Examination for Internal Auditors of Quality Management Systems

Section 1
Choose the most appropriate answer for the following questions & circled.

1.01 Quality System audits are used to verify

a the number of persons working on a contract

b the extent to which audit criteria are fulfilled
c that all suppliers to the organization have ISO 9001 certification
d all of the above
e none of the above

1.02 A third party audit is

a an internal audit
b an audit by the customer or client
c an audit by an independent organization
d all of the above
e none of the above

1.03 ISO 9001 includes:

a health and safety requirements

b quality planning
c quality costing
d all of the above
e none of the above

1.04 In preparing for an audit it is important to

a plan
b define the scope of the audit
c select a lead auditor and a component team
d all of the above
e none of the above

1.05 Which of the following activities some one who does not perform the activity
being evaluated must carry out?

a a contract review
b an inspection of product
c a quality system audit
d all of the above
e none of the above

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1.06 A system based on the requirements of ISO 9001 aims to

a achieve customer satisfaction

b demonstrate a companys ability to consistently supply conforming product
c prevent non-conformity
d all of the above
e none of the above

1.07 Data supporting the existence or verify of something is called:

a objective evidence
b a deficiency
c a nonconformity report
d all of the above
e none of the above

1.08 What information is being sought during a 3rd party audit of a quality system?

a a list of nonconformities to ISO 9001

b objective evidence of conformity with ISO 9001
c a management commitment to quality assurance
d all of the above
e none of the above

1.09 To act as an auditor of a quality system a person has to

a be registered as a Certificated Auditor

b have detailed knowledge of products / services of the company to be audited
c have been a quality systems manager
d all of the above
e none of the above

1.10 The process approach to quality management system aims to help

organizations:

a manage numerous linked activities

b understand and fulfill requirements
c continually improve processes
d all of the above
e none of the above

1.11 If the audit team does not find any nonconformity the audit team leader should

a explain to the management of the audited organization that the audit only
investigated a sample of activities and that there may be nonconformities
which the sample did not uncover.
b conclude that there are no nonconformities existing in the quality system:
c cancel the closing meeting.
d all of the above
e none of the above

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1.12 The extent of documentation of the quality system should be determined by:

a the complexity of processes and their interactions

b the expectations of auditees
c the culture of the quality department
d all of the above
e none of the above

1.13 degree to which a set of inherent characteristics fulfils requirements is the

ISO 9000 : 2000 definition of :

a continual improvement.
b quality assurance.
c quality.
d all of the above
e none of the above

1.14 Indicate fully the clause of ISO 9001 that is applicable to the following:

ensure that its personnel are aware of the relevance and importance of their
activities and how they contribute to the achievement of quality objectives

This is covered by clause

1.15 Indicate fully the clause of ISO 9001 that is applicable to the following:

the organization shall continually improve the effectiveness of the quality

management system

This is covered by clause ________________________

Section 2
Write a brief answer to each of the following five questions using only the space
provided.

2.01 There are three types of quality system audit based on a first, second and
third party involvement. Explain the specific features that distinguish each of
them.

2.02 What are the objectives and benefits of quality management system
documentation?

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2.03 ISO 9000 identifies a process approach as one of the 8 quality principles,
which facilitate achievement of quality objectives. Please explain your
understanding of what is meant b y a process approach, and identify at least
4 ISO 9001 clauses that support such an approach.

2.04 An auditor is conducting a third party audit. The guide who has been
appointed to accompany the auditor around the various departments is called
away by a senior manager. After five minutes the guide has not returned.
What should the auditor do? What should the auditor not do?

2.05 What objective evidence could be available in order to verify compliance with
the requirements of clause 7.2.3 of ISO 9001? In your answer, make links to
other ISO 9001 clauses as necessary.

Section 3
3.1 You are planning an audit of an organisation that supplies electronic cabling
and networking products. The organisation consists of the following
departments: sales and marketing purchasing warehouse packing and
dispatch human resources support services including maintenance, IT and
Quality. The top management team consists of the Managing Director and
departmental managers from each of the above areas.

a) What would be your 2 main considerations in deciding the sequence of

activities for the audit?

b) How would you approach the audit of continual improvement in this

organization?

3.2 Describe the principal actions which should be taken, and by whom, when a
non-conformity has been identified during an audit? A simple flow chart may
be used to answer this question.

3.3 You are conducting an audit of a medium sized manufacturing company. The
document review has raised a concern about how the organization ensures
the competence of staff.

Prepare a checklist that would guide you through a process audit of this area,
and state the relevant ISO 9001 clauses.

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Section 4

Examine the following incidents carefully then take one of the following actions:

1. If you think that there is sufficient objective evidence of nonconformity then you
should complete a nonconformity report and categorise it as major or minor.

2. If you do not think that there is sufficient objective evidence of nonconformity then:

a. State why you think that there is insufficient evidence of nonconformity

b. Make a list of things you would look for as evidence that the situation is
under control

INCIDENT 1

In the audit of a food manufacturer the auditor noticed 6 cans of an unknown product
in an unmarked box under the production line. The cans were unmarked and the
operator told the auditor that they were left from the previous shift and he thought
they might be reject beans.

INCIDENT 2

During an audit of internal audits, you are shown internal audit reports from the last
audit. These include a non-conformity report stating that 3 people in the purchasing
department had not been trained in the use of the approved supplier list. The
corrective action taken was to train the 3 members of staff. The audit report has
been closed. The management representative tells you that no further investigation
was made, as the corrective action was obvious. The internal auditor had checked
the training records of the staff concerned before closing the reports.

INCIDENT 3

In the Purchasing Department the auditor asks how the new subcontractor for PAF
items was selected. The purchasing clerk explains that the regular supplier could
not meet the delivery date and the order was placed with a subcontractor, which they
had never used before, only because the price quoted was extremely low. The clerk
states that no other evaluation was conducted.

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INCIDENT 4

During an audit at the packaging area the auditor encountered the operator not
following the procedure OP 18 issue 7 for packing. He was using different
component polythene T2 to those specified in the instruction and required by the
customer specification. T2 made from cardboard. The operator informed the auditor
that he was acting on the verbal instruction of the supervisor whilst they were
temporally out of that component. The working instruction was issued by the
Production Manager and no amendments had been produced.

INCIDENT 5

In the Purchasing Department the auditor discovered that the supplier of packaging
components T3 for the packaging of product was not on the list of approved
suppliers. The purchasing officer said that all packaging was a standard product
specified by the customer so it did not matter which supplier supplied it. The
Purchasing Procedure OP 4 issue 2 specified that all materials, which would be
incorporated into products, would be subject to supplier controls.

INCIDENT 6

In the maintenance department, the auditor discovered that he 7 fork lift truck did not
have a written procedure, diagram or instruction for the operation of the trucks. The
Maintenance Manager explained that he drivers all had licenses and that any
instruction would be a waste of paper. There was a Procedure for handling
materials.

INCIDENT 7

During an audit management review activities you notice from the minutes of
management review meetings that the meetings are not attended by any of the top
management team. When you query this, the management representative tells you
that management review has evolved into a two-tier process, as it was proving so
difficult to get all of the departmental and top managers available at the same time.
The process is now that departmental managers meet and conduct the first level of
management review. The management representative prepares a summary report
including actions and recommendations. This is passed round each of the top
management team for comment, and the Managing Director finally agrees the action
plan.