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Viewing page 8 out of 9 pages
Viewing questions 71-80 out of questions
Questions # 71:

Who is responsible for the development of surveillance activities?

Options:

A.

A representative of the auditee ' s top management

B.

The certification body

C.

The audit team leader

Questions # 72:

An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oll and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged

steel structures. You, as one of the auditors, 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 release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.

Which of the following options for the best description of the nonconformity?

Options:

A.

A retrospective concession was not sought from the customer once the test results had been approved by the Quality Manager.

B.

Release of the product without acceptable test results has been accepted by the customer for Project DK.

C.

Products for Project DK have been released before product approval through the quality control process.

D.

The untested product was not recalled until the galvanic efficiency of the anodes was verified.

Questions # 73:

XYZ Corporation employs 100 people, and during a Stage 1 certification audit, certain issues are identified with the Quality Management System (QMS). Which two options describe the circumstances in which you could raise a nonconformity against Clause 6.2 of ISO 9001:2015?

Options:

A.

Quality objectives are not being implemented by the organisation ' s personnel.

B.

The consultant has not interpreted ISO 9001 correctly.

C.

Establishing quality objectives did not include top management.

D.

Quality objectives were not established in alignment with the organisation ' s quality policy.

E.

The organisation cannot afford to undertake quality objectives all at once.

F.

Quality objectives are not maintained as documented information.

Questions # 74:

XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS)

documentation, you find that quality objectives have been set for every employee in the organisation except top management. 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. He asks for your opinion on whether this is the correct method of setting objectives.

How would you respond with the following options? Select three.

Options:

A.

Suggest asking the certification body for guidance on this matter.

B.

Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organisation ' s requirements.

C.

Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly.

D.

Inform the Quality Manager that you will comment on the subject in your audit report.

E.

Indicate that ISO 9001 requires a minimum of two quality objectives.

F.

Suggest that all employees undertake a training course on ISO 9001.

G.

Advise the Quality Manager that, as an auditor, you cannot provide advice to the organisation on how it should operate its QMS.

Questions # 75:

During an ISO 9001 audit of an electric cable manufacturer, you are reviewing the customer file for XYZ Construction in the Sales Department. This contract specifies that the installation configuration of the cable runs should meet national fire safety standards for Category A. You ask to see the test results for the specified configuration but are told that they are not available as they have never produced Category A cable before.

When interviewing the Technical Director, you ask about the tests for XYZ Construction. He advises that the order was never reviewed technically but shows you test results that satisfy Category B, which is less stringent.

You discover that he had a meeting with the customer to request approval of a Category B configuration. He provided the minutes of a meeting at which the customer agreed to accept the new test results subject to an agreed discount on the contract price.

Select the two statements for which there is evidence of a non-conformity to ISO 9001.

Options:

A.

Cable runs for Category B do not meet national fire safety standards.

B.

XYZ Construction did not reissue the order for Category B cables.

C.

The order from XYZ Construction was not reviewed.

D.

Test results for Category A cable runs were not documented.

E.

The organisation accepted an order without confirming its ability to meet customer requirements.

F.

The organisation did not determine the intended use of the cables.

Questions # 76:

You are conducting a Stage 2 audit at an organisation that services refrigeration equipment for a large customer base. The scope of certification is “Provision of refrigeration equipment maintenance and repair services”. You are interviewing the Managing Director to learn more about the organisation and to explore how the requirements for policy, objectives, and risks and opportunities in ISO 9001 are addressed.

The Managing Director explains that they only use sub-contract refrigeration engineers and do not have any full-time refrigeration engineers, which helps to optimise overhead costs.

The Managing Director adds that the ISO 9001 requirements for the competence of personnel extend to both sub-contract and full-time staff.

You then asked 2 of the sub-contract engineers what they could do to contribute to the effectiveness of the quality management system, they replied stating that “we are not really sure as we have not been told how we could contribute”. The Managing Director added that this is not applicable as they only use sub-contractors who operate ISO 9001 certificated quality management systems. The documented information provided to the auditor confirms this.

Which clause in ISO 9001 has not been fulfilled in this instance?

Options:

A.

7.4 Communication – because the sub-contract engineers claim they have not been told of their role in the QMS.

B.

7.2 Competence – because the sub-contract engineers are not competent to work in a QMS environment.

C.

7.3 Awareness – because the sub-contract engineers do not know of their role in the QMS.

D.

7.5 Documented information – because the sub-contract engineers did not have training records in QMS awareness.

Questions # 77:

Even though past audits have highlighted a consistently large number of nonconformities within an organisation ' s design team, the organisation has not varied the frequency or duration of audits on its audit plan.

The decision for whether this situation is acceptable or not should be governed by which of the following?

Options:

A.

A risk-based approach to the audit programme

B.

The authority of the audit team leader

C.

The availability of competent internal auditors

D.

The organization ' s reasoning behind the lack of change to the audit plan

Questions # 78:

You work as an external quality consultant for an organisation, ' A ' , which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit a supplier, ' B ' , to ISO 9001 which provides packaging materials to your organisation. It is 4 pm and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled at 5 pm.

You, as Audit Team Leader, audited top management. You explain to the audit team that you identified two nonconformities:

a. There is no documented information on Top Management Reviews, as required in clause 9.3 of ISO 9001:2015.

b. There is no evidence of Top Management Commitment as required in clause 5.1 of ISO 9001:2015. (e.g., not ensuring the availability of resources

to operate the QMS, not ensuring the establishment of objectives, no promotion of improvement, no promotion of the process approach).

All agreed to present these two nonconformities. They went to meet the Top Management of ' B ' and noticed that the General Manager and three other managers (Production, Human Resources, and Sales) were present in the meeting room.

Considering the seriousness of the two nonconformities to Top Management, as audit team leader, from the following select the best option:

Options:

A.

Present the nonconformities to the whole group and inform that you will recommend your company to remove them from the approved suppliers list.

B.

Present the nonconformities to the managers, inform them that the report will be sent within 10 days, close the meeting and leave the site.

C.

Ask the General Manager to have a private conversation in which you present the nonconformities only to him because of their sensitive nature.

D.

Present the nonconformities to the whole group and analyse with them how to overcome this situation.

Questions # 79:

What competence, among others, should each audit team member have?

Options:

A.

Knowledge of the industry in which the auditee operates.

B.

Knowledge of the risk-based approach to auditing.

C.

Expertise in each domain to be audited.

D.

A formal degree in quality management.

Questions # 80:

You are conducting an ISO 9001 audit of a Materials Recycling Facility (MRF). The organisation processes

waste plastics into raw materials for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process. You interview the line supervisor.

You: " Why are these plastic items being rejected at this stage? "

Auditee: " They do not meet our processing standards. "

You: " What is the reason for that? "

Auditee: " These items are likely to damage the machinery down the line. They can also compromise our

quality standards. We need to protect our reputation for good quality output materials. "

You: " What happens to the rejected items? "

Auditee: " Some get melted down in another process later on and some are disposed of as waste products that cannot be recycled. "

You: " What happens to the waste products? "

Auditee: " I ' m not sure. I suppose they go to landfill. "

Which two. of the following actions would you take to investigate further?

Options:

A.

Check the process for handling nonconforming items.

B.

Ask to review the percentage of waste materials.

C.

Find out if operators have regular hearing tests.

D.

Determine what happens to the waste products.

E.

Ask about operator PPE (Personal Protective Equipment).

F.

Determine whether there are quality objectives for reducing rejected material.

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Viewing questions 71-80 out of questions
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