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NEW QUESTION # 165
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 # 166
In the context of a third-party audit, select the issue which is not expected to be included in the audit plan.
Answer: D
Explanation:
According to ISO 19011:2018, clause 6.3.2, the audit plan is a document that provides the basis for agreement regarding the conduct of the audit. The audit plan should include the following information1:
*the audit objectives, scope and criteria
*the audit team members and their roles and responsibilities
*the audit schedule, including the date, time and location of each audit activity
*the expected time and duration of meetings and interviews
*the allocation of appropriate resources to critical areas of the audit
*the identification of the audit client and the auditee
*the identification of the guides and observers, if any
*the documents and records to be reviewed before and during the audit
*the audit methods and tools to be used
*the audit language and terminology
*the audit report content, format, distribution and expected completion date
*the risk to achieving audit objectives and the contingency plan, if any Therefore, the issue which is not expected to be included in the audit plan is C, expectations of the organisation's management. This issue is not relevant to the conduct of the audit, as the audit is based on the audit criteria, not on the management's expectations. The management's expectations may be considered during the audit initiation or the audit programme management, but they are not part of the audit plan.
References: ISO 19011:2018(en), Guidelines for auditing management systems, How to create an ISO 9001 internal audit plan - Advisera
NEW QUESTION # 167
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 statement related to the last paragraph of scenario 2 is correct?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:ISO 9001:2015, Clause 5.1.2 (Customer Focus) states that top management must ensure customer satisfaction by monitoring customer perceptions.
In scenario 2, top management initiated customer surveys, demonstrating their commitment to customer focus as required by Clause 5.1.2.
NEW QUESTION # 168
Which of the following is correct with regard to the internal audit?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 9001:2015, Clause 9.2 (Internal Audit):
* Internal audits can be conducted on an ongoing basis as part of continual improvement.
* Audits consider both conformity and effectiveness (A is incorrect).
Thus, C is the correct answer.
NEW QUESTION # 169
In the context of a third-party certification audit, it is very important to have effective communication. Which is not the responsibility of the audit team leader?
Answer: D
NEW QUESTION # 170
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