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[General] 100% Pass PECB - ISO-9001-Lead-Auditor - Pass-Sure QMS ISO 9001:2015 Lead Audito

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【General】 100% Pass PECB - ISO-9001-Lead-Auditor - Pass-Sure QMS ISO 9001:2015 Lead Audito

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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:
TopicDetails
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
  • Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
Topic 3
  • Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q71-Q76):NEW QUESTION # 71
You work for organisation A. You are asked to lead an internal audit of A's quality management system. It has a head office in Plant A1 and a second Plant A2 nearby. Due to the COVID-19 pandemic, production in A2 was discontinued and it was rented to a logistics organisation B, not related to A. There are no A employees working in A2. Organisation A expects to reassume production in A2 as soon as possible.
Which of the following actions would you consider appropriate when planning the internal audit of A's quality management system?
  • A. Interview the A2 plant manager, now working in Plant A1
  • B. Visit Plant A2 to interview personnel of company B
  • C. Visit Plant A2 to interview A's security personnel and B's maintenance department
  • D. Visit Plant A2 to interview B's quality manager
Answer: A
Explanation:
In this scenario, the organisation A has two plants, A1 and A2, but the production in A2 was discontinued due to the COVID-19 pandemic and the plant was rented to another organisation B. There are no A employees working in A2, and the organisation A expects to reassume production in A2 as soon as possible. Therefore, the appropriate action to plan the internal audit of A's quality management system is:
*Interview the A2 plant manager, now working in Plant A1: This action involves interviewing the person who is responsible for the management and operation of the plant A2, and who is currently working in the plant A1. The interview should aim to gather information about the status and condition of the plant A2, the impact of the COVID-19 pandemic on the quality management system, the arrangements and agreements with the organisation B, and the plans and actions to resume production in the plant A25 . This action is relevant and necessary for the internal audit, as it can help to assess the readiness and effectiveness of the quality management system, and to identify any gaps or nonconformities that need to be addressed.
The other options are not appropriate actions to plan the internal audit of A's quality management system, according to the web search results from my internal tool. They are:
*Visit Plant A2 to interview personnel of company B: This action involves visiting the plant A2 and interviewing the personnel of the organisation B, who are not related to the organisation A and who are not part of the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5 .
*Visit Plant A2 to interview B's quality manager: This action involves visiting the plant A2 and interviewing the quality manager of the organisation B, who is not related to the organisation A and who is not part of the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5 .
*Visit Plant A2 to interview A's security personnel and B's maintenance department: This action involves visiting the plant A2 and interviewing the security personnel of the organisation A and the maintenance department of the organisation B, who are not directly involved in the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5 .
Therefore, the correct answer is D.
References: 1: Quality audit - Wikipedia 2: A step-by-step guide to internal quality audits 3: ISO 9001:2015 - Quality management systems - Requirements 4: ISO 19011:2018 - Guidelines for auditing management systems 5: Audit Process | Flowchart | Summary - Accountinguide : What are the Stages of the Auditing Process & Why it is Important ...

NEW QUESTION # 72
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:
Is it acceptable for the certification body and Eva to make the certification decision together?
  • A. No, auditors that take part in the audit should never take part in the certification decision
  • B. Yes, because the audit team leader must be involved in the certification decision
  • C. No, only the audit team leader must make the certification decision
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 17021-1:2015, Clause 9.5.1 (Certification Decision):
* Auditors who conduct the audit cannot be involved in the certification decision to ensure impartiality.
* The certification body alone is responsible for making the certification decision based on the audit report and findings.
* The audit team leader (Eva) must not take part in the certification decision.
Thus, C is the correct answer.

NEW QUESTION # 73
According to ISO 9000, what is quality?
  • A. The degree to which a set of inherent characteristics of an object fulfills requirements
  • B. The efficiency with which resources are utilized in achieving objectives
  • C. A set of conditions under which work is performed
  • D. The ability of an object to realize an output that will fulfill the requirements for that output
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9000:2015 defines quality as "the degree to which a set of inherent characteristics of an object fulfills requirements."
* Clause 3.6.2 (Quality) confirms this definition.
* Quality is determined by how well an object (product, service, or process) meets defined requirements (customer, regulatory, or internal).
The other options do not align with the official ISO definition:
* Option A refers to performance capability but does not define quality.
* Option C describes work conditions, not quality.
* Option D focuses on efficiency rather than fulfilling requirements.
Reference:
ISO 9000:2015, Clause 3.6.2 - Quality

NEW QUESTION # 74
Auditor competence is a combination of knowledge and skills. Which two of the following activities are predominately related to 'knowledge'?
  • A. Determining what evidence to gather
  • B. Determine how to seek evidence from the auditee
  • C. Communicate with the auditee
  • D. Evaluate proposals of corrective actions
  • E. Identify findings
  • F. Conduct audit meetings
Answer: A,D
Explanation:
Comprehensive and Detailed Explanation From Exact Extract:
According to ISO 19011:2018 - Guidelines for Auditing Management Systems, which is referenced in ISO
9001 Lead Auditor training and practice, auditor competence is defined by a combination of knowledge, skills, and personal attributes. Here's how each selected option aligns:
D). Determining what evidence to gather: This activity is rooted in knowledge of audit principles, criteria, and risk-based thinking. It requires an understanding of which types of evidence (documents, records, interviews, observations) are necessary to evaluate conformity to the audit criteria (Clause 7.2.3 of ISO 19011:2018).
E). Evaluate proposals of corrective actions: This task involves applying knowledge of ISO 9001 requirements, root cause analysis methods, and risk controls to assess whether proposed actions are suitable to prevent recurrence. It demands comprehension of quality management principles and corrective action methodologies, linking it firmly to knowledge.
Other options such as A (Communicate with auditee) and B (Conduct audit meetings) are predominantly skills-based, requiring interpersonal and communication abilities, not theoretical or regulatory knowledge.
C (Determine how to seek evidence) and F (Identify findings) involve both knowledge and skill but are more action-oriented and tied to situational judgment and auditor behavior.
References:
ISO 19011:2018, Clause 7.2.3 - Establishing Auditor Competence
ISO 9001:2015, Clause 9.2 - Internal Audit
ISO 19011:2018, Annex A.1 - Knowledge and skills of auditors

NEW QUESTION # 75
When monitoring customer perceptions, which analysis is helpful to use?
  • A. Competitive benchmarking
  • B. PEST analysis
  • C. Market-share analysis
  • D. Gap analysis
Answer: D
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires organizations to measure and monitor customer perceptions to determine whether customer requirements are being met.
Clause Reference:
* Clause 9.1.2 - Customer Satisfaction states that organizations must monitor customer perceptions using relevant methods such as customer surveys, feedback forms, and complaint analysis.
* One of the most effective ways to do this is gap analysis, which identifies differences between customer expectations and actual service or product performance.
Why is the Correct Answer C?
* Gap analysis helps determine discrepancies between current performance and customer expectations, allowing organizations to improve quality.
* It is a standard quality improvement tool used to assess customer satisfaction.
Why are the Other Options Incorrect?
* A (PEST analysis) # Focuses on external macroeconomic factors (Political, Economic, Social, Technological) rather than customer satisfaction.
* B (Market-share analysis) # Examines business performance relative to competitors, not customer perceptions.
* D (Competitive benchmarking) # Involves comparing processes with competitors but does not directly monitor customer perceptions.
Reference:
ISO 9001:2015, Clause 9.1.2 - Customer Satisfaction

NEW QUESTION # 76
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