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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | QMS ISO 9001:2015 Lead Auditor Exam |
| Exam Number: | ISO-9001-Lead-Auditor |
| Related Certifications: | ISO 9001 Foundation ISO 9001 Auditor ISO 9001 Provisional Auditor |
| Exam Format: | Multi-response, Open-book, Scenario-based, Multiple choice |
| Real Exam Qty: | 40–80 |
| Passing Score: | 70% (minimum 28/40 or 56/80 correct answers) |
| Exam Duration: | 180 (120 + 30 for non-native speakers) |
| Available Languages: | Italian, Russian, French, Spanish, Arabic, Chinese, German, Portuguese, English |
| Exam Price: | $1000 USD |
| 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 # 127
You are conducting 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 You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.
Answer:
Explanation:
Explanation:
The table below shows the possible matching of the ISO 9001 Clause 8.3 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8.3 extract
Half of all new products launched in the past 12 months were late. The NPD Manager explains he has not got enough people on his team to cope with the demand for new products.
"8.3.2 e) ... internal ... resource needs for the design and development of products ..." The NPD Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT.
"8.3.5 ... retain documented information ..."
The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT.
"8.3.6 ... retain documented information ..."
The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior to full-scale launch.
"8.3.4 d) ... conducted to ensure that the resulting products and services meet the requirements ..." The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development.
"8.3.2 e) ... external ... resource needs for the design and development of products ..."
NEW QUESTION # 128
During a second-party audit of a fruit grower (apples, pears, peaches) by a potential customer complying with ISO 9001:2015, the auditor verifies that there is a large variability in the quality of fruit production. In the last two years, they have noticed an increasing variability in daily production quality. The auditor found a trend of delivered produce showing signs of bruising and over-ripening, which led to an increasing number of customer complaints.
This process has been in operation for decades. The business was founded by the grandfather of the current owners, who did not want to alter the established practices.
The auditor raises a non-conformity against ISO 9001.
Which one of the following options would be acceptable as corrective action by the auditee?
Answer: B
Explanation:
Corrective action must eliminate the cause of a nonconformity and prevent recurrence. In this case, the problem is process variability causing bruised and over-ripe fruit and increasing complaints.
Option C is acceptable because applying improved process controls aligned with customer criteria directly addresses the cause and prevents recurrence.
A may help only if competence is the cause, which is not established. B is investigation, not corrective action itself. D disposes of rejected product but does not prevent recurrence.
NEW QUESTION # 129
Technical experts must operate under the supervision of:
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 5.5 (Determining Audit Team Competence), technical experts:
* Provide specialized knowledge in an audit.
* Must operate under the supervision of an auditor to ensure compliance with audit protocols.
* Cannot work independently or under the auditee's supervision, as they are not responsible for the audit's findings.
The audit team leader has overall responsibility, but technical experts are supervised by an auditor during the audit process.
Reference:
ISO 19011:2018, Clause 5.5 (Determining Audit Team Competence)
NEW QUESTION # 130
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:
According to Scenario 6, the audit team required DC's top management to submit corrective action plans within two weeks. Is this action acceptable?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions) states:
The auditor can set a reasonable deadline for corrective actions.
10 to 60 days is a best practice timeframe for the auditee to respond.
The auditee must propose corrective actions, but the audit team has the authority to set the deadline.
A 7-day deadline (A) is too short, and the audit team-not the auditee-determines the timeframe (B).
Reference:
ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions)
NEW QUESTION # 131
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: B,E,F
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 # 132
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