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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q36-Q41):

NEW QUESTION # 36
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures cosmetics for major retailers.
You are interviewing the Manufacturing Manager (MM).
You: "I would like to begin by looking at the cleaning controls."
MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside." Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.

You decide to raise a non-conformity.

Answer:

Explanation:

Explanation:
Clause: 8.5.4
Nature of Problem: Cleaning and sanitising records are not available for every batch.
Unfulfilled Requirement: "The organization shall implement production provision under controlled conditions."

NEW QUESTION # 37
Which two of the following may be changed once a Stage 2 certification audit has commenced?

A. Audit scope
B. Agreed language of the audit
C. Agreed standard for the audit criteria
D. Audit checklist
E. Audit plan
F. Increase of audit duration

Answer: E,F

Explanation:
Comprehensive and Detailed In-Depth Explanation:
Once a Stage 2 certification audit has commenced, certain logistical or planning-related elements may still be adjusted, while others are fixed by prior agreement and cannot be changed.
# C. Audit Plan:
The audit plan is a document that outlines the scope, objectives, criteria, and logistics of the audit. According to ISO/IEC 17021-1:2015 (the standard for bodies providing audit and certification of management systems), clause 9.2.3.3 allows for modification of the audit plan based on real-time conditions during the audit - such as availability of auditees or changes in process access.
# F. Increase of Audit Duration:
Audit duration is generally determined during audit planning based on factors like employee count, risk, complexity, etc. However, if during Stage 2 it is found that more time is needed (e.g., due to additional processes, scope not fully covered, or significant findings), auditors are permitted to extend the audit. This ensures full coverage of all required areas as per ISO/IEC 17021-1 clause 9.1.4 and IAF MD 5.
# A. Agreed Language of the Audit:
This is determined and agreed upon in the contract and audit planning stages. Changing it during Stage 2 would create communication and documentation issues, especially in multi-site or multi-national audits.
# B. Audit Scope:
The audit scope is defined in the contract and certification agreement based on clause 4.3 of ISO 9001:2015.
Changing it mid-audit would invalidate planning, required competencies, and potentially even the certification basis.
# D. Agreed Standard for the Audit Criteria:
Changing the standard (e.g., from ISO 9001 to ISO 13485) is fundamentally altering the purpose and contractual basis of the audit and is not permissible once Stage 2 has started.
# E. Audit Checklist:
The checklist is a tool prepared by the auditor as part of audit preparation and is based on the audit plan and standard requirements. While it may be adapted during the audit (e.g., if new risks arise), it does not constitute a formal change like duration or scope.
Relevant References:
* ISO/IEC 17021-1:2015 Clause 9.2.3.3 (Audit Plan Modification)
* IAF MD 5:2019 (Duration of QMS Audits)
* ISO 9001:2015 Clause 4.3 (Scope of the QMS)
* ISO/IEC 17021-1:2015 Clause 9.1.4 (Audit Duration)

NEW QUESTION # 38
What competence, among others, should each audit team member have?

A. Knowledge of the risk-based approach to auditing.
B. Expertise in each domain to be audited.
C. Knowledge of the industry in which the auditee operates.
D. A formal degree in quality management.

Answer: A

Explanation:
Comprehensive and Detailed In-Depth Explanation:
Auditors must have competence in risk-based auditing to effectively assess an organization's QMS performance and compliance.
Clause References:
* ISO 19011:2018, Clause 7.2.3 - Determining Auditor Competence:
* Auditors must have knowledge of risk-based thinking to assess risk impact on processes.
* ISO 9001:2015, Clause 0.3.3 - Risk-Based Thinking:
* The standard emphasizes proactive risk management, which auditors must understand.
Why is the Correct Answer B?
* Risk-based auditing ensures audits focus on high-risk areas, improving audit effectiveness.
* Auditors must assess how organizations apply risk-based thinking in decision-making, process control, and improvement.
Why are the Other Options Incorrect?
* A (Industry knowledge) # While helpful, it is not mandatory for all auditors.
* C (Expertise in all domains) # Auditors are not required to be experts in all areas, just in audit methodology.
* D (Formal degree in quality management) # ISO does not require a formal degree, just competence in audit principles and methods.

NEW QUESTION # 39
Which one of the following documents addresses audit time calculation for third-party certification audits?

A. ISO 9001
B. ISO 17021-1
C. ISO 19011
D. ISO 9000

Answer: B

Explanation:
ISO/IEC 17021-1 is the standard that specifies requirements for bodies providing audit and certification of management systems. It includes provisions for determining audit time for third-party certification audits, ensuring that the audits are conducted in a consistent, comparable, and reliable manner, which can be applied to a variety of management systems, including ISO 9001.
References: ISO/IEC 17021-1; IAF Mandatory Document for the Determination of Audit Time of Quality and Environmental Management Systems Certification

NEW QUESTION # 40
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, the quality policy can be established by the QMS implementation team and be approved by top management.
B. No, the quality policy must be established and approved only by the quality manager.
C. No, the quality policy must be established and approved by top management.
D. Yes, as long as top management is informed, the policy can be established by any responsible employee.

Answer: C

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.
Reference:
ISO 9001:2015, Clause 5.2.1 - Establishing the Quality Policy

NEW QUESTION # 41
......

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