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質問 # 168
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:
According to Scenario 7, one of the auditors requested permission from Sean to audit the department in which he worked on a daily basis. Should Sean grant the auditor permission?
正解:C
解説:
Comprehensive and Detailed In-Depth Explanation:ISO 19011:2018, Clause 5.1 (Impartiality) states that:
* Internal auditors must be independent of the processes they audit to ensure objectivity.
* Auditing one's own department introduces bias and is not permitted.
Thus, Sean must not allow the auditor to audit their own department.
質問 # 169
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:
Sean requested unrestricted access to the employees, executives, and documented information of POLKA. Is this in accordance with audit best practices?
正解:A
解説:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 5.3.2 (Access to Information), internal auditors must have unrestricted access to:
* Employees and executives for interviews and observations.
* Documented information to verify compliance with ISO 9001.
This ensures a transparent and objective audit process. The CEO's approval (B) is not required unless restricted information is involved.
質問 # 170
ISO 9001 requires that the organisation shall continually improve the quality management system.
Select the two options for how this can best be achieved.
正解:A、F
解説:
Comprehensive and Detailed Explanation From Exact Extract:
Correct Option B - "Communicate a policy commitment to continual improvement" This aligns directly with Clause 5.2.1(d) of ISO 9001:2015, which states that the quality policy shall include a commitment to continual improvement of the QMS:
"Top management shall establish, implement and maintain a quality policy that... includes a commitment to continual improvement of the quality management system." A clearly communicated policy sets expectations and a strategic direction that cascades throughout the organization, promoting a culture that values ongoing enhancement.
Correct Option F - "Use the management review process to identify improvements" This is based on Clause 9.3.3 of ISO 9001:2015, which specifies that outputs of management reviews must include decisions and actions related to:
"a) opportunities for improvement;
b) any need for changes to the quality management system;
c) resource needs."
The management review process is a structured mechanism to analyze data, monitor performance, assess risks and opportunities, and drive continual improvement initiatives.
Why the Other Options Are Incorrect:
* A (Appoint external consultants to train staff): While training may help improve competence, ISO
9001 emphasizes internal process evaluation and strategic improvement. This option is not directly aligned with the systematic improvement of the QMS.
* C (Require higher standards): Higher standards alone don't ensure continual improvement unless supported by a structured QMS approach involving evaluation, planning, and measurement.
* D (Require fewer mistakes): Unrealistic or unqualified demands like "make fewer mistakes" don't support structured process-based improvement and may conflict with ISO's emphasis on risk-based thinking and root cause analysis.
* E (Send Chief Executive on a course): While leadership involvement is vital (Clause 5), this action by itself does not constitute a continual improvement mechanism for the QMS.
References:
ISO 9001:2015 Clause 5.2.1(d) - Establishing the Quality Policy
ISO 9001:2015 Clause 9.3.3 - Management Review Outputs
ISO 9001:2015 Clause 10.3 - Continual Improvement
質問 # 171
During a third-party audit of a pharmaceutical company (CD9000) having seven COVID-19 vaccination stations in various terminals at a major international airport, you, as audit team leader, interview the CD9000' s Supervisor in Terminal 2.
You: "I see that the temperature of the freezer where you keep the vaccines reads -17.2 °C. I understood that the upper limit for storing vaccines was < -18.0 °C." Supervisor: "Yes, I know this. But do not worry, the people who calibrated the temperature sensors said that they have an uncertainty of +/- 1 °C. So, we ensure that the reading remains between -17 °C and -19 °C." From the following, select two options that would form your next step.
正解:A、F
解説:
ISO 9001:2015 requires auditors to base conclusions on objective evidence and to investigate potential issues before determining whether a nonconformity exists.
In this scenario, the auditor has observed:
* A freezer temperature of -17.2 °C .
* An understood storage requirement of less than -18.0 °C .
* A statement from the supervisor regarding measurement uncertainty of ±1 °C .
Before raising a nonconformity, the auditor must verify:
* The exact storage requirements and any permitted tolerances.
* The validity and calibration status of the measuring equipment.
Why A is Correct
Ask to see the documented test method to determine if there is additional information on the limits for storage temperature.
The auditor must confirm:
* The exact specification.
* Whether tolerances or measurement uncertainty have been considered in the requirement.
* Whether the storage criterion is truly a hard limit or includes allowable variation.
This follows the audit principle of obtaining sufficient objective evidence before reaching a conclusion.
Why B is Correct
Ask to see the calibration report for the measuring equipment.
ISO 9001 Clause 7.1.5 requires monitoring and measuring resources to be suitable and maintained to ensure valid results.
The supervisor has based his justification on measurement uncertainty. Therefore, the auditor should verify:
* Calibration status,
* Calibration validity,
* Measurement uncertainty,
* Traceability of calibration results.
Why the Other Options Are Incorrect
C). Raise a non-conformance immediately
At this point there is insufficient evidence. The auditor has not yet verified the specification or calibration records.
D). Ask to see competence records of supervisors of all terminals
This is not the immediate audit trail arising from the observation.
E). Immediately halt the vaccination process
Auditors do not normally have authority to stop operations except in exceptional circumstances defined by legal or contractual arrangements. The auditor must first gather evidence.
F). Accept the comment and proceed
Auditors must verify statements with objective evidence rather than accepting explanations without verification.
ISO-Aligned Conclusion
The next appropriate audit actions are to:
* Verify the storage temperature requirements, and
* Verify the calibration and uncertainty information of the measuring equipment.
Therefore, the correct answers are:
A). Ask to see the documented test method to determine if there is additional information on the limits for storage temperature.
B). Ask to see the calibration report for the measuring equipment.
質問 # 172
How much time is usually spent on the Stage 1 audit?
正解:B
解説:
Comprehensive and Detailed In-Depth Explanation:According to ISO 17021-1:2015 (Conformity Assessment - Requirements for Certification Bodies), Clause 9.3.1.2, the Stage 1 Audit typically consumes around 30% of the total audit time.
This time is allocated to:
* Reviewing documented information.
* Assessing the readiness for Stage 2.
* Identifying potential nonconformities.
A 20% allocation (Answer A) is too low, and 40% (Answer C) is excessive, as the majority of the audit should be spent on Stage 2 (on-site verification).
質問 # 173
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無料でクラウドストレージから最新のJPNTest ISO-9001-Lead-Auditor PDFダンプをダウンロードする:https://drive.google.com/open?id=14MDF7ySG4Su7Xio1iZHYswmcu24sl8qw