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>> ISO-9001-Lead-Auditor日本語試験情報 <<
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質問 # 189
A Health Trust has contracted with Servitup, a catering services organisation that has been certified to ISO
9001 for one year. It provides services to
10 small rural hospitals in remote locations involving the purchase and storage of dry goods and fresh produce, preparing meals, and loading heated trolleys for Ward Service by hospital staff. You, as auditor, are conducting the first surveillance audit at one site with the Deputy Catering Manager (DCM).
DCM: "I apologise for the absence of the Catering Manager. He has called in sick today and we are really short of staff." You: "I see. It really shouldn't affect the QMS so the audit can progress as normal." DCM: "The Catering Manager set up the system. I'm afraid I'm not as familiar with it as he is." You: "OK, let's start with the Quality Policy. What are the main issues for the QMS here?" DCM: "Give me a minute. I need to look at the Quality Policy on the noticeboard in his office." As the audit progresses, it is clear that the DCM has a very low knowledge of the QMS. He continually has to look up the answers to your questions or ask staff members about their processes. You decide to raise a nonconformity.
Select one of the following options that best describes the nonconformity.
正解：B
質問 # 190
Which one of the following options is the definition of the context of an organisation?
正解：A
質問 # 191
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.
In scenario 3, the audit team required access to see the organizational chart and job descriptions to verify the employees' competence. Based on audit best practices, is this acceptable?
正解：B
解説：
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires organizations to ensure competence of personnel whose work affects quality performance.
Clause References:
Clause 7.2 - Competence: Organizations must determine, provide, and evaluate competence of employees performing work under the QMS.
ISO 19011:2018, Clause 6.4.6 - Audit Evidence: Auditors should use a combination of document review, interviews, and observation to verify competence.
Why is the Correct Answer C?
The organizational chart shows reporting structures and helps verify roles and responsibilities.
Job descriptions outline required qualifications, skills, and competencies for each role.
These documents provide objective audit evidence that personnel meet the required competencies for their positions.
Why are the Other Options Incorrect?
A (Sufficient evidence) # Partially correct, but competence verification often requires multiple sources of evidence, including training records, certifications, and observations.
B (Not relevant) # Incorrect because verifying competence is crucial for ensuring effective QMS implementation.
D (Direct observation only) # Observation alone is insufficient; documentation and interviews are also required to confirm competence.
Reference:
ISO 9001:2015, Clause 7.2 - Competence
ISO 19011:2018, Clause 6.4.6 - Audit Evidence
質問 # 192
You are the supervisor in Production of a medium size manufacturing organisation. You are qualified as an internal auditor. The Quality Manager asks you to lead the next internal audit of Production and Logistics Dispatch. The audit team includes two other internal auditors.
正解：
解説：
Explanation:
Here is the correct matching of actions to the statements in the context of leading the internal audit:
* If practicablecarry out a formal opening meeting
* You should notaudit production (as you are a supervisor in that area, and this would compromise audit objectivity)
* You need notchange the audit team (unless there is a specific reason, such as conflict of interest)
* You mustraise audit findings if necessary (this is a key responsibility of an auditor when nonconformities are found)
* You must notsend the audit report to the Quality Manager (the audit report must be reviewed first; it is typically part of the internal audit process to go through necessary channels before final submission)
* You shouldsend the audit report to the Quality Manager (after appropriate reviews and approvals) This reflects key principles of conducting an internal audit according to ISO 9001:2015, ensuring objectivity, proper documentation, and clear reporting procedures.
質問 # 193
In the context of a third-party certification audit, it is very important to have effective communication. Which is not the responsibility of the audit team leader?
正解：A
解説：
Responsibilities of the Audit Team Leader:
ISO 19011:2018 (guidelines for auditing management systems), which supports the principles in ISO 9001:
2015, specifies the responsibilities of an audit team leader. These responsibilities include:
* Planning the audit and establishing effective communication between the audit team and auditee.
* Ensuring that formal communication channels are agreed upon and followed.
* Reporting the audit progress, significant findings, and any concerns to the auditee or audit client as necessary.
* Managing the audit team and ensuring adherence to the defined objectives and scope.
Analysis of Options:
* A. Reporting unattainable audit objectives to the accreditation body:Incorrect. This is not the responsibility of the audit team leader. The accreditation body oversees the certification body and is not directly involved in specific audits. If objectives are unattainable, the audit team leader would report them to the audit client (the certification body), not the accreditation body.
* B. Planning formal communication arrangements:Correct. This is one of the responsibilities of the audit team leader. They ensure auditees can communicate with auditors as needed during the audit process.
* C. Confirming communication channels during the opening meeting:Correct. During the opening meeting, the audit team leader must establish clear communication protocols to ensure effective information exchange between the audit team and auditee.
* D. Communicating progress, findings, and concerns:Correct. Keeping the auditee and audit client informed about progress and significant findings is a critical responsibility of the audit team leader to maintain transparency and ensure the audit objectives are met.
Why Option A is Correct:
The audit team leader does not have any obligation to report unattainable objectives to the accreditation body
. Instead, they are responsible for communicating issues to the audit client (typically the certification body).
The accreditation body operates at a higher level and is concerned with overseeing certification bodies, not individual audits.
Relevant References:
* ISO 19011:2018, Clause 6.4 (Conducting the Audit): Emphasizes the responsibilities of the audit team leader, including communication with the auditee and client.
* ISO 9001:2015, Clause 9.2 (Internal Audit): Highlights the importance of planning and communication during audits, which is reflected in third-party audits as well.
質問 # 194
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