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>> ISO-14001-Lead-Auditor認定テキスト <<
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質問 # 42
You work for a certification body. In two months, you will have to lead an audit of a pharmaceutical organisation, ABC, that manufactures vaccines to combat a pandemic. When planning the audit team, you select one of the certification body auditors who is professionally qualified in Biochemistry and Pharmacy.
However, she is not fully aware of all legal applicable requirements. You recommend the certification body hire a compliance expert to assist the audit team. In which two clauses of ISO 14001:2015 would you consider that auditors may need the help of the expert?
正解：B、F
解説：
According to ISO 14001:2015:
Clause 4.2:
The organization must understand the needs and expectations of interested parties, which includes regulatory bodies and applicable legal requirements. Legal expertise may be necessary to fully assess this.
Clause 9.1.2:
The organization must evaluate compliance obligations, which requires understanding applicable legal requirements.
Legal compliance evaluation often requires specialized legal or regulatory knowledge, especially in highly regulated sectors like pharmaceuticals.
Reference: ISO 14001:2015 Clauses 4.2 and 9.1.2.
質問 # 43
Auditors need to communicate effectively with auditees. Therefore, their personal behaviour is a key characteristic in ensuring a successful audit.
Below is a list of these characteristics and a brief related description. Match the characteristics to the descriptions.
正解：
解説：
Explanation:
1-C, 2-B, 3-A, 4-D
The correct matching is:
1. Fair, truthful, sincere, honest, discreet # C. Ethical
An auditor must act with integrity and honesty. Being fair, truthful, sincere, honest, and discreet reflects ethical behaviour, which is essential because auditors handle sensitive information and must maintain trust.
2. Willing to learn from situations # B. Open to improvement
An auditor should be willing to improve their own audit approach, learn from experience, and adjust based on new situations. This supports continual improvement in audit competence.
3. Tactful in dealing with individuals # A. Diplomatic
Being diplomatic means handling people respectfully and tactfully, especially when discussing sensitive issues, audit findings, or possible nonconformities.
4. Aware of and able to understand situations # D. Perceptive
A perceptive auditor notices and understands situations, behaviours, risks, and evidence during the audit. This helps the auditor identify relevant issues and evaluate audit evidence effectively.
So, the final matched answer is:
Fair, truthful, sincere, honest, discreet - Ethical
Willing to learn from situations - Open to improvement
Tactful in dealing with individuals - Diplomatic
Aware of and able to understand situations - Perceptive
質問 # 44
Whistlekleen is a national dry cleaning and laundry organisation with 50 shops. You are conducting an EMS surveillance audit of Head Office and are sampling environmental performance measurement. You find that
80 per cent of failures to meet performance criteria originate from five shops in the same region. Most of these failures relate to the release of volatile organic compounds (VOCs) that exceeds regulations. The Environmental Manager tells you that these are the oldest shops in the organisation. The cleaning equipment needs replacing but the organisation cannot afford it at the moment.
On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.
Select two options that apply to how you should respond to the information given.
正解：B、E
質問 # 45
A key audit process is the way auditors gather information and determine the findings ' characteristics. Put the actions in the correct order to complete this process.
正解：
解説：
Explanation:
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This sequence is derived from ISO 19011:2018 - Guidelines for Auditing Management Systems, which is used in conjunction with ISO 14001:2015 by auditors. Specifically, the audit process steps during the " conducting the audit " phase include:
Determining the source of information (Clause 6.4.5): Includes documents, interviews, records, and observations.
Collecting data by sampling (Clause 6.4.6): Sampling helps in managing resources and gathering relevant evidence effectively.
Gathering audit evidence (Clause 3.8): Audit evidence is the data collected and verified to support findings.
Evaluating against audit criteria (Clause 3.9): Evidence must be evaluated against standards such as ISO
14001 requirements, internal policies, etc.
Developing audit findings (Clause 6.4.9): Conclusions regarding conformance, nonconformance, and opportunities for improvement.
Review of findings (Clause 6.4.10): Cross-verification and validation before finalizing results.
Audit conclusions (Clause 6.4.11): Final statements summarizing the audit based on findings.
This structured process ensures audits are performed impartially, with verifiable, evidence-based outcomes that contribute to continual improvement.
Reference:
ISO 19011:2018, Clauses 6.4.5 to 6.4.11
ISO 14001:2015, Clause 9.2 - Internal audit requirements
質問 # 46
XM, a chain of 25 petrol stations, established an EMS following the requirements of ISO 14001, which was third-party certified 10 years ago. You are performing an internal audit before the fourth certification cycle.
During the audit to the EMS Manager (EM), the following dialogue takes place:
You: Could you please give me some details on the inspection of underground tanks in each station?
EM: It's very simple. There is a regulation that requires an annual leak inspection.
You: Who performs these inspections?
EM: I personally contract the inspectors and submit the results to the local authority. These are the certificates submitted last year.
You: I see only 22 certificates. There are three missing.
EM: The tanks of those three stations will be removed next year and replaced by new ones. I phoned the local authority and they told me that I do not need to send any report of the tanks that will be changed.
Which one of the following would be your next question?
正解：D
解説：
According to ISO 14001:2015 Clause 9.1.2 (Compliance Obligations) and Clause 7.4 (Communication):
The organization must retain evidence of compliance obligations and communications with regulatory bodies.
Verbal confirmation from the authority is insufficient; written confirmation ensures objective evidence for audit purposes.
Reference: ISO 14001:2015 Clause 9.1.2, 7.4.
質問 # 47
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