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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

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 3

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

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q224-Q229):

NEW QUESTION # 224
Match the process descriptions below to the process names:

Answer:

Explanation:

Explanation:
Match the process descriptions below to the process names:
The process by which the accuracy of test equipment is checked against a known standard. = Calibration The process by which a product or service is visually examined to determine conformity to requirements. = Evaluation The process by which data is examined in detail to reach a specific answer or answers. = Analysis The process by which a parameter of a product or service is examined to determine a specific value. = Measurement According to the ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, the definitions of the process names are as follows:
Calibration: operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.
Evaluation: determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.
Analysis: detailed examination of the elements or structure of something.
Measurement: process to experimentally obtain one or more quantity values that can reasonably be attributed to a quantity.
Therefore, the process descriptions can be matched to the process names based on these definitions.
References:
ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary

NEW QUESTION # 225
For each of the following scenarios, select four that are corrective actions.

A. The organization uses fertilizers to prevent plants dying in a section of a garden centre
B. The government increases payments to dentists for dental checks for children
C. Call out roadside assistance to a broken-down car
D. The government develops a vaccine against a virulent virus
E. The organization improves product identification to prevent customer complaints
F. A complaint about cold food was resolved by reheating food in the restaurant kitchen
G. After the loss of an important football match 4-0, the manager is sacked
H. The government enforces a lockdown against a virulent virus

Answer: A,D,E,G

NEW QUESTION # 226
You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers.
You are interviewing the Quality Systems Manager (QSM).
You: "What risks and opportunities have the business identified?"
QSM: "I'1l show you. This was discussed with the Managing Director at the latest management review." Narrative: The QSM shows you the latest management review record and points to the following table:

You: "How is the business planning to address these risks and opportunities?" QSM: "The MD said that they already knew about them so it was not necessary."

Answer:

Explanation:

Explanation:
Non-Conformity Report:
ISO 9001 Clause Number
Nature of Problem
ISO 9001 Requirement That Has Not Been Fulfilled
6.1.1
Several risks and opportunities have not been determined.
"The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed."
6.1.2 (a)
Actions to address risks and opportunities not planned.
"The organization shall plan actions to address risks and opportunities." Step-by-Step Reasoning:
* Clause 6.1.1 - Determining Risks and Opportunities:
* Requirement: The organization must determine risks and opportunities that are relevant to its Quality Management System (QMS). This ensures that the QMS achieves intended results and prevents undesired effects.
* Problem Identified: While some risks and opportunities were discussed, the organization did not perform a systematic evaluation of all risks (e.g., health and safety legislation changes, retiring trainers).
* Clause 6.1.2 (a) - Planning Actions for Risks and Opportunities:
* Requirement: The organization must plan actions to address identified risks and opportunities.
These actions should be integrated into the QMS processes to ensure continuous improvement.
* Problem Identified: The Quality Systems Manager confirmed that no plans were made to address the risks and opportunities because the Managing Director deemed it unnecessary. This violates the requirement to plan actions.
* Correct Options Selected:
* Clause 6.1.1 with the nature of the problem as: "Several risks and opportunities have not been determined."
* Clause 6.1.2 (a) with the nature of the problem as: "Actions to address risks and opportunities not planned."
* ISO 9001 Requirements Not Fulfilled:
* For 6.1.1:"The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed."
* For 6.1.2 (a):"The organization shall plan actions to address risks and opportunities."

NEW QUESTION # 227
When monitoring customer perceptions, which analysis is helpful to use?

A. Gap analysis
B. Competitive benchmarking
C. PEST analysis
D. Market-share analysis

Answer: A

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 # 228
The certification body has not been able to verify the implementation of corrective actions for any identified major nonconformity within six months after the last day of the Stage 2 audit. What must the certification body do in this case?

A. It must issue an unfavorable recommendation of certification
B. It must conduct all audit activities from the beginning
C. It must conduct another Stage 2 audit before granting certification

Answer: A

Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 17021-1:2015, Clause 9.4.10 (Corrective Actions for Major Nonconformities):
* If a major nonconformity is not corrected within six months, the certification body must reject the certification request.
* Another Stage 2 audit (C) is not required unless the organization reapplies for certification.
* Restarting all audit activities (B) is unnecessary; instead, certification is denied.
Thus, A is the correct answer.
Reference:
ISO 17021-1:2015, Clause 9.4.10 (Corrective Actions for Major Nonconformities)

NEW QUESTION # 229
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