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

Topic
Details

Topic 1

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

Topic 2

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

Topic 3

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

Topic 4

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 5

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

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q181-Q186):

NEW QUESTION # 181
You have been just hired as the Internal Lead Auditor of a large organisation, responsible for internal audits.
Your first job is to analyse the answers to nonconformities included in the report of a recent internal audit to Top Management.
The report contained one nonconformity as follows:
There is no evidence of Top Management ensuring the availability of resources to operate the QMS, the establishment of objectives, the promotion of continual improvement, and the promoting of the process approach.
Which four of the following Top Management actions can be considered 'corrections to the nonconformity'?

A. Process approach has been communicated to the personnel
B. Top Management appoints a senior manager to oversee the quality manangement system
C. Top Management review will be carried out every six months instead of annually
D. Top Management completed a course on ISO 9001
E. All these actions will be reviewed during the Top Management meetings
F. Resources have been provided
G. Objectives have been established
H. Improvement action has been promoted

Answer: A,F,G,H

NEW QUESTION # 182
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 # 183
Which two of the following should be included in an audit plan?

A. List of findings from the last audit
B. Sequence and timings of audit activities
C. Date of next audit
D. Signature of Certification Body Technical Reviewer
E. Name of auditees and auditors
F. Name of the auditee general manager

Answer: B,E

Explanation:
According to ISO 19011:2018, clause 6.3.2, an audit plan should include the following information:
The audit objectives, scope, and criteria
The audit team members and their roles and responsibilities
The audit schedule, including the sequence and timings of audit activities, such as opening meeting, document review, interviews, observations, closing meeting, etc.
The expected time and duration of each audit activity and location
The name and contact details of the auditee's representative and other relevant parties The allocation of appropriate resources to support the audit activities The audit methods and techniques to be used, such as interviews, observations, sampling, etc.
The audit documents and records to be prepared and retained
The audit language and communication methods
The audit risks and opportunities and how to address them
The audit follow-up arrangements, if applicable
Therefore, the correct answer is D and F, as they are essential elements of an audit plan. The other options are either irrelevant or optional for an audit plan. References:
ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.3.2 ISO 19011: Guidelines for Auditing Management Systems | ASQ, section "Making audit arrangements" ISO 19011 Management Systems Audit Checklist | Process Street, task 6.3.2

NEW QUESTION # 184
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.
The quality policy was established by Leslie and approved by top management. Is this acceptable?
Please refer to scenario 2.

A. Yes, as long as top management is informed, the policy can be established by any responsible employee.
B. Yes, the quality policy can be established by the QMS implementation team and be approved by top management.
C. No, the quality policy must be established and approved only by the quality manager.
D. No, the quality policy must be established and approved by top management.

Answer: D

Explanation:
Comprehensive and Detailed In-Depth Explanation:ISO 9001:2015, Clause 5.2.1 (Establishing the Quality Policy) states that top management must establish, implement, and maintain a quality policy.
In the scenario, the quality manager (Leslie) created the policy, but top management did not establish it themselves, which violates Clause 5.2.1. While the policy can be drafted by a team, top management must take full ownership of its development and approval.

NEW QUESTION # 185
What are the criteria for reviewing documented information?

A. Archive, volume, and confidentiality of documented information
B. Language of documented information, internal audit reports, client feedback
C. Content, format, and the procedure for managing documented information

Answer: C

Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 9001:2015, Clause 7.5.2 (Creating and Updating Documented Information), the criteria for reviewing documented information include:
* Content - The accuracy and relevance of the information.
* Format - Ensuring readability and proper structuring (e.g., language, versioning).
* Procedure for managing documented information - Ensuring control, access, and updates.
Other options, such as internal audit reports and client feedback, are important for overall QMS evaluation but are not the main criteria for reviewing documented information.

NEW QUESTION # 186
......

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Sean Shaw Sean Shaw

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