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質問 1：
Which of the following is a principle of maintaining audit work documents?
A. Transparency
B. Fair presentation
C. Completeness
正解：C
解説: (Pass4Test メンバーにのみ表示されます)
質問 2：
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 3：
The certification body has not been able to verify the implementation of corrective actions for any identified major nonconformity within six months after the last day of the Stage 2 audit. What must the certification body do in this case?
A. It must conduct another Stage 2 audit before granting certification
B. It must conduct all audit activities from the beginning
C. It must issue an unfavorable recommendation of certification
正解：C
解説: (Pass4Test メンバーにのみ表示されます)
質問 4：
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oll and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. You, as one of the auditors, find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
Which of the following options for the best description of the nonconformity?
A. A retrospective concession was not sought from the customer once the test results had been approved by the Quality Manager.
B. The untested product was not recalled until the galvanic efficiency of the anodes was verified.
C. Release of the product without acceptable test results has been accepted by the customer for Project DK.
D. Products for Project DK have been released before product approval through the quality control process.
正解：D
解説: (Pass4Test メンバーにのみ表示されます)
質問 5：
You are auditing a manufacturer of specialty tea products during a Stage 2 certification audit. In the quality laboratory, you interview one of three operatives conducting sensory testing of a batch from the production line.
Select three options of evidence which could demonstrate conformance with clause 9.1.1 of ISO 9001:
2015.
A. Operatives having a university degree in food science
B. Independent experts were brought in to review test processes
C. The Hedonic Method is used to monitor the quality of the product
D. Analysis of the results of sensory tests
E. Laboratory staff routinely tested for respiratory ailments
F. Outsourcing the sensory testing to an accredited laboratory
G. Sensory testing results are recorded
H. Safe disposal of the tested product
正解：C,D,G
解説: (Pass4Test メンバーにのみ表示されます)
Which of the following is a principle of maintaining audit work documents?
A. Transparency
B. Fair presentation
C. Completeness
正解：C
解説: (Pass4Test メンバーにのみ表示されます)
質問 2：
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 3：
The certification body has not been able to verify the implementation of corrective actions for any identified major nonconformity within six months after the last day of the Stage 2 audit. What must the certification body do in this case?
A. It must conduct another Stage 2 audit before granting certification
B. It must conduct all audit activities from the beginning
C. It must issue an unfavorable recommendation of certification
正解：C
解説: (Pass4Test メンバーにのみ表示されます)
質問 4：
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oll and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. You, as one of the auditors, find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
Which of the following options for the best description of the nonconformity?
A. A retrospective concession was not sought from the customer once the test results had been approved by the Quality Manager.
B. The untested product was not recalled until the galvanic efficiency of the anodes was verified.
C. Release of the product without acceptable test results has been accepted by the customer for Project DK.
D. Products for Project DK have been released before product approval through the quality control process.
正解：D
解説: (Pass4Test メンバーにのみ表示されます)
質問 5：
You are auditing a manufacturer of specialty tea products during a Stage 2 certification audit. In the quality laboratory, you interview one of three operatives conducting sensory testing of a batch from the production line.
Select three options of evidence which could demonstrate conformance with clause 9.1.1 of ISO 9001:
2015.
A. Operatives having a university degree in food science
B. Independent experts were brought in to review test processes
C. The Hedonic Method is used to monitor the quality of the product
D. Analysis of the results of sensory tests
E. Laboratory staff routinely tested for respiratory ailments
F. Outsourcing the sensory testing to an accredited laboratory
G. Sensory testing results are recorded
H. Safe disposal of the tested product
正解：C,D,G
解説: (Pass4Test メンバーにのみ表示されます)
Nakamura -
きっちりとまとまっていてわかりやすかったです。効率よくISO-9001-Lead-Auditor学習できそうです。