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NEW QUESTION # 111
Who maintains ownership of the audit report?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting):
* The certification body retains ownership of the audit report as it is responsible for the certification decision.
* The auditee may receive a copy, but it does not own the report.
* The audit team leader compiles the report but does not own it.
Thus, C is the correct answer.
Reference:
ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting)
NEW QUESTION # 112
(Which of the following two options could be considered the most likely potential threats to impartiality in an audit context?)
Answer: C,D
Explanation:
ISO 9001:2015 requires audits to be conducted in an objective and impartial manner. Although ISO 9001 does not list specific threats to impartiality, it explicitly refers to ISO 19011 for guidance on auditing principles, including impartiality.
ISO 9001:2015, Clause 9.2.2 (NOTE) states that guidance on auditing is given in ISO 19011 .
According to ISO 19011:2018, one of the fundamental auditing principles is impartiality, defined as the basis for the objectivity of audit conclusions. ISO 19011 identifies several threats to impartiality, including self-interest and familiarity.
Explanation of the correct options:
C). Self-interest
ISO 19011 identifies self-interest as a primary threat to impartiality. This occurs when an auditor has a personal, financial, or professional interest in the outcome of the audit, which could influence audit judgement or conclusions.
Examples include financial gain, career advantage, or personal benefit linked to the audit outcome.
E). Your spouse is working in the organisation being audited
This represents a familiarity or relationship threat. ISO 19011 highlights that close personal relationships with the auditee can compromise, or be perceived to compromise, auditor impartiality. Even if the auditor remains objective, the relationship creates a clear conflict of interest.
Explanation of why the other options are not selected:
* A. Competence: Competence supports effective auditing and is not a threat to impartiality.
* B. Lack of Experience: This affects audit effectiveness, not impartiality.
* D. Consulting: Consulting can create a conflict of interest in certain contexts, but on its own it is not necessarily an impartiality threat unless it involves consulting for the same organisation or system being audited, which is not stated here.
* F. Expert knowledge of the process: Technical expertise improves audit effectiveness and does not threaten impartiality.
Summary aligned to ISO guidance:
The most likely threats to auditor impartiality are those involving personal interest or close relationships with the auditee. Therefore, self-interest and a spouse working in the audited organisation are the correct answers under ISO 9001-aligned auditing guidance.
NEW QUESTION # 113
A small deaning services organisation is about to start work on a hospital dleaning contract for the local Health Trust. You, as auditor, are conducting a Stage 2 audit to ISO 9001 and review the contract with the Service Manager. The contract requires that a cleaning plan is produced. You: "How was the cleaning plan for the contract developed?" Service Manager: "We have a basic template that covers the materials, labour requirements and cleaning methods to be employed. Some of that is specified by the customer." You: "How does the plan deal with locations like the intensive care wards and the operating theatres, which are included in the contract?" Service Manager: "The basic plan covers general wards, but we will do more frequent cleaning in those areas if the hospital requests it." You: "Are you aware of the regulatory requirements for cleaning standards in hospitals?" Service Manager: "No. We depend on the hospital to look after that side of things in the contract." You decide to raise a non-conformity against section 8.2.2.a.1 of ISO 9001. You decide to raise another non-conformity against section 8.2.4 of ISO 9001 when finding that the cleaning plan was amended without the agreement of the Health Trust. A different cleaning chemical was substituted to that specified in the contract. At the follow- up audit, the corrective action proposed was to "obtain a concession from the Health Trust for use of the new chemical." Which one of the following options is the reason why you did not accept this action taken?
Answer: E
Explanation:
* Clause 8.2.4 of ISO 9001:2015 - Changes to Requirements for Products and Services:ISO 9001:
2015 Clause 8.2.4 states that when changes to requirements for products or services are made, they must be communicated and agreed upon with relevant interested parties (in this case, the Health Trust).
The lack of communication and agreement for substituting the cleaning chemical represents a clear violation of this clause.
* Analysis of the Corrective Action Proposed:The organization proposed "obtaining a concession from the Health Trust for the use of the new chemical." This action is reactive and assumes approval from the Health Trust without addressing the systemic issue: the lack of a defined change control process for managing contract changes.
* Option Analysis:
* A. The substitute chemical has not been used before in the Health Trust:Incorrect. While this may be a concern, it is not directly relevant to the root cause of the nonconformity, which is the absence of a process to handle contract changes.
* B. The action assumes that the Health Trust will agree to the change:Incorrect. Although this is true, it is not the primary issue. The nonconformity lies in the lack of a structured approach to obtain agreement, not whether the Health Trust agrees.
* C. Staff have not been trained in the use of the new chemical:Incorrect. This is a separate issue related to staff competence (Clause 7.2), but it is not the main reason why the corrective action is unacceptable under Clause 8.2.4.
* D. The process for making changes to the contract has not been addressed:Correct. The fundamental issue is the organization's failure to follow or establish a change control process for amending contracts, including gaining formal agreement from the Health Trust. The proposed corrective action does not ensure that such issues will be systematically prevented in the future.
* E. The substitute chemical may not be as effective as the original:Incorrect. The effectiveness of the substitute chemical is secondary to the primary issue, which is the lack of a change management process.
* ISO 9001 References Supporting the Correct answer:
* Clause 8.2.4: Requires that changes to product/service requirements be reviewed, communicated, and agreed upon with the customer.
* Clause 10.2 (Nonconformity and Corrective Action): Requires the organization to address the root cause of the nonconformity and take actions to ensure it does not recur. In this case, the root cause is the absence of a change control process.
* Why D is the Best answer:The core issue is that the organization did not have a formalized process for managing and agreeing upon changes to contract requirements. Addressing this process gap is essential to prevent recurrence of similar nonconformities. Merely seeking a concession from the Health Trust is a one-off solution that does not address the systemic issue.
NEW QUESTION # 114
You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory equipment and furniture.
You: "I'd like to look at how you manage change in the organisation. What changes have you made as a business, say, over the last 12 months?" Auditee: "We have made some strategic changes, the main one being that we no longer manufacture our own products in house." You: "That sounds like quite a significant change. What has been the impact of that?" Auditee: "We now mainly sell other manufacturers' products, under their brand names, and have outsourced manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging time." You: "I'm sure. What were the reasons for making the change?" Auditee: "Our manufacturing section was a small operation, and we struggled to cope with fluctuations in demand. During busy periods, we found it hard to meet lead times, and in quiet periods we had staff with little to do. This was having an impact on customer satisfaction and meant we had to charge premium prices that made our product uncompetitive." You: "How did you go about the change?" The auditor asks to speak to the purchasing manager about the selection of the subcontractor to manufacture the company's own brand products.
You: "How did you choose a supplier to manufacture your products?"
Auditee: "We have had a long-term relationship with a supplier ABC Ltd - we gave them our design drawings, got them to complete a supplier questionnaire and run a couple of trial batches for us. We were happy with the result and we have used them ever since." ISO 9001:2015, clause 8.4.1 outlines situations when controls need to be applied to externally provided processes, products and services. Which one of the following situations is applicable to this scenario?
Answer: A
Explanation:
According to the ISO 9001:2015 standard, clause 8.4.1 requires organizations to ensure that externally provided processes, products and services conform to requirements. Controls must be applied to externally provided processes, products and services when:
The products and services are intended for incorporation into the organization's own products and services.
They are provided directly to customers by the external provider on behalf of the organization.
A process, or part of a process, is provided by an external provider as a result of a decision by the organization.
In this scenario, the auditee has chosen a supplier to manufacture their own brand products based on their design drawings, supplier questionnaire and trial batches. This means that the supplier is providing a process (manufacturing) as a result of a decision by the organization (the auditee). Therefore, clause 8.4.1 applies to this situation.
NEW QUESTION # 115
During an internal audit, a manufacturer of polystyrene packaging products for the electronics industry found that six per cent of finished products being ejected from the moulding machines fell onto the factory floor instead of into collection baskets. The factory floor was wet and dirty in places, so a lot of products were rejected at inspection. Auditors raised a non-conformity to the Maintenance Manager.
Select three options for the corrective action to be taken by the Maintenance Manager that could be needed to prevent rejects from recurring.
Answer: B,D,F
Explanation:
ISO 9001:2015 requires organisations to take corrective action to eliminate the cause of a nonconformity in order to prevent recurrence, not merely to contain or correct individual instances.
Relevant ISO 9001 requirements
* Clause 10.2.1 - Nonconformity and corrective actionThe organisation shall react to the nonconformity, evaluate the need for action to eliminate the cause(s), and implement actions to prevent recurrence.
* Clause 8.5.1 - Control of production and service provisionProduction shall be carried out under controlled conditions, including suitable infrastructure and environmental conditions.
Explanation of the correct corrective actions:
D). Redesign the factory layout to better handle finished products
This addresses a systemic cause of the problem by improving how finished products are handled after ejection, reducing the likelihood of products falling to the floor. This is a true corrective action aligned with Clause 10.2.
E). Set up a system of regular inspection of the floor condition
The dirty and wet floor is a contributing cause to product rejection. Establishing regular inspection and maintenance of floor conditions addresses the environmental conditions for production, as required by Clause 8.5.1, and helps prevent recurrence.
G). Install guides at the point of ejection to better direct products into the baskets This directly eliminates the root cause of products missing the collection baskets by improving equipment control. It is an effective corrective action that prevents the nonconformity from happening again.
Explanation of why the other options are not corrective actions:
* A: Recording nonconformities is detection, not prevention.
* B: Placing a worker is a temporary containment action, not elimination of the root cause.
* C: Asking customers to accept dirty products is unacceptable and contrary to ISO 9001.
* F: Awareness alone does not remove the cause of the problem.
* H: Cleaning products before release is correction, not corrective action, and does not prevent recurrence.
ISO-aligned conclusion:
Corrective actions must remove the root causes of nonconformities. In this scenario, improving product handling design, controlling environmental conditions, and modifying equipment to ensure correct ejection are the only actions that effectively prevent the recurrence of rejected products. Therefore, the correct answers are D, E and G.
NEW QUESTION # 116
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