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>> ISO-9001-Lead-Auditor최신 업데이트버전 인증시험자료 <<
IT인증자격증을 취득하는 것은 IT업계에서 자신의 경쟁율을 높이는 유력한 수단입니다. 경쟁에서 밀리지 않으려면 자격증을 많이 취득하는 편이 안전합니다.하지만 IT자격증취득은 생각보다 많이 어려운 일입니다. PECB인증 ISO-9001-Lead-Auditor시험은 인기자격증을 취득하는데 필요한 시험과목입니다. Itcertkr는 여러분이 자격증을 취득하는 길에서의 없어서는 안될 동반자입니다. Itcertkr의PECB인증 ISO-9001-Lead-Auditor덤프로 자격증을 편하게 취득하는게 어떨가요?
질문 # 78
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?
정답：B
설명：
* 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.
질문 # 79
Who maintains ownership of the audit report?
정답：B
설명：
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)
질문 # 80
Takitup is a small fabrication company that manufactures steel fencing, stairs and platforms for the construction sector. It has been certified to ISO 9001 for some time and has appointed a new Quality Manager. The audit plan during a surveillance audit is to cover the company's improvement actions and the auditor asks to see the most recent management review meeting minutes.
Which two of the options would be relevant points for the auditor's checklist for the audit?
정답：B,E
설명：
ISO 9001:2015 requires top management to review the quality management system at planned intervals to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organisation . The auditor's focus, especially during a surveillance audit covering improvement actions
, must therefore be on evidence that management review is being carried out correctly and that it results in QMS-related decisions and changes .
Relevant ISO 9001 clauses include:
* Clause 9.3.1 - Management review (General) Top management shall review the organisation's quality management system at planned intervals.
* Clause 9.3.3 - Management review outputs The outputs of management review shall include decisions and actions related to opportunities for improvement and any need for changes to the QMS.
Explanation of the correct options:
A). The date of the most recent management review meeting
This is directly relevant because ISO 9001 requires management reviews to occur at planned intervals . The auditor must confirm that the review has taken place and that it is current, especially during a surveillance audit.
E). Changes made to the quality system by the new Quality Manager
This is directly linked to management review outputs and improvement actions . Since a new Quality Manager has been appointed, the auditor must verify whether changes to the QMS were reviewed, approved, and monitored through management review in line with Clauses 9.3.3 and 10.3.
Explanation of why the other options are not relevant:
* B : Workforce redundancies are a human resources or business decision unless they directly affect QMS effectiveness, which is not indicated here.
* C : Increased profitability is a business outcome, not a required management review input or output under ISO 9001.
* D : Pension scheme improvements are unrelated to QMS performance or improvement.
* F : A bonus scheme may relate to productivity, but unless it directly affects QMS objectives or process performance reviewed in management review, it is not a required checklist item.
ISO-aligned conclusion:
For an audit focusing on improvement actions and management review , the auditor's checklist should confirm:
* That management review has been conducted as required, and
* That QMS-related changes and improvements (especially under a new Quality Manager) are being reviewed and controlled.
질문 # 81
You are conducting an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements.
The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.
You have gathered audit evidence as outlined below. Match the ISO 9001 Clause 8 extract to the audit evidence.
정답：
설명：
Explanation:
Here is the correct matching of the ISO 9001 Clause 8 extracts to the audit evidence:
* Audit evidence: Three subcontract trainers who had delivered training were not approved as defined in procedure SA1 Supplier Approval revision 3.ISO 9001 Clause 8 extract: 8.4.1 ...shall apply criteria for
... external providers...(This clause requires the organization to control external providers, including ensuring their approval and competence.)
* Audit evidence: A training programme for a customer was not documented as required in procedure TD
2 Training revision 2.ISO 9001 Clause 8 extract: 8.3.5 ...shall retain documented information on design and development outputs.(This clause addresses the need to retain documented information related to design and development outputs, such as a training programme.)
* Audit evidence: One trainer had not recorded the damage to a customer's training room wall caused by using sticky tape to hang training aids, as required in procedure TD 2 Training revision 2.ISO 9001 Clause 8 extract: 8.5.3 ...shall retain documented information on what has occurred.(This clause relates to retaining documented information on activities and outcomes, including records of damage or issues encountered.)
* Audit evidence: Five sales orders had no record of having been reviewed to verify the ability to provide these courses.ISO 9001 Clause 8 extract: 8.2.3.1 ...shall conduct a review before committing...(This clause specifies the requirement to review and verify the organization's ability to meet customer requirements before accepting sales orders.) These mappings reflect the specific requirements of ISO 9001:2015 for managing external providers, retaining documented information, and reviewing contracts.
질문 # 82
An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:
"The reject rate of 'finished' product of 9.7% needs improvement as it doesn't meet the stated objective of top management of 5%." Just before the Closing meeting of a third-party audit, the audit team leader is invited to a meeting with the Quality Manager. He tells the audit team leader that a member of the audit team was seen taking photographs of the factory on his phone during the day and wants him suspended from the Closing meeting with any nonconformities raised by him rescinded. The issue of photographs was not discussed during the opening meeting.
Select the three options for how the audit team leader might deal with this situation.
정답：B,D,F
질문 # 83
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ISO-9001-Lead-Auditor인기덤프자료: https://www.itcertkr.com/ISO-9001-Lead-Auditor_exam.html
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