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| Section | Objectives |
|---|---|
| Audit Principles and Fundamentals | - Audit Concepts
|
| Conducting Audit Activities | - Audit Evidence Collection
|
| Quality Management System (QMS) Fundamentals | - Quality Principles
|
| Audit Reporting and Follow-up | - Audit Reporting
|
| Audit Planning and Preparation | - Audit Program Management
|
>> ISO-9001-Lead-Auditor學習筆記 <<
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問題 #267
You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.
You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.
You: " How do you ensure your regulatory team ' s competence concerning regulatory requirements is maintained? " TD: " The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry. " You: " How is their regulatory competence maintained? " TD: " They are dedicated individuals with lots of contacts in the sector. " You: " How does the business enable them to maintain their understanding of current regulatory requirements? " TD: " We leave that up to them. "
答案：
解題說明：
問題 #268
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?
答案：B
解題說明：
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.
問題 #269
In the context of a third-party certification audit, match the roles with the following responsibilities:
答案：
解題說明：
Explanation:
In the context of a third-party certification audit, match the roles with the following responsibilities:
Responsibilities:
Conduct the audit to the assigned area.= Auditors
Assist the auditors in identifying personnel to participate in the audit.= Guide Assign each team member's responsibility for the audit.= Audit team leader Respond to questions and provide evidence to the auditor.= Auditee According to ISO 19011:2018, clause 3, the definitions of the roles are as follows1:
Auditors: persons with the competence to conduct an audit
Guide: person appointed by the auditee to assist the audit team
Auditee: organization being audited
Audit team leader: member of an audit team appointed to manage the audit or an audit team Therefore, the roles can be matched to the responsibilities based on these definitions and the description of the audit process in clause 6 of the standard1.
References: ISO 19011:2018(en), Guidelines for auditing management systems
問題 #270
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? " In relation to the auditor ' s question about how the change was managed, the auditee mentions the steps listed below. Match the ISO 9001 clauses to the steps.
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 step the requirement applies to.
答案：
解題說明：
Explanation:
Here is the correct matching of ISO 9001:2015 clauses to the steps mentioned in the change management process:
We identified risks and opportunities and fed these into our risk management processes.
Clause 6.1 (Actions to address risks and opportunities)
We found a suitable supplier.
Clause 8.4 (Control of externally provided processes, products, and services) We monitored customer feedback and noticed an increase in negative feedback about lead times.
Clause 9.1.2 (Customer satisfaction)
We put together a plan for implementation.
Clause 6.2.2 (Planning to achieve quality objectives)
We monitored the performance of the new supplier.
Clause 8.4.2 (Type and extent of control of external providers)
We noticed that productivity targets were being missed.
Clause 9.1.1 (Monitoring, measurement, analysis, and evaluation)
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)
We reorganised the staffing and implemented redundancies.
Clause 7.1.2 (People)
We set an objective to effectively implement the transition and outsource manufacturing.
Clause 6.2.1 (Quality objectives and planning to achieve them)
This aligns the steps of the change process with relevant ISO 9001:2015 clauses related to risk, planning, communication, and monitoring.
問題 #271
Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.
A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.
In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.
Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.
Based on the scenario above, answer the following question:
According to Scenario 6, the audit team required DC's top management to submit corrective action plans within two weeks. Is this action acceptable?
答案：A
解題說明：
Comprehensive and Detailed In-Depth Explanation:ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions) states:
* The auditor can set a reasonable deadline for corrective actions.
* 10 to 60 days is a best practice timeframe for the auditee to respond.
* The auditee must propose corrective actions, but the audit team has the authority to set the deadline
.
A 7-day deadline (A) is too short, and the audit team-not the auditee-determines the timeframe (B).
問題 #272
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ISO-9001-Lead-Auditor最新考題: https://www.kaoguti.com/ISO-9001-Lead-Auditor_exam-pdf.html
順便提一下，可以從雲存儲中下載KaoGuTi ISO-9001-Lead-Auditor考試題庫的完整版：https://drive.google.com/open?id=1eSpG3y6PpcGW_IY5DjnviX9B2rkOPxu2