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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | PECB Certified ISO 9001:2015 Lead Auditor Examination |
| Exam Number: | ISO 9001 Lead Auditor Exam |
| Certificate Validity Period: | 3 years (renewal required for certification validity) |
| Passing Score: | 70% |
| Exam Format: | Multiple Choice Questions, Closed-book exam, Scenario-based questions |
| Related Certifications: | ISO 9001:2015 Foundation QMS ISO 9001:2015 Internal Auditor ISO 9001:2015 Lead Implementer ISO 19011 Lead Auditor |
| Available Languages: | Portuguese, Arabic, French, Chinese, Spanish, German, English |
| Exam Price: | Varies by region (typically approx. USD 500–800) |
| Exam Duration: | 180 minutes |
| Real Exam Qty: | 80 MCQs |
| Recommended Training: | PECB ISO 9001 Lead Auditor Training ISO 9001:2015 QMS Training Resources |
| Exam Registration: | PECB Exam Registration Portal PECB Official Certification Page |
| 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考題資訊 <<
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問題 #44
Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).
答案：
解題說明：
Explanation:
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According to the ISO 9000:2015 document, the seven quality management principles are:
Customer focus
Leadership
Engagement of people
Process approach
Improvement
Evidence-based decision making
Relationship management
For each principle, the document provides a statement, a rationale, key benefits, and actions you can take to apply the principle in your organization.
Based on the document, here is a possible way to match a potential benefit to each of the four quality management principles you mentioned:
Table
Quality management principle
Potential benefit
Customer focus
Increased revenue and market share
Engagement of people
Enhanced trust and collaboration throughout the organization
Improvement
Enhanced drive for innovation
Evidence-based decision making
Increased ability to demonstrate effectiveness of past actions
問題 #45
During a third-party audit of a pharmaceutical company (CD9000) having seven COVID-19 vaccination stations in various terminals at a major international airport, you, as audit team leader, interview the CD9000' s Supervisor in Terminal 2.
You: "I see that the temperature of the freezer where you keep the vaccines reads -17.2 °C. I understood that the upper limit for storing vaccines was < -18.0 °C." Supervisor: "Yes, I know this. But do not worry, the people who calibrated the temperature sensors said that they have an uncertainty of +/- 1 °C. So, we ensure that the reading remains between -17 °C and -19 °C." From the following, select two options that would form your next step.
答案：E,F
解題說明：
ISO 9001:2015 requires auditors to base conclusions on objective evidence and to investigate potential issues before determining whether a nonconformity exists.
In this scenario, the auditor has observed:
* A freezer temperature of -17.2 °C .
* An understood storage requirement of less than -18.0 °C .
* A statement from the supervisor regarding measurement uncertainty of ±1 °C .
Before raising a nonconformity, the auditor must verify:
* The exact storage requirements and any permitted tolerances.
* The validity and calibration status of the measuring equipment.
Why A is Correct
Ask to see the documented test method to determine if there is additional information on the limits for storage temperature.
The auditor must confirm:
* The exact specification.
* Whether tolerances or measurement uncertainty have been considered in the requirement.
* Whether the storage criterion is truly a hard limit or includes allowable variation.
This follows the audit principle of obtaining sufficient objective evidence before reaching a conclusion.
Why B is Correct
Ask to see the calibration report for the measuring equipment.
ISO 9001 Clause 7.1.5 requires monitoring and measuring resources to be suitable and maintained to ensure valid results.
The supervisor has based his justification on measurement uncertainty. Therefore, the auditor should verify:
* Calibration status,
* Calibration validity,
* Measurement uncertainty,
* Traceability of calibration results.
Why the Other Options Are Incorrect
C). Raise a non-conformance immediately
At this point there is insufficient evidence. The auditor has not yet verified the specification or calibration records.
D). Ask to see competence records of supervisors of all terminals
This is not the immediate audit trail arising from the observation.
E). Immediately halt the vaccination process
Auditors do not normally have authority to stop operations except in exceptional circumstances defined by legal or contractual arrangements. The auditor must first gather evidence.
F). Accept the comment and proceed
Auditors must verify statements with objective evidence rather than accepting explanations without verification.
ISO-Aligned Conclusion
The next appropriate audit actions are to:
* Verify the storage temperature requirements, and
* Verify the calibration and uncertainty information of the measuring equipment.
Therefore, the correct answers are:
A). Ask to see the documented test method to determine if there is additional information on the limits for storage temperature.
B). Ask to see the calibration report for the measuring equipment.
問題 #46
What type of audit evidence are policies and guidelines?
答案：C
解題說明：
Comprehensive and Detailed In-Depth Explanation:
Policies and guidelines are considered documentary evidence because they are written records that demonstrate how an organization complies with ISO 9001 requirements.
Clause References:
* ISO 19011:2018, Clause 6.4.6 - Audit Evidence:
* Documentary evidence includes manuals, procedures, and policies.
Why is the Correct Answer C?
* Documentary evidence includes written records such as policies, procedures, and documented instructions that support QMS implementation.
* Auditors review policies to verify conformance with ISO 9001.
Why are the Other Options Incorrect?
* A (Confirmative evidence) # Not a recognized category in ISO auditing.
* B (Technical evidence) # Technical evidence refers to measurements, test results, or product data, not policies.
Reference:
ISO 19011:2018, Clause 6.4.6 - Audit Evidence
問題 #47
Auditor competence is a combination of knowledge and skills. Which two of the following activities are predominately related to ' knowledge ' ?
答案：A,E
問題 #48
Select the words that best complete the sentence:
答案：
解題說明：
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
問題 #49
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