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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

Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.

Topic 4

Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.

Topic 5

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 6

Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q180-Q185):

NEW QUESTION # 180
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.
According to scenario 5, Li Na conducted group interviews with departmental managers and top management by herself. Is this in accordance with audit best practices?

A. Yes, the auditee's top management is always interviewed by the audit team leader only.
B. No, two auditors should be present in case of group interviews.
C. Yes, only the audit team leader should conduct group interviews.

Answer: B

Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 6.4.6 (Conducting Interviews), group interviews should be conducted with at least two auditors to ensure objectivity and accuracy.
* This prevents bias or misinterpretation of responses.
* It allows for cross-validation of information.
* It ensures that the audit results remain objective and impartial.
Since Li Na conducted the group interviews alone, she did not follow audit best practices. The correct approach would have been to have another auditor present during the interviews.
Reference:
ISO 19011:2018, Clause 6.4.6 (Conducting Interviews)

NEW QUESTION # 181
What is the responsibility of the audit committee during an internal audit?

A. To establish an internal audit program
B. To define the audit schedule
C. To supervise all audit functions and activities

Answer: A

Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 5.2 (Audit Program Management):
* The audit committee is responsible for establishing the internal audit program.
* The audit schedule (A) is determined within the program, but it is not the main role of the committee.
Thus, C is the correct answer.
Reference:
ISO 19011:2018, Clause 5.2 (Audit Program Management)

NEW QUESTION # 182
Which action indicates that an organization is meeting the requirements of ISO 9001 regarding nonconforming outputs?

A. Retaining documented information only on the actions taken.
B. Verifying conformity to the applicable requirements prior to correction of the nonconforming outputs.
C. Allowing employees to handle nonconformities based on their own judgment without structured procedures.
D. Taking appropriate action to nonconforming products and services detected after the delivery of products, during or after the provision of services.

Answer: D

Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires organizations to identify and control nonconforming outputs to prevent unintended use or delivery.
Clause References:
* Clause 8.7 (Control of Nonconforming Outputs): Organizations must ensure that nonconforming outputs are identified and controlled to prevent unintended use or delivery.
* Clause 10.2 (Nonconformity and Corrective Action): Requires organizations to take appropriate actions when nonconformities are found, including during or after service provision.
Why is the Correct Answer C?
* If nonconforming products or services are identified after delivery or during service, organizations must take corrective actions to protect customers and stakeholders.
* Actions may include recalls, rework, customer notifications, compensation, or process improvements.
* This approach aligns with ISO 9001:2015, ensuring that products/services consistently meet requirements.
Why are the Other Options Incorrect?
* A (Retaining documentation only) # While documentation is required, it alone does not ensure proper handling of nonconforming outputs.
* B (Verifying conformity before correction) # While verification is good practice, ISO 9001 prioritizes corrective action over mere verification.
* D (Allowing employees to handle nonconformities without structure) # ISO 9001 requires documented procedures for handling nonconformities (Clause 8.7).

NEW QUESTION # 183
Select the word that best completes the sentence:

Answer:

Explanation:

According to the ISO - Management system standards page, the key benefits of an effective management system include improved operational effectiveness and efficiency, improved risk management and protection of people and the environment, and enhanced drive for innovation. The Integrated Use of Management System Standards (IUMSS) handbook also states that the purpose and objectives of management system standards are to help organizations improve their performance by specifying repeatable steps that organizations consciously implement to achieve their goals and objectives.
Therefore, the complete sentence is:
"The purpose of a management system standard is to improve the performance of an organisation."

NEW QUESTION # 184
The following list gives examples of records that may be evidence of how an organisation has fulfilled the requirements of clause 8.4 of ISO 9001. Match the records to the appropriate requirement of clause 8.4.

Answer:

Explanation:

The following table shows the possible matching of the records to the requirements of clause 8.4:
Table
Requirements
Records
Define product requirements
Product specification
Criteria for selection
List of requirements to be met by the external provider
Evaluation of potential external provider
External provider questionnaire
External provider selection
Approved external provider list
Communicate requirements
Purchase order
Monitoring of performance
External provider delivery times and quality issues
Comprehensive and Detailed Explanation: = According to clause 8.4 of ISO 9001:2015, the organization should ensure that externally provided processes, products, and services conform to the specified requirements. To do so, the organization should:
Define the product requirements that are relevant for the external provision, such as specifications, drawings, standards, codes, etc. These should be documented and communicated to the external provider. A record of the product specification can be used as evidence of this requirement.
Establish the criteria for the selection, evaluation, and re-evaluation of external providers, based on their ability to provide processes, products, and services in accordance with the requirements. The criteria should be documented and applied consistently. A record of the list of requirements to be met by the external provider can be used as evidence of this requirement.
Evaluate the potential external providers before selecting them, using the established criteria. The evaluation methods may include questionnaires, audits, references, samples, etc. The results of the evaluation should be documented and reviewed. A record of the external provider questionnaire can be used as evidence of this requirement.
Select the external providers that have demonstrated their competence and conformity to the requirements.
The selection should be based on the evaluation results and the organization's needs. The selection should be documented and approved. A record of the approved external provider list can be used as evidence of this requirement.
Communicate the requirements for the processes, products, and services to be provided by the external provider, including the verification and validation activities, the acceptance criteria, the documentation requirements, the changes control, etc. The communication methods may include purchase orders, contracts, agreements, etc. The communication should be clear, complete, and timely. A record of the purchase order can be used as evidence of this requirement.
Monitor the performance and conformity of the external provider, using the established criteria and methods.
The monitoring methods may include inspections, tests, audits, feedback, complaints, etc. The monitoring results should be documented and analyzed. A record of the external provider delivery times and quality issues can be used as evidence of this requirement.
References: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Scope], Mastering the Scope of ISO 9001 Quality Management Systems

NEW QUESTION # 185
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