問題1
Which two of the following are included in the objectives of the ' Stage 1 initial certification audit ' ?
Which two of the following are included in the objectives of the ' Stage 1 initial certification audit ' ?
正確答案: B,C
說明：（僅 NewDumps 成員可見）
問題2
You are conducting an ISO 9001 audit of a Materials Recycling Facility. The organisation processes waste plastics into raw materials for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process. You interview the line supervisor.
You: " Why are these plastic items being rejected at this stage? "
Auditee: " They do not meet our processing standards. "
You: " What is the reason for that? "
Auditee: " These items are likely to damage the machinery down the line. They can also compromise our quality standards. We need to protect our reputation for good quality output materials. " You: " What happens to the rejected items? " Auditee: " Some get melted down in another process later on, and some are disposed of as waste products that cannot be recycled. " You: " What happens to the waste products? " Auditee: " I ' m not sure. I suppose they go to landfill. " After further auditing, you have gathered additional evidence. Match the following statements to the correct ISO 9001 standard clause shown.
To complete the table, click on the blank section you want to complete so that it is highlighted in red, and then click on the applicable text from the options below.
Alternatively, drag and drop each option to the appropriate blank section.
You are conducting an ISO 9001 audit of a Materials Recycling Facility. The organisation processes waste plastics into raw materials for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process. You interview the line supervisor.
You: " Why are these plastic items being rejected at this stage? "
Auditee: " They do not meet our processing standards. "
You: " What is the reason for that? "
Auditee: " These items are likely to damage the machinery down the line. They can also compromise our quality standards. We need to protect our reputation for good quality output materials. " You: " What happens to the rejected items? " Auditee: " Some get melted down in another process later on, and some are disposed of as waste products that cannot be recycled. " You: " What happens to the waste products? " Auditee: " I ' m not sure. I suppose they go to landfill. " After further auditing, you have gathered additional evidence. Match the following statements to the correct ISO 9001 standard clause shown.
To complete the table, click on the blank section you want to complete so that it is highlighted in red, and then click on the applicable text from the options below.
Alternatively, drag and drop each option to the appropriate blank section.
正確答案:
Explanation:
A # 8.4.3.a
B # 7.2.b
C # 10.2.2
D # 10.2.1
E # 6.2
F # 5.2.2.c
8.4.3.a - No specification is issued to the suppliers of waste plastic:This clause refers to the information provided to external providers, including requirements for products and services. If no specification is issued, it means the organization is not complying with this clause, which states:
"The organization shall ensure that the requirements for the products and services to be provided are adequately defined prior to communication to the external provider."
7.2.b - The picking operators have been trained:This falls under Competence requirements. Clause 7.2(b) requires that persons are competent on the basis of education, training, or experience:
"Ensure that these persons are competent on the basis of appropriate education, training, or experience."
10.2.2 - No documentation is retained for rejected materials:This relates to corrective action documentation.
Clause 10.2.2 requires organizations to retain documented information as evidence of nonconformities and actions taken:
"The organization shall retain documented information as evidence of: the nature of the nonconformities and any subsequent actions taken..."
10.2.1 - The rejected materials are segregated:This links to the treatment of nonconforming outputs. Clause
10.2.1 discusses actions such as containment or segregation for nonconforming outputs:
"Deal with nonconforming outputs in one or more of the following ways: correction; segregation, containment..."
6.2 - Management has set an objective for the level of recycling:This refers to quality objectives. Clause 6.2 requires that measurable quality objectives be established, and this includes setting performance targets:
"The organization shall establish quality objectives at relevant functions... The quality objectives shall be measurable..."
5.2.2.c - The quality policy appears in promotional material:Clause 5.2.2(c) requires the quality policy to be available to relevant interested parties. Using it in promotional material ensures that it is communicated externally:
"The quality policy shall be... available to relevant interested parties, as appropriate." References:
ISO 9001:2015, Clause 8.4.3 - Information for external providers
Clause 7.2 - Competence
Clause 10.2.2 - Corrective action documentation
Clause 10.2.1 - Nonconforming outputs
Clause 6.2 - Quality objectives
Clause 5.2.2 - Communicating the quality policy
問題3
Even though past audits have highlighted a consistently large number of nonconformities within an organisation ' s design team, the organisation has not varied the frequency or duration of audits on its audit plan.
The decision for whether this situation is acceptable or not should be governed by which of the following?
Even though past audits have highlighted a consistently large number of nonconformities within an organisation ' s design team, the organisation has not varied the frequency or duration of audits on its audit plan.
The decision for whether this situation is acceptable or not should be governed by which of the following?
正確答案: B
問題4
In the context of a third-party management system certification audit, which two of the following statements are correct?
In the context of a third-party management system certification audit, which two of the following statements are correct?
正確答案: C,D
問題5
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.
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.
正確答案: C
說明：（僅 NewDumps 成員可見）
問題6
Which action indicates that an organization is meeting the requirements of ISO 9001 regarding nonconforming outputs?
Which action indicates that an organization is meeting the requirements of ISO 9001 regarding nonconforming outputs?
正確答案: C
說明：（僅 NewDumps 成員可見）
問題7
TIX provides services to the informatic equipment of large organisations. They operate an ISO 9001:2015 QMS that is being audited by an important customer (second-party audit). During the audit, the audit team has identified two nonconformities. When preparing the Closing meeting, the audit team discussed and agreed both nonconformities with TIX ' s quality manager. The Closing meeting was planned for 6pm with the general manager, quality manager and service manager at the meeting room.
At 6pm, when the audit team enters the meeting room, only two people are present and waiting for them: the Health and Safety supervisor and the warehouse supervisor. Neither have participated in the audit.
The dialogue among them is as follows:
Audit team leader: " Good evening, could you please inform the three managers that we are ready to start with the Closing meeting? " Health and Safety supervisor: " Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and the other two managers have had to leave urgently to attend the emergency. " Warehouse supervisor: " They have asked us to listen to what you need to say and to sign whatever we need to sign. We also have a message from them about the two nonconformities. They wanted us to ask you if you could contact them in a couple of days to determine how to proceed. " Which one of the following options would be your preferred response to the final comment made by the warehouse manager?
TIX provides services to the informatic equipment of large organisations. They operate an ISO 9001:2015 QMS that is being audited by an important customer (second-party audit). During the audit, the audit team has identified two nonconformities. When preparing the Closing meeting, the audit team discussed and agreed both nonconformities with TIX ' s quality manager. The Closing meeting was planned for 6pm with the general manager, quality manager and service manager at the meeting room.
At 6pm, when the audit team enters the meeting room, only two people are present and waiting for them: the Health and Safety supervisor and the warehouse supervisor. Neither have participated in the audit.
The dialogue among them is as follows:
Audit team leader: " Good evening, could you please inform the three managers that we are ready to start with the Closing meeting? " Health and Safety supervisor: " Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and the other two managers have had to leave urgently to attend the emergency. " Warehouse supervisor: " They have asked us to listen to what you need to say and to sign whatever we need to sign. We also have a message from them about the two nonconformities. They wanted us to ask you if you could contact them in a couple of days to determine how to proceed. " Which one of the following options would be your preferred response to the final comment made by the warehouse manager?
正確答案: C
問題8
Which of the following is correct with regard to the internal audit?
Which of the following is correct with regard to the internal audit?
正確答案: C
說明：（僅 NewDumps 成員可見）