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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:
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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q99-Q104):
NEW QUESTION # 99
When monitoring customer perceptions, which analysis is helpful to use?
- A. Market-share analysis
- B. PEST analysis
- C. Competitive benchmarking
- 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 # 100
Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:
2015 are true?
- A. Reviews the processes with high level of risk
- B. Reviews the client's management system documented information
- C. During the Stage 1 audit, the audit team:
- D. Verifies the compliance with legal requirements
- E. Verifies the degrees of customer satisfaction
- F. Evaluates the conditions of all sites
- G. Evaluates the results of the last management review
Answer: A,G
Explanation:
The Stage 1 audit is a readiness review that verifies the organization's ability to conduct the Stage 2 audit. It involves reviewing the documented information, evaluating the site-specific conditions, and having discussions with personnel. The auditor does not verify the degrees of customer satisfaction, the compliance with legal requirements, or the results of the last management review during the Stage 1 audit. These are done during the Stage 2 audit or later in the certification process. References:
ISO 9001 Lead Auditor Reference Materials
ISO 9001 Lead Auditor Candidate Handbook
ISO 9001 Lead Auditor Course Material
ISO 9001 Lead Auditor Training Course IRCA Certified
NEW QUESTION # 101
ISO 9001 addresses changes through several requirements, two examples of which are Clause 6.3 (Planning of Changes) and Clause 8.5.6 (Control of Changes). How do the requirements of Clause 8.5.6 differ from those of Clause 6.3?
- A. Clause 8.5.6 refers to changes during the design and development of products and services.
- B. Clause 8.5.6 refers to changes during the production and service provision.
- C. Clause 8.5.6 refers to leadership and management system responsibilities.
- D. Clause 8.5.6 refers to changes to legal and regulatory requirements.
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 recognizes change management as essential for maintaining process integrity and preventing nonconformities.
Clause References:
* Clause 6.3 (Planning of Changes) # Focuses on long-term changes that may impact QMS integrity.
* Clause 8.5.6 (Control of Changes) # Focuses on changes occurring during production and service provision to ensure conformity.
Why is the Correct Answer A?
* Clause 8.5.6 applies specifically to operational changes, ensuring that modifications in production or service processes do not compromise quality.
* Organizations must document who approves changes, how they are controlled, and how they affect product/service conformity.
Why are the Other Options Incorrect?
* B (Changes during design and development) # Covered under Clause 8.3 (Design and Development), not 8.5.6.
* C (Changes to legal and regulatory requirements) # Addressed under Clause 4.2 (Interested Parties
' Requirements).
* D (Leadership responsibilities) # Covered under Clause 5.1 (Leadership and Commitment), not
8.5.6.
NEW QUESTION # 102
In the context of a third-party certification audit, it is very important to have effective communication. Which is not the responsibility of the audit team leader?
- A. Confirming formal communication channels between the audit team and the auditee during the opening meeting.
- B. If audit objectives are unattainable, reporting the reasons to the accreditation body.
- C. Planning formal communication arrangements, so an auditee can communicate with the auditor any time during the audit.
- D. Communicating the progress, any significant findings and any concerns to the auditee and audit client, as appropriate.
Answer: B
NEW QUESTION # 103
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. Complexity of internal and external issues that can have an effect on an organisation's approach to developing and achieving its purpose.
- C. Combination of internal and external issues that can have an effect on an organisation's approach to developing and achieving its objectives.
- D. Comparison of internal and external issues that can have an effect on an organisation's desire to achieve its objectives.
Answer: C
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 # 104
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