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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:

SectionWeightObjectives
Closing an ISO 9001 audit13.75%- Audit report preparation
- Management of audit records
- Audit completion and follow-up
Fundamental audit concepts and principles12.5%- Personal attributes and behaviors of a professional auditor
- Audit concepts and principles
- Management of combined audits
Quality management system (QMS) and ISO 9001 requirements13.75%- Structure of the standard
- Leadership and commitment, quality policy, roles and responsibilities (clause 5)
- Context of the organization, interested parties, and QMS scope (clause 4)
- Risks and opportunities
Managing an ISO 9001 audit program12.5%- Audit program monitoring and improvement
- Audit program management
Conducting an ISO 9001 audit22.5%- Audit conducting process
- Audit findings and conclusions
- Audit techniques and evidence collection
Fundamental principles and concepts of a quality management system (QMS)12.5%- Connection between ISO 9001 and other standards (ISO 9001, ISO/TS 9002, ISO 9004)
- Advantages of implementing a QMS based on ISO 9001
- Applicability and scope of ISO 9001
Preparing an ISO 9001 audit12.5%- Steps and activities to prepare a QMS audit
- Evidence types and their characteristics
- Audit feasibility
- Roles and responsibilities of the audit team leader and members

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PECB QMS ISO 9001:2015 Lead Auditor Exam 認定 ISO-9001-Lead-Auditor 試験問題 (Q137-Q142):

質問 # 137
You work as an external quality consultant for an organisation, "ABC", which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit an external provider,
"XYZ", which provides packaging materials to "ABC". It is 4 pm, and the closing meeting was scheduled for
5 pm.
You, as the audit team leader, audited Top Management. You explain to the audit team that you identified two non-conformities:
a. There is no documented information on the results of Top Management Reviews, as required in clause 9.3 of ISO 9001:2015.
b. There is no evidence of Top Management commitment as required in clause 5.1 of ISO 9001:2015 (e.g., not ensuring the availability of resources to operate the QMS, not ensuring the establishment of objectives).
All agreed to present these two non-conformities, graded as major.
As the audit team leader, select the best option on how to handle the closing meeting.

正解:B

解説:
ISO 9001 audits (including second-party audits) must be conducted in line with audit principles of fairness, objectivity, and impartiality, with guidance provided by ISO 19011:2018 for audit activities, including closing meetings.
Relevant ISO guidance
* ISO 19011 - Closing meeting guidance states that the purpose of the closing meeting is to:
* present audit findings and conclusions,
* ensure the auditee understands the non-conformities,
* explain the next steps, including reporting and follow-up.
Auditors must not:
* prescribe solutions,
* analyse or design corrective actions,
* make commercial or approval decisions on behalf of the audited organisation.
Explanation of the correct option:
C). Present the non-conformities and inform them that the report will be sent within ten working days, close the meeting and leave the site.
This option correctly reflects the auditor's role:
* The non-conformities are presented clearly and transparently in the closing meeting.
* The auditee is informed of the reporting process and timeline.
* The auditor does not analyse solutions, recommend actions, or influence supplier approval decisions.
* The meeting is closed professionally and objectively, in line with ISO 19011.
Explanation of why the other options are incorrect:
* A: Closing meetings must be conducted with the agreed auditee representatives; hiding findings undermines transparency and audit integrity.
* B: Analysing how to overcome the situation constitutes consulting, which compromises auditor impartiality.
* D: Recommending removal from an approved supplier list exceeds the auditor's authority and violates audit independence.
ISO-aligned conclusion:
The auditor's responsibility at the closing meeting is limited to presenting findings and explaining next steps, not advising, consulting, or making business decisions. Therefore, the correct and ISO-compliant option is C.


質問 # 138
You work as an external quality consultant for an organisation, 'A', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit a supplier, 'B', to ISO
9001 which provides packaging materials to your organisation. It is 4 pm and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled at 5 pm.
You, as Audit Team Leader, audited top management. You explain to the audit team that you identified two nonconformities:
a. There is no documented information on Top Management Reviews, as required in clause 9.3 of ISO 9001:
2015.
b. There is no evidence of Top Management Commitment as required in clause 5.1 of ISO 9001:2015. (e.g., not ensuring the availability of resources to operate the QMS, not ensuring the establishment of objectives, no promotion of improvement, no promotion of the process approach).
All agreed to present these two nonconformities. They went to meet the Top Management of 'B' and noticed that the General Manager and three other managers (Production, Human Resources, and Sales) were present in the meeting room.
Considering the seriousness of the two nonconformities to Top Management, as audit team leader, from the following select the best option:

正解:C

解説:
According to the guidance on conducting the audit closing meeting1, the audit team leader should provide a summary of the audit findings and conclusions, invite discussions, and agree on timelines for any corrective actions. The audit team leader should also be respectful, constructive, and objective when presenting the nonconformities, and avoid any personal or emotional comments. The audit team leader should also consider the impact of the disruptive event (such as the Covid-19 pandemic) on the auditee's context, interested parties, and risks2, and acknowledge any good practices or improvements observed during the audit. Therefore, option D is the best option, as it follows the best practices for the closing meeting and allows the auditee to understand the nonconformities and their implications, and to participate in the analysis and resolution of the issues. Option A is not correct, as it is not respectful, constructive, or objective, and it does not invite any discussion or feedback from the auditee. It also assumes that the audit team leader has the authority to recommend the removal of the supplier from the approved list, which may not be the case. Option B is not correct, as it does not provide enough information or explanation to the auditee, and it does not allow any discussion or feedback from the auditee. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, acknowledging any good practices, and agreeing on timelines for corrective actions. Option C is not correct, as it does not involve the other managers who are responsible for the functions or processes that were audited, and who may have valuable input or information to share. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, inviting discussions, and agreeing on timelines for corrective actions. References: 1: Conducting the Audit Closing Meeting: Sharing the Results2: Auditing ISO 9001:2015 in the Context of a Disruptive Event.


質問 # 139
Scenario 2:
Bell is a Canadian food manufacturing company that operates globally. Their main products include nuts, dried fruits, and confections. Bell has always prioritized product quality and has maintained a good reputation for many years. However, the company's production error rate increased significantly, leading to more customer complaints.
To increase efficiency and customer satisfaction, Bell implemented a Quality Management System (QMS) based on ISO 9001. The top management established a QMS implementation team comprising five middle managers from various departments, including Leslie, the quality manager.
Leslie was responsible for assigning responsibilities and authorities for QMS-related roles. He also suggested including a top management representative in the QMS team, but top management declined due to other priorities.
The team defined the QMS scope as:
"The scope of the QMS includes all activities related to food processing." Leslie established a quality policy and presented it to the team for review before top management approval
. Top management also proposed a new strategy for handling customer complaints, requiring biweekly customer surveys to monitor customer perceptions.
In scenario 2, the team determined the QMS scope by taking into account only the requirements of top management. Is this compliant with ISO 9001?

正解:B

解説:
Comprehensive and Detailed In-Depth Explanation:ISO 9001:2015, Clause 4.3 (Determining the Scope of the Quality Management System) states that when determining the QMS scope, an organization must consider:
* External and internal issues (Clause 4.1)
* The needs and expectations of interested parties (Clause 4.2)
* The products and services provided by the organization
In the scenario, Bell only considered top management's input, which fails to address Clause 4.2 (interested parties' expectations)-such as customers, suppliers, and regulatory authorities.


質問 # 140
A person who provides specific knowledge or expertise to the audit team during the audit is known as a/an:

正解:A

解説:
Comprehensive and Detailed In-Depth Explanation:
A technical expert is someone with specialized knowledge that helps the audit team understand specific technical aspects of the auditee's processes.
Clause References:
ISO 19011:2018, Clause 7.3.4 - Use of Technical Experts:
Technical experts support the audit team with specialized knowledge but do not perform the audit themselves.
Why is the Correct Answer B?
A technical expert is needed when auditors lack deep expertise in specific areas, such as engineering, software, or medical devices.
They assist in interpreting complex technical requirements but do not act as auditors.
Why are the Other Options Incorrect?
A (Observer) # Observers do not contribute expertise; they only watch the audit (e.g., trainees).
C (Guide) # Guides help with logistics but do not provide technical expertise.
Reference:
ISO 19011:2018, Clause 7.3.4 - Use of Technical Experts


質問 # 141
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. 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 are interviewing the Training Manager (TM).
You: "What quality objectives apply to the training process?"
TM: "One of the quality objectives we aim for is a 90% minimum exam pass rate for all open training courses." You: "How do you measure this objective?" The Training Manager shows you a record on her computer and you see the following:

Which two of the following statements are true?

正解:A、D

解説:
In this scenario, the organization has set a quality objective of achieving a 90% minimum exam pass rate for all courses. The auditor's task is to assess whether this objective is being monitored effectively and if appropriate actions are taken when the objective is not met.
B). You would determine how the exam pass rate figures were analysed: ISO 9001:2015, particularly Clause
9.1 (Monitoring, measurement, analysis, and evaluation), requires organizations to evaluate performance data.
The auditor should verify how the organization analyses the pass rate data to ensure trends are identified, and corrective actions are planned based on this analysis.
D). You would determine what corrective action was being taken to address the low pass rates: When performance falls short of the objective, as seen with Course 4 (where the pass rate is below 90% in all months), Clause 10.2 (Nonconformity and corrective action) requires organizations to take corrective actions to address issues. The auditor would need to check if corrective actions have been initiated to address consistently low pass rates.
Statements A, C, E, and F do not directly address the monitoring and corrective action required under ISO
9001:2015 in this context.


質問 # 142
......

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