QMS Lac 4

Examination for Auditors of Quality Management Systems
INTERNATIONAL REGISTER
OF CERTIFICATED AUDITORS
QMS AUDITOR EXAMINATION PAPER, QMS LAC 4

for use on the
Quality Management Systems Auditor/Lead Auditor Training Course (IRCA/2245)
CONFIDENTIAL TO IRCA APPROVED TRAINING ORGANIZATIONS

Please write your name in the space:
Date:
Venue:
THESE SPACES ARE FOR OFFICIAL USE ONLY

Section
Pass mark
Maximum
10
20
20
12
30
Total
56
80
Name of marker
Marker 1
Marker 2
Confirmed:
Result
Course Manager
EXAMINATION PAPER QMS LAC 4, issued September 2004

Amended for use on certified course A17038 operated by SGS United Kingdom Ltd.
IRCA/146 QMS 4/04/1, QMS LAC 4
Page 1 of
15
Information for candidates

This examination paper is in four sections. Please attempt all sections.
The time allowed is two hours. There is no additional time allowed for reading the question
paper. There are a maximum of 80 marks available; the pass mark is 70% (56 marks) and you
must also achieve at least 40% in each of the four sections.
Your answers must be written on the sheets that are supplied. Additional loose sheets will not
be accepted.
The phrase "ISO 9001" and standard always refer to ISO 9001:2000.
The word "clause" refers to a paragraph or section of ISO 9001 that is identified by a number
such as 5.4.1 or a number and letter such as 7.1b.
You may take into the examination a copy of ISO 9001:2000, the Course Manual and any notes
that you have made during the Course. You may also use a dictionary.
Section 1 is worth 10 marks
Comprises questions which require you to place a circle around the letter (a, b, c, d or e) to
indicate which you judge to be the best answer. You must only give one answer for each
question. If it is not clear which option you have selected, you will be awarded zero marks.
Comprises questions that require a brief written answer in the space provided.
Comprises questions that require a detailed written answer that will normally fill the space
provided.
Comprises a number of audit situations for which a Corrective Action Request (CAR) may be
required.

Page 2 of
15
Section 1 worth 10 marks

Each question is worth 1 mark
1.01
Quality system audits are used to verify that

a.
b.
c.
d.
e.
1.02
customers are satisfied with the product.

inspection is capable of identifying quality problems.
a supplier has the capacity to meet an organizations requirements.
all of the above.
none of the above.
The customers perception of the degree to which the customers requirements have
been fulfilled is the definition of
a.
b.
c.
d.
e.
1.03
quality.
quality characteristics.
customer satisfaction.
all of the above.
none of the above.
To comply with ISO 9001, the basis on which internal audits are scheduled is
a.
b.
c.
d.
e.
1.04
the schedule of operational activities.

the frequency of third party surveillance visits.
the status and importance of the activity to be audited.
all of the above.
none of the above.
During the audit there should be frequent exchange of information amongst members of
the audit team in order to
a.
b.
c.
d.
e.
1.05
ensure that all of the audit objectives are met.

ensure that as many nonconformities as possible are found.
evaluate the performance of each member of the team.
all of the above.
none of the above.
Recurring action to increase ability to fulfil requirements is called:
a.
b.
c.
d.
e.
continual improvement.
preventive action.
quality improvement.
all of the above.
none of the above.

Page 3 of
15
1.06
In order to conform to ISO 9001, the management representative must be

a.
b.
c.
d.
e.
1.07
the chief executive officer.

the quality assurance manager.
a member of management.
all of the above.
none of the above.
At the closing meeting of a third-party audit, the organizations Chief Executive Officer
asks the auditor, What is the outcome of the audit ? The audit team leader should
a.
b.
c.
d.
e.
1.08
tell the auditee that they have passed or failed.

tell the auditee that it is not a decision for the audit team.
tell the auditee what recommendation will be made.
all of the above.
none of the above.
An advantage of a well-planned checklist is that
a.
b.
c.
d.
e.
1.09
the auditor does not need to study the supplier's quality manual.
it ensures that all aspects of the audit scope can be covered.
it ensures that all audits follow a standard sequence.
all of the above.
none of the above.
To act as an auditor of a quality system a person must
a.
b.
c.
d.
e.
1.10
be a certificated auditor.
be free from bias which could affect the objectivity and impartiality of the audit.
have a detailed knowledge of the product or service of the organization to be audited.
all of the above.
none of the above.
The extent to which planned activities are realised and planned results are achieved is
called:
a.
b.
c.
d.
e.
audit conclusion.
conformity.
effectiveness.
all of the above.
none of the above.

Page 4 of
15

Each question is worth 5 marks
2.01
Explain the purpose and benefits of a preliminary visit to an organization to be audited

by the audit team leader prior to the actual audit.
(5 marks)
2.2
ISO 9000 identifies a continual improvement as one of the eight quality principles that
supports the achievement of quality objectives.
a.
b.
Explain your understanding of what is meant by continual improvement, in this

context.
(2 marks)
List six clauses in ISO 9001:2000 that support such an approach (provide clause
number and clause name for each).
(3 marks)

Page 5 of
15
2.3
At the completion of a third-party audit, the auditor issued a CAR containing the
following finding statement:: "Three of the fifteen inspectors in the operations
department were using measuring equipment that was not calibrated."
The corrective action proposed by the management representative is that these three
inspectors will be given a verbal warning to use calibrated equipment in the future.
Give two reasons why this corrective action is not acceptable and list three other actions
that would be more acceptable. (5 marks)
2.4
Give five examples of audit evidence could be available in order to verify conformance
with the requirements of clause 4.2.1 of ISO 9001.
In your answer, make links to other ISO 9001 clauses as necessary. (5 marks)

Page 6 of
15
Section 3 maximum 20 marks

3.1 During an audit of an organization that manufactures components, the auditor observes the
inspection activity that happens at the end of the production line, before packaging. The
inspector examines each item, determines if it conforms to the specification, and then
makes an entry onto a chart. The auditor sees that the chart contains information on
the time taken to produce a batch, and on the number and nature of any nonconformity.
The auditor notices that the trends for both time taken and number of nonconformities
are increasing. The inspector explains that they do not know what happens with the
information on the chart but volunteers that in their opinion the problems are caused by
the machinery which is old and increasingly unreliable.
List the questions that the auditor should ask in order to investigate this situation.
Provide clause references from ISO 9001 as appropriate.
(10 marks)

Page 7 of
15
3.2
You are conducting a third party audit. The next item is a meeting with top
management to discuss quality policy, quality objectives and management
commitment.
Prepare checklist to take you through at this stage of the audit. You must identify at
least three points for each area of the audit (quality policy, quality objectives and
management commitment.) and state relevant ISO 9001 clauses.
(10
marks)

Page 8 of
15

Three incidents that occur during a third party audit of a supplier are described below. They
contain situations for which Corrective Action Requests (CARs) may be required. Examine
each incident carefully then take one of the following actions:
a)
If you think that there is sufficient evidence of nonconformity, you should complete a
CAR and categorise it as Major or Minor.
b)
If you do not think that there is sufficient evidence of nonconformity, you should:
state why you think there is insufficient evidence of nonconformity

make a list of things you would look for as evidence that the situation is under
control
The answer to each incident is worth 10 marks.

Page 9 of
15
Incident Number 1
In the production department, the auditor notices a batch of items, identification number
6633, which have recently been manufactured. The items are labelled "awaiting customer
approval". The production supervisor explains that these items conform to the well-known
and established capability of the production department but do not conform to the customer's
specification. The supervisor shows the auditor the quality control charts for the batch. The
charts show clearly that the batch 6633 items had been controlled to the known capability
and were manufactured in accordance with process control procedures. The supervisor
states that the contract department is currently discussing with the customer how to resolve
this situation.
If you think there is evidence of a nonconformity, complete this CAR:
IRCA QMS AUDIT

CORRECTIVE ACTION REQUEST
Company under Audit: XYZ plc
CAR No. ..................
Area under review:

................................................................................
ISO 9001 Clause Number :

..
Category: MAJOR* MINOR*
* delete one
Nonconformity:
Auditor:
Date:
Or, if you do not think that there is sufficient evidence of nonconformity, state the reasons for
your decision and state also what further actions the auditor should take.
Please use overleaf
Page 10 of
15

Page 11 of
15
Incident Number 2
In the Personnel Managers office of an insurance company, the auditor asks to see training
records for three people who work in the Claims Department. The auditor observes from the
training records that each had attended a course on customer care.
The auditor asks the Personnel Manager how they knew that the training had been effective.
The Personnel Manager replies, Well, I spoke to several people in the Claims Department after
they had attended the course. They said that the training had been enjoyable and useful.
IRCA QMS AUDIT

CAR No. ..................
Area under review:

................................................................................

..
* delete one
Nonconformity:
Auditor:
Date:
Please use overleaf
Page 12 of
15

Page 13 of
15
Incident Number 3
The management review meeting minutes for organization XYZ plc, includes details of the
achievement of quality objectives. One of the quality objectives is 100% on time delivery, and
the minutes indicate that on time delivery is only achieved for 65% of orders. No related action
points are recorded in the minutes.
When the auditor queries this with the Chief Executive, she is told that it is inevitable that major
customers take priority. When the auditor asks if sales people should be quoting longer lead
times, the Chief Executive indicates that this would lead to loss of business, commenting that
the delivery figures are still better than others in the industry.
IRCA QMS AUDIT

CAR No. ..................
Area under review:

................................................................................

..
* delete one
Nonconformity:
Auditor:
Date:
Please use overleaf
Page 14 of
15
End of examination

Page 15 of
15

QMS Lac 4

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QMS Lac 4

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Examination for Auditors of Quality Management Systems

QMS AUDITOR EXAMINATION PAPER, QMS LAC 4

CONFIDENTIAL TO IRCA APPROVED TRAINING ORGANIZATIONS

THESE SPACES ARE FOR OFFICIAL USE ONLY

EXAMINATION PAPER QMS LAC 4, issued September 2004

Examination for Auditors of Quality Management Systems

Information for candidates

EXAMINATION PAPER QMS LAC 4, issued September 2004

Examination for Auditors of Quality Management Systems

Section 1 worth 10 marks

Quality system audits are used to verify that

customers are satisfied with the product.

the schedule of operational activities.

ensure that all of the audit objectives are met.

EXAMINATION PAPER QMS LAC 4, issued September 2004

Examination for Auditors of Quality Management Systems

In order to conform to ISO 9001, the management representative must be

the chief executive officer.

tell the auditee that they have passed or failed.

EXAMINATION PAPER QMS LAC 4, issued September 2004

Examination for Auditors of Quality Management Systems

Section 2 worth 20 marks

Explain the purpose and benefits of a preliminary visit to an organization to be audited

Explain your understanding of what is meant by continual improvement, in this

EXAMINATION PAPER QMS LAC 4, issued September 2004

Examination for Auditors of Quality Management Systems

EXAMINATION PAPER QMS LAC 4, issued September 2004

Examination for Auditors of Quality Management Systems

Section 3 maximum 20 marks

EXAMINATION PAPER QMS LAC 4, issued September 2004

Examination for Auditors of Quality Management Systems

EXAMINATION PAPER QMS LAC 4, issued September 2004

Examination for Auditors of Quality Management Systems

Section 4 worth 30 marks

state why you think there is insufficient evidence of nonconformity

The answer to each incident is worth 10 marks.

EXAMINATION PAPER QMS LAC 4, issued September 2004

Examination for Auditors of Quality Management Systems

IRCA QMS AUDIT

CAR No. ..................

Area under review:

ISO 9001 Clause Number :

Category: MAJOR* MINOR*

Examination for Auditors of Quality Management Systems

EXAMINATION PAPER QMS LAC 4, issued September 2004

Examination for Auditors of Quality Management Systems

IRCA QMS AUDIT

CAR No. ..................

Area under review:

ISO 9001 Clause Number :

Category: MAJOR* MINOR*

Examination for Auditors of Quality Management Systems

EXAMINATION PAPER QMS LAC 4, issued September 2004

Examination for Auditors of Quality Management Systems

IRCA QMS AUDIT

CAR No. ..................

Area under review:

ISO 9001 Clause Number :

Category: MAJOR* MINOR*

Examination for Auditors of Quality Management Systems

EXAMINATION PAPER QMS LAC 4, issued September 2004

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