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

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Question # 4

ABC is a service organisation that cleans and irons bed and table linen for four large hospitals in the city centre. It claims to meet ISO 9001:2015 requirements. During an internal audit, an auditor observes that

machine No. 4 is being operated with the three variables outside the limits established in the applicable documented procedure SP-701. The auditor has decided to raise a nonconformity.

Which six elements should be included in the nonconformity report?

A.

Condition of the table linens upon receipt from the hospital

B.

Applicable procedure: SP-701

C.

Competence record of the machine operator

D.

Identification number of the washing machine

E.

Manufacturer of the washing machine

F.

Name of the Quality Manager

G.

Number of the production order

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Question # 5

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:

A.

The audit team leader will refer to the quality manager to determine which clause they agree with.

B.

Advise that he will think about the clause and announce his decision during the Closing meeting.

C.

Immediately agree with the second auditor that clause 9.1.1 would be better.

D.

Immediately overule the objection of the second auditor with no discussion of the clause.

E.

Invite you and the second auditor to fully explain your point of view and then decide which clause to select.

F.

Review the evidence with you and the second auditor, and then decide which clause of ISO 9001 would best apply.

G.

Suggest that neither clause is accurate and instead propose clause 9.1.3 as the best one for the nonconformity.

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Question # 6

"A set of interrelated or interlacing elements of an organization to establish policies and objectives, and processes to achieve those objectives" is the definition of a/an:

A.

Management system

B.

Standard

C.

Organization scope

D.

Quality manual

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Question # 7

Select one of the options that best describes the purpose of conducting a document review:

A.

To establish nonconformity in the documented system with audit criteria and to gather information to compile the audit report.

B.

To confirm the conformity of the system, where documented, with audit criteria and to gather information to support the audit findings.

C.

To reveal whether the documented system is nonconforming with audit criteria and to gather evidence to support the audit report.

D.

To decide about the conformity of the documented system with audit standards and to gather findings to support the audit process.

E.

To detect any nonconformity of the system, if documented, with audit criteria and to identify information to support the audit plan.

F.

To determine the conformity of the system, as far as documented, with audit criteria and to gather information to support the audit activities.

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Question # 8

According to ISO 9000, what is quality?

A.

The ability of an object to realize an output that will fulfill the requirements for that output

B.

The degree to which a set of inherent characteristics of an object fulfills requirements

C.

A set of conditions under which work is performed

D.

The efficiency with which resources are utilized in achieving objectives

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