes actions to improve customer satisfaction.
H). ABC obtains customer feedback.
NEW QUESTION # 255
Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.
A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.
In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.
Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.
Based on the scenario above, answer the following question:
Scenario 6 indicates that although the top management did not agree with the audit findings, the audit team began preparing the audit report. Is this acceptable?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 6.4.11 (Closing Meeting):
* The audit team must proceed with the audit report, even if the auditee disagrees with findings.
* Disagreements do not invalidate audit results.
* The auditee has the right to file a complaint or appeal, but this is handled after the audit report is submitted.
Thus, the audit team acted correctly by proceeding with the audit report despite top management's disagreement.
Reference:
ISO 19011:2018, Clause 6.4.11 (Closing Meeting & Handling Disputes)
NEW QUESTION # 256
You are conducting 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 have gathered audit evidence as outlined below. Match the ISO 9001 Clause 8 extract to the audit evidence.
Answer:
Explanation:
Explanation:
Here is the correct matching of the ISO 9001 Clause 8 extracts to the audit evidence:
* Audit evidence: Three subcontract trainers who had delivered training were not approved as defined in procedure SA1 Supplier Approval revision 3.ISO 9001 Clause 8 extract: 8.4.1 ...shall apply criteria for
... external providers...(This clause requires the organization to control external providers, including ensuring their approval and competence.)
* Audit evidence: A training programme for a customer was not documented as required in procedure TD
2 Training revision 2.ISO 9001 Clause 8 extract: 8.3.5 ...shall retain documented information on design and development outputs.(This clause addresses the need to retain documented information related to design and development outputs, such as a training programme.)
* Audit evidence: One trainer had not recorded the damage to a customer's training room wall caused by using sticky tape to hang training aids, as required in procedure TD 2 Training revision 2.ISO 9001 Clause 8 extract: 8.5.3 ...shall retain documented information on what has occurred.(This clause relates to retaining documented information on activities and outcomes, including records of damage or issues encountered.)
* Audit evidence: Five sales orders had no record of having been reviewed to verify the ability to provide these courses.ISO 9001 Clause 8 extract: 8.2.3.1 ...shall conduct a review before committing...(This clause specifies the requirement to review and verify the organization's ability to meet customer requirements before accepting sales orders.) These mappings reflect the specific requirements of ISO 9001:2015 for managing external providers, retaining documented information, and reviewing contracts.
NEW QUESTION # 257
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