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質問 # 18
You are conducting a third-party Stage 1 audit at ABC Ltd, a single-site organisation that manufactures wooden furniture. You interview the Technical Director to learn more about the organisation. The Technical Director explains that they have had a successful year and that obtaining ISO 9001 certification will support the further growth of the business. You ask for an overview of the organisation's structure and its interrelationships with external interested parties.
The Technical Director shows you a document detailing all business processes and interrelationships. You notice in this document that another organisation called Teak Ltd manufactures wooden furniture on behalf of ABC Ltd. The Technical Director confirms this capability has been accounted for in the scope of the quality management system. You learn that the furniture manufactured by Teak Ltd has accounted for 40% of the sales revenue over the previous 12 months.
Which two of the following options best describe how you would plan the audit of the interrelationship with Teak Ltd during the Stage 2 audit at ABC Ltd?
- A. Verify the controls concerning customer property implemented by Teak Ltd
- B. Verify the quality management system at Teak Ltd by conducting an audit at their site
- C. Verify if Teak Ltd are certified to ISO 9001
- D. Verify how ABC Ltd evaluates the performance of Teak Ltd
- E. Verify Teak Ltd supply arrangements as described in the ABC Ltd quality management system
- F. Verify whether the design processes of Teak Ltd comply with ISO 9001
正解：D、E
解説：
According to ISO 9001:2015, clause 8.4, an organization is required to control the processes, products and services provided by external providers, including those that affect the quality of the organization's own products and services. This includes determining the controls to be applied to the external provision of processes, products and services, as well as the information to be communicated to the external providers. The organization is also required to monitor, measure, and evaluate the performance of the external providers and retain documented information of these activities.
Therefore, in the scenario given, ABC Ltd is responsible for controlling the processes, products and services provided by Teak Ltd, as they affect the quality of ABC Ltd's own products and services. This means that ABC Ltd should have established criteria and methods for evaluating the performance of Teak Ltd, as well as documented information of the results of such evaluation. ABC Ltd should also have defined the supply arrangements with Teak Ltd, including the specifications, requirements, and verification activities related to the products and services provided by Teak Ltd.
Hence, the best options to describe how to plan the audit of the interrelationship with Teak Ltd during the Stage 2 audit at ABC Ltd are A and D, as they are aligned with the requirements of ISO 9001:2015, clause 8.4.
The other options are either irrelevant or beyond the scope of the audit, as they do not pertain to the control of external provision by ABC Ltd.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 8.4 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.3.1 and 6.4.2 ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6
質問 # 19
You have been nominated audit team leader of a third-party audit. Which of the following could be the two most relevant objectives of this audit?
- A. Evaluate the effectiveness of the management system
- B. Identify the need of resources
- C. Evaluate the satisfaction interested parties
- D. Evaluate the capability of the management system to establish and achieve objectives
- E. Evaluate the benefits obtained since the implementation of the management system
- F. Identify opportunities for improvement
正解：A、D
質問 # 20
Which one of the following options best describes the purpose of a Stage 1 third-party audit?
- A. To determine the auditees understanding of ISO 9001.
- B. To introduce the audit team to the client.
- C. To learn about the organisation's procurement processes.
- D. To get to know the organisation's customers.
正解：A
解説：
The purpose of a Stage 1 third-party audit is to determine an organization's readiness for their Stage 2 Certification Audit. During the Stage 1, the auditor will review the organization's management system documented information, evaluate the site-specific conditions, and have discussions with personnel. The objective is to assess the alignment of the organization's design with ISO 9001 requirements and to identify any areas of concern that could be classified as a nonconformance during the Stage 2 Audit. The auditor will also use the Stage 1 Audit to complete Stage 2 Audit planning, including a review of the allocation of resources and details for the next phase of the audit. Therefore, the option that best describes the purpose of a Stage 1 third-party audit is A, to determine the auditees understanding of ISO 9001. The other options are not correct, as they are not the main focus of a Stage 1 audit:
*B. To get to know the organization's customers: This is not the purpose of a Stage 1 audit, as the auditor is not interested in the specific details of the organization's customers, but rather in the organization's ability to meet customer and applicable statutory and regulatory requirements.
*C. To learn about the organization's procurement processes: This is not the purpose of a Stage 1 audit, as the auditor is not interested in the specific details of the organization's procurement processes, but rather in the organization's ability to control externally provided processes, products and services.
*D. To introduce the audit team to the client: This is not the purpose of a Stage 1 audit, as the auditor is not there to make introductions, but rather to conduct a preliminary examination of the organization's compliance with ISO 9001 standards.
References: What is the difference between Stage 1 and Stage 2 Audits? - ISO Update, The ISO 9001 Audit Process Explained | ISO Explained, What is an ISO Stage 2 Audit? - RiskOptics - Reciprocity
質問 # 21
Select six of the activities that are specifically required by ISO 17021-1 as part third-party (Certification Body) surveillance audit processes.
- A. Review the calibration status of the instrumentation.
- B. Complete a full document review of the quality management system.
- C. Review changes to the QMS since last visit.
- D. Failing to meet financial responsibilities.
- E. Audit use of certification marks on marketing materials.
- F. Review the status of previously raised findings and audit effectiveness of any outstanding findings.
- G. Conduct a minimum number of annual surveillance audits during the certification period.
- H. Confirm effectiveness of internal audit and management review.
- I. Handling of customer complaints since last visit.
- J. Verify legal compliance.
正解：C、E、F、H、I、J
解説：
The activities that are specifically required by ISO 17021-1 as part of third-party (Certification Body) surveillance audit processes are:
*Option A: Audit use of certification marks on marketing materials. This option is correct because ISO
17021-1:2015 clause 9.6.2.2 requires the certification body to audit the client's use of marks and/or any other reference to certification, as applicable, to ensure conformity with the certification requirements.
*Option B: Review changes to the QMS since last visit. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review any changes affecting the client's quality management system and its ability to continue to fulfil the requirements of the standard used for certification.
*Option C: Confirm effectiveness of internal audit and management review. This option is correct because ISO
17021-1:2015 clause 9.6.2.2 requires the certification body to confirm the continuing effectiveness of the client's quality management system, including the effectiveness of the internal audit and management review processes.
*Option F: Review the status of previously raised findings and audit effectiveness of any outstanding findings.
This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review the status of findings and any corrective actions taken by the client in response to previous audits, and to verify the effectiveness of the implemented corrective actions.
*Option H: Verify legal compliance. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to verify the client's compliance with applicable statutory and regulatory requirements related to the scope of certification.
*Option I: Handling of customer complaints since last visit. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review the client's handling of customer complaints related to the certified activities since the last audit.
The following options are not correct:
*Option D: Complete a full document review of the quality management system. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to complete a full document review of the quality management system during surveillance audits. A full document review is only required during the initial certification audit or when there are significant changes to the quality management system or the certification requirements.
*Option E: Failing to meet financial responsibilities. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to audit the client's financial responsibilities during surveillance audits. The certification body may have contractual arrangements with the client regarding the payment of fees, but this is not part of the surveillance audit process.
*Option G: Review the calibration status of the instrumentation. This option is not correct because ISO
17021-1:2015 clause 9.6.2.2 does not require the certification body to review the calibration status of the instrumentation during surveillance audits. The certification body may audit the client's monitoring and measuring resources as part of the quality management system requirements, but this is not a specific activity required by ISO 17021-1.
*Option J: Conduct a minimum number of annual surveillance audits during the certification period. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to conduct a minimum number of annual surveillance audits during the certification period. The certification body may determine the frequency and duration of surveillance audits based on the risk and performance of the client, but this is not a specific activity required by ISO 17021-1.
References:
*ISO 17021-1:2015 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements
*ISO 9001 Lead Auditor Course Material, Module 7: Audit Follow-up and Surveillance, Slide 8: Surveillance Audit
*ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 7.2: Audit Follow-up and Surveillance
*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
質問 # 22
Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).
正解：
解説：
Explanation:
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According to the ISO 9000:2015 document, the seven quality management principles are:
Customer focus
Leadership
Engagement of people
Process approach
Improvement
Evidence-based decision making
Relationship management
For each principle, the document provides a statement, a rationale, key benefits, and actions you can take to apply the principle in your organization.
Based on the document, here is a possible way to match a potential benefit to each of the four quality management principles you mentioned:
Table
Quality management principle
Potential benefit
Customer focus
Increased revenue and market share
Engagement of people
Enhanced trust and collaboration throughout the organization
Improvement
Enhanced drive for innovation
Evidence-based decision making
Increased ability to demonstrate effectiveness of past actions
質問 # 23
Which two of the following auditors would not participate in a first-party audit?
- A. An auditor employed by an external consultancy organisation
- B. An auditor trained in the IRCA scheme
- C. An auditor certified by IRCA
- D. An auditor from a customer
- E. An auditor trained in-house
- F. An auditor from an interested party
正解：A、D
解説：
A first-party audit is an internal audit conducted by auditors who are employed by the organization being audited but who have no vested interest in the audit results of the area being audited1. The purpose of a first-party audit is to assess the conformity of the organization's quality management system to the requirements of ISO 9001 and to identify opportunities for improvement2. Therefore, the two auditors who would not participate in a first-party audit are:
*A. An auditor employed by an external consultancy organization: This auditor is not employed by the organization being audited, and therefore does not qualify as a first-party auditor. This auditor may be hired to conduct a second-party audit (if the external consultancy organization is a customer or supplier of the organization being audited) or a third-party audit (if the external consultancy organization is a certification body or registrar).
*F. An auditor from a customer: This auditor is not employed by the organization being audited, and therefore does not qualify as a first-party auditor. This auditor may be hired to conduct a second-party audit, as a customer is an interested party that has specific requirements for the organization being audited.
The other options are not correct, as they could participate in a first-party audit, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited:
*B. An auditor from an interested party: This auditor could be a first-party auditor, as long as the interested party is within the organization being audited. For example, an auditor from the finance department could audit the production department, as long as they are not involved in the production process or affected by its outcomes.
*C. An auditor trained in-house: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. The source of the auditor's training is not relevant for determining the type of audit, as long as the auditor is competent and qualified to perform the audit.
*D. An auditor trained in the IRCA scheme: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. The IRCA scheme is a professional certification scheme for auditors of management systems, which provides recognition of the auditor's competence and credibility3. However, being trained in the IRCA scheme does not determine the type of audit, as long as the auditor is competent and qualified to perform the audit.
*E. An auditor certified by IRCA: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. Being certified by IRCA means that the auditor has met the requirements of the IRCA scheme and has demonstrated their competence and credibility as an auditor of management systems3. However, being certified by IRCA does not determine the type of audit, as long as the auditor is competent and qualified to perform the audit.
References: First Party Audits: The 5 Steps to Success - Sync Resource Inc, ISO 9001 Auditing Practices Group, IRCA - International Register of Certificated Auditors
質問 # 24
An audit team leader arrives at a printing company to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer manufacturer to print and compile computer documentation packages. The Quality Manager wants the ISO
9001 certificate to cover the new contract.
During the audit, a team member found that some print jobs had been rejected by several clients over some months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract.
The auditor finds that the responsibility for checking spelling errors is placed on the printer that sets up the print run.
In line with the policy of the certification body, the audit team raise improvement opportunities in the audit report. Which three of the following options would represent acceptable opportunities for improvement in the report?
- A. Operational planning activities may benefit from a clearer risk-based approach.
- B. An intensive training plan that involves all production personnel.
- C. The recruitment process to include spelling tests to filter out unsuitable candidates.
- D. More process time needs to be allocated to the new employees.
- E. The responsibility for checking printing needs to be independent of the operators.
- F. The organisation needs to delay its certification to gain more experience of the QMS.
- G. A business consultant can be recommended for advice on improving operations.
- H. A plan to determine why the errors occur and to prevent them.
正解：A、E、H
解説：
According to the ISO 9001 Auditing Practices Group Guidance on Improvement Opportunities1, an improvement opportunity is a suggestion made by the auditor for the auditee to consider that, if implemented, may enhance the performance of the QMS. Improvement opportunities are not mandatory, but they should be based on objective evidence and aligned with the audit criteria and objectives. Improvement opportunities should also be realistic, feasible, and beneficial for the auditee. In this case, the evidence statements that represent acceptable improvement opportunities in the report are A, C, and E, because they address the potential causes and effects of the spelling errors in the print run, and propose possible actions that may improve the quality of the products and services, and the effectiveness of the QMS. These options are consistent with the requirements and principles of ISO 9001, such as clause 6.1 on actions to address risks and opportunities, clause 8.1 on operational planning and control, clause 8.5.1 on control of production and service provision, and clause 10.2 on nonconformity and corrective action. The other options are not appropriate improvement opportunities, because they are either irrelevant, unrealistic, or unhelpful for the auditee. For example, option B may contradict the audit objective and scope, option D may imply a lack of auditor competence or impartiality, option F may not address the root cause of the problem, option G may not be applicable or effective, and option H may not be feasible or justified. References: ISO 9001 Auditing Practices Group Guidance on Improvement Opportunities, ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Audit Evidence
質問 # 25
Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?
- A. Decreased number of warranty claims
- B. Increased profits
- C. Decreased number of nonconforming products in all stages of the manufacturing cycle
- D. Decreased number of management system nonconformities
- E. Enhanced customer satisfaction
- F. Consistently provide products that meet customers' requirements
正解：E、F
解説：
According to the ISO 9001:2015 document, the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015 are:
*the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;
*the enhancement of customer satisfaction.
These results are derived from the quality management principles of customer focus and process approach, which are the basis of the ISO 9000 family of standards1. Customer focus means understanding and meeting customer needs and expectations, as well as exceeding them when possible1. Process approach means managing activities as interrelated processes that function as a coherent system, which leads to consistent and predictable results1.
Therefore, the correct answer is C and F.
References: 2: ISO 9001:2015 - Quality management systems - Requirements 1: ISO - Quality management principles
質問 # 26
In the context of a third-party audit, select the issue which is not expected to be included in the audit plan.
- A. Expectations of the organisation's management
- B. Number of sites to be audited
- C. Scope of the audit
- D. Risk to achieving audit objectives
正解：A
解説：
According to ISO 19011:2018, clause 6.3.2, the audit plan is a document that provides the basis for agreement regarding the conduct of the audit. The audit plan should include the following information1:
*the audit objectives, scope and criteria
*the audit team members and their roles and responsibilities
*the audit schedule, including the date, time and location of each audit activity
*the expected time and duration of meetings and interviews
*the allocation of appropriate resources to critical areas of the audit
*the identification of the audit client and the auditee
*the identification of the guides and observers, if any
*the documents and records to be reviewed before and during the audit
*the audit methods and tools to be used
*the audit language and terminology
*the audit report content, format, distribution and expected completion date
*the risk to achieving audit objectives and the contingency plan, if any Therefore, the issue which is not expected to be included in the audit plan is C, expectations of the organisation's management. This issue is not relevant to the conduct of the audit, as the audit is based on the audit criteria, not on the management's expectations. The management's expectations may be considered during the audit initiation or the audit programme management, but they are not part of the audit plan.
References: ISO 19011:2018(en), Guidelines for auditing management systems, How to create an ISO 9001 internal audit plan - Advisera
質問 # 27
Select one option that must be considered when determining the scope of a QMS to ISO 9001.
- A. Competence of top management
- B. Performance of business processes
- C. External issues of the organisation's context
- D. Business improvement
正解：C
解説：
According to ISO 9001:2015, clause 4.3, the organization is required to determine the scope of its quality management system (QMS) by considering the external and internal issues referred to in clause 4.1. Clause 4.1 requires the organization to determine the external and internal issues that are relevant to its purpose and strategic direction, and that affect its ability to achieve the intended results of its QMS. These issues can include positive and negative factors or conditions for consideration, such as legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local. The organization is also required to monitor and review these issues.
Therefore, the correct answer is C, as external issues of the organization's context are one of the factors that must be considered when determining the scope of the QMS. The other options are either not directly related to the scope of the QMS, or are not explicitly mentioned in clause 4.3.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 4.1 and 4.3 ISO 9001:2015 - How to determine the scope of your QMS - Advisera, section "Considerations for determining the scope of the QMS in ISO 9001" ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 4
質問 # 28
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?
- A. Close the meeting immediately after the DCM's response and advise that the issues will be addressed at the next surveillance visit.
- B. Recommend that all personnel should be given urgent in-depth training in the QMS.
- C. Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work.
- D. Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due course.
- E. Thank the DCM for his time and express an expectation that improvements will be made in the QMS.
- F. 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.
正解：D、F
解説：
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
質問 # 29
You are an auditor from a construction organisation who is conducting a second party audit to ISO 9001 at a steel rolling mill producing structural steelwork. When auditing the rolling process, you find that the operator who is unloading the furnace does not use the adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.
You: "How do you tell when the billet is ready for the rolling stage?"
Operator: "I've done this job for 20 years. I can tell by the bright red colour." You: "What happens if the colour is wrong?" Operator: "The billet goes back into the furnace." You: "Is the pyrometer ever used?" Operator: "Only in borderline cases." You continue to interview the operator and find that around 25% of the billets are sent back to the furnace.
This includes 80% of the borderline cases.
Select three options that would provide evidence of conformance with clause 9.1.1 of ISO 9001.
- A. Planning for monitoring and measuring the billet temperature.
- B. A quality objective to achieve lower recycle rates for billets.
- C. A procedure that provides instruction in taking billet temperature.
- D. An increase in the use of the pyrometer by operators.
- E. Annual review records for furnace operators.
- F. Maintenance plan for the furnace.
- G. Periodic analysis of the results of temperature checks.
- H. Certification of conformance to national standards from the manufacture of the pyrometer.
正解：A、C、G
解説：
According to ISO 9001:2015, clause 9.1.1, the organization is required to determine what needs to be monitored and measured, the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results, and when the monitoring and measuring shall be performed. The organization is also required to retain appropriate documented information as evidence of the results.
Therefore, in the scenario given, the organization should have planned for monitoring and measuring the billet temperature, as it is a critical factor for the quality of the product and the process. The organization should also have established a procedure that provides instruction in taking billet temperature, using the pyrometer or other suitable methods, to ensure consistency and accuracy. The organization should also have performed periodic analysis of the results of temperature checks, to identify trends, problems, and opportunities for improvement.
Hence, the options that would provide evidence of conformance with clause 9.1.1 of ISO 9001 are A, E, and F, as they are aligned with the requirements of the clause. The other options are either irrelevant or not directly related to clause 9.1.1, as they do not pertain to the monitoring and measurement of the billet temperature.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 9.1.1 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.4.4 and 6.7.2 ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6
質問 # 30
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures
cosmetics for major retailers.
You are interviewing the Manufacturing Manager (MM).
You: "I would like to begin by looking at the cleaning controls."
MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside." Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.
正解：
解説：
質問 # 31
Audit criteria are a set of requirements used as a reference against which objective evidence is compared.
Which two of the following are not potential audit criteria?
- A. Written agreements with interested parties
- B. Verbal agreements with interested parties
- C. ISO management system standards
- D. Commitment to follow principles issued by an NGO
- E. Commercial advertisements
- F. Claims made on the organisation's website
- G. Health and safety notices
- H. Organisation's documented information
- I. Verbal statements by the general manager
- J. Environmental aspects register
正解：E、F
解説：
According to ISO 19011:2018, clause 3.2, audit criteria are a set of policies, procedures or requirements used as a reference against which objective evidence is compared. Audit criteria are usually selected by the audit client or by agreement between the audit client and the auditee, and they should be appropriate for the audit scope and objectives1. Audit criteria may include, but are not limited to, the following sources2:
*ISO management system standards, such as ISO 9001, ISO 14001, ISO 45001, etc.
*Verbal statements by the general manager or other top management, as long as they are consistent with the documented policies and objectives of the organisation
*Verbal agreements with interested parties, such as customers, suppliers, regulators, etc., as long as they are documented and approved by the relevant authorities
*Health and safety notices, such as posters, signs, labels, etc., that communicate the organisation's legal obligations, policies, or procedures
*Written agreements with interested parties, such as contracts, orders, specifications, etc., that define the requirements and expectations of the parties involved
*Organisation's documented information, such as policies, procedures, manuals, records, etc., that describe the organisation's management system and its processes
*Commitment to follow principles issued by an NGO, such as the United Nations Global Compact, the International Labour Organization, etc., as long as they are relevant to the organisation's context and objectives
*Environmental aspects register, such as a list of the environmental impacts and risks associated with the organisation's activities, products, and services Therefore, the two options that are not potential audit criteria are F and H, as they are not reliable or verifiable sources of information, and they may not reflect the actual performance or conformity of the organisation's management system. Commercial advertisements and claims made on the organisation's website are forms of marketing communication that may be exaggerated, misleading, or inaccurate, and they are not subject to the same level of scrutiny or approval as the other sources of audit criteria.
References: ISO 19011:2018(en), Guidelines for auditing management systems, What are audit criteria? - ISO Update
質問 # 32
Which of the following two documents does an auditor need to prepare and complete prior to the on-site audit?
- A. Checklist / Prompts
- B. Procedures
- C. Risk Matrices
- D. Findings
- E. Audit Report
- F. Audit Plan
正解：A、F
解説：
According to ISO 19011:2018, clause 6.3, the audit plan is a document that provides the basis for agreement regarding the conduct of the audit. The audit plan should include the information listed in my previous response, such as the audit objectives, scope, criteria, schedule, team, methods, report, etc. The audit plan should be prepared and completed prior to the on-site audit, and should be communicated to the audit team and the auditee1.
According to ISO 19011:2018, clause 6.4.3, the checklist / prompts are documents that list the questions or topics that need to be covered during an audit. The checklist / prompts can help the auditor to collect and verify information relevant to the audit criteria, and to ensure the consistency and completeness of the audit.
The checklist / prompts should be prepared and completed prior to the on-site audit, and should be based on the audit plan and the audit scope and objectives1.
Therefore, the two documents that an auditor needs to prepare and complete prior to the on-site audit are B and D, as they are essential for planning and conducting the audit. The other options are not correct, as they are either prepared or completed after the on-site audit, or not required by the standard:
*A. Audit Report: The audit report is a document that provides a complete, accurate, concise, and clear record of the audit. The audit report should include the information listed in my previous response, such as the audit objectives, scope, criteria, findings, conclusions, etc. The audit report should be prepared and completed after the on-site audit, and should be distributed to the audit client and the auditee1.
*C. Procedures: Procedures are documents that specify the way activities are to be performed. Procedures may be part of the audit criteria, if they are part of the organization's management system, or part of the audit programme, if they are part of the certification body's or registrar's requirements. Procedures are not prepared or completed by the auditor prior to the on-site audit, but rather reviewed or followed by the auditor during the audit1.
*E. Risk Matrices: Risk matrices are tools that help to assess and prioritize the risks and opportunities associated with the audit programme or the audit. Risk matrices may be part of the audit programme management, if they are used to determine and evaluate the audit programme risks and opportunities, or part of the audit preparation, if they are used to determine and evaluate the audit risks and opportunities. Risk matrices are not prepared or completed by the auditor prior to the on-site audit, but rather used or updated by the auditor during the audit programme management or the audit preparation1.
*F. Findings: Findings are the results of the evaluation of the collected audit evidence against the audit criteria.
Findings can indicate either conformity or nonconformity, as well as positive aspects or opportunities for improvement. Findings are not prepared or completed by the auditor prior to the on-site audit, but rather generated and recorded by the auditor during the audit activities1.
References: ISO 19011:2018(en), Guidelines for auditing management systems
質問 # 33
During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at a major international airport, you interview the CD 9000's General Manager (GM), who was accompanied by Jack, the legal compliance expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.
You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?" GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon, shortage of chemicals for the analysis. It was quite a good experience." You: "Did you document these issues?" GM: "No. Jack said that ISO 9001 does not require us to document these issues." You: "How did you determine the risks associated with the issues and did you plan actions to address them?" GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence." Select two options for how you would respond to the General Manager's suggestion:
- A. I would ask the consultant to leave the meeting since he is not an employee of the organisation.
- B. I would look for evidence that the actions resulting from the risk assessment had been taken.
- C. I would not accept the legal compliance expert answering the question.
- D. I would delay the audit until the return of the technical manager
- E. I would ask to audit the Technical Manager by phone.
- F. I would ask for a different guide instead of the legal compliance expert.
正解：B、C
解説：
According to clause 4.1 of ISO 9001:2015, the organization should determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended results of its quality management system. The organization should monitor and review these issues and update them as necessary. Although the standard does not explicitly require documented information of these issues, it does require documented information as evidence of the implementation of the actions taken to address risks and opportunities, as per clause 6.1. The organization should also retain documented information as evidence of the results of the monitoring, measurement, analysis and evaluation of its QMS, as per clause 9.1. Therefore, the auditor should not accept the legal compliance expert answering the question, as he is not the person responsible for the process and may not have the necessary competence or knowledge of the QMS. The auditor should also look for evidence that the actions resulting from the risk assessment had been taken, as this is a requirement of the standard and a way to verify the effectiveness of the QMS. The other options are not appropriate courses of action for the auditor, because they do not address the audit objective or criteria, or they may compromise the audit integrity or impartiality. For example, option B may not be feasible or reliable, as the Technical Manager may not be available or able to provide the necessary evidence by phone. Option C may cause unnecessary delay and inconvenience for the audit process and the auditee. Option E may not solve the problem, as the guide is not the main source of evidence or information for the audit. Option F may be disrespectful or unprofessional, as the consultant may have a legitimate role or interest in the audit.
References: ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Context of the Organization, ISO 9001 Auditing Practices Group Guidance on Audit Evidence
質問 # 34
Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?
- A. Decreased number of warranty claims
- B. Increased profits
- C. Decreased number of nonconforming products in all stages of the manufacturing cycle
- D. Decreased number of management system nonconformities
- E. Enhanced customer satisfaction
- F. Consistently provide products that meet customers' requirements
正解：E、F
解説：
The key expected results of a quality management system that conforms to the requirements of ISO 9001:2015 are stated in clause 0.1 of the standard, which says: "The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to an organization of implementing a quality management system based on this International Standard are: a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risks and opportunities associated with its context and objectives; d) the ability to demonstrate conformity to specified quality management system requirements." Therefore, the two options that best match these benefits are A and E, as they directly relate to providing products and services that meet customer requirements and enhancing customer satisfaction. The other options are not explicitly mentioned as key expected results, although they may be possible outcomes of implementing a quality management system. References: ISO 9001:2015 - Quality management systems - Requirements, Key Elements of an ISO 9001:2015 Quality Management System, What is ISO 9001 2015 as a Quality Management Systems?
質問 # 35
Select the words that best complete the sentence:
正解：
解説：
Explanation:
According to the ISO 19011:2018 document, the audit plan should provide the basis for agreement regarding the conduct and scheduling of the audit activities. The amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives1. The scope of the audit refers to the extent and boundaries of the audit, such as the audit criteria, the audit objectives, the organizational and functional units, and the processes to be audited1. The complexity of the audit refers to the degree of difficulty or intricacy of the audit, such as the number and diversity of the auditees, the audit criteria, the audit methods, and the audit team composition2. The risk of not achieving the audit objectives refers to the possibility that the audit may fail to provide reliable and sufficient audit evidence to support the audit conclusions and report1.
Therefore, the complete sentence is:
In the context of a third-party audit, the amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives.
References: 1: ISO 19011:2018 - Guidelines for auditing management systems 2: Audit Complexity - an overview | ScienceDirect Topics
質問 # 36
The following are stages of an audit, put them in the order they would be conducted.
正解：
解説：
Explanation:
Establishing the audit programme objectives
Determining and evaluating the audit programme risks and opportunities
Establishing the audit programme
Initiating the audit
Preparing all audit activity
Conducting the audit activities
To complete the sequence, you can drag and drop the options to the appropriate blank section.
Here is a brief explanation of each stage:
Establishing the audit programme objectives: This is the first stage of the audit process, where the purpose, scope, and criteria of the audit programme are defined. The audit programme objectives should be aligned with the strategic direction and policies of the organization, and should address the needs and expectations of the interested parties12.
Determining and evaluating the audit programme risks and opportunities: This is the second stage of the audit process, where the factors that can affect the achievement of the audit programme objectives are identified and assessed. The audit programme risks and opportunities should consider the internal and external issues, the requirements and changes of the interested parties, and the results and feedback from previous audits12.
Establishing the audit programme: This is the third stage of the audit process, where the audit programme is designed and implemented. The audit programme should include the audit programme procedures, the audit programme resources, the audit methods and techniques, the audit frequency and schedule, and the audit programme performance indicators12.
Initiating the audit: This is the fourth stage of the audit process, where the audit is prepared and planned. The audit initiation involves selecting the audit team, establishing the contact with the auditee, defining the audit objectives, scope, and criteria, developing the audit plan, and conducting the document review123.
Preparing all audit activity: This is the fifth stage of the audit process, where the audit activities are organized and coordinated. The audit preparation involves assigning the audit tasks, communicating with the auditee and the audit team, arranging the logistics, preparing the working documents, and conducting the opening meeting123.
Conducting the audit activities: This is the sixth and final stage of the audit process, where the audit evidence is collected and evaluated. The audit conduct involves performing the audit activities, such as interviews, observations, document reviews, and tests, documenting the audit findings, preparing the audit conclusions, and conducting the closing meeting123.
I hope this helps you with your ISO 9001 Lead Auditor objectives and content. If you have any further questions, please feel free to ask.
References: 1: ISO 19011:2018 - Guidelines for auditing management systems 2: Audit Process | Flowchart | Summary - Accountinguide 3: What are the Stages of the Auditing Process & Why it is Important ...
質問 # 37
Who would be defined as a witness during a witness audit?
Choose two of the following options:
- A. An existing member of the audit team
- B. An assessor for the accreditation body
- C. An auditor
- D. Someone with a qualification from the certification body
正解：B、C
解説：
Comprehensive and Detailed Explanation: = According to the web search results from my internal tool, a witness audit is a technique used during an accreditation audit, where the accreditation body observes the performance and competence of the certification body auditors in conducting an audit12. A witness audit can also be used by a certification body to monitor and evaluate its own auditors3. During a witness audit, the following roles can be defined:
*An auditor: This is the person who is being witnessed by the accreditation body or the certification body. The auditor is responsible for conducting the audit according to the audit plan, criteria, and standards, and for providing audit evidence and findings123.
*An assessor for the accreditation body: This is the person who witnesses the auditor on behalf of the accreditation body. The assessor is responsible for evaluating the auditor's performance and competence, and for providing feedback and recommendations to the accreditation body123.
The other options are not defined as witnesses during a witness audit, according to the web search results from my internal tool. They are:
*Someone with a qualification from the certification body: This is not a specific role in a witness audit, as anyone who is involved in the audit process should have a qualification from the certification body. Moreover, having a qualification does not necessarily mean that the person is a witness or an auditor4.
*An existing member of the audit team: This is not a specific role in a witness audit, as the audit team consists of the auditors who are conducting the audit, not the ones who are witnessing it. The witness audit is a separate activity from the audit itself, and the witness should not interfere with the audit process or influence the audit outcome123.
Therefore, the correct answer is B and D.
References: 1: DQS Inc. | Witness Audits | Auditor Training 2: Have you ever been involved with a witness audit? - IFSQN 3: Certac - Witness Audit of Certification Bodies 4: ISO 19011:2018 - Guidelines for auditing management systems
質問 # 38
According to ISO 19011, what two activities take place during the conduct of a audit follow-up?
- A. Verify corrections taken to fix the reported non-conformities
- B. Assign roles and responsibilities of observers
- C. Verify legal compliance
- D. Plan the next audit
- E. Determine feasibility of the audit
- F. Verify the effectiveness of the implemented corrective actions
正解：A、F
解説：
According to ISO 19011:2018, clause 6.7, the audit follow-up is the process of verifying the completion and effectiveness of corrective actions taken by the auditee as a result of an audit. The audit follow-up can include two main activities:
Verifying the effectiveness of the implemented corrective actions: this means checking whether the actions taken by the auditee have addressed the root causes of the nonconformities and prevented their recurrence or occurrence in other areas. The verification can be done by reviewing documents, records, data, or other evidence provided by the auditee, or by conducting a follow-up audit on site or remotely.
Verifying corrections taken to fix the reported non-conformities: this means checking whether the auditee has corrected the nonconformities identified during the audit and eliminated their immediate effects. The verification can be done by reviewing documents, records, data, or other evidence provided by the auditee, or by conducting a follow-up audit on site or remotely.
The audit follow-up can be conducted as a separate audit or as part of a subsequent audit, depending on the audit programme, the audit objectives, the audit criteria, the audit scope, the audit risks, and the audit findings.
The audit follow-up should be planned and conducted in accordance with the same principles and processes as the initial audit, and the results should be documented and reported accordingly. References:
ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.7 ISO 19011 Management Systems Audit Checklist | Process Street, task 6.7.1 and 6.7.2 Conducting the Audit Follow-Up: When to Verify - The Auditor, section "Conducting the audit follow-up"
質問 # 39
Select the word that best completes the sentence:
正解：
解説：
Explanation:
According to the ISO - Management system standards page, the key benefits of an effective management system include improved operational effectiveness and efficiency, improved risk management and protection of people and the environment, and enhanced drive for innovation. The Integrated Use of Management System Standards (IUMSS) handbook also states that the purpose and objectives of management system standards are to help organizations improve their performance by specifying repeatable steps that organizations consciously implement to achieve their goals and objectives.
Therefore, the complete sentence is:
"The purpose of a management system standard is to improve the performance of an organisation."
質問 # 40
During a second-party audit, the auditor examines the records that are available for the external provider, ABC Forgings, to whom manufacturing has recently been outsourced.
There are standard external provider checklists for three competitors for the contract and there are inspection records from the trial manufacturing batches produced by ABC Forgings. There is no documented evidence of the criteria used to confirm the appointment of ABC Forgings, and no contract or terms and conditions.
Ongoing monitoring indicates that external provider performance is satisfactory, but no documented information has been retained.
Select two options for the evidence which demonstrates a nonconformity with clause 8.4 of ISO 9001.
- A. There were no receipt inspection records of the incoming materials.
- B. The auditee required the outsourced products on an urgent basis before the completion of the paperwork.
- C. The auditee trusted the external provider because of a long-standing relationship with them.
- D. The auditee did not retain documentation on the selection and evaluation of the external provider.
- E. There was no documentation which provided evidence of any monitoring of the external provider.
- F. The external provider asked for the contract details to be verbal only.
正解：D、E
解説：
According to clause 8.4 of ISO 9001:2015, the organization should ensure that externally provided processes, products, and services conform to the specified requirements. To do so, the organization should:
*Establish the criteria for the selection, evaluation, and re-evaluation of external providers, based on their ability to provide processes, products, and services in accordance with the requirements. The criteria should be documented and applied consistently.
*Evaluate the potential external providers before selecting them, using the established criteria. The evaluation methods may include questionnaires, audits, references, samples, etc. The results of the evaluation should be documented and reviewed.
*Select the external providers that have demonstrated their competence and conformity to the requirements.
The selection should be based on the evaluation results and the organization's needs. The selection should be documented and approved.
*Communicate the requirements for the processes, products, and services to be provided by the external provider, including the verification and validation activities, the acceptance criteria, the documentation requirements, the changes control, etc. The communication methods may include purchase orders, contracts, agreements, etc. The communication should be clear, complete, and timely.
*Monitor the performance and conformity of the external provider, using the established criteria and methods.
The monitoring methods may include inspections, tests, audits, feedback, complaints, etc. The monitoring results should be documented and analyzed.
In this case, the evidence statements that demonstrate a nonconformity with clause 8.4 are A and C, because they show that the organization did not retain documented information of the selection and evaluation of the external provider, and the monitoring of the external provider's performance. These are requirements of the standard and essential for ensuring the quality of the externally provided processes, products, and services.
The other options are not directly related to clause 8.4, although they may indicate other nonconformities or weaknesses in the organization's QMS. For example, option B may relate to clause 7.1.3 on contingency planning, option D may relate to clause 8.2.3 on review of requirements, option E may relate to clause 8.6 on release of products and services, and option F may relate to clause 5.1.1 on leadership and commitment.
References: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Scope], Mastering the Scope of ISO 9001 Quality Management Systems
質問 # 41
Takitup is a small fabrication organisation 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 covers the organisation's improvement actions and the auditor asks to see the most recent management review meeting minutes.
The auditor finds that the management review report records that none of the improvement actions set by the previous review has been realised for a second time. A new Quality Manager has been brought in at the middle management level to rectify the situation as the organisation is concerned that it might lose its certification.
Select three options that would provide evidence of conformance with clause 10.3 of ISO 9001.
- A. An increase in the number of quality staff.
- B. Considering results from the analysis of the effectiveness of corrective actions to determine improvement opportunities.
- C. Automate the fabrication process to increase profitability.
- D. The certification body auditor reporting fewer nonconformities.
- E. An enhanced customer satisfaction survey score than in the previous year.
- F. A quality objective to achieve lower reject rates by quality control.
- G. Removing expensive external providers from the database.
- H. Outsource more processes to external providers
正解：B、E、F
質問 # 42
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有効なISO-9001-Lead-Auditorテスト解答とPECB ISO-9001-Lead-Auditor試験PDF：https://www.passtest.jp/PECB/ISO-9001-Lead-Auditor-shiken.html
実際に出るISO-9001-Lead-Auditor試験問題集には正確で更新された問題：https://drive.google.com/open?id=1eelPuIqGZDrnBi2SRcD87PFqI6TbGNhx