QUESTION 47
Select the word that best completes the sentence:

QUESTION 48
You are auditing an organisation that has been certificated to ISO 9001 for ten years. The organisation is a privately-owned, multi-site car tyre fitting organisation. You are auditing one of the sites. You are auditing the car tyre fitting service. You are interviewing the Site Manager (SM).
You: “Would you explain the car tyre fitting service?”
SM: “Of course. Customers typically call us by phone with their requirements. We ask them what they want.
We check whether we have the tyres
they need in stock. If we don’t have the tyres in stock, we contact our supplier to confirm when they would be able to supply the tyres. We then determine the cost. We then check what availability we have in our busy schedule to fit the new tyres. We then inform the customer with details of cost and when we can fit the tyres. If the customer is happy to proceed with the booking, we update our Work Schedule. The same process applies for customers who walk into our office and for online requests.” You: “What information do you retain should there be a defect reported by a manufacturer of tyres that you have fitted?” SM: “We maintain records of customer names, addresses and contact phone numbers. We maintain a record of the type of tyre fitted and the tyre manufacturers batch information. We also maintain a record of the registration numbers of the vehicles we have fitted tyres to. All records are in our Work Schedule.” Which two of the following options you would take to enable you to gather further audit evidence to validate what the Site Manager has told you?

QUESTION 49
Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?

QUESTION 50
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?

QUESTION 51
At the end of a second-party audit, the audit team enters the meeting room to hold the closing meeting; only two people are present and waiting for them: the Health and Safety supervisor and the Administrative Officer.
Neither has participated in the audit. However, the team had previously agreed with the auditee Quality Manager on two nonconformities identified during the audit (NC1 and NC2).
They said:
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 to the emergency.” The Administration Officer: “Concerning ‘nonconformity 2’, the General Manager left a message asking us to tell you that he does not accept it and requests you not to include it in the audit report. Here is a note in which he explains why.” Which one of the following would be your preferred answer (as team leader) to the General Manager’s request?

QUESTION 52
Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?

QUESTION 53
In the context of a third-party audit, match the event with the responsibility for conducting it.

QUESTION 54
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 and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years. The organisation uses a software programme called SWIFT, which is used to record sales, plan production, purchase supplies, print despatch notes, track new product development, perform traceability exercises, carry out mass balance checks, raise invoices, create budgets, and support financial control.
You are nearing the end of the audit and you are reviewing your audit notes. You notice a recurring trend concerning the SWIFT database as shown below:

You ask the Quality Manager to explain how the SWIFT database is controlled. You learn that the Operations Director is responsible for determining and progressing SWIFT software updates. You decide to meet the Operations Director (OD).
You: “Good afternoon.”
OD: “Good afternoon.”
You: “What responsibility do you have concerning the SWIFT database?”
OD: “I maintain it. If anyone wishes to propose an update to the database, they send me an email with details of their proposal. I then either process the database update myself, or I send the request to the consultant who designed the database 20 years ago. The necessary software changes are made, and the amended software is immediately released to users.” You: “Would you explain how the software amendments are controlled?” OD: “Of course. I personally update every computer myself.” You: “Do you inform the database users of the changes?” OD: “No I don’t. They find out for themselves by using the software, or they come to see me if they have any questions.” You: “How do you ensure that the database users use the latest version?” OD: “That’s easy, I update every computer myself.” You: “During the audit, I noted there were several versions of SWIFT in use (you refer to your audit notes).” OD: “I know. That’s because some versions work better than others, and depending on user needs and experiences, we allow users to revert to using an earlier version if they find it works better for them.” Based on the scenario, which two of the following statements are true? There is evidence of nonconformity with a requirement defined in …

QUESTION 55
XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you conduct a certification audit at Stage 1. When reviewing the quality management system (QMS), you find that the objectives have been defined by an external consultant using those of a competitor, but nothing is documented.
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.
Which two options describe the circumstances in which you could raise a nonconformity against clause 6.2 of ISO 9001?

QUESTION 56
You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers.
You are interviewing the Quality Systems Manager (QSM).
You: “What risks and opportunities have the business identified?”
QSM: “I’1l show you. This was discussed with the Managing Director at the latest management review.” Narrative: The QSM shows you the latest management review record and points to the following table:

You: “How is the business planning to address these risks and opportunities?” QSM: “The MD said that they already knew about them so it was not necessary.”

QUESTION 57
An organisation wants to certify their ISO 9001:2015-based QMS for the first time. Arrange the activities in the correct sequence from 2 to 5.
To complete the sequence, click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.

QUESTION 58
You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation 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.

QUESTION 59
Which two of the following roles do not contribute to the audit outcomes?

QUESTION 60
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. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry.
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 at the moment. You learn that the shop managers were told to dismiss most of the claims on the basis 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.
When reviewing the customer complaint file, you find that the organisation is facing a legal dispute with a customer over damage to an expensive cashmere coat.
Select the best option for how this should be handled by the Quality Management System.

QUESTION 61
At the end of a second-party audit, the audit team enters the meeting room to hold the closing meeting; only two people are present and waiting for them: the Health and Safety supervisor and the administrative officer. Neither has participated in the audit. However, the team had previously agreed with the auditee Quality Manager on two nonconformities identified during the audit (NC1 and NC2).
They said:
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 to the emergency.” Administration officer: “Our quality manager, before leaving, left a written message about ‘NC2’. He declares that the correction and corrective action have been already implemented and has attached some documents to the message as evidence of these actions. Therefore, he expects that ‘NC2’ will not be included in the report.” Which one of the following would be your preferred answer to the Quallty Manager’s request?

QUESTION 62
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.

QUESTION 63
Which one of the following documents addresses audit time calculation for third-party certification audits?

QUESTION 64
The Closing meeting of a second-party audit was planned for 6 pm with the general manager and the quality manager.
At 6 pm, when the audit team enters the meeting room, only the Quality Manager is present and walting for them.
The dialogue among them is as follows:
Auditor team leader: “Good evening, could you please inform the general manager that we are ready to start with the closing meeting?” Quality manager: “Good evening. I am sorry to inform you that the general manager will not be able to attend the meeting. He will try to participate virtually to make some closing remarks.” Auditor team leader: “OK. We identified seven nonconformities – these are the reports. Could you please review them and sign them?” Quality manager: “OK. As you know, I reviewed them after yesterday’s meeting and accept of all them, where shall I sign?” General manager (from speakers in the room and addressing the quality manager): “Hold on! Do not sign the two nonconformities related to ABC Bank! I have just checked, and we did not provide any services to ABC Bank during September! You can sign the remaining five nonconformities.” How would you proceed with the audit? Select one.

QUESTION 65
According to ISO 19011, what two activities take place during the conduct of a audit follow-up?

QUESTION 66
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation which manufactures sacrificial anodes for the oil and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. As one of the auditors, you find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised the release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
During the audit team meeting in preparation for the Closing meeting, the second auditor disagreed with the clause of ISO 9001 selected for the above nonconformity. He thinks it should be clause 9.1.1.
Choose three options for how the audit team leader should best respond to the situation:

QUESTION 67
Select the words that best complete the sentence:

QUESTION 68
According to ISO 19011, what two activities take place during the conduct of a audit follow-up?

QUESTION 69
The following list gives examples of records that may be evidence of how an organisation has fulfilled the requirements of clause 8.4 of ISO 9001. Match the records to the appropriate requirement of clause 8.4.