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.)
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.)
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?
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?
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?
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.
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.)
Answer : AD
Read the following role descriptions. Select two roles that are not directly involved in the audit process. (Choose two.)
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.
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?
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.)
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.)
Answer : AF
Select the two activities which pertain to Third-Party Audit. (Choose two.)
Answer : AE
Which two of the following work documents are not required for audit planning by an auditor conducting a certification audit? (Choose two.)
Answer : AF
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