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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 |
| Exam Format: | Closed-book exam, Scenario-based questions, Multiple Choice Questions |
| Related Certifications: | QMS ISO 9001:2015 Internal Auditor ISO 9001:2015 Lead Implementer ISO 19011 Lead Auditor ISO 9001:2015 Foundation |
| Certificate Validity Period: | 3 years (renewal required for certification validity) |
| Exam Price: | Varies by region (typically approx. USD 500–800) |
| Exam Duration: | 180 minutes |
| Passing Score: | 70% |
| Available Languages: | Spanish, Arabic, German, French, Portuguese, Chinese, English |
| 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 |
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NEW QUESTION # 209
What is reliability in the context of service quality?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:Reliability in service quality refers to the consistent and dependable delivery of promised services.
ISO 9001:2015 emphasizes reliability through:
* Clause 8.2.1 (Customer Communication) - Ensuring clarity in service commitments.
* Clause 8.5.1 (Control of Service Provision) - Ensuring processes meet requirements consistently.
Other options do not fully define reliability:
* Option A (Safe services) relates to safety, not reliability.
* Option B (Readiness and goodwill) relates to responsiveness, not reliability.
* Option D (Low cost) focuses on pricing, not quality.
NEW QUESTION # 210
XYZ Corporation employs 100 people, and during a Stage 1 certification audit, certain issues are identified with the Quality Management System (QMS). Which two options describe the circumstances in which you could raise a nonconformity against Clause 6.2 of ISO 9001:2015?
Answer: A,D
Explanation:
* Understanding Clause 6.2 of ISO 9001:2015:Clause 6.2 (Quality Objectives and Planning to Achieve Them) specifies that organizations must:
* Establish measurable and relevant quality objectives consistent with the quality policy (Clause
6.2.1).
* Include objectives applicable to product/service conformity and customer satisfaction.
* Document these objectives and their planning as documented information (Clause 6.2.1 &
6.2.2).
* Plan how to achieve the objectives, including defining actions, resources, responsibilities, timelines, and methods for evaluation.
* Analysis of Options:
* A. Quality objectives are not being implemented by the organisation's personnel:Incorrect.
While implementation is critical, this relates more to operational aspects rather than the direct requirements of Clause 6.2. Implementation issues would typically raise concerns under Clause
9.1 (Performance Evaluation).
* B. The consultant has not interpreted ISO 9001 correctly:Incorrect. The consultant's interpretation of ISO 9001 is irrelevant in terms of Clause 6.2 compliance. The focus is on whether the organization aligns with the requirements, not the consultant's role.
* C. Establishing quality objectives did not include top management:Incorrect. While top management involvement is vital for QMS effectiveness (Clause 5.1), this is not a direct requirement of Clause 6.2. Top management alignment is implied but not explicitly mandated for establishing quality objectives.
* D. Quality objectives were not established in alignment with the organisation's quality policy:Correct. Clause 6.2.1 requires that quality objectives be consistent with the organization's quality policy, ensuring they reflect its purpose, strategic direction, and commitment to continual improvement. Misalignment would constitute a nonconformity.
* E. The organisation cannot afford to undertake quality objectives all at once:Incorrect.
Financial constraints are not directly addressed in Clause 6.2. The clause focuses on planning to achieve objectives, which includes defining the necessary resources but does not demand achieving all objectives simultaneously.
* F. Quality objectives are not maintained as documented information:Correct. Clause 6.2.1 specifically requires that quality objectives be maintained as documented information. Failure to document the objectives is a direct violation of this clause.
* Why Options D and F Are Correct:
* D: Misalignment between the quality objectives and the quality policy directly violates Clause
6.2.1, which mandates that objectives support the strategic direction of the organization.
* F: Lack of documentation for quality objectives breaches the requirement to maintain them as documented information under Clause 6.2.1.
* Relevant References:
* Clause 6.2.1: Establishing quality objectives aligned with the quality policy.
* Clause 6.2.2: Maintaining documented information for quality objectives and planning to achieve them.
* Clause 5.1.1: Top management's responsibility to ensure alignment between the QMS and strategic direction.
NEW QUESTION # 211
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: C
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.
NEW QUESTION # 212
When should the certification body accept the audit?
Answer: D
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Before accepting an audit, the certification body must assess the integrity of the auditee and the nature of its operations to ensure compliance feasibility.
Clause References:
* ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning:
* The certification body must review the auditee's background, reputation, and operational complexity before accepting the audit.
Why is the Correct Answer C?
* The auditee's integrity and reputation impact the credibility of certification.
* The nature of operations determines audit complexity and resource allocation.
Why are the Other Options Incorrect?
* A (Integrity and reputation only) # Correct but incomplete; nature of operations is equally important.
* B (Nature of operations only) # Integrity is also a factor, not just operations.
* D (No previous major nonconformities required) # Auditees with past major nonconformities can still be audited if corrective actions are taken.
NEW QUESTION # 213
(In the context of a second-party quality management system audit, select the two correct statements from the following:)
Answer: A,B
Explanation:
ISO 9001:2015 does not define detailed audit role terminology itself, but it explicitly refers to ISO 19011 for audit guidance. This makes ISO 19011 authoritative for defining audit roles and responsibilities within ISO
9001 audits.
ISO 9001:2015, Clause 9.2.2 - NOTE:
"See ISO 19011 for guidance."
Therefore, the correctness of the statements is determined using ISO 19011 (Auditing management systems) principles, which are fully applicable to second-party audits.
# B. An auditor is a person who conducts an audit
# Correct
* ISO 19011 defines an auditor simply and clearly as "a person who conducts an audit."
* This definition applies equally to first-, second-, and third-party audits.
This statement is universally correct and fully aligned with ISO auditing terminology.
# F. When needed, a translator appointed by the auditee
# Correct
* ISO 19011 allows the use of translators/interpreters to support communication during audits.
* Translators are typically appointed by the auditee, not the audit team.
* Translators are not members of the audit team and do not influence audit conclusions.
This is a valid and correct statement for second-party audits.
# Why the other options are incorrect
# A. Guide appointed by the audit team leader
* In ISO 19011, a guide is appointed by the auditee, not by the audit team leader.
* The guide assists with logistics and access, not audit execution.
# Incorrect appointment authority.
# C. The audit team cannot include auditors-in-training
* ISO 19011 explicitly allows auditors-in-training to be part of the audit team under supervision.
# Incorrect restriction.
# D. Observer provides information about the organisation
* An observer does not provide information or participate in the audit.
* Observers may attend (e.g. regulators, accreditation bodies) but remain passive.
# Incorrect role description.
# E. A technical expert is part of the audit team
* A technical expert supports the audit team, but is not considered an auditor.
* They provide subject-matter expertise under the direction of auditors.
# The statement is misleading and therefore incorrect.
NEW QUESTION # 214
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