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ISO-9001-Lead-Auditor問題集で2025年最新のPECB ISO-9001-Lead-Auditor試験問題
質問 # 62
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.
正解：
解説：
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.
質問 # 63
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."
正解：
解説：
Explanation:
A screenshot of a computer Description automatically generated
質問 # 64
In the context of a second-party audit, match the activity with the party responsible for conducting it.
正解：
解説：
Explanation:
Here is the correct matching of the activities with the responsible parties in the context of a second-party audit:
* Define the audit scope: Customer
* Develop the audit plan: Audit team leader
* Respond to the audit findings: External provider
* Conduct the audit: Audit team
This reflects the typical division of responsibilities in a second-party audit, where the customer (the party commissioning the audit) sets the scope, the audit team leader manages the planning, the external provider responds to findings, and the audit team carries out the audit.
質問 # 65
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 if Teak Ltd are certified to ISO 9001
- C. Verify the quality management system at Teak Ltd by conducting an audit at their site
- D. Verify how ABC Ltd evaluates the performance of Teak Ltd
- E. Verify whether the design processes of Teak Ltd comply with ISO 9001
- F. Verify Teak Ltd supply arrangements as described in the ABC Ltd quality management system
正解：D、F
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 # 66
You are conducting an ISO 9001 audit of a Materials Recycling Facility (MRF). The organisation processes waste plastics into raw materials for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process. You interview the line supervisor.
You: "Why are these plastic items being rejected at this stage?"
Auditee: "They do not meet our processing standards."
You: "What is the reason for that?"
Auditee: "These items are likely to damage the machinery down the line. They can also compromise our quality standards. We need to protect our reputation for good quality output materials." You: "What happens to the rejected items?" Auditee: "Some get melted down in another process later on and some are disposed of as waste products that cannot be recycled." You: "What happens to the waste products?" Auditee: "I'm not sure. I suppose they go to landfill." Which two. of the following actions would you take to investigate further?
- A. Find out if operators have regular hearing tests.
- B. Ask about operator PPE (Personal Protective Equipment).
- C. Check the process for handling nonconforming items.
- D. Determine whether there are quality objectives for reducing rejected material.
- E. Determine what happens to the waste products.
- F. Ask to review the percentage of waste materials.
正解：C、E
解説：
According to the ISO 9001:2015 standard, clause 8.7 requires that an organization identify and control any nonconforming outputs that do not conform to the requirements of the customer or other relevant requirements. Nonconforming outputs are any outputs from the process, product or service that do not meet the specified quality criteria. Nonconforming outputs must be dealt with in one or more of the following ways:
Correction of the nonconformity
Segregation, containment, return or suspension of provision of products and services Informing the customer Authorisation for acceptance under concession The organization must also retain documented information on the description of the nonconformity, the actions taken, any concessions obtained, and the identification of the authority deciding the action to resolve the nonconformity.
In this scenario, you have interviewed a line supervisor who is responsible for managing a manual picking line where operators are removing contaminant materials from incoming products. The supervisor has explained that these plastic items are rejected at this stage because they do not meet their processing standards and they can damage their machinery and compromise their quality standards. The supervisor has also mentioned that some of these rejected items are melted down in another process later on and some are disposed of as waste products that cannot be recycled.
B: Check the process for handling nonconforming items: You can verify whether there is a documented procedure for identifying, segregating, containing, returning or suspending provision of nonconforming items at this stage. You can also check whether there is a system for informing customers about any nonconforming items that may affect their satisfaction or expectations.
D: Determine what happens to the waste products: You can verify whether there is a documented procedure for disposing of waste products that cannot be recycled as per environmental regulations and customer requirements.
These two actions would help you to determine whether there are any nonconforming outputs at this stage and how they are controlled by the organization.
質問 # 67
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?" The auditor asks to speak to the purchasing manager about the selection of the subcontractor to manufacture the company's own brand products.
You: "How did you choose a supplier to manufacture your products?"
Auditee: "We have had a long-term relationship with a supplier ABC Ltd - we gave them our design drawings, got them to complete a supplier questionnaire and run a couple of trial batches for us. We were happy with the result and we have used them ever since." ISO 9001:2015, clause 8.4.1 outlines situations when controls need to be applied to externally provided processes, products and services. Which one of the following situations is applicable to this scenario?
- A. Raw materials from external providers are intended for incorporation into the organisation's own products.
- B. A process or part of a process is provided by an external provider as a result of a decision by the organisation.
- C. Products and services are provided directly to the customer(s) by external providers on behalf of the organisation.
- D. Products and services for which the customer(s) supplies materials
正解：B
解説：
According to the ISO 9001:2015 standard, clause 8.4.1 requires organizations to ensure that externally provided processes, products and services conform to requirements. Controls must be applied to externally provided processes, products and services when:
The products and services are intended for incorporation into the organization's own products and services.
They are provided directly to customers by the external provider on behalf of the organization.
A process, or part of a process, is provided by an external provider as a result of a decision by the organization.
In this scenario, the auditee has chosen a supplier to manufacture their own brand products based on their design drawings, supplier questionnaire and trial batches. This means that the supplier is providing a process (manufacturing) as a result of a decision by the organization (the auditee). Therefore, clause 8.4.1 applies to this situation.
質問 # 68
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 to audit the Technical Manager by phone.
- B. I would ask for a different guide instead of the legal compliance expert.
- 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 look for evidence that the actions resulting from the risk assessment had been taken.
- F. I would ask the consultant to leave the meeting since he is not an employee of the organisation.
正解：C、E
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 # 69
You are leading a Stage 2 certification audit of a multi-site organisation and have received the audit schedule below; Head Office and Site 1 - Day 1 Site 2 (150 Km from HQ) - Days 2 and 3 During Day 1 of the audit, the dient informs you that the laboratory at Site 2 has been dosed for decontamination due to a serious outbreak of an infectious disease among workers. In Site 2, all other functions could be audited as planned.
As the audit team leader, what would you do?
Choose the best acceptable action you could take:
Ask the audit Programme Manager for direction.
Complete the audit on day 3 and report back to the certification body for a certification decision.
Continue the audit on days 2 and 3 and return later to audit the Site 2 laboratory.
Immediately cancel the audit since the audit plan cannot be completed.
Who has the responsibility for assigning work to the audit team?
- A. The audit team leader
- B. The audit team member
- C. The certification body
- D. The auditee organisation
正解：A
解説：
In the context of ISO 9001:2015 audits, it is the audit team leader who holds the responsibility for assigning work to the audit team. According to ISO 19011:2018 (Guidelines for auditing management systems, which complements ISO 9001:2015), the audit team leader is responsible for the organization and direction of the audit, including assigning specific roles and responsibilities to audit team members. This includes preparation of the audit plan, leading the audit, and ensuring that each team member understands their tasks.
質問 # 70
Select which one of the following statements is true.
- A. An audit team can include non-qualified auditors.
- B. The team leader shall be an auditor that is qualified in the scheme.
- C. A technical expert can replace a qualified auditor on an audit team.
- D. Audits leading to auditor qualification are undertaken annually.
正解：B
解説：
According to the ISO 19011:2018 standard, which provides guidelines for auditing management systems, the team leader of an audit team should be an auditor who has demonstrated the competence to manage an audit of the relevant management system scheme. This means that the team leader should have the appropriate knowledge, skills, and experience to plan, conduct, report, and follow-up an audit of the specific management system, such as ISO 9001 for quality management systems. The other options are false because: B. An audit team can include non-qualified auditors, but only as observers or trainees who do not contribute to the audit findings or conclusions. C. A technical expert can assist a qualified auditor on an audit team, but cannot replace them, as a technical expert does not have the competence to perform audits. D. Audits leading to auditor qualification are not undertaken annually, but rather as part of a certification process that involves meeting certain criteria, such as education, work experience, audit experience, and examination. References:
ISO 19011:2018, PECB Certified ISO 9001 Lead Auditor Exam Preparation Guide, ISO 9001:2015 Quality Management Systems Lead Auditor Training Course
質問 # 71
You are the supervisor in Production of a medium size manufacturing organisation. You are qualified as an internal auditor. The Quality Manager asks you to lead the next internal audit of Production and Logistics Dispatch. The audit team includes two other internal auditors.
正解：
解説：
Explanation:
Here is the correct matching of actions to the statements in the context of leading the internal audit:
* If practicablecarry out a formal opening meeting
* You should notaudit production (as you are a supervisor in that area, and this would compromise audit objectivity)
* You need notchange the audit team (unless there is a specific reason, such as conflict of interest)
* You mustraise audit findings if necessary (this is a key responsibility of an auditor when nonconformities are found)
* You must notsend the audit report to the Quality Manager (the audit report must be reviewed first; it is typically part of the internal audit process to go through necessary channels before final submission)
* You shouldsend the audit report to the Quality Manager (after appropriate reviews and approvals) This reflects key principles of conducting an internal audit according to ISO 9001:2015, ensuring objectivity, proper documentation, and clear reporting procedures.
質問 # 72
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation offers warehousing and export services to customers. Customers are invoiced for the time stock items are stored in the warehouse. Transport to and from the warehouse is controlled by the organisation and approved subcontract transport services are used. The organization does not have its own transport vehicles. Stock items are not purchased by the organisation.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 Clause 8 extract to the audit evidence.
正解：
解説：
Explanation:
The table below shows the possible matching of the ISO 9001 Clause 8 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8 extract
Four of the 10 pallets of stock sampled in the warehouse were not labelled.
"8.5.2 ... shall use suitable means to identify outputs ..."
A damaged pallet of stock seen in the quarantine area was leaking liquid onto the floor.
"8.7.1 ... shall ensure that outputs that do not conform to their requirements are identified and controlled ..." One of the fork-lift truck drivers had no fork-lift truck driving licence.
"8.5.1 e ... shall include, as applicable ... the appointment of competent persons ..." There was no pest control provision in the warehouse.
"8.5.4 ... shall preserve the outputs during production and service provision ..." Two pallets of temperature-sensitive stock items were being stored at ambient as the chilled storage facility was full.
"8.1 ... shall plan, implement and control the processes ..."
質問 # 73
You are a member of the audit team of a second-party audit of an organisation with 625 employees. The audit procedure recommends using sampling criteria which requires the review of the documented competence for
25 personnel. The audit team leader developed an audit plan allocating one hour to audit the Human Resources department (from 11:30 am to 12:30 pm). She told you that she could not allocate any additional time.
What would you do?
- A. Plan to miss lunch and review as many as possible.
- B. Plan to review less than 25 cases.
- C. Plan to review as many as possible and see if you can extend the audit duration by one day.
- D. Extend the audit until 1.00pm and ask for a quick lunch later.
正解：B
解説：
In this scenario, the time allocated by the audit team leader for the Human Resources audit is fixed, and as an auditor, you must work within that constraint. Although the sampling criteria suggests reviewing 25 personnel files, it is acceptable to adjust the sample size based on time and resource limitations. ISO 9001:2015 emphasizes risk-based thinking and practical resource management (Clause 7.1), so it is reasonable to review a smaller sample if the time is insufficient.
Option B is a pragmatic approach, allowing you to focus on quality over quantity by reviewing as many cases as time allows without compromising the audit schedule.
Options like extending the audit (A, C, D) are impractical in a structured audit environment, especially for second-party audits where maintaining the agreed schedule is important.
質問 # 74
TIX provides services to the informatic equipment of large organisations. They operate an ISO 9001:2015 QMS that is being audited by an important customer (second-party audit). During the audit, the audit team has identified two nonconformities. When preparing the Closing meeting, the audit team discussed and agreed both nonconformities with TIX's quality manager. The Closing meeting was planned for 6pm with the general manager, quality manager and service manager at the meeting room.
At 6pm, when the audit team enters the meeting room, only two people are present and waiting for them: the Health and Safety supervisor and the warehouse supervisor. Neither have participated in the audit.
The dialogue among them is as follows:
Audit team leader: "Good evening, could you please inform the three managers that we are ready to start with the Closing meeting?" Health and Safety supervisor: "Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and the other two managers have had to leave urgently to attend the emergency." Warehouse supervisor: "They have asked us to listen to what you need to say and to sign whatever we need to sign. We also have a message from them about the two nonconformities. They wanted us to ask you if you could contact them in a couple of days to determine how to proceed." Which one of the following options would be your preferred response to the final comment made by the warehouse manager?
- A. We will hear what you were asked to tell us and will then leave. Please ask the managers to contact us as soon as the emergency is over to agree on a new date to carry out the Closing meeting.
- B. We will hear what you were asked to tell us and will leave copies of the nonconformity reports that have been agreed with the quality manager. Please tell the managers that we will consider this as the Closing meeting and that the individual(s) managing the audit programme will send the full report in five days.
- C. We will hear what you were asked to tell us and will ask you to sign the nonconformity reports as evidence that you have accepted them. Please ask the managers to contact us as soon as the emergency is over to agree on a new date to complete the Closing meeting.
- D. Sorry, but we cannot proceed with the Closing meeting. So, we are leaving now, and please tell the quality manager that I will phone him tomorrow early in the morning.
正解：A
質問 # 75
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 # 76
Read the following role descriptions. Select two roles that are not directly involved in the audit process.
- A. A technical expert - a person who provides specific knowledge or expertise to the audit team but is not normally an auditor.
- B. An auditor-in-training - a person who accompanies the audit team leader or team members during the audit.
- C. An audit team leader - a person responsible for managing an audit until the audit is completed.
- D. An observer - a person who sees the performance of the audit team leader, audit team members and/or auditee.
- E. An interpreter - a person who witnesses the audit to assist the auditors with language issues.
- F. A guide - a person who is appointed by the auditee to assist the audit team during the audit.
正解：D、E
質問 # 77
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.
正解：
解説：
質問 # 78
Knowledge and skills are requirements of the auditor's competence. Select two from the following topics of knowledge that apply to every member of an audit team auditing an ISO 9001 quality management system.
- A. ISO 19011 Audit principles
- B. Requirements of auditee's interested parties other than customers
- C. Organisation's invoicing and profits of the last 5 years
- D. Requirements of ISO 9001
- E. Organisation's processes
- F. Organisation's market sector
正解：A、D
解説：
According to ISO 9001:2015, clause 7.2, an auditor shall have the competence to:
* Understand the requirements of ISO 9001 and how they relate to the audit
* Understand the organization's quality management system and its processes
* Understand the applicable legal, regulatory, contractual and other requirements that affect the audit
* Understand the needs and expectations of interested parties other than customers
* Plan and conduct audits in accordance with ISO 19011
* Evaluate audit evidence and draw appropriate conclusions
* Communicate audit findings effectively1
Therefore, knowledge of ISO 9001 requirements and ISO 19011 audit principles are essential for every member of an audit team auditing an ISO 9001 quality management system.
References:
* ISO 9001:2015 - Quality management systems - Requirements
* ISO 19011:2018 - Guidelines for auditing management systems
質問 # 79
ABC is a fast food shop that receives orders by phone or the internet. The normal menu includes 15 different types of hamburgers; however, in the last two days, due to a shortage of a special type of meat, they can only prepare six of the 15 varieties.
You are performing a third-party audit of ABC; you observed that the menu offering food on the website is still the normal one, with 15 different hamburgers. During a 30-minute period, you observed several customers reluctantly accepting other than the hamburger they preferred. You decided to raise the following nonconformity as follows:
"There is evidence that ABC has not reviewed the ability to provide customers the offered products".
The restaurant manager does not accept the nonconformity. She says that ABC had an extensive training programme for all personnel, which you have already seen when auditing Human Resources. This shortage of some hamburgers cannot be considered a management system failure.
Which one would be your answer from the following options?
- A. I will maintain it open, and I will see what the Certification Body thinks about it.
- B. I will raise it as a major nonconformity and, therefore, cannot recommend certification of the quality management system.
- C. You are right, it is not a system failure. I will change the nonconformity to a recommendation, but it will be audited carefully next time.
- D. I will raise it as a minor nonconformity; you have the option to appeal to our Certification Body.
正解：D
解説：
The appropriate response in this situation would be:
C: I will raise it as a minor nonconformity; you have the option to appeal to our Certification Body.
This response acknowledges the restaurant manager's point that the shortage of some hamburgers may not constitute a management system failure. However, the fact remains that the menu was not updated to reflect the current availability of products, which led to customer dissatisfaction. This is a deviation from the ISO
9001 standard, which requires that the organization ensures the availability of resources needed to provide products and services as promised1. Raising it as a minor nonconformity allows the organization to address the issue within a specified timeframe and provides an opportunity for appeal if the organization disagrees with the auditor's decision2.
質問 # 80
According to ISO 19011, what two activities take place during the conduct of a audit follow-up?
- A. Determine feasibility of the audit
- B. Verify corrections taken to fix the reported non-conformities
- C. Verify legal compliance
- D. Verify the effectiveness of the implemented corrective actions
- E. Assign roles and responsibilities of observers
- F. Plan the next audit
正解：B、D
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 # 81
XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality objectives have been set for every employee in the organisation except top management. The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost. He asks for your opinion on whether this is the correct method of setting objectives.
How would you respond with the following options? Select three.
- A. Indicate that ISO 9001 requires a minimum of two quality objectives.
- B. Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organisation's requirements.
- C. Suggest that all employees undertake a training course on ISO 9001.
- D. Inform the Quality Manager that you will comment on the subject in your audit report.
- E. Advise the Quality Manager that, as an auditor, you cannot provide advice to the organisation on how it should operate its QMS.
- F. Suggest that the Quality Manager obtains external consultancy on the use of quality objectives.
- G. Suggest asking the certification body for guidance on this matter.
- H. Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly.
正解：B、D、H
解説：
According to the ISO 9001:2015 standard, clause 6.2.1 requires organizations to establish quality objectives at relevant functions, levels, and processes needed for the quality management system. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The quality objectives must also be measurable, monitored, communicated, and updated as appropriate.
In this scenario, the Quality Manager of XYZ Corporation has set quality objectives for every employee in the organization except top management. This has created a lot of resistance to the QMS, and the Chief Executive is asking questions about the cost and the method of setting objectives. The Quality Manager asks for your opinion as an auditor on whether this is the correct method of setting objectives.
As an auditor, you cannot provide advice to the organization on how it should operate its QMS. Your role is to assess the conformity and effectiveness of the QMS against the requirements of the standard and the organization's own policies and objectives. Therefore, you should respond with the following options:
B: Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organization's requirements: You can suggest that the Quality Manager should familiarize himself with the requirements of clause 6.2.1 and understand how they apply to his organization. He should also consider the context and the needs and expectations of interested parties when setting quality objectives. He should ensure that the quality objectives are aligned with the quality policy and the strategic direction of the organization.
C: Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly: You can inform the Quality Manager that you will evaluate the quality objectives during the audit and check whether they meet the requirements of clause 6.2.1. If you find any gaps or weaknesses in the quality objectives, you will raise an opportunity for improvement to help the organization improve its QMS. You will also verify whether the quality objectives are monitored, communicated, and updated as appropriate.
D: Inform the Quality Manager that you will comment on the subject in your audit report: You can inform the Quality Manager that you will document your findings and observations on the quality objectives in your audit report. You will also provide a summary of the audit results and any recommendations for improvement.
You will also indicate the level of conformity and effectiveness of the QMS.
These three options would help you to maintain your impartiality and professionalism as an auditor and to provide constructive feedback to the organization
質問 # 82
You are carrying out an annual audit at an organisation that offers home security services. You are interviewing the Quality Manager (QM) You: "Would you tell me about your management review process?" QM: "The senior management team plans to review the management system every six months. The review follows a set agenda and records are maintained." You: "May I see the records from the last two management reviews?" Narrative: The Quality Manager gives you the latest record, which shows the last management review took place nine months ago.
The Quality Manager then gives you the previous management review record, which took place one year before the latest review.
You: "Are there any other review reports in the last two years?
QM: "No, these are the only ones."
正解：
解説：
Explanation:
Nonconformity report
ISO 9001 Clause Number: 9.3.1 Nature of problem: Management review has not been conducted at the defined frequency. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "Top management shall review the organization's quality management system at planned intervals." Evidence: The last management review took place nine months ago, and the previous one took place one year before the latest review. The planned interval is six months.
質問 # 83
Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. 80% of complaints originate from five shops in the same region. Most of these complaints relate to customer laundry not being cleaned as customers require. The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it now. You learn that the shop managers were told to dismiss most of the complaints because of the poor quality of the laundered materials.
On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.
You raised a nonconformity against clause 8.5.1 of ISO 9001.
Based on the scenario, select the three options which best describe the evidence for raising such a nonconformity.
- A. The management failed in planning to replace obsolete equipment.
- B. The operators did not check the laundry before release to the customer.
- C. Customer complaints are not taken seriously by the organisation.
- D. The operators did not check the condition of the customer's product upon receipt.
- E. Shop managers were told to make excuses to customers with complaints.
- F. The organisation failed to maintain all of its equipment to an adequate standard.
- G. The organisation failed to control the laundry operations in 5 shops adequately.
- H. Some equipment used was not suitable for the laundry process.
正解：C、E、G
質問 # 84
Which one of the following options is the definition of the context of an organisation?
- A. Combination of internal and external issues that can have an effect on an organisation's approach to developing and achieving its objectives.
- B. Comparison of internal and external issues that can have an effect on an organisation's desire to achieve its objectives.
- C. Complexity of internal and external issues that can have an effect on an organisation's approach to developing and achieving its purpose.
- D. Coordination of internal and external issues that can have a positive or negative effect on an organisation's success.
正解：A
質問 # 85
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