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質問 1：
What type of audit evidence are policies and guidelines?
A. Confirmative evidence.
B. Technical evidence.
C. Documentary evidence.
正解：C
解説: (Pass4Test メンバーにのみ表示されます)
質問 2：
A person who provides specific knowledge or expertise to the audit team during the audit is known as a
/an:
A. Guide.
B. Observer.
C. Technical expert.
正解：C
解説: (Pass4Test メンバーにのみ表示されます)
質問 3：
An organisation decides to purchase products and services only from ISO 9001 certified suppliers.
Match the four organisational functions to a potential benefit.
正解：
Explanation:
Reduced incoming inspection # A. Quality
Improved communication with suppliers # B. Procurement
Purchased materials received on time # C. Logistics
Reduced variability within processes # D. Production
According to ISO 9001:2015, Clause 8.4 - Control of externally provided processes, products and services, organisations are required to ensure that externally provided products and services conform to specified requirements. When an organisation sources from ISO 9001 certified suppliers, there is greater assurance of consistency in quality, delivery, and communication. This enhances internal operations across various functions:
* Reduced incoming inspection (Quality): ISO 9001 certified suppliers have robust quality controls (Clause 8.4.2), reducing the need for repeated inspections upon receipt. This aligns with Quality's responsibility for incoming inspection and verification.
* Improved communication with suppliers (Procurement): Clause 8.4.3 emphasizes the communication of detailed requirements to external providers. Procurement plays a key role in ensuring these requirements are understood and met.
* Purchased materials received on time (Logistics): Timely deliveries are often a result of structured supplier evaluation and selection (Clause 8.4.1). Logistics benefits through fewer delays and better scheduling of internal processes.
* Reduced variability within processes (Production): Consistency of supplied materials supports stable and predictable production processes, which is a key aspect of Clause 8.5 - Production and service provision.
References:
ISO 9001:2015 Clause 8.4.1 - General
ISO 9001:2015 Clause 8.4.2 - Type and extent of control
ISO 9001:2015 Clause 8.4.3 - Information for external providers
ISO 9001:2015 Clause 8.5 - Production and service provision
質問 4：
Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.
Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled.
The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.
The top management, in cooperation with Sean, assigned 10 more employees to the audit team.
Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.
Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.
Based on the scenario above, answer the following question:
Based on Scenario 7, the team worked together to draft the final audit report. Is this acceptable?
A. Yes, audit team members should contribute to drafting one general report for the findings and conclusions
B. No, it is the responsibility of the audit team leader to draft the audit report
C. No, audit team members should draft separate reports for their findings and conclusions
正解：A
解説: (Pass4Test メンバーにのみ表示されます)
質問 5：
Who assigns a guide to assist the audit team?
A. The certification body
B. The auditee
C. The audit team leader
正解：B
解説: (Pass4Test メンバーにのみ表示されます)
What type of audit evidence are policies and guidelines?
A. Confirmative evidence.
B. Technical evidence.
C. Documentary evidence.
正解：C
解説: (Pass4Test メンバーにのみ表示されます)
質問 2：
A person who provides specific knowledge or expertise to the audit team during the audit is known as a
/an:
A. Guide.
B. Observer.
C. Technical expert.
正解：C
解説: (Pass4Test メンバーにのみ表示されます)
質問 3：
An organisation decides to purchase products and services only from ISO 9001 certified suppliers.
Match the four organisational functions to a potential benefit.
正解：
Explanation:
Reduced incoming inspection # A. Quality
Improved communication with suppliers # B. Procurement
Purchased materials received on time # C. Logistics
Reduced variability within processes # D. Production
According to ISO 9001:2015, Clause 8.4 - Control of externally provided processes, products and services, organisations are required to ensure that externally provided products and services conform to specified requirements. When an organisation sources from ISO 9001 certified suppliers, there is greater assurance of consistency in quality, delivery, and communication. This enhances internal operations across various functions:
* Reduced incoming inspection (Quality): ISO 9001 certified suppliers have robust quality controls (Clause 8.4.2), reducing the need for repeated inspections upon receipt. This aligns with Quality's responsibility for incoming inspection and verification.
* Improved communication with suppliers (Procurement): Clause 8.4.3 emphasizes the communication of detailed requirements to external providers. Procurement plays a key role in ensuring these requirements are understood and met.
* Purchased materials received on time (Logistics): Timely deliveries are often a result of structured supplier evaluation and selection (Clause 8.4.1). Logistics benefits through fewer delays and better scheduling of internal processes.
* Reduced variability within processes (Production): Consistency of supplied materials supports stable and predictable production processes, which is a key aspect of Clause 8.5 - Production and service provision.
References:
ISO 9001:2015 Clause 8.4.1 - General
ISO 9001:2015 Clause 8.4.2 - Type and extent of control
ISO 9001:2015 Clause 8.4.3 - Information for external providers
ISO 9001:2015 Clause 8.5 - Production and service provision
質問 4：
Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.
Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled.
The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.
The top management, in cooperation with Sean, assigned 10 more employees to the audit team.
Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.
Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.
Based on the scenario above, answer the following question:
Based on Scenario 7, the team worked together to draft the final audit report. Is this acceptable?
A. Yes, audit team members should contribute to drafting one general report for the findings and conclusions
B. No, it is the responsibility of the audit team leader to draft the audit report
C. No, audit team members should draft separate reports for their findings and conclusions
正解：A
解説: (Pass4Test メンバーにのみ表示されます)
質問 5：
Who assigns a guide to assist the audit team?
A. The certification body
B. The auditee
C. The audit team leader
正解：B
解説: (Pass4Test メンバーにのみ表示されます)
高田** -
このISO-9001-Lead-Auditor問題集を勉強させてもらって、次回は受かりそうです。この問題集を読んで基礎を理解することができました。