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ISO-9001-Lead-Auditor Exam Dumps - QMS ISO 9001:2015 Lead Auditor Exam

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Question # 33

At the end of an initial third-party certification audit, the audit team enters the closing 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 a major non-conformity.

They said:

Health and Safety Supervisor says: " Good evening. We are sorry to inform you that the General Manager was convened by the CEO of the organization to analyze an unexpected, very serious situation with the personnel.

The Administration Officer: " Concerning the major non-conformity, the General Manager called us on the phone asking us to tell you that he agrees with the non-conformity and that the correction will be taken this week, and the corrective action is to be implemented before the end of this month. He also asked us to tell you that it would be a pity to postpone the recommendation for certification due to this ongoing issue that can be solved so easily. Do you want me to describe to you what he told me he would do? "

Which one of the following would be the correct response (as team leader) to the General Manager ' s request?

A.

OK. Then I will get in contact with my organization for instructions on what to do with this non-conformity.

B.

No, but please tell the General Manager that I will include in the report the non-conformity as an ongoing issue and also include his suggestion about certification.

C.

No, but please tell the General Manager that I will phone him in two days and will discuss the issue. Could you please give me his mobile phone number?

D.

OK. Please let me review his message. I will try to see if I can delay my train schedule for a couple of hours and review the proposed correction and corrective action.

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Question # 34

You are an auditor from a construction organisation who is conducting a second party audit to ISO 9001 at a steel rolling mill producing

structural steelwork. When auditing the rolling process, you find that the operator who is unloading the furnace does not use the

adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.

You: " How do you tell when the billet is ready for the rolling stage? "

Operator: " I ' ve done this job for 20 years. I can tell by the bright red colour. "

You: " What happens if the colour is wrong? "

Operator: " The billet goes back into the furnace. "

You: " Is the pyrometer ever used? "

Operator: " Only in borderline cases. "

You continue to interview the operator and find that around 25% of the billets are sent back to the furnace. This includes 80% of the borderline cases.

Select three options that would provide evidence of conformance with clause 9.1.1 of ISO 9001.

A.

Periodic analysis of the results of temperature checks.

B.

Certification of conformance to national standards from the manufacture of the pyrometer.

C.

An increase in the use of the pyrometer by operators.

D.

Maintenance plan for the furnace.

E.

A procedure that provides instruction in taking billet temperature.

F.

Planning for monitoring and measuring the billet temperature.

G.

A quality objective to achieve lower recycle rates for billets.

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Question # 35

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 ...

A.

clause 7.1.3 Infrastructure

B.

... clause 7.1.4 Environment for the operation of processes

C.

clause 7.5.1 Documented information - General

D.

... clause 7.5.2 Documented information - Creating and updating

E.

... clause 7.5.3 Control of documented information

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Question # 36

Select the word that best completes the sentence:

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Question # 37

Scenario 3:

Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.

To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.

The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.

The audit team began by gathering information about Fin-Pro’s understanding of ISO 9001 requirements. While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.

The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the company’s working environment (social, psychological, and physical conditions).

The audit team analyzed the evidence and prepared an audit report with findings and conclusions.

Which statement below represents the level of responsibility demonstrated by the audit team in scenario 3?

A.

No negligence, the audit team has demonstrated diligence during the audit and followed the best practices.

B.

Ordinary negligence, the audit team has demonstrated lack of diligence.

C.

Gross negligence, the audit team has demonstrated a total lack of diligence.

D.

Willful misconduct, the audit team intentionally disregarded audit procedures.

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Question # 38

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.

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Question # 39

Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.

A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC ' s top management and then drafted the audit conclusions.

In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.

Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.

Based on the scenario above, answer the following question:

Scenario 6 indicates that although the top management did not agree with the audit findings, the audit team began preparing the audit report. Is this acceptable?

A.

No, the audit report should have been prepared before the audit findings were presented in the closing meeting

B.

No, during the closing meeting, the audit team had to inform the auditee about the complaint and appeal handling process

C.

Yes, the audit team had to begin preparing the audit report although the top management did not agree with the audit findings

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Question # 40

What should the auditor document during the Stage 1 audit?

A.

The main processes of the auditee

B.

The interviews with the auditee’s employees

C.

The observations that could result in nonconformities during the on-site audit

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