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ISO-9001-Lead-Auditor QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

Questions 4

Which of the following two documents does an auditor need to prepare and complete prior to the on-site audit?

Options:

A.

Audit Report

B.

Audit Plan

C.

Procedures

D.

Checklist / Prompts

E.

Risk Matrices

F.

Findings

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Questions 5

An audit team leader arrives at a printing company 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. The Quality Manager wants the ISO 9001 certificate to cover the new contract.

During the audit, a team member found that some print jobs had been rejected by several clients over some 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 finds that the responsibility for checking spelling errors is placed on the printer that sets up the print run.

In line with the policy of the certification body, the audit team raise improvement opportunities in the audit report. Which

three of the following options would represent acceptable opportunities for improvement in the report?

Options:

A.

Operational planning activities may benefit from a clearer risk-based approach.

B.

The organisation needs to delay its certification to gain more experience of the QMS.

C.

The responsibility for checking printing needs to be independent of the operators.

D.

A business consultant can be recommended for advice on improving operations.

E.

A plan to determine why the errors occur and to prevent them.

F.

An intensive training plan that involves all production personnel.

G.

The recruitment process to include spelling tests to filter out unsuitable candidates.

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Questions 6

Takitup is a small fabrication organisation that manufactures steel fencing, stairs and platforms for the construction sector. It has been certified to ISO 9001 for some time and has appointed a new Quality Manager. The audit plan during a surveillance audit covers the organisation's improvement actions and the auditor asks to see the most recent management review meeting minutes.

The auditor finds that the management review report records that none of the improvement actions set by the previous review has been realised for a second time. A new Quality Manager has been brought in at the middle management level to rectify the situation as the organisation is concerned that it might lose its certification.

Select three options that would provide evidence of conformance with clause 10.3 of ISO 9001.

Options:

A.

Outsource more processes to external providers

B.

Removing expensive external providers from the database.

C.

An increase in the number of quality staff.

D.

A quality objective to achieve lower reject rates by quality control.

E.

Considering results from the analysis of the effectiveness of corrective actions to determine improvement opportunities.

F.

The certification body auditor reporting fewer nonconformities.

G.

An enhanced customer satisfaction survey score than in the previous year.

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Questions 7

You work 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', which provides packaging materials to your organisation. It is 4 p.m. 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

for 5 p.m.

You, as audit team leader, audited top management, the laboratory, and the storage of raw materials.

Auditor 1 audited the two manufacturing lines and dispatch areas.

You to Auditor 1: "What findings would you report?"

Auditor 1: "When reviewing the Dispatch records, I noticed that during the morning two different trucks (Number 011 and 025) delivered the same

batch number of the product (Batch 33555). Truck 011 left the plant at 9.15 am and Truck 025 left the plant at 11.30 am. Procedure P-02 Rev.3 says

that trucks should carry a complete batch. The batch number, once on the truck, is captured using a QR device."

You: "OK, what do you think?"

Auditor 2: "I think that this is a nonconformity."

You: "OK. How would you describe the evidence on which the nonconformity will be based"?

Identify which one of the following statements best describes the identified nonconformity.

Options:

A.

Dispatch personnel are not fully aware of the need to conform to written procedures.

B.

Dispatch personnel do not always carry out its activities in conformance with Procedure P-02 rev 3.

C.

The batch 33555 was delivered split in two different trucks (011 and 025).

D.

A product delivered to the client was not identified as required in P-02 Rev 3.

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Questions 8

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

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Questions 9

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.

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Questions 10

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

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Questions 11

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.

ISO-9001-Lead-Auditor Question 11

Options:

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Questions 12

You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.

You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.

You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?"

TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry."

You: "How is their regulatory competence maintained?"

TD: "They are dedicated individuals with lots of contacts in the sector."

You: "How does the business enable them to maintain their understanding of current regulatory requirements?"

TD: "We leave that up to them."

ISO-9001-Lead-Auditor Question 12

Options:

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Questions 13

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.

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Questions 14

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

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Questions 15

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.

ISO-9001-Lead-Auditor Question 15

ISO-9001-Lead-Auditor Question 15

Options:

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Questions 16

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

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Questions 17

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.

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.

ISO-9001-Lead-Auditor Question 17

ISO-9001-Lead-Auditor Question 17

Options:

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Questions 18

Select the word that best completes the sentence:

ISO-9001-Lead-Auditor Question 18

Options:

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Exam Name: QMS ISO 9001:2015 Lead Auditor Exam
Last Update: Dec 4, 2024
Questions: 123

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