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質問 # 101
(Which of the following two activities can be carried out on-site by an auditor with no human interaction?)
正解：A、F
解説：
ISO 9001:2015 requires audits to be objective, evidence-based, and independent. While the standard does not prescribe detailed audit techniques, it clearly supports the use of objective evidence that can be obtained without human interaction, particularly through observation and review of documented information.
# C. Observing work performed
* Observation is a recognized audit technique where the auditor watches activities being carried out without questioning personnel.
* ISO 9001 emphasizes verifying that processes are implemented as planned and achieve intended results.
* Observation provides direct, objective evidence of process implementation.
# Supported by:
* Clause 9.2.1 - Internal audits must determine whether the QMS is effectively implemented and maintained
* Clause 4.4.1 - Processes must be implemented and controlled as planned Observation can therefore be done on-site, silently, and without interaction.
# F. Conducting a document review
* Reviewing documented information (procedures, records, logs, policies) does not require interaction with auditees.
* ISO 9001 explicitly requires the use and control of documented information and allows auditors to verify conformity by reviewing it independently.
# Supported by:
* Clause 7.5.1 - The QMS shall include documented information required by ISO 9001
* Clause 9.2.2 - Audit evidence shall demonstrate conformity to requirements Document review can be conducted on-site, at a desk, without speaking to anyone.
# Why the other options are NOT correct
* A. Completing a questionnaire for the auditeeRequires interaction and responses from people.
* B. Audit understanding of Business ContextRequires discussions with top management and review of strategic inputs (Clause 4.1).
* D. Audit customer communications about order handling enquiriesNormally requires discussion, clarification, or explanation of communication processes.
* E. Conducting interviewsBy definition requires human interaction.
質問 # 102
You work for an organisation, 'A', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit a supplier, 'B', which provides packaging materials to your organisation. It is 4 p.m. and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting.
The Closing meeting was scheduled
for 5 p.m.
You, as audit team leader, audited top management, the laboratory, and the storage of raw materials.
Auditor 1 audited the two manufacturing lines and dispatch areas.
You to Auditor 1: "What findings would you report?"
Auditor 1: "When reviewing the Dispatch records, I noticed that during the morning two different trucks (Number 011 and 025) delivered the same batch number of the product (Batch 33555). Truck 011 left the plant at 9.15 am and Truck 025 left the plant at
11.30 am. Procedure P-02 Rev.3 says
that trucks should carry a complete batch. The batch number, once on the truck, is captured using a QR device." You: "OK, what do you think?" Auditor 2: "I think that this is a nonconformity." You: "OK. How would you describe the evidence on which the nonconformity will be based"?
Identify which one of the following statements best describes the identified nonconformity.
正解：B
解説：
According to the definition in ISO 9000, a nonconformity is "non-fulfillment of a requirement". There are three parts to a well-documented nonconformity: the audit evidence to support auditor findings; a record of the requirement against which the nonconformity is detected; and the statement of nonconformity1. In this case, the audit evidence is the dispatch records that show the same batch number of the product being delivered by two different trucks at different times. The requirement is the procedure P-02 Rev.3 that says that trucks should carry a complete batch. The statement of nonconformity is that the batch 33555 was delivered split in two different trucks (011 and 025), which does not conform to the procedure. Therefore, option C best describes the identified nonconformity, as it includes all three parts of a well-documented nonconformity.
Option A is not correct, as it does not state the audit evidence or the requirement. Option B is not correct, as it does not specify the audit evidence or the statement of nonconformity. Option D is not correct, as it does not match the audit evidence or the requirement. References: 1: ISO 9001 Auditing Practices Group Guidance on Nonconformity - Documenting.
質問 # 103
How can an organization ensure the objectivity and impartiality of the internal audit function?
正解：A
解説：
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 5.1 (Impartiality):
* Internal auditors must not audit areas where they have direct responsibilities to avoid conflicts of interest.
* Outsourcing (C) is not required, as long as impartiality is maintained internally.
Thus, B is the correct answer.
Reference:
ISO 19011:2018, Clause 5.1 (Impartiality)
質問 # 104
Which quality management principle does an organization fulfill when it assesses risks, consequences, and impacts before taking action?
正解：A
解説：
Comprehensive and Detailed In-Depth Explanation:One of the seven quality management principles in ISO 9001:2015 is Improvement, which emphasizes continual enhancement of processes, products, and services.
Clause 10.3 (Continual Improvement) states that organizations must continuously assess risks, consequences, and impacts to improve their QMS.
* Risk-based thinking (Clause 0.3.3) supports improvement by identifying and mitigating risks before they affect performance.
* Clause 6.1 (Actions to Address Risks and Opportunities) requires organizations to take a proactive approach, ensuring long-term success.
Other options do not fully align with the question:
* Process approach (A) focuses on managing interrelated activities.
* Leadership (B) ensures commitment but does not directly address risk assessment.
* Relationship management (D) deals with interested parties, not risk mitigation.
質問 # 105
(When raising a non-conformity during an audit, which two of the following items should you include in the non-conformity statement?)
正解：A、E
解説：
ISO 9001:2015 requires that nonconformities be objective, evidence-based, and referenced against defined requirements, not personal, prescriptive, or solution-driven.
When a nonconformity is raised, it must clearly show what requirement was not met and what objective evidence demonstrates this failure.
# Why D (Audit criteria) is required
* A nonconformity must reference the requirement that was not fulfilled (e.g., ISO 9001 clause, procedure, contract, or legal requirement).
* ISO 9001 defines nonconformity as "non-fulfilment of a requirement".
* Without audit criteria, there is no basis for declaring a nonconformity.
# Supported by:
* Clause 9.2.2 - Internal audits must determine whether the QMS conforms to requirements
* Clause 10.2.2 - Documented information shall describe the nature of the nonconformity
# Why E (Relevant audit evidence) is required
* ISO 9001 requires decisions and conclusions (including audit findings) to be based on evidence.
* Audit evidence ensures objectivity and prevents subjective or opinion-based findings.
# Supported by:
* Clause 9.1.3 - Analysis and evaluation shall be based on data and information
* Clause 9.2.2 - Audit results must demonstrate conformity or nonconformity based on evidence
# Why the other options are NOT correct
* A (Name of person responsible)ISO 9001 focuses on system and process failures, not blaming individuals.
* B (Target time for corrective action)This is part of corrective action planning, not the nonconformity statement itself (Clause 10.2).
* C (Name of technical expert)ISO 9001 does not require identifying auditors or experts in the nonconformity statement.
* F (Action to eliminate the nonconformity)Auditors must not prescribe solutions. The auditee determines corrective actions (Clause 10.2).
質問 # 106
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