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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:

Topic	Details
Topic 1	Fundamental principles and concepts of a quality management system: The main objective of this domain is to evaluate your skills of explaining and applying ISO 9001 principles and concepts.
Topic 2	Quality management system (QMS) requirements: It assesses your abilities to point out and explain different requirements for a quality management system based on ISO 9001.
Topic 3	Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q128-Q133):

NEW QUESTION # 128
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:
Why is it important to discuss the audit findings with DC's top management prior to the closing meeting and the submission of the final audit report?

A. To identify the persons responsible for the nonconformities
B. To verify whether the audit objectives have been met
C. To encourage the implementation of corrective actions as soon as possible

Answer: B

Explanation:
Comprehensive and Detailed In-Depth Explanation:Discussing audit findings before the closing meeting ensures that:
* The audit objectives have been met (ISO 19011:2018, Clause 6.4.10).
* The auditee has an opportunity to clarify misunderstandings or provide additional evidence.
* The audit team and the auditee agree on the accuracy of findings before finalizing the report.
While encouraging corrective actions (B) is beneficial, the primary purpose of discussing findings is to ensure that the audit was conducted effectively and aligned with objectives. Identifying responsible persons (C) is not the auditor's role.

NEW QUESTION # 129
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?

A. The organisation cannot afford to undertake quality objectives all at once.
B. The consultant has not interpreted ISO 9001 correctly.
C. Quality objectives are not being implemented by the organisation's personnel.
D. Quality objectives are not maintained as documented information.
E. Establishing quality objectives did not include top management.
F. Quality objectives were not established in alignment with the organisation's quality policy.

Answer: D,F

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 # 130
ABC is a service organisation that cleans and irons bed and table linen for four large hospitals in the city centre. It claims to meet ISO 9001:2015 requirements. During an internal audit, an auditor observes that machine No. 4 is being operated with the three variables outside the limits established in the applicable documented procedure SP-701. The auditor has decided to raise a nonconformity.
Which six elements should be included in the nonconformity report?

A. The planned duration of the process vs the minimum time required in SP-701
B. Name of the Quality Manager
C. Condition of the table linens upon receipt from the hospital
D. Weight of linen being washed vs the maximum weight required in SP-701
E. The concentration of the cleaning liquid used vs the concentration fixed in SP-701
F. Identification number of the washing machine
G. Applicable procedure: SP-701
H. Number of the production order
I. Manufacturer of the washing machine
J. Competence record of the machine operator

Answer: A,D,E,F,G,J

Explanation:
B: Applicable procedure: SP-701
D: Identification number of the washing machine
H: The concentration of the cleaning liquid used vs the concentration fixed in SP-701 I: The planned duration of the process vs the minimum time required in SP-701 J: Weight of linen being washed vs the maximum weight required in SP-701 C: Competence record of the machine operator

NEW QUESTION # 131
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD's top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
In scenario 4, the audit team determined the audit feasibility by considering only the resources available for the audit. Is this acceptable?

A. No, the audit feasibility should be determined by TD's top management.
B. Yes, considering only the resources available for the audit is sufficient for determining the audit feasibility.
C. No, because other factors should be considered when determining the audit feasibility, such as information needed to plan the audit, the cooperation of the auditee, duration of the audit, etc.
D. Yes, because the audit team leader has final authority over audit feasibility.

Answer: C

Explanation:
Comprehensive and Detailed In-Depth Explanation:
An audit's feasibility must be assessed using multiple factors, not just resource availability.
Clause References:
* ISO 19011:2018, Clause 5.3 - Establishing the Audit Program: Requires consideration of logistical, technical, and cooperation factors when assessing audit feasibility.
* ISO/IEC 17021-1:2015, Clause 9.1.3 - Determining Feasibility of the Audit: Requires evaluating more than just resources to ensure a successful audit.
Why is the Correct Answer B?
* Audit feasibility should consider:
* Availability of information (documents, records).
* Cooperation from the auditee.
* Operational conditions that might affect the audit.
* Scope and complexity of the QMS being audited.
* Resource availability alone is not enough to determine feasibility.
Why are the Other Options Incorrect?
* A (Top management determines feasibility) # Incorrect because feasibility is determined by the certification body, not the auditee.
* C (Resources alone are sufficient) # Incorrect because other key factors must be evaluated.
* D (Final authority lies with the audit leader) # Incorrect because ISO requires multiple factors to be considered, not just an auditor's decision.

NEW QUESTION # 132
The certification body has not been able to verify the implementation of corrective actions for any identified major nonconformity within six months after the last day of the Stage 2 audit. What must the certification body do in this case?

A. It must conduct all audit activities from the beginning
B. It must conduct another Stage 2 audit before granting certification
C. It must issue an unfavorable recommendation of certification

Answer: C

Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 17021-1:2015, Clause 9.4.10 (Corrective Actions for Major Nonconformities):
* If a major nonconformity is not corrected within six months, the certification body must reject the certification request.
* Another Stage 2 audit (C) is not required unless the organization reapplies for certification.
* Restarting all audit activities (B) is unnecessary; instead, certification is denied.
Thus, A is the correct answer.

NEW QUESTION # 133
......

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Accurate PECB ISO-9001-Lead-Auditor Prep Material, Exam ISO-9001-Lead-Auditor Actual Tests

PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:

Free PDF PECB - Authoritative ISO-9001-Lead-Auditor - Accurate QMS ISO 9001:2015 Lead Auditor Exam Prep Material

PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q128-Q133):

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