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>> New ISO-9001-Lead-Auditor Exam Objectives <<
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NEW QUESTION # 141
Who is responsible for the development of surveillance activities?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 17021-1:2015, Clause 9.6.2 (Surveillance Activities):
* The certification body is responsible for planning and conducting surveillance audits to ensure continued compliance.
* The auditee's top management (A) does not develop surveillance activities, but they must participate.
* The audit team leader (C) conducts the surveillance audit, but they do not develop the program.
Thus, B is the correct answer.
NEW QUESTION # 142
What competence, among others, should each audit team member have?
Answer: D
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 # 143
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.
Which situation presented in scenario 2 is NOT compliant with ISO 9001?
Answer: D
Explanation:
Comprehensive and Detailed In-Depth Explanation:ISO 9001:2015 Clause 5.1.1 (Leadership and Commitment) states that top management must demonstrate leadership and commitment to the QMS by actively participating in QMS implementation, integration, and effectiveness.
In scenario 2, top management refused to be directly involved in the QMS implementation team, which violates Clause 5.1.1 because leadership involvement is essential for the system's success.
Other options do not indicate nonconformance:
* Option A (Middle managers in the QMS team) is acceptable.
* Option C (Leslie assigning roles) is valid if competence is ensured (Clause 5.3 - Organizational Roles, Responsibilities, and Authorities).
* Option D (Team reviewing the policy before approval) aligns with best practices.
NEW QUESTION # 144
You work for an organisation which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) of a one-day audit of HMB, a supplier of hamburgers. It is 4 pm, and the audit is coming to an end. You are having an internal meeting with the team to decide what will be presented to the auditee during the closing meeting. The closing meeting is scheduled for 5 pm.
You, as the audit team leader, audited HMB's Top Management and the two production lines of hamburger production (PL1 and PL2).
Auditor 1 audited the laboratory.
You to Auditor 1: "What findings would you report?"
Auditor 1: "When reviewing the laboratory records, I noticed that during the whole morning, HMB's supervisors of each production line sent samples to be analysed by the laboratory. The samples from PL1 included the reference to the raw meat batch being used and the name of the sub-supplier, while the reports from PL2 referred only to the name of the sub-supplier. HMB's Procedure P-02 Rev.3 says that samples sent to the laboratory have to include reference to the raw meat batch being used, to ensure traceability of the products." You to Auditor 2: "OK, what do you think?" Auditor 2: "I think that this is a non-conformity." You to Auditor 1: "OK. How would you describe the evidence on which the non-conformity will be based?" Identify which one of the following statements best describes the identified evidence.
Answer: B
Explanation:
ISO 9001:2015 requires audit findings, including non-conformities, to be based on objective evidence and to be clearly described, stating exactly what requirement was not met and where.
A non-conformity statement must:
* Reference the specific requirement (procedure or ISO clause), and
* Describe the objective evidence observed, without assumptions, generalisations, or conclusions about causes.
In this scenario:
* The requirement is clearly stated in Procedure P-02 Rev.3, which requires samples sent to the laboratory to include reference to the raw meat batch number to ensure traceability.
* The objective evidence observed by Auditor 1 is that samples from PL2 did not include the raw meat batch reference, while samples from PL1 did.
Why option C is correct:
C). "Samples of hamburgers sent to the HMB's laboratory for analysis by PL2 did not refer to the raw meat batch number as required by P-02 Rev.3." This statement:
* Accurately reflects what was observed,
* Clearly identifies the affected process (PL2),
* Directly references the unmet requirement (P-02 Rev.3), and
* Is factual, specific, and evidence-based.
Why the other options are not the best description of evidence:
* A is a generalised conclusion and does not describe the specific evidence observed.
* B assumes a lack of awareness, which was not evidenced during the audit.
* D refers to product identification for delivery to the client, which is not what was observed (the issue was laboratory sample identification).
ISO-aligned conclusion:
The correct way to describe audit evidence is to state precisely what was observed against the requirement
, without interpretation or assumption. Therefore, the statement that best describes the identified evidence is Option C.
NEW QUESTION # 145
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.

Answer:
Explanation:

NEW QUESTION # 146
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