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NEW QUESTION # 68
Select the words that best complete the sentence:
Answer:
Explanation:
Explanation:
According to the ISO 19011:2018 document, the audit plan should provide the basis for agreement regarding the conduct and scheduling of the audit activities. The amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives1. The scope of the audit refers to the extent and boundaries of the audit, such as the audit criteria, the audit objectives, the organizational and functional units, and the processes to be audited1. The complexity of the audit refers to the degree of difficulty or intricacy of the audit, such as the number and diversity of the auditees, the audit criteria, the audit methods, and the audit team composition2. The risk of not achieving the audit objectives refers to the possibility that the audit may fail to provide reliable and sufficient audit evidence to support the audit conclusions and report1.
Therefore, the complete sentence is:
In the context of a third-party audit, the amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives.
References: 1: ISO 19011:2018 - Guidelines for auditing management systems 2: Audit Complexity - an overview | ScienceDirect Topics
NEW QUESTION # 69
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 and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years. The organisation uses a software programme called SWIFT, which is used to record sales, plan production, purchase supplies, print despatch notes, track new product development, perform traceability exercises, carry out mass balance checks, raise invoices, create budgets, and support financial control.
You are nearing the end of the audit and you are reviewing your audit notes. You notice a recurring trend concerning the SWIFT database as shown below:
You ask the Quality Manager to explain how the SWIFT database is controlled. You learn that the Operations Director is responsible for determining and progressing SWIFT software updates. You decide to meet the Operations Director (OD).
You: " Good afternoon. "
OD: " Good afternoon. "
You: " What responsibility do you have concerning the SWIFT database? " OD: " I maintain it. If anyone wishes to propose an update to the database, they send me an email with details of their proposal. I then either process the database update myself, or I send the request to the consultant who designed the database 20 years ago. The necessary software changes are made, and the amended software is immediately released to users. " You: " Would you explain how the software amendments are controlled? " OD: " Of course. I personally update every computer myself. " You: " Do you inform the database users of the changes? " OD: " No I don ' t. They find out for themselves by using the software, or they come to see me if they have any questions. " You: " How do you ensure that the database users use the latest version? " OD: " That ' s easy, I update every computer myself. " You: " During the audit, I noted there were several versions of SWIFT in use (you refer to your audit notes). " OD: " I know. That ' s because some versions work better than others, and depending on user needs and experiences, we allow users to revert to using an earlier version if they find it works better for them. " Based on the scenario, which two of the following statements are true? There is evidence of nonconformity with a requirement defined in ...
Answer: C,D
Explanation:
Based on the scenario provided, there is evidence of nonconformity with the requirements defined in:
C). Clause 7.5.1 Documented information - General: The scenario indicates that there is no formal process for informing users about updates to the SWIFT database, which suggests a lack of control over documented information. This could lead to users being unaware of important changes and not using the latest version of the software, which is required by the quality management system1.
E). Clause 7.5.3 Control of documented information: The Operations Director's approach to updating the SWIFT database and the lack of communication to users about these updates indicate that the documented information is not adequately controlled. Allowing users to revert to earlier versions of the software at their discretion further suggests that the organization does not have a proper mechanism in place to ensure the integrity and suitability of documented information2.
These clauses are part of the ISO 9001:2015 standard, which requires organizations to have a systematic approach to controlling and managing documented information as part of their quality management system.
The scenario described shows a casual approach to managing critical software updates, which could affect the organization's ability to consistently meet customer and regulatory requirements.
NEW QUESTION # 70
Scenario 3:
Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.
To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.
The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.
The audit team began by gathering information about Fin-Pro's understanding of ISO 9001 requirements.
While reviewing documented information, they noticed missing records of training and awareness sessions.
They conducted employee interviews to verify attendance.
The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the company's working environment (social, psychological, and physical conditions).
The audit team analyzed the evidence and prepared an audit report with findings and conclusions.
ACB sent the audit objectives to the audit team after an agreement was reached. Is this acceptable?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Clause References:
ISO 19011:2018 (Guidelines for Auditing Management Systems), Clause 5.3 - Establishing the Audit Objectives ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning Why is the Correct Answer C?
Audit objectives must be clearly defined in the audit offer to ensure that the scope, criteria, and purpose are agreed upon in advance.
ISO/IEC 17021-1:2015 (which governs certification bodies) requires that audit objectives be established before the audit begins to ensure transparency and effectiveness.
Sending audit objectives after an agreement has been reached could lead to misalignment between the auditee' s expectations and the audit's purpose.
Why are the Other Options Incorrect?
A (Audit objectives should be known only after agreement) # Incorrect because objectives must be pre- defined in the audit offer.
B (Only the auditee should know the objectives) # Incorrect because both the auditor and auditee must align on objectives.
D (Approval from the lead auditor is sufficient) # Incorrect because audit planning follows formal procedures defined by ISO/IEC 17021-1.
Reference:
ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning
ISO 19011:2018, Clause 5.3 - Establishing the Audit Objectives
NEW QUESTION # 71
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.
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.
NEW QUESTION # 72
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.
In scenario 2, the team determined the QMS scope by taking into account only the requirements of top management. Is this compliant with ISO 9001?
Answer: D
Explanation:
Comprehensive and Detailed In-Depth Explanation:ISO 9001:2015, Clause 4.3 (Determining the Scope of the Quality Management System) states that when determining the QMS scope, an organization must consider:
* External and internal issues (Clause 4.1)
* The needs and expectations of interested parties (Clause 4.2)
* The products and services provided by the organization
In the scenario, Bell only considered top management's input, which fails to address Clause 4.2 (interested parties' expectations)-such as customers, suppliers, and regulatory authorities.
NEW QUESTION # 73
......
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