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>> ISO-9001-Lead-Auditor PDF <<
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問題 #166
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.
答案：
解題說明：
問題 #167
In the context of a second-party audit, match the activity with the party responsible for conducting it.
答案：
解題說明：
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.
問題 #168
You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers.
You are interviewing the Quality Systems Manager (QSM).
You: " What risks and opportunities have the business identified? "
QSM: " I ' 1l show you. This was discussed with the Managing Director at the latest management review. " Narrative: The QSM shows you the latest management review record and points to the following table:
You: " How is the business planning to address these risks and opportunities? " QSM: " The MD said that they already knew about them so it was not necessary. "
答案：
解題說明：
Explanation:
Non-Conformity Report:
ISO 9001 Clause Number
Nature of Problem
ISO 9001 Requirement That Has Not Been Fulfilled
6.1.1
Several risks and opportunities have not been determined.
" The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed. "
6.1.2 (a)
Actions to address risks and opportunities not planned.
" The organization shall plan actions to address risks and opportunities. " Step-by-Step Reasoning:
Clause 6.1.1 - Determining Risks and Opportunities:
Requirement: The organization must determine risks and opportunities that are relevant to its Quality Management System (QMS). This ensures that the QMS achieves intended results and prevents undesired effects.
Problem Identified: While some risks and opportunities were discussed, the organization did not perform a systematic evaluation of all risks (e.g., health and safety legislation changes, retiring trainers).
Clause 6.1.2 (a) - Planning Actions for Risks and Opportunities:
Requirement: The organization must plan actions to address identified risks and opportunities. These actions should be integrated into the QMS processes to ensure continuous improvement.
Problem Identified: The Quality Systems Manager confirmed that no plans were made to address the risks and opportunities because the Managing Director deemed it unnecessary. This violates the requirement to plan actions.
Correct Options Selected:
Clause 6.1.1 with the nature of the problem as: " Several risks and opportunities have not been determined. " Clause 6.1.2 (a) with the nature of the problem as: " Actions to address risks and opportunities not planned. " ISO 9001 Requirements Not Fulfilled:
For 6.1.1: " The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed. " For 6.1.2 (a): " The organization shall plan actions to address risks and opportunities. "
問題 #169
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.
Which statement below represents the level of responsibility demonstrated by the audit team in scenario 3?
答案：A
解題說明：
Comprehensive and Detailed In-Depth Explanation:
ISO 19011:2018 requires auditors to conduct audits professionally and diligently.
Clause References:
* ISO 19011:2018, Clause 4.4 - Professional Care: Auditors must exercise due diligence in conducting audits.
* ISO 9001:2015, Clause 9.2 - Internal Audit: Requires objective and systematic audits to evaluate QMS effectiveness.
Why is the Correct Answer A?
* The audit team followed best practices by gathering verifiable audit evidence through interviews, document reviews, and observations.
* They ensured fair presentation of findings in the final audit report.
* They complied with ISO 9001 and ISO 19011 guidelines for audit procedures.
Why are the Other Options Incorrect?
* B (Ordinary negligence) # No evidence of negligence; the team followed structured audit processes.
* C (Gross negligence) # No indication that the auditors ignored important responsibilities.
* D (Willful misconduct) # The auditors acted professionally and did not intentionally disregard rules.
Reference:
ISO 19011:2018, Clause 4.4 - Professional Care
ISO 9001:2015, Clause 9.2 - Internal Audit
問題 #170
You are an auditor and are in dialogue with the quality manager and the managing director of a small business that supplies specific IT hardware and software for manufacturers of medical equipment.
You: "I would like to look at how you manage the design and development of your products.
Auditee: "We have made some strategic changes, the main one being that since last month we no longer produce the software of our products in-house." You: "What has been the impact of that?" Auditee: "We now subcontract the provision of the software needed for our hardware. This allowed us to concentrate our efforts on the hardware and let specialised organisations develop the software. For the time being, we have subcontracted our software requirements to three different organisations.
You: "What were the reasons for making the change?"
Auditee: "Our IT software section was a small operation, and we struggled to cope with new technologies.
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." You: "How did you go about the change?" In relation to the auditor's question about how the change was managed, the auditee mentions the actions listed below. Match the ISO 9001 clauses to show which action the requirement applies to.
To complete the table, click on the blank section you want to complete so it is highlighted in red and then click on the ISO 9001 clauses listed below. Alternatively, drag and drop each clause to show which clause the action applies to.
答案：
解題說明：
Explanation:
Actions and Applicable ISO 9001:2015 Clauses
* We identified risks and opportunities.# Clause 6.1 (Actions to address risks and opportunities)
* We found suitable suppliers.# Clause 8.4 (Control of externally provided processes, products and services)
* We determined the need to keep updated with new IT technologies.# Clause 4.1 (Understanding the organization and its context)
* We put together a plan for the change to IT provision outsourcing.# Clause 6.3 (Planning of changes)
* We monitored the performance of the new suppliers.# Clause 8.4.2 (Type and extent of control of external providers)
* We monitored our productivity targets to understand why they were being missed.# Clause 9.1.1 (Monitoring, measurement, analysis and evaluation - General)
* We communicated the plan internally.# Clause 7.4 (Communication)
* We looked at the data at the management review and decided we needed to do something different.# Clause 9.3.2 (Management review inputs) ISO 9001:2015 requires organizations to manage change in a planned, risk-based, and controlled manner, particularly when changes affect product realization and customer satisfaction.
* Clause 6.1 requires organizations to identify risks and opportunities arising from changes, such as outsourcing software development.
* Clause 4.1 supports understanding internal and external issues, including rapid changes in IT technology that affect strategic direction.
* Clause 6.3 requires changes to the QMS (such as outsourcing a core activity) to be planned, considering purpose, consequences, resources, and responsibilities.
* Clause 8.4 and 8.4.2 ensure that when processes are outsourced, the organization selects suitable providers and monitors their performance to ensure conformity.
* Clause 7.4 requires effective internal communication so that personnel understand changes and their roles.
* Clause 9.1.1 requires monitoring and measurement of performance indicators (such as productivity targets) to understand performance issues.
* Clause 9.3.2 requires top management to review performance data and determine actions when the QMS is no longer achieving intended results.
ISO-aligned conclusion:
The auditee's actions demonstrate a systematic and compliant approach to managing change, covering context analysis, risk-based thinking, planning, control of outsourced processes, performance monitoring, communication, and management review, all in line with ISO 9001:2015 requirements.
問題 #171
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P.S. Testpdf在Google Drive上分享了免費的、最新的ISO-9001-Lead-Auditor考試題庫：https://drive.google.com/open?id=1Aj8OwHxlSI3umIvQnJv8BnmnOs-dBUf9