100% Pass 2025 ISO-9001-Lead-Auditor: QMS ISO 9001:2015 Lead Auditor Exam–High-quality Valid Dumps Book
100% Pass 2025 ISO-9001-Lead-Auditor: QMS ISO 9001:2015 Lead Auditor Exam–High-quality Valid Dumps Book
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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:
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>> ISO-9001-Lead-Auditor Valid Dumps Book <<
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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q172-Q177):
NEW QUESTION # 172
Which one of the following is not an ISO 9000:2015 quality management principle?
- A. Evidence-based decision-making
- B. Risk-based approach
- C. Process approach
- D. Leadership
Answer: B
Explanation:
According to the ISO 9000:2015 quality management principles document1, risk-based approach is not one of the seven quality management principles that ISO 9000, ISO 9001 and other related quality management standards are based on. The seven quality management principles are:
* Customer focus
* Leadership
* Engagement of people
* Process approach
* Improvement
* Evidence-based decision making
* Relationship management
Therefore, risk-based approach is not a quality management principle under ISO 9001:2015.
References: ISO - Quality management principles
NEW QUESTION # 173
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 to legal and regulatory requirements.
- B. Clause 8.5.6 refers to leadership and management system responsibilities.
- C. Clause 8.5.6 refers to changes during the design and development of products and services.
- D. Clause 8.5.6 refers to changes during the production and service provision.
Answer: D
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 # 174
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME's QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME' s operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of
45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
After reviewing the documented information, Li Na claimed that it was not necessary to report the minor nonconformities that were identified; instead, they would be discussed in the next audit phase. Is this acceptable?
- A. No, identification of minor nonconformities or areas of concern that could become nonconformities need to be documented and communicated to the auditee before proceeding to the next audit phase.
- B. Yes, all identified nonconformities throughout the audit need to be documented and communicated at the end of the audit.
- C. Yes, during the review of documented information, only major nonconformities need to be documented if detected.
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
As per ISO 9001:2015, Clause 10.2 (Nonconformity and Corrective Action), all identified nonconformities, including minor ones, must be documented and communicated to the auditee.
Minor nonconformities can lead to major issues if left unaddressed. The auditor must inform the organization before moving to the next audit phase so that corrective actions can be taken. Clause 9.2.2 (Internal Audit) states that audit findings should be reported without undue delay.
Since Li Na did not report the minor nonconformities immediately, her decision was incorrect. Minor nonconformities should always be documented and communicated before proceeding to the next phase.
Reference:
ISO 9001:2015, Clause 9.2.2 (Internal Audit Reporting)
ISO 9001:2015, Clause 10.2 (Nonconformity and Corrective Action)
NEW QUESTION # 175
What are the objectives of the Stage 2 audit?
- A. To evaluate whether the QMS is effectively implemented
- B. To gather information regarding the scope of the QMS
- C. To review the auditee's management system documented information
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
The Stage 2 audit (ISO 17021-1:2015, Clause 9.3.1.3) is conducted to:
* Verify whether the QMS is effectively implemented and operational.
* Ensure compliance with ISO 9001 requirements in actual practice.
* Identify nonconformities that may impact certification.
Reviewing documented information (Answer B) is part of Stage 1, and gathering scope information (Answer C) is done before the certification audit.
Reference:
ISO 17021-1:2015, Clause 9.3.1.3 (Stage 2 Audit)
NEW QUESTION # 176
In the context of a second-party audit, match the activity with the party responsible for conducting it.
Answer:
Explanation:
Explanation:
Here is the correct matching of the activities with the responsible parties in the context of a second-party audit:
* Define the audit scope: Customer
* Develop the audit plan: Audit team leader
* Respond to the audit findings: External provider
* Conduct the audit: Audit team
This reflects the typical division of responsibilities in a second-party audit, where the customer (the party commissioning the audit) sets the scope, the audit team leader manages the planning, the external provider responds to findings, and the audit team carries out the audit.
NEW QUESTION # 177
......
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