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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Fundamental Principles and Concepts of Quality Management System | 10–15% | - Relationship between ISO 9001 and other standards - Concepts of QMS, risk, process approach - Quality management principles |
| Topic 2: Preparation of an ISO 9001 Audit | 10–15% | - Initiating audit, defining objectives and scope - Selecting audit team, preparing plan and checklist - Document review and communication |
| Topic 3: Managing an ISO 9001 Audit Program | 5–10% | - Establishing, implementing and monitoring audit program - Competence and evaluation of auditors |
| Topic 4: Closing an ISO 9001 Audit | 5–10% | - Audit report, follow-up actions - Preparing conclusions, closing meeting |
| Topic 5: Fundamental Audit Concepts and Principles | 10–15% | - ISO 19011 and ISO/IEC 17021-1 requirements - Audit principles, types, roles and responsibilities - Independence, evidence-based approach |
| Topic 6: Quality Management System (QMS) Requirements | 25–30% | - Support, operation, performance evaluation, improvement - Scope, normative references, terms and definitions - Context of the organization, leadership, planning |
| Topic 7: Conducting an ISO 9001 Audit | 15–20% | - Team meetings, audit observations - Evaluating conformity, identifying nonconformities - Opening meeting, on-site activities, evidence collection |
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PECB인증 ISO-9001-Lead-Auditor시험은 IT인증자격증중 가장 인기있는 자격증을 취득하는 필수시험 과목입니다. PECB인증 ISO-9001-Lead-Auditor시험을 패스해야만 자격증 취득이 가능합니다. Itcertkr의PECB인증 ISO-9001-Lead-Auditor는 최신 시험문제 커버율이 높아 시험패스가 아주 간단합니다. PECB인증 ISO-9001-Lead-Auditor덤프만 공부하시면 아무런 우려없이 시험 보셔도 됩니다. 시험합격하면 좋은 소식 전해주세요.
질문 # 127
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?
정답：D
설명：
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.
질문 # 128
A Health Trust has contracted with Servitup, a catering services organisation which has been certified to ISO
9001 for 1 year. It provides services to ten, small rural
hospitals in remote locations involving purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for ward service by hospital staff. An auditor is conducting the first sole surveillance audit at one site with the Deputy Catering Manager (DCM).
At the closing meeting attended solely by the DCM, the auditor informs him that he has found numerous gaps in the QMS processes which lead him to consider recommending suspension of the organisation's certification. He is particularly concerned with the evidence that patient health is being adversely affected by produce stored beyond its safe consumption date, poor kitchen hygiene and undercooked meals. The DCM says that he cannot make any decisions about these issues in the absence of the Catering Manager due to illness but will write everything down and report to the Catering Manager.
Which two actions should you take in the context of the audit?
정답：A,F
설명：
The actions that should be taken in the context of the audit are:
*Option B: Call the individual(s) managing the audit programme to explain the situation and recommend immediate suspension of certification to protect the integrity of the Certification Body. This option is correct because the auditor has found serious and significant gaps in the QMS processes that affect the health and safety of the patients, which is a major nonconformity that may warrant suspension of certification. The auditor should inform the individual(s) managing the audit programme of the situation and the audit findings, and recommend immediate suspension of certification to protect the integrity of the Certification Body and the credibility of the certification scheme. The auditor should also follow the Certification Body's procedures and rules for suspension of certification and communicate the decision and the consequences to the auditee.
*Option C: Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due course. This option is correct because the auditor should not terminate or postpone the closing meeting due to the absence of the Catering Manager, as the DCM is the auditee's nominated representative for the audit. The auditor should continue with the meeting, present the audit conclusions and the audit findings, and inform the DCM that the organisation will receive the audit report in due course. The auditor should also explain the audit outcome recommendation and the suspension of certification, and request the DCM to acknowledge the receipt and understanding of the audit results.
The following options are not correct:
*Option A: Close the meeting immediately after the DCM's response and advise that the issues will be addressed at the next surveillance visit. This option is not correct because the auditor should not close the meeting without presenting the audit conclusions and the audit findings, as this would violate the audit principles of fairness and transparency. The auditor should also not advise that the issues will be addressed at the next surveillance visit, as this would imply that the auditor is accepting the auditee's delay and inaction, and that the auditor is not taking the major nonconformity seriously.
*Option D: Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work. This option is not correct because the auditor should not conclude the meeting early or reschedule it due to the absence of the Catering Manager, as this would disrupt the audit process and the audit schedule. The auditor should also not wait for the Catering Manager to return to work, as this would delay the communication and resolution of the major nonconformity, and potentially compromise the health and safety of the patients.
*Option E: Recommend that all personnel should be given urgent in-depth training in the QMS. This option is not correct because the auditor should not recommend or prescribe specific corrective actions to the auditee, as this would violate the audit principles of independence and objectivity. The auditor should only report the audit findings and the audit outcome recommendation, and leave the responsibility and authority for determining and implementing the corrective actions to the auditee.
*Option F: Thank the DCM for his time and express an expectation that improvements will be made in the QMS. This option is not correct because the auditor should not thank the DCM for his time and express an expectation that improvements will be made in the QMS, as this would imply that the auditor is satisfied and optimistic with the auditee's performance and response, and that the auditor is not taking the major nonconformity seriously. The auditor should instead express the concern and dissatisfaction with the auditee's QMS processes and the impact on the health and safety of the patients, and communicate the suspension of certification and the need for urgent and effective corrective actions.
References:
*ISO 19011:2018 Guidelines for auditing management systems, Clause 6.4.2: Conducting audit activities, Subclause k) and l)
*ISO 9001 Lead Auditor Course Material, Module 5: Conducting an Audit, Slide 20: Closing Meeting
*ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 5.5: Closing Meeting
*Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 - Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection
3.2.3: Section 3 - Audit Process, Subsection 3.2.4: Section 4 - Audit Competencies
질문 # 129
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:
The audit team delayed audit activities until DC's top management submitted their action plans. Is this acceptable?
정답：B
설명：
Comprehensive and Detailed In-Depth Explanation:
According to ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting):
* The audit report must be submitted to the certification body regardless of corrective actions.
* Corrective actions are reviewed after the audit, but the audit process should not be delayed.
* Certification decisions should be made based on the audit findings and evidence, not pending corrective actions.
Thus, delaying audit activities until corrective actions are submitted is not acceptable.
Reference:
ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting)
질문 # 130
You are auditing an organisation that has been certified to ISO 9001 for 10 years. The organisation is a privately owned, multi-site car tyre fitting company. You are auditing one of the sites.
You have confirmed with the Workshop Supervisor that tyre batch numbers shall be recorded in the Work Schedule. You have sampled recent Work Schedule records and written the following in your audit notes:
No batch numbers for tyres fitted to customers' cars were recorded in the Work Schedule for job numbers 1/5,
1/16, 2/2, 2/7, 3/2, 3/5, 3/7 and 3/9. 15 jobs completed over the past five days were sampled. The Workshop Supervisor and the Tyre Fitter were aware of this missing information in the records, but no action had been taken.
You decide to raise a non-conformity.
정답：
설명：
Explanation:
ISO 9001 Clause Number:
8.5.2
Nature of problem:
Tyre batch numbers have not been recorded in the Work Schedule.
ISO 9001 requirement that has not been fulfilled:
ISO 9001 - "The organization shall retain the documented information necessary to enable traceability." This is a traceability issue. The organisation requires tyre batch numbers to be recorded in the Work Schedule, but sampled records showed that batch numbers were missing for multiple completed jobs.
ISO 9001 clause 8.5.2 Identification and traceability requires the organisation to control unique identification when traceability is required and retain the documented information necessary to enable traceability.
Clause 7.2 competence and clause 7.3 awareness are not the best fit because the evidence shows the Workshop Supervisor and Tyre Fitter were aware of the missing records. The issue is the failure to retain required traceability information.
질문 # 131
Among others, what does Clause 4.4 (Quality Management System and Its Processes) of ISO 9001 require from organizations?
정답：D
설명：
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 emphasizes continual improvement as a fundamental requirement of an effective Quality Management System (QMS).
Clause Reference:
* Clause 4.4.1 (Quality Management System and Its Processes) states that organizations must:
* Determine processes needed for the QMS
* Establish criteria and methods for process effectiveness
* Ensure continual improvement of the system
Why is the Correct Answer C?
* Continual improvement is a core principle of ISO 9001.
* Organizations must regularly assess and enhance their QMS to adapt to new challenges and maintain effectiveness.
Why are the Other Options Incorrect?
* A (To change the QMS quarterly) # ISO 9001 does not mandate a specific frequency for system changes.
* B (To review the QMS annually) # QMS reviews must be conducted as needed, not strictly annually.
* D (To conduct a QMS gap analysis every two years) # Gap analysis is useful but is not a mandatory requirement under Clause 4.4.
질문 # 132
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