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質問 # 182
XYZ Corporation is an organisation that employs 100 people. As audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality objectives have been set for every employee in the organisation except top management.
The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost. He asks for your opinion on whether this is the correct method of setting objectives.
Three months after Stage 1, you return to XYZ Corporation to conduct a Stage 2 certification audit as Audit Team Leader with one other auditor. You find that the Quality Manager has cancelled the previous quality objectives for all employees and replaced them with a single objective for himself. This states that "The Quality Manager will drive multiple improvements in the QMS in the next year". The Quality Manager indicates that this gives him the authority to issue instructions to department managers when quality improvement is needed. He says that this approach has the full backing of senior management. He shows you the latest Quality Improvement Request that was included in the last management review.
After further auditing, the issues below were found. Select three statements that apply to the term 'audit trail'
正解：D、E、F
解説：
Based on the scenario and the concept of an 'audit trail' within the context of ISO 9001, the three statements that apply would likely be:
A). Decisions on improvement action timescales not involving departmental managers. This indicates a lack of involvement and communication with those responsible for implementing the improvements, which is a key part of an effective audit trail1.
B). Evaluation of the results of the improvement action not always documented by the Quality Manager.
Proper documentation is essential for an audit trail, as it provides evidence that actions have been evaluated and are effective1.
C). Limited knowledge of the content of Quality Improvement Requests by departmental staff. An audit trail should ensure that all relevant parties are aware of and understand the actions being taken, which is not the case here1.
These points suggest issues with the communication, documentation, and involvement of relevant personnel in the quality management system processes, which are crucial for maintaining an effective audit trail and, by extension, a robust quality management system.
質問 # 183
During a third-party surveillance audit, the auditor finds that the management review meeting minutes record that the improvement actions set by the previous review have not been completed for a second year running. It states that a new Quality Manager has been brought in at the middle management level to rectify the situation.
You learn that top management is not involved in the QMS other than being copied into the minutes of the management review meeting.
The audit reveals that the new Quality Manager was given responsibility by top management to:
a) take accountability for the effectiveness of the QMS,
b) select, approve, and monitor improvement actions without involving and reporting to top management, c) promote the improvement of the QMS, and d) make efficient use of the limited financial and personnel resources allocated for the QMS by top management.
The auditor considers whether there is a nonconformity against clause 5.1.1 of ISO 9001:2015.
Select two options of the evidence required for such a nonconformity:
正解：A、C
解説：
Comprehensive and Detailed In-Depth Explanation:
Clause 5.1.1 of ISO 9001:2015 - Leadership and Commitment - specifically mandates that top management must take accountability for the effectiveness of the QMS. They are also responsible for ensuring:
* Integration of the QMS into business processes (5.1.1 c)
* Promotion of customer focus and continual improvement (5.1.1 d, i)
* Availability of necessary resources (5.1.1 e)
* That the QMS achieves its intended results (5.1.1 g)
Let's analyze the selected options:
# A. Top management is not accountable for the effectiveness of the QMS.
This directly violates clause 5.1.1 a, which explicitly requires top management to take accountability for the effectiveness of the QMS. Delegating this to a middle-level Quality Manager, as described in the scenario, constitutes a nonconformity.
# F. The Quality Manager does not have access to the resources needed for the QMS.
According to clause 5.1.1 e, top management must ensure the availability of required resources for maintaining and improving the QMS. If the Quality Manager is resource-constrained, it indicates top management has failed to meet this requirement.
Now, why the other options are incorrect in terms of direct clause 5.1.1 nonconformity:
# B. Avoiding giving improvement actions to the Chief Executive - While this may reflect poor communication, it is not, by itself, a clear breach of 5.1.1 unless linked directly to top management's lack of accountability or commitment.
# C. Chief Executive never attending meetings - ISO 9001 does not require physical attendance of the Chief Executive at management reviews. What matters is whether top management is fulfilling their roles, not how.
# D. Completing only half of improvement actions - This indicates performance issues but does not necessarily indicate top management's lack of accountability, unless they failed to monitor progress entirely.
# E. Reporting to one designated senior manager - This is not inherently nonconforming unless that senior manager does not fulfill top management's responsibilities under 5.1.1.
Relevant ISO 9001:2015 Reference:
* Clause 5.1.1 a, e, g, h:
"Top management shall demonstrate leadership and commitment with respect to the quality management system by:
a) taking accountability for the effectiveness of the quality management system; e) ensuring that the resources needed for the quality management system are available..."
質問 # 184
In the context of a second-party audit, match the activity with the party responsible for conducting it.
正解：
解説：
Explanation:
Here is the correct matching of the activities with the responsible parties in the context of a second-party audit:
* Define the audit scope: Customer
* Develop the audit plan: Audit team leader
* Respond to the audit findings: External provider
* Conduct the audit: Audit team
This reflects the typical division of responsibilities in a second-party audit, where the customer (the party commissioning the audit) sets the scope, the audit team leader manages the planning, the external provider responds to findings, and the audit team carries out the audit.
質問 # 185
You are conducting a Stage 1 audit at an organisation that services refrigeration equipment for a large customer base.
The scope of certification is "Provision of refrigeration equipment maintenance and repair services". You are interviewing the Managing Director to learn more about the organisation and to explore how the requirements for policy, objectives, and risks and opportunities in ISO 9001 are addressed.
The Managing Director explains that they only use sub-contract refrigeration engineers and do not have any full-time refrigeration engineers, which helps to optimise overhead costs. The full-time staff employed are essentially a small team of office staff who process customer enquiries, schedule jobs and process invoices.
The Managing Director adds that the ISO 9001 requirements for competence of personnel extends to both sub- contract and full-time staff. He also states that the full-time staff are aware of the Quality Policy, objectives and plans to address risk and opportunities.
You ask if the sub-contract engineers have been informed of the Quality Policy, objectives and plans to address risks and opportunities, to which the Managing Director replies that this is not applicable as they only use sub- contractors who operate ISO 9001 certificated quality management systems. The documented information provided to the auditor confirms this.
Which clause in ISO 9001 is most likely not to have been fulfilled in this instance?
正解：D
解説：
Questions no: 16 Verified = C. 7.4 Communication Comprehensive But Short Explanation: = Clause
7.4 of ISO 9001:2015 requires the organization to determine the internal and external communications relevant to the quality management system, including what will be communicated, when, with whom, and how. The scenario indicates a potential gap in communication with subcontractors regarding the Quality Policy, objectives, and plans to address risks and opportunities, which is a requirement even if the subcontractors have their own ISO 9001 certified systems123. References: = This response is based on the general requirements of ISO 9001:2015 related to communication with external parties, such as subcontractors, as outlined in various resources discussing Clause 7.4123.
質問 # 186
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.
ACB sent the audit objectives to the audit team after an agreement was reached. Is this acceptable?
正解：D
解説：
Comprehensive and Detailed In-Depth Explanation:
Clause References:
ISO 19011:2018 (Guidelines for Auditing Management Systems), Clause 5.3 - Establishing the Audit Objectives ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning Why is the Correct Answer C?
Audit objectives must be clearly defined in the audit offer to ensure that the scope, criteria, and purpose are agreed upon in advance.
ISO/IEC 17021-1:2015 (which governs certification bodies) requires that audit objectives be established before the audit begins to ensure transparency and effectiveness.
Sending audit objectives after an agreement has been reached could lead to misalignment between the auditee' s expectations and the audit's purpose.
Why are the Other Options Incorrect?
A (Audit objectives should be known only after agreement) # Incorrect because objectives must be pre- defined in the audit offer.
B (Only the auditee should know the objectives) # Incorrect because both the auditor and auditee must align on objectives.
D (Approval from the lead auditor is sufficient) # Incorrect because audit planning follows formal procedures defined by ISO/IEC 17021-1.
Reference:
ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning
ISO 19011:2018, Clause 5.3 - Establishing the Audit Objectives
質問 # 187
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