ISO-9001-LEAD-AUDITOR LATEST EXAMPREP - ISO-9001-LEAD-AUDITOR NEW EXAM MATERIALS

ISO-9001-Lead-Auditor Latest Examprep - ISO-9001-Lead-Auditor New Exam Materials

ISO-9001-Lead-Auditor Latest Examprep - ISO-9001-Lead-Auditor New Exam Materials

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

TopicDetails
Topic 1
  • Fundamental audit concepts and principles: Questions about interpreting and applying the main concepts and principles related to a QMS audit appear in this topic.
Topic 2
  • 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 3
  • Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.

PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q82-Q87):

NEW QUESTION # 82
According to ISO 19011, what two activities take place during the conduct of a audit follow-up?

  • A. Determine feasibility of the audit
  • B. Plan the next audit
  • C. Verify legal compliance
  • D. Verify corrections taken to fix the reported non-conformities
  • E. Assign roles and responsibilities of observers
  • F. Verify the effectiveness of the implemented corrective actions

Answer: D,F

Explanation:
According to ISO 19011:2018, clause 6.7, the audit follow-up is the process of verifying the completion and effectiveness of corrective actions taken by the auditee as a result of an audit. The audit follow-up can include two main activities:
Verifying the effectiveness of the implemented corrective actions: this means checking whether the actions taken by the auditee have addressed the root causes of the nonconformities and prevented their recurrence or occurrence in other areas. The verification can be done by reviewing documents, records, data, or other evidence provided by the auditee, or by conducting a follow-up audit on site or remotely.
Verifying corrections taken to fix the reported non-conformities: this means checking whether the auditee has corrected the nonconformities identified during the audit and eliminated their immediate effects. The verification can be done by reviewing documents, records, data, or other evidence provided by the auditee, or by conducting a follow-up audit on site or remotely.
The audit follow-up can be conducted as a separate audit or as part of a subsequent audit, depending on the audit programme, the audit objectives, the audit criteria, the audit scope, the audit risks, and the audit findings. The audit follow-up should be planned and conducted in accordance with the same principles and processes as the initial audit, and the results should be documented and reported accordingly. References:
ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.7 ISO 19011 Management Systems Audit Checklist | Process Street, task 6.7.1 and 6.7.2 Conducting the Audit Follow-Up: When to Verify - The Auditor, section "Conducting the audit follow-up"


NEW QUESTION # 83
What competence, among others, should each audit team member have?

  • A. Knowledge of the risk-based approach to auditing.
  • B. A formal degree in quality management.
  • C. Expertise in each domain to be audited.
  • D. Knowledge of the industry in which the auditee operates.

Answer: A

Explanation:
Comprehensive and Detailed In-Depth Explanation:
Auditors must have competence in risk-based auditing to effectively assess an organization's QMS performance and compliance.
Clause References:
* ISO 19011:2018, Clause 7.2.3 - Determining Auditor Competence:
* Auditors must have knowledge of risk-based thinking to assess risk impact on processes.
* ISO 9001:2015, Clause 0.3.3 - Risk-Based Thinking:
* The standard emphasizes proactive risk management, which auditors must understand.
Why is the Correct Answer B?
* Risk-based auditing ensures audits focus on high-risk areas, improving audit effectiveness.
* Auditors must assess how organizations apply risk-based thinking in decision-making, process control, and improvement.
Why are the Other Options Incorrect?
* A (Industry knowledge) # While helpful, it is not mandatory for all auditors.
* C (Expertise in all domains) # Auditors are not required to be experts in all areas, just in audit methodology.
* D (Formal degree in quality management) # ISO does not require a formal degree, just competence in audit principles and methods.


NEW QUESTION # 84
Technical experts must operate under the supervision of:

  • A. The audit team leader only
  • B. The auditee
  • C. An auditor

Answer: C

Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 5.5 (Determining Audit Team Competence), technical experts:
* Provide specialized knowledge in an audit.
* Must operate under the supervision of an auditor to ensure compliance with audit protocols.
* Cannot work independently or under the auditee's supervision, as they are not responsible for the audit's findings.
The audit team leader has overall responsibility, but technical experts are supervised by an auditor during the audit process.


NEW QUESTION # 85
You are conducting a Stage 1 audit at an organisation that services refrigeration equipment for a large customer base.
The scope of certification is "Provision of refrigeration equipment maintenance and repair services". You are interviewing the Managing Director to learn more about the organisation and to explore how the requirements for policy, objectives, and risks and opportunities in ISO 9001 are addressed.
The Managing Director explains that they only use sub-contract refrigeration engineers and do not have any full-time refrigeration engineers, which helps to optimise overhead costs. The full-time staff employed are essentially a small team of office staff who process customer enquiries, schedule jobs and process invoices.
The Managing Director adds that the ISO 9001 requirements for competence of personnel extends to both sub- contract and full-time staff. He also states that the full-time staff are aware of the Quality Policy, objectives and plans to address risk and opportunities.
You ask if the sub-contract engineers have been informed of the Quality Policy, objectives and plans to address risks and opportunities, to which the Managing Director replies that this is not applicable as they only use sub- contractors who operate ISO 9001 certificated quality management systems. The documented information provided to the auditor confirms this.
Which clause in ISO 9001 is most likely not to have been fulfilled in this instance?

  • A. 7.2 Competence
  • B. 7.5 Documented information
  • C. 7.4 Communication
  • D. 7.3 Awareness

Answer: C

Explanation:
Questions no: 16 Verified = C. 7.4 Communication Comprehensive But Short Explanation: = Clause
7.4 of ISO 9001:2015 requires the organization to determine the internal and external communications relevant to the quality management system, including what will be communicated, when, with whom, and how. The scenario indicates a potential gap in communication with subcontractors regarding the Quality Policy, objectives, and plans to address risks and opportunities, which is a requirement even if the subcontractors have their own ISO 9001 certified systems123. References: = This response is based on the general requirements of ISO 9001:2015 related to communication with external parties, such as subcontractors, as outlined in various resources discussing Clause 7.4123.


NEW QUESTION # 86
Which one of the following options is the definition of the context of an organisation?

  • A. Coordination of internal and external issues that can have a positive or negative effect on an organisation's success.
  • B. Combination of internal and external issues that can have an effect on an organisation's approach to developing and achieving its objectives.
  • C. Comparison of internal and external issues that can have an effect on an organisation's desire to achieve its objectives.
  • D. Complexity of internal and external issues that can have an effect on an organisation's approach to developing and achieving its purpose.

Answer: B

Explanation:
Understanding "Context of the Organization":The term "context of the organization" is defined in ISO
9001:2015 Clause 4.1, which states:
"The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
"
The definition emphasizes identifying both internal and external issues that influence the organization's approach to developing and achieving its objectives.
Option Analysis:
* Option A:Correct. This option aligns with the standard definition as it explicitly mentions the combination of internal and external issues that affect the organization's approach to achieving its objectives, which is the essence of Clause 4.1.
* Option B:Incorrect. The term "comparison of internal and external issues" does not reflect the ISO
9001 requirements. The standard does not require a comparison but rather an understanding of these issues.
* Option C:Incorrect. Although it mentions "complexity," the focus of ISO 9001:2015 is on identifying relevant issues rather than the complexity of those issues.
* Option D:Incorrect. This option mentions "coordination" and focuses only on the positive or negative effects. ISO 9001 requires identifying issues but does not emphasize coordination.
Clause Reference and Relevance:ISO 9001:2015 requires organizations to understand their context because internal and external factors can influence the Quality Management System's effectiveness. Understanding this context helps in:
* Addressing risks and opportunities (Clause 6.1).
* Aligning the QMS with the organization's strategic direction.
Why A is Correct:"Combination of internal and external issues" captures the essence of Clause 4.1, making it the accurate definition of the context of the organization.


NEW QUESTION # 87
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