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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | PECB Certified ISO 9001:2015 Lead Auditor Examination |
| Exam Number: | ISO 9001 Lead Auditor Exam |
| Real Exam Qty: | 80 MCQs |
| Certificate Validity Period: | 3 years (renewal required for certification validity) |
| Exam Duration: | 180 minutes |
| Related Certifications: | QMS ISO 9001:2015 Internal Auditor ISO 19011 Lead Auditor ISO 9001:2015 Lead Implementer ISO 9001:2015 Foundation |
| Passing Score: | 70% |
| Exam Price: | Varies by region (typically approx. USD 500โ800) |
| Available Languages: | Arabic, French, Spanish, English, Portuguese, Chinese, German |
| Exam Format: | Scenario-based questions, Multiple Choice Questions, Closed-book exam |
| Recommended Training: | PECB ISO 9001 Lead Auditor Training ISO 9001:2015 QMS Training Resources |
| Exam Registration: | PECB Official Certification Page PECB Exam Registration Portal |
| Sample Questions: | PECB ISO-9001-Lead-Auditor Sample Questions |
| Exam Way: | Online proctored or onsite exam (depending on PECB authorized providers) |
| Pre Condition: | Recommended: basic knowledge of ISO 9001:2015 or prior experience in quality management systems or auditing. |
| Official Syllabus URL: | https://pecb.com |
>> ISO-9001-Lead-Auditor Detailed Answers <<
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NEW QUESTION # 159
You are an auditor from a construction company who is conducting a second-party audit to ISO 9001 at a steel rolling mill producing structural steelwork. When auditing the rolling process, you find that the operator who is unloading the furnace does not use the adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.
You: "How do you tell when the billet is ready for the rolling stage?"
Operator: "I've done this job for 20 years. I can tell by the bright red colour." You: "What happens if the colour is wrong?" Operator: "The billet goes back into the furnace." You: "Is the pyrometer ever used?" Operator: "Only in borderline cases." Select the two checkpoints you should investigate further in the situation.
Answer: A,D
Explanation:
ISO 9001:2015 requires organisations to control production processes and ensure that personnel performing work affecting product conformity are competent and follow defined operational controls, particularly where objective measurement is available and specified.
Relevant ISO 9001 requirements include:
* Clause 8.5.1 - Control of production and service provisionProduction shall be carried out under controlled conditions, including the availability and use of suitable monitoring and measuring resources and the implementation of monitoring and measurement activities at appropriate stages.
* Clause 7.2 - CompetenceThe organisation shall determine the necessary competence of persons doing work that affects product conformity and ensure that these persons are competent on the basis of appropriate education, training, or experience.
Explanation of the correct checkpoints:
A). How is the unloading process controlled and managed?
The operator is relying on personal judgement rather than consistently using the specified measuring equipment (infrared pyrometer). This raises a clear audit concern about whether the unloading process is defined, standardised, and controlled in accordance with Clause 8.5.1, and whether required measurement methods are being followed.
C). What training does an operator need for the unloading task?
The operator's reliance on experience rather than defined criteria indicates the need to verify whether the organisation has formally defined competence requirements and training for this task, including the correct use of temperature-measuring equipment, as required by Clause 7.2.
Explanation of why the other options are not selected:
* B: Measurement of finished products occurs later and does not address the immediate process control issue identified at unloading.
* D: While risk-based thinking is important, the primary concern here is operational control and competence at the process level, not higher-level risk analysis.
* E: Customers do not define how internal furnace unloading operations are performed.
* F: The issue relates to operator behaviour and process control, not process design staff qualifications.
ISO-aligned conclusion:
In this scenario, the most relevant audit follow-up checkpoints are those that confirm:
* The process is controlled and defined, and
* The operator is competent and trained to perform the task in line with defined requirements.
Therefore, the correct answers are A and C.
NEW QUESTION # 160
During an internal audit, it was discovered that the calibration of a spectrometer used daily for production had expired, causing a nonconformance under Clause 7.1.5.2 of ISO 9001:2015. The root cause was the organization not considering the risk of the calibration provider leaving the country.
Which corrective action is the best one?
Answer: D
Explanation:
* Understanding Clause 7.1.5.2 - Measurement Traceability:ISO 9001:2015 requires organizations to ensure that measuring equipment (e.g., spectrometers) is calibrated and traceable to recognized standards. The failure to maintain calibration within valid dates directly violates this clause and raises concerns about the reliability of the measurement results.
* Root Cause of the Nonconformity:The organization failed to plan for the possibility that the calibration service provider (X-TECH) might become unavailable, leading to expired calibration. This indicates inadequate risk-based thinking, which is required under Clause 6.1 of ISO 9001:2015.
* Option Analysis:
* A. Select one sample for external lab analysis to use as an internal standard:Incorrect. While using an internal standard could provide short-term verification of results, this action does not address the root cause (failure to consider risks associated with external providers).
* B. Look for a local company to provide this service:Incorrect. While finding a new local service provider resolves the immediate calibration issue, it does not address the risk of future provider unavailability.
* C. Double-check one out of ten samples externally:Incorrect. This corrective action ensures some quality assurance for batch release but does not resolve the nonconformance related to expired calibration.
* D. Add this issue to the external issue register, assess its associated risk, and plan action to address that risk:Correct. This approach directly addresses the root cause (failure to anticipate the calibration provider leaving) and ensures proper risk management. ISO 9001:2015 emphasizes risk-based thinking under Clause 6.1, requiring organizations to identify risks and opportunities and implement plans to mitigate them.
* Why D is the Best Option:
* By adding the issue to the external issue register, the organization ensures it is monitored and tracked.
* Assessing the risk ensures proactive measures are in place for similar issues in the future.
* Planning actions to address the risk ensures a sustainable solution is implemented, such as identifying multiple service providers or ensuring backup plans for calibration services.
* ISO 9001 References:
* Clause 6.1 (Actions to Address Risks and Opportunities): Requires organizations to consider risks and opportunities that could affect the intended results of the QMS.
* Clause 7.1.5.2 (Measurement Traceability): Mandates that measuring equipment must be calibrated and traceable to ensure valid results.
* Clause 10.2 (Nonconformity and Corrective Action): Requires organizations to determine the root cause of nonconformities and take actions to ensure they do not recur.
NEW QUESTION # 161
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 # 162
One of the conflict resolution techniques is toning down. How is the conflict managed in that case?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:Toning down (or de-escalation) is a conflict resolution technique where:
* Common agreements are emphasized to reduce tension.
* Disagreements are addressed with a rational and constructive approach.
Option A describes compromise, and Option B describes authoritative resolution, which are different conflict resolution techniques.
NEW QUESTION # 163
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: C
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).
NEW QUESTION # 164
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