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質問 # 17
According to the guidance provided in ISO 19011, a second-party opening meeting should cover many elements.
From the following options, select the four items that should not be included in the opening meeting.
正解：C、D、E、F
質問 # 18
ABC is a worldwide fast-food organisation. One of the branches, in downtown Cape Town, decided to implement an ISO 9001 quality management system and you are the audit team leader (with two other auditors) that will carry out the certification audits, Stage 2.
ABC receive the orders by phone or internet; some of the employees deliver the ordered food to indicated addresses. The normal menu includes 15 different types of hamburgers; however, in the last two weeks, due to a shortage of a special type of meat, they can only prepare six of the 15 varieties.
During the internal meeting of the audit team, you ask one of the auditors to describe what she has observed. She audited the reception of orders from customers (via phone or internet) and the communication of the orders to the kitchen. She noticed that the menu offering food on the website is still the normal one, with 15 different hamburgers, and during a 30-minute period, she observed many customers reluctantly accepting something other than the hamburger they preferred.
You, as audit team leader, inform the Quality Manager of your concern about the major nonconformity, since you consider this a serious breach of the basic principles of quality that lasted two weeks without action being taken.
Right at the beginning of the Closing meeting, you discuss the nonconformity with the General Manager.
She got quite upset and said she was going to make a complaint to the certification body and left the room; the Quality Manager was the only member of ABC left with the audit team. The Quality Manager said the General Manager would not come back to the meeting.
What would you do? Choose the best from the following options:
正解：C
質問 # 19
You are conducting a third-party audit to ISO 9001 and interviewing the Training Manager. She explains that training is more important than ever because the organisation has had to reduce the number of staff employed. Many of the remaining staff are now required to be 'multi-skilled'. You ask to see plans for the multi-skilling training and are shown plans that look comprehensive, and include both 'on the job" training and internal and external training courses.
The records indicate that several staff required parts of their training to be repeated one month after the first training was provided. You ask why this was needed and are told that an investigation of customer complaints identified that several staff members did not complete certain tasks in the correct manner. The extra training was therefore recommended as a corrective action.
Based on this interview, which two of the tollowing audit trails would be the most appropriate to follow?
Select the two most appropriate audit trails from the following.
正解：B、F
解説：
When conducting a third-party audit to ISO 9001, especially in the context of training and corrective actions taken due to customer complaints, the most appropriate audit trails to follow would be:
A: Ask if customer complaints had ceased since the multi-skilled training finished. This audit trail is relevant because it directly relates to the effectiveness of the corrective action taken. If customer complaints have decreased or ceased, it could indicate that the additional training was effective1.
F: Review records to assess if all planned training has been completed. This trail is important to ensure that the training plan has been fully implemented and to verify that all staff members have received the necessary training. It also helps in assessing the adequacy of the training in terms of content, frequency, and outcomes1.
These two trails, A and F, are closely linked to the issue of customer complaints and the organization's response to them. They provide insight into whether the actions taken were suitable and whether they have led to improvements in staff performance and customer satisfaction1. The other options, while potentially useful, do not directly address the immediate concern of the effectiveness of the corrective actions taken in response to the customer complaints1.
質問 # 20
You are carrying out an annual audit at an organisation that has been certificated to ISO 9001 for two years.
The organisation offers home security
services. The scope of the quality management system covers alarm installation, alarm servicing, alarm monitoring and response. The business operates from a single office and employs subcontract installers and service technicians across the country.
You have just completed the opening meeting. You are interviewing the Managing Director (MD).
You: "I would like to gain an understanding of how the quality management system has been supporting your business and its strategic direction." MD: "We are continuing to face difficult times. The market is extremely competitive, and customers typically look for the least expensive option when choosing home security services. We have not yet seen any business benefit from our quality management system." You: "Tell me how you determine external and internal issues." MD: "We use SWOT analysis (Strengths Weaknesses, Opportunities, Threats)." You: "How have the outputs from your SWOT been used?" Select two of the following audit trails would you take to explore the extent to which the SWOT analysis and the outputs from this have been used to enable the business to achieve the intended results(s) of its quality management system according to ISO 9001.
正解：B、C
解説：
According to ISO 9001:2015, clause 4.1, the organisation must determine the external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended results of its quality management system. The organisation must also monitor and review the information about these issues. SWOT analysis is a tool that can help the organisation to identify its strengths, weaknesses, opportunities, and threats. However, the SWOT analysis alone is not sufficient to comply with the requirement, as the organisation also needs to review the information periodically and update it as necessary. Therefore, one audit trail would be to establish how the organisation reviews information about external and internal issues, such as how often, by whom, using what criteria, and with what results. 123 According to ISO 9001:2015, clause 10.3, the organisation must continually improve the suitability, adequacy, and effectiveness of the quality management system. The organisation must also consider the results of analysis and evaluation, and the outputs from management review, to determine if there are any needs or opportunities for improvement. SWOT analysis can help the organisation to identify the areas where improvement is needed or possible, such as addressing the weaknesses and threats, or exploiting the strengths and opportunities. However, the SWOT analysis alone is not sufficient to comply with the requirement, as the organisation also needs to take actions to implement the improvement, such as setting objectives, allocating resources, assigning responsibilities, and evaluating the effectiveness. Therefore, another audit trail would be to establish what actions were taken to improve the QMS, such as what, when, by whom, how, and with what results. 124 References:
1: ISO 9001:2015 - Quality management systems - Requirements
2: Advisera, "Context of the organization in ISO 9001:2015 explained", https://advisera.com/9001academy
/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/
3: ISO Templates, "ISO 9001 - Clause 4: Context of the organisation explained", https://resources.iso- templates.com/blog/iso-9001-clause-4-context-of-the-organisation-explained
4: Advisera, "How to implement continual improvement in ISO 9001", https://advisera.com/9001academy
/knowledgebase/how-to-implement-continual-improvement-in-iso-9001/
質問 # 21
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:
A screenshot of a chat Description automatically generated
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 # 22
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