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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:
Topic
Details
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
- Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.
Topic 3
- 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 4
- Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.
Topic 5
- Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
Topic 6
- 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.
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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q205-Q210):
NEW QUESTION # 205
(A third-party audit has been planned at a single-site organisation. The audit team comprises one audit team leader, one auditor and one auditor who is undertaking his first third-party audit.
During the on-site audit, the auditor who is undertaking his first third-party audit shall...)
- A. conduct the closing meeting on behalf of the audit team leader who has left the audit owing to illness.
- B. act as an observer until they have the required audit experience.
- C. conduct interviews of auditee staff on their own to help overcome audit delays.
- D. decide the category of each nonconformity during audit team meetings.
- E. conduct interviews of auditee staff with the audit team leader present.
- F. conduct reviews of his/her auditing capability with the audit team leader.
Answer: E,F
Explanation:
An auditor undertaking their first third-party audit is normally treated as an auditor under supervision. They may participate in audit activities, but should be monitored and supported by the audit team leader.
They should therefore review their auditing performance with the audit team leader and conduct interviews only with the audit team leader present.
They should not lead the closing meeting, independently interview auditees, or decide nonconformity grading alone. ISO 9001:2015 requires audits to be conducted objectively and by competent auditors, and ISO 9001 refers to ISO 19011 for audit guidance.
NEW QUESTION # 206
You will perform a third-party initial audit of ABC, a car manufacturer located on the outskirts of Sao Paulo, Brazil.
ABC is a local branch of an American car manufacturer that wants to introduce a new model, the GX-1, into the Brazilian market. In your audit plan, you included a two-hour interview with the Production Engineering department to audit clause 8.3 of ISO 9001.
When you sent the audit plan to ABC for their review, ABC said, "There is no need for that interview because the design of the model GX-1 was made in the USA, and we did not participate in that process." Millions of cars have already been sold in the USA and the Far East with fantastic success.
Which one of these potential actions is acceptable?
- A. Accept the comment and remove from the audit plan the interview to the Production Engineering Department since 8.3 Design is not applicable.
- B. Maintain the interview with the Production Engineering Department to verify if the car design has been verified and validated in the USA, as required in clause 8.3.
- C. Maintain the interview with the Production Engineering Department to check if the car specifications to be used in Brazil have been verified and validated by ABC in Brazil.
- D. Maintain the interview with the Production Engineering Department, to check whether the cars manufactured in Brazil meet the GX-1 design specifications already developed in the USA.
Answer: C
Explanation:
Clause 8.3 may still apply because ABC is introducing the GX-1 into a new market. Even if the original design was done in the USA, ABC in Brazil must ensure that the specifications used for the Brazilian market are appropriate, verified, and validated where applicable.
Option C is best because it focuses on whether ABC Brazil has verified and validated the specifications for use in Brazil. This may include local regulatory, customer, environmental, safety, production, or market requirements.
Option A is not best because the auditor of ABC Brazil should not simply audit the USA design process.
Option B is incorrect because design and development cannot automatically be excluded just because the original design was performed elsewhere. Option D relates more to production conformity against existing specifications, not design and development verification/validation under clause 8.3.
NEW QUESTION # 207
Which of the following is a responsibility of a guide in an audit?
- A. Filling any potential gaps in the auditor's knowledge
- B. Maintaining logistics
- C. Witnessing the audit process on behalf of the certification body
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
A guide is assigned by the auditee to assist the audit team by:
* Managing logistics, such as ensuring that relevant documents are available and arranging interviews.
* Assisting in the coordination of meetings and access to facilities.
* Helping the auditors navigate the organization during the audit.
However, the guide does not fill gaps in the auditor's knowledge or witness the audit for the certification body. Their primary function is logistical support, not providing interpretations or assessments.
Reference:
ISO 19011:2018, Clause 6.4.3 (Roles and Responsibilities of Guides and Observers)
NEW QUESTION # 208
"A set of interrelated or interlacing elements of an organization to establish policies and objectives, and processes to achieve those objectives" is the definition of a/an:
- A. Quality manual
- B. Management system
- C. Standard
- D. Organization scope
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 9000:2015, which provides definitions for terms used in ISO 9001:2015, a management system is defined as a set of interrelated or interacting elements of an organization to establish policies, objectives, and processes to achieve those objectives.
A Quality Management System (QMS) is a type of management system that ensures organizations meet customer and regulatory requirements while improving performance.
Clause 3.5.3 of ISO 9000:2015 clearly defines "management system" and aligns with this question. The other options do not fit the definition:
* Standard refers to an established norm or requirement.
* Organization scope defines the boundaries of a QMS but is not a system itself.
* Quality manual is a document (optional under ISO 9001:2015) that describes a QMS but is not the system itself.
NEW QUESTION # 209
The ISO 9001 clause 5.1.1 states top management shall demonstrate leadership and commitment with respect to the quality management system.
In the context of the ISO 9001 management system certification, select the one correct description of top management's responsibilities.
- A. Top management shall ensure that all requirements are fulfilled.
- B. Depending on the size, complexity and business context, some of the 5.1.1 requirements can be excluded.
- C. Depending on the organization's available resources, top management can comply with one or more of the 5.1.1 requirements.
- D. Top management needs only to comply with 50% of the 5.1.1 requirements.
Answer: A
NEW QUESTION # 210
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