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

Topic
Details

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

Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.

Topic 3

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.

Topic 4

Fundamental audit concepts and principles: Questions about interpreting and applying the main concepts and principles related to a QMS audit appear in this topic.

PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q67-Q72):

NEW QUESTION # 67
Scenario 2:
Bell is a Canadian food manufacturing company that operates globally. Their main products include nuts, dried fruits, and confections. Bell has always prioritized product quality and has maintained a good reputation for many years. However, the company's production error rate increased significantly, leading to more customer complaints.
To increase efficiency and customer satisfaction, Bell implemented a Quality Management System (QMS) based on ISO 9001. The top management established a QMS implementation team comprising five middle managers from various departments, including Leslie, the quality manager.
Leslie was responsible for assigning responsibilities and authorities for QMS-related roles. He also suggested including a top management representative in the QMS team, but top management declined due to other priorities.
The team defined the QMS scope as:
"The scope of the QMS includes all activities related to food processing." Leslie established a quality policy and presented it to the team for review before top management approval
. Top management also proposed a new strategy for handling customer complaints, requiring biweekly customer surveys to monitor customer perceptions.
In scenario 2, the team determined the QMS scope by taking into account only the requirements of top management. Is this compliant with ISO 9001?

A. Yes, ISO 9001 does not specify whether any interested party should be considered when determining QMS scope.
B. No, the QMS scope must take into account only those directly involved in QMS implementation.
C. Yes, as long as the top management defines the scope, it meets ISO 9001 requirements.
D. No, the QMS scope must be determined by considering the needs and expectations of relevant interested parties.

Answer: D

Explanation:
Comprehensive and Detailed In-Depth Explanation:ISO 9001:2015, Clause 4.3 (Determining the Scope of the Quality Management System) states that when determining the QMS scope, an organization must consider:
* External and internal issues (Clause 4.1)
* The needs and expectations of interested parties (Clause 4.2)
* The products and services provided by the organization
In the scenario, Bell only considered top management's input, which fails to address Clause 4.2 (interested parties' expectations)-such as customers, suppliers, and regulatory authorities.

NEW QUESTION # 68
Knowledge and skills are requirements of the auditor's competence. Select two from the following topics of knowledge that apply to every member of an audit team auditing an ISO 9001 quality management system.

A. Organisation's processes
B. ISO 19011 Audit principles
C. Organisation's market sector
D. Requirements of ISO 9001
E. Organisation's invoicing and profits of the last 5 years
F. Requirements of auditee's interested parties other than customers

Answer: B,D

Explanation:
According to ISO 9001:2015, clause 7.2, an auditor shall have the competence to:
Understand the requirements of ISO 9001 and how they relate to the audit Understand the organization's quality management system and its processes Understand the applicable legal, regulatory, contractual and other requirements that affect the audit Understand the needs and expectations of interested parties other than customers Plan and conduct audits in accordance with ISO 19011 Evaluate audit evidence and draw appropriate conclusions Communicate audit findings effectively1 Therefore, knowledge of ISO 9001 requirements and ISO 19011 audit principles are essential for every member of an audit team auditing an ISO 9001 quality management system.
References:
ISO 9001:2015 - Quality management systems - Requirements
ISO 19011:2018 - Guidelines for auditing management systems

NEW QUESTION # 69
Consultancy ABC, which is a subsidiary of a certification body called ABC-CERT, provided consultancy services regarding the implementation of a QMS based on ISO 9001 to an organization.
Considering this, can ABC-CERT provide certification services to the organization which obtained consultancy services from Consultancy ABC?

A. No, ABC-CERT is not allowed to provide certification services to that organization ever, as this would be a conflict of interest.
B. Yes, after a minimum period of two years has passed.
C. Yes, if both parties sign an agreement which states that previous services by Consultancy ABC will not impact the judgment of auditors.

Answer: A

Explanation:
Comprehensive and Detailed In-Depth Explanation:
Certification bodies must remain independent and impartial. If a certification body (ABC-CERT) provides consulting services to an organization through its subsidiary (Consultancy ABC), it cannot later certify the same organization.
Clause References:
* ISO/IEC 17021-1:2015, Clause 5.2.5 - Impartiality Requirements:
* A certification body must not certify an organization to which it has provided consultancy services.
* ISO/IEC 17021-1:2015, Clause 5.2.6:
* Subsidiaries of certification bodies must not provide consulting services to prevent conflicts of interest.
Why is the Correct Answer C?
* Certifying a client after providing consultancy creates a conflict of interest and violates ISO/IEC
17021-1:2015 impartiality rules.
* The certification body (ABC-CERT) and consultancy firm (Consultancy ABC) are related entities
, making it impossible to remain objective and independent.
Why are the Other Options Incorrect?
* A (Waiting two years) # ISO does not specify a time frame; the issue is impartiality, not just time.
* B (Signing an agreement to ensure objectivity) # Conflicts of interest cannot be resolved through an agreement; independence is required.
Reference:
ISO/IEC 17021-1:2015, Clause 5.2.5 - Impartiality Requirements

NEW QUESTION # 70
Which statement regarding the drafting of the audit conclusions is correct?

A. The audit conclusions must be drafted based on observation
B. The audit conclusions must not include the revisions that resulted from the closing meeting
C. The audit conclusions must be based on evidence that is examined and evaluated in terms of quantity and quality

Answer: C

Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 6.4.9 (Audit Conclusions):
* Audit conclusions must be based on verified evidence.
* The evidence must be evaluated both quantitatively and qualitatively to ensure accuracy.
* Observations alone (A) are insufficient; conclusions must be supported by objective evidence.
Thus, B is the correct answer.
Reference:
ISO 19011:2018, Clause 6.4.9 (Audit Conclusions)

NEW QUESTION # 71
You are carrying out an annual audit at an organisation that offers home security services. You are interviewing the Quality Manager (QM) You: "Would you tell me about your management review process?" QM: "The senior management team plans to review the management system every six months. The review follows a set agenda and records are maintained." You: "May I see the records from the last two management reviews?" Narrative: The Quality Manager gives you the latest record, which shows the last management review took place nine months ago.
The Quality Manager then gives you the previous management review record, which took place one year before the latest review.
You: "Are there any other review reports in the last two years?
QM: "No, these are the only ones."

Answer:

Explanation:

Nonconformity report
ISO 9001 Clause Number: 9.3.1 Nature of problem: Management review has not been conducted at the defined frequency. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "Top management shall review the organization's quality management system at planned intervals." Evidence: The last management review took place nine months ago, and the previous one took place one year before the latest review. The planned interval is six months.

NEW QUESTION # 72
......

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