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PECB ISO-9001-Lead-Auditor Dumps

QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

Question 1

Select which one of the following statements is true.

Options:

A.

The team leader shall be an auditor that is qualified in the scheme.

B.

An audit team can include non-qualified auditors.

C.

A technical expert can replace a qualified auditor on an audit team.

D.

Audits leading to auditor qualification are undertaken annually.

Question 2

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.

Options:

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.

Question 3

Which two of the following aspects of a quality management system must the organisation continually improve?

Options:

A.

Suitability

B.

Adaptability

C.

Effectiveness

D.

Responsiveness

E.

Efficiency

F.

Applicability

Question 4

In the context of a third-party audit, select the issue which is not expected to be included in the audit plan.

Options:

A.

Number of sites to be audited

B.

Risk to achieving audit objectives

C.

Expectations of the organisation's management

D.

Scope of the audit

Question 5

Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer

complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry. The Quality

Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it at the moment. You learn

that the shop managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials.

On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.

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Options:

Question 6

Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?

Options:

A.

Decreased number of nonconforming products in all stages of the manufacturing cycle

B.

Decreased number of management system nonconformities

C.

Consistently provide products that meet customers' requirements

D.

Increased profits

E.

Decreased number of warranty claims

F.

Enhanced customer satisfaction

Question 7

Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.

Options:

A.

Concession

B.

Correction

C.

Corrective action

D.

Preventive action

Question 8

A Health Trust has contracted with Servitup, a catering services organisation which has been certified to ISO 9001 for 1 year. It provides services to ten, small rural

hospitals in remote locations involving purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for ward service by hospital

staff. An auditor is conducting the first sole surveillance audit at one site with the Deputy Catering Manager (DCM).

At the closing meeting attended solely by the DCM, the auditor informs him that he has found numerous gaps in the QMS processes which lead him to consider

recommending suspension of the organisation's certification. He is particularly concerned with the evidence that patient health is being adversely affected by produce

stored beyond its safe consumption date, poor kitchen hygiene and undercooked meals. The DCM says that he cannot make any decisions about these issues in the

absence of the Catering Manager due to illness but will write everything down and report to the Catering Manager.

Which two actions should you take in the context of the audit?

Options:

A.

Close the meeting immediately after the DCM's response and advise that the issues will be addressed at the next surveillance visit.

B.

Call the individual(s) managing the audit programme to explain the situation and recommend immediate suspension of certification to protect the integrity of the Certification Body.

C.

Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due course.

D.

Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work.

E.

Recommend that all personnel should be given urgent in-depth training in the QMS.

F.

Thank the DCM for his time and express an expectation that improvements will be made in the QMS.

Question 9

Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).

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Options:

Question 10

You work for organisation A. You are asked to lead an internal audit of A's quality management system. It has a head office in Plant A1 and a second Plant A2 nearby. Due to the COVID-19 pandemic, production in A2 was discontinued and it was rented to a logistics organisation B, not related to A. There are no A employees working in A2. Organisation A expects to reassume production in A2 as soon as possible.

Which of the following actions would you consider appropriate when planning the internal audit of A's quality management system?

Options:

A.

Visit Plant A2 to interview personnel of company B

B.

Visit Plant A2 to interview B's quality manager

C.

Visit Plant A2 to interview A's security personnel and B's maintenance department

D.

Interview the A2 plant manager, now working in Plant A1

Question 11

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organization manufactures cosmetics for major retailers.

You are interviewing the Manufacturing Manager (MM).

You: "I would like to begin by looking at the cleaning controls."

MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside."

Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.

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Options:

Question 12

According to ISO 19011, what two activities take place during the conduct of a audit follow-up?

Options:

A.

Verify the effectiveness of the implemented corrective actions

B.

Verify corrections taken to fix the reported non-conformities

C.

Verify legal compliance

D.

Plan the next audit

E.

Determine feasibility of the audit

F.

Assign roles and responsibilities of observers

Question 13

An audit team leader arrives at a printing organisation to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer manufacturer to print and compile computer documentation packages. They have leased the unit next door for space reasons but have never worked in this sector before. The Quality Manager wants the ISO 9001 certificate to cover the new contract.

During the audit, a team member finds that a number of print jobs have been rejected by several clients over a number of months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract. The auditor raises a nonconformance against clause 10.2.1.b of ISO 9001.

Which one of the evidence statements would support this finding?

Options:

A.

There was no record that the organisation evaluated the effectiveness of the training given to new employees.

B.

There was no evidence that a check of spelling took place before the release of printing to the client.

C.

The actions taken to deal with customer complaints did not prevent recurrence of the problem.

D.

The organisation did not provide the correct resources to prevent nonconformity.

Question 14

In a third-party audit to ISO 9001, select two options of when the organisation is required to act in response to reported findings.

Options:

A.

A recommendation is given in the report.

B.

A finding of good practice is reported.

C.

An opportunity for improvement is raised.

D.

A major non-conformity is raised.

E.

A finding of conformity is reported.

F.

A minor non-conformity is raised.

Question 15

Which two of the following are included in the objectives of the 'Stage 1 initial certification audit'?

Options:

A.

To evaluate the performance of monitoring and reviewing activities.

B.

To evaluate the preparedness of the organisation for a Stage 2 audit.

C.

To evaluate the internal audit and management review processes.

D.

To review the quality manual.

E.

To make a decision on certification to ISO 9001:2015.

F.

To evaluate the operational processes of the organisation.

Question 16

During a second-party audit, the auditor examines the records that are available for the external provider, ABC Forgings, to whom manufacturing has recently been outsourced.

There are standard external provider checklists for three competitors for the contract and there are inspection records from the trial manufacturing batches produced by ABC Forgings. There is no documented evidence of the criteria used to confirm the appointment of ABC Forgings, and no contract or terms and conditions. Ongoing monitoring indicates that external provider performance is satisfactory, but no documented information has been retained.

Select two options for the evidence which demonstrates a nonconformity with clause 8.4 of ISO 9001.

Options:

A.

There was no documentation which provided evidence of any monitoring of the external provider.

B.

The auditee required the outsourced products on an urgent basis before the completion of the paperwork.

C.

The auditee did not retain documentation on the selection and evaluation of the external provider.

D.

The external provider asked for the contract details to be verbal only.

E.

There were no receipt inspection records of the incoming materials.

F.

The auditee trusted the external provider because of a long-standing relationship with them.

Question 17

Select one option that must be considered when determining the scope of a QMS to ISO 9001.

Options:

A.

Business improvement

B.

Performance of business processes

C.

External issues of the organisation's context

D.

Competence of top management

Question 18

You have been nominated audit team leader of a third-party audit. Which of the following could be the two most relevant objectives of this audit?

Options:

A.

Evaluate the satisfaction interested parties

B.

Evaluate the effectiveness of the management system

C.

Identify the need of resources

D.

Evaluate the capability of the management system to establish and achieve objectives

E.

Identify opportunities for improvement

F.

Evaluate the benefits obtained since the implementation of the management system

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Total 60 questions