PECB Certified ISO 9001 Lead Auditor v1.0

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Exam contains 64 questions

An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organization which manufactures sacrificial anodes for the oil and gas industry in marine environments. These are aluminum products designed to prevent corrosion of submerged steel structures. As one of the auditors, you find that the organization has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analyzed and reported as required by the customer. The Quality Manager explains that the Managing Director authorized 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: (Choose three.)

  • A. Advise that he will think about the clause and announce his decision during the Closing meeting.
  • B. Try to obtain a consensus between you and the second auditor after a discussion of the different options.
  • C. Immediately overrule the objection of the second auditor with no discussion of the clause.
  • D. The audit team leader will refer to the quality manager to determine which clause they agree with.
  • E. Immediately agree with the second auditor that clause 9.1.1 would be better.
  • F. Review the evidence with you and the second auditor, and then decide which clause of ISO 9001 would best apply.
  • G. Invite you and the second auditor to fully explain your point of view and then decide which clause to select.
  • H. Suggest that neither clause is accurate and instead propose clause 9.1.3 as the best one for the nonconformity.


Answer : BFG

A Health Trust has contracted with Servitup,a catering services company that has been certified to ISO 9001 for one year. It provides services to 10 small rural hospitals in remote locations involving the purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for ward service by hospital staff. You, as auditor, are conducting the first surveillance audit at one site with the Deputy Catering Manager (DCM).
DCM: “I apologize for the absence of the Catering Manager. He has called in sick today and we are really short of staff.”
You: “I see. It really shouldn’t affect the QMS the audit can progress as normal.”
DCM: “The Catering Manager set up the system. I’m afraid I’m not as familiar with it as he is.”
You: “OK, let’s start with the Quality Policy. What are the main issues for the QMS here?”
DCM: Give me a minute. I need to look at the Quality Policy on the noticeboard in his office.
You find that two internal audits have been carried out in the first year by the Catering Manager. One of them indicates that complaints from patients are increasing in number, mainly due to food being served too cold. The DCM comments that the trolley thermometer is often unreliable.
Which two of the following actions would be “corrective action” in dealing with the complaints? (Choose two.)

  • A. Keep records of patient complaints of cold food.
  • B. Purchase a new thermometer to replace the unreliable one used for the ward trolleys.
  • C. Monitor and record the temperature of food on the trolleys against defined standards before release to the wards.
  • D. Calibrate thermometers more frequently to ensure the accuracy of readings for food temperature on the trolleys.
  • E. Request patients taste the food to check if it is too cold.
  • F. Plug trolleys into ward electricity sockets to heat food to the correct temperature after a patient complains.


Answer : BD

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 serios 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 learn leader) to the General Manager’s request?

  • A. Please, tell him that this nonconformity has been previously accepted by the quality manager during the audit and will stand. I will include it in the report, along with the concern of the General Manager about it.
  • B. Please tell him that I will phone him in two days and will discuss the issue. Could you please give me his mobile phone number?
  • C. OK, I will get in contact with my company tomorrow to ask for instructions on what to do with this non-conformity.
  • D. OK. Please, let me review the message. I will try to see if I can change the text of the nonconformity if necessary. Let’s take a 10-minute break, as I would like to discuss this issue with the audit team.


Answer : D

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 Quality Manager’s request?

  • A. The scope of the audit does not allow auditors to review actions taken in response to the nonconformity. There would not be enough time for the full cycle of corrective action to take effect
  • B. OK. Let’s all go to the workshop to see the supervisor. I hope he will be able to explain what they did to correct the nonconformity and prevent its recurrence
  • C. OK. I will record in the audit report that ‘nonconformity 2’ was closed during the Closing meeting
  • D. Let me review the message and documents, and I will give you my answer in a few minutes


Answer : D

TIX provides services to the informatic equipment of large organizations. 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 6 pm with the general manager, quality manager and service manager at the meeting room.
At 6 pm, when the audit team enters the meeting room, only two people are present and waiting form them: the Health and Safety supervisor and the warehouse supervisor. Neither have participated in the audit.
The dialog 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 managers?

  • A. We will hear what you were asked to tell us and 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 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.
  • C. 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.
  • 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.


Answer : C

The ISO 9001 clause 5.1.1 states top management shall demonstrate leadership and commitment with respect to the quality management system.
In the context of the ISO 9001 management system certification, select the one correct description of top management’s responsibilities.

  • A. Depending on the size, complexity and business context, some of the 5.1.1 requirements can be excluded.
  • B. Top management needs only to comply with 50% of the 5.1.1 requirements.
  • C. Top management shall ensure that all requirements are fulfilled.
  • D. Depending on the organization’s available resources, top management can comply with one or more of the 5.1.1 requirements.


Answer : C

An ISO 9001 certified organization sells packaged food. To maximize the benefits of third-party certification to the organization and stakeholders, the organization has labelled their product ‘ISO 9001 certified product’ and is selling it as ‘quality food’.
Which two of the following describes this situation in the context of the purpose and benefits of third-party ISO 9001 certification? (Choose two.)

  • A. ISO 9001 certification can be used to identify opportunities for improvement of the management system
  • B. ISO 9001 certified food can increase customer confidence and satisfaction
  • C. ISO 9001 certified food can increase revenue
  • D. ISO 9001 is not for product certification
  • E. The organization will be able to increase its market share
  • F. The product from an ISO 9001 certified organization will taste better


Answer : AD

Read the following role descriptions. Select two roles that are not directly involved in the audit process. (Choose two.)

  • A. An auditor-in-training – a person who accompanies the audit team leader or team members during the audit.
  • B. A technical expert – a person who provides specific knowledge or expertise to the audit team but is not normally an auditor.
  • C. An audit team leader- a person responsible for managing an audit until the audit is completed.
  • D. An interpreter – a person who witnesses the audit to assist the auditors with language issues.
  • E. An observer – a person who sees the performance of the audit team leader, audit team members and/or auditee.
  • F. A guide – a person who is appointed by the auditee to assist the audit team during the audit.


Answer : DE

Knowledge is one of the requirements of the auditor’s competence. Select two from the following topics of generic knowledge that apply to every member of an audit team auditing an ISO 9001 quality management system.

  • A. Detailed requirements of all the auditee’s interested parties
  • B. How to review the requirements for products and services
  • C. How to select and determine audit methods
  • D. Organization’s expansion plans for the next 2 years
  • E. Organization’s processes, procedures and work instructions
  • F. Organization’s recruitment policies


Answer : BC

DRAG DROP -
In the context of a management system audit, identify the sequence of a typical process for collecting and verifying information. The first one has been done for you.
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.



Answer :

In the context of a third-party certification audit, it is very important to have effective communication. Which is not the responsibility of the audit team leader?

  • A. During the opening meeting, confirm formal communication channels between the audit team and the auditee.
  • B. Ensuring that the auditees attend the audit as agreed in the plan.
  • C. Ensuring that the functions included in the audit plan are audited even if there is not much activity in them.
  • D. Planning formal communication arrangements, so an auditee can communicate with the auditor at any time during the audit.


Answer : B

In a third-party audit to ISO 9901, select two options of when the organization is required to act in response to reported findings. (Choose two.)

  • A. A finding of conformity is reported.
  • B. A finding of good practice is reported.
  • C. A major non-conformity is raised.
  • D. A minor non-conformity is raised.
  • E. A recommendation is given in the report.
  • F. An opportunity for improvement is raised.


Answer : CD

Confidence in the audit process and its ability to achieve its objectives depends on the competence of those involved in performing audits:
According to ISO 19011, select the two participants who need to be competent in performing audits. (Choose two.)

  • A. Auditor(s)
  • B. Auditee
  • C. Guides
  • D. Observers
  • E. Translators
  • F. Audit team leaders


Answer : AF

Select the two activities which pertain to Third-Party Audit. (Choose two.)

  • A. A Certification Body is auditing an organization for its conformance to ISO 9001.
  • B. An auditing firm was hired by organization XYZ to audit a training company that will supply online training services to XYZ.
  • C. An organization audited to implementation of its management system to verify the effectiveness of its implementation.
  • D. An organization decided to outsource their auditing requirements to a consulting organization.
  • E. An organization was audited by the environmental authority for its ability to comply with statutory requirements in relation to its expansion plans.
  • F. An organization XYZ sent to their QMS Manager to evaluate a consulting firm to verify if it meets their requirements for help in meeting ISO 9001.


Answer : AE

Which two of the following work documents are not required for audit planning by an auditor conducting a certification audit? (Choose two.)

  • A. A career history of the quality manager
  • B. A checklist
  • C. A list of interested parties
  • D. An audit plan
  • E. An evidence sampling strategy
  • F. An organisation’s financial statement


Answer : AF

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Exam contains 64 questions

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