Examination for Auditors of Quality Management Systems

INTERNATIONAL REGISTER
OF CERTIFICATED AUDITORS

QUALITY MANAGEMENT SYSTEMS AUDITOR

TYPICAL SOLUTIONS TO EXAMINATION PAPER QMS 5 SPECIMEN PAPER

CONFIDENTIAL TO IRCA APPROVED TRAINING ORGANIZATIONS

Note to markers.
Markers are expected to use their experience and judgement as certificated auditors, bound
by the IRCA code of conduct. Markers must give due consideration to logically argued
solutions that might not conform precisely to the typical solution and other answers may be
acceptable. This is especially relevant when marking section 4. A record of this
discretionary judgement must be made on the examination script of the delegate so that it
can be brought to the attention of the IRCA Reviewing Officer during the annual
surveillance visit.

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 Examination for Auditors of Quality Management Systems

Section 1 worth 10 marks

Each question is worth 1 mark.

These multi-choice questions are to be marked either correct for one mark or incorrect for zero marks.
If it is at all unclear which is the answer you are intended to mark, then zero marks must be awarded.
Fractional marks (¼, ½, ¾ etc.) must not be awarded unless specified in the typical solution.

Statements in Italics are for reference only and are not part of the expected answer.

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 Which of the following activities must be carried out by someone who does not
perform the activity being evaluated?

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

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

a. achieve customer satisfaction.

b. demonstrate an organization’s ability to consistently supply conforming product.
c. prevent non conformity.
d. all of the above.
e. none of the above.

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 Examination for Auditors of Quality Management Systems

1.06 Data supporting the existence or verity of something is called:

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

1.07 What information is being sought during a third party audit of a quality system?

a. a list of non-conformities 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.

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

a. be registered as a certificated auditor.

b. have a detailed knowledge of the product or service of the organization to be
audited.
c. have been a quality systems manager.
d. all of the above.
e. none of the above.

1.09 The process approach to a quality management system seeks to help organizations:

a. manage numerous linked activities.

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

1.10 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.

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 Examination for Auditors of Quality Management Systems

Section 2 worth 20 marks

Each question is worth 5 marks

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.

• First party audit is an INTERNAL audit authorized by the organization’s own

management, and frequently conducted by its own staff. The
organization will determine the purpose, scope and objectives for the
audit. 2 marks

• Second party audit
is typically where an organization (as a customer) audits a SUPPLIER.
Audits are usually requested by the customer and the purpose of the
audit is usually to award a contract to supply or for the rating of an
existing supplier.
2 marks

• Third party audit is an EXTERNAL audit (term EXTRINSIC audit is allowable but not
preferable) in which auditors have no commercial interests in the
organization being audited nor its customers. The purpose of a third
party audit is usually certification. 2 marks

Maximum of 5 marks

2.02 What is the objective of quality management system documentation? (2 marks)

Give six examples of the benefits that can arise from effective documentation. (3
marks)

Objective of a documented system; to ensure the effective planning, operation and control of the
organization’s processes. 2 marks

Benefits:
• Communicates the same message to many people simultaneously
• Saves time – methods and processes do not need to be re-invented each time
• Can be used as a training aid to induct people into new roles or activities
• Documenting processes can help to ensure there are no gaps, and that the interfaces have
been properly considered
• Record and reminder of what has been agreed.
• Acts as a reference so that people can work independently
• Help to ensure consistency of output
• Provides a mechanism to communicate and implement changes.
0.5 marks each to a maximum of 3 marks

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 Examination for Auditors of Quality Management Systems

2.03 ISO 9000 identifies a “process approach” as one of the 8 quality principles that
support the achievement of quality objectives.

a. Explain your understanding of what is meant by “a process approach” (1 mark).

b. Identify at least 4 ISO 9001 clauses that support such an approach (4 marks).

• Process approach: A desired result is achieved more efficiently when related resources
and activities are managed as a process. 1 mark

4.1a: identify
processes

4.1b: determine the

sequence and interaction
of processes

7.1: plan and develop the

processes needed for product
realisation

8.2.3:
4.1f: implement actions to monitor and
achieve planned results and measure
continual improvement of processes
processes

5.6.2: review 8.2.4: analyse

process characteristics and trends
performance of processes

1 mark per point to 4 marks

Maximum 5 marks

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? (3 marks)

• attempt to contact the guide 1 mark

• seek help to get to where you need to go 1 mark
• ask for another guide 1 mark
• request that it does not happen again without another guide being made available 1 mark
Maximum 3 marks

What should the auditor not do? (2 marks)

• continue without a guide unless it is possible to do so without violating any security or safety
requirements
• do not panic
• do not get angry Maximum 2 marks

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 Examination for Auditors of Quality Management Systems

Section 3 maximum 20 marks

In this section reasonable coverage is expected of the points listed. Marks should be given for
alternative answers that are logically presented and comply with the requirements of ISO 9001.

3.01 You are planning a process audit of an organization that consists of the following
departments:

- sales and marketing

- purchasing
- warehouse
- packing and despatch
- support services

The top management team consists of the Managing Director and departmental
managers from each of the above areas.

Note: this is a broad question, and there may be considerable variation in delegates’ answers,
and judgement should be exercised in awarding marks. Key points to look for are highlighted
in bold.

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

activities for the audit? (4 marks)

• to start with an understanding of what the organization is trying to achieve (quality

planning, policy, objectives) and how this relates to customers
• to follow the processes (either forward or backward) in order to establish that process
outputs at each stage meet customer requirements.
Maximum 4 marks

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

organization? (6 marks)

• talk to top management:

- what is the quality policy, and how was it derived?
- what are the quality objectives, including continual improvement objectives?
- how do policy and objectives relate to customer requirements and customer
feedback?
- do objectives and targets seek to improve, or only maintain?
- what evidence is there from management review that objectives and targets are
met?

• Sales/purchasing/packing:
- what is the purpose of the activity?
- what objectives are relevant?
- how are processes and products measured?
- what are the results?
- what corrective action is taken?
- how is data analysed and fed into management review?
- what preventive actions are taken?
- does customer satisfaction data indicate an increase in satisfaction?
Maximum 6 marks

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 Examination for Auditors of Quality Management Systems

3.02 You are conducting an audit of a medium sized organization. During the document
review you have raised a concern about the organization’s system for ensuring the
competence of staff.

Prepare a checklist that would guide you through a process audit of competence of
staff and state the relevant ISO 9001 clauses. (10 marks)

• Ask for an overview of the process for assigning tasks/activities to people (6.2.1) 1 mark
• Are competence requirements for each role or task defined? Sample job roles. (6.2.2a) 1 mark
• How is competence measured? (6.2.2a) 1 mark
- for new staff? 1 mark
- for existing staff? 1 mark
• What records are available to demonstrate competence against requirements? (6.2.2e) 1 mark
• Where such measures identify a training need, or competence gap, is there evidence that
such needs have been met? (6.2.2b) 1 mark
- sample recruitment /performance review records 1 mark
• What is the process for evaluating training to ensure that staff are competent? (6.2.2c) 1 mark
• What is the process for inducting new employees (6.2.2)
a) into their job role? 1 mark
b) into the quality system? 1 mark
• What procedures and work instructions are available to guide staff?(4.2.1d) 1 mark
• Are there any quality objectives that relate to the training and competence? (5.4.1) 1 mark
• Look for evidence of how achievement of objectives is being measured (8.1/5.4.1) 1 mark
• Review process and product monitoring results to determine whether requirements are met
(8.2.3/8.2.4). If not, what evidence exists that this might be linked to competence issues? 1 mark
• Is there any evidence that any problems are caused by the lack of competent staff?(8.5.2)1 mark

Maximum 10 marks

NOTE:
The layout of the checklist should be consistent with approaches discussed on the course.
No more than 0.5 marks per item may be given if the relevant clause has been omitted.

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 Examination for Auditors of Quality Management Systems

Section 4 worth 30 marks

Section 4 is intended to test auditor judgement. A principle that can be useful is "would
this report withstand the scrutiny of a sceptical Chief Executive Officer". Another
principle is that it is better to err on the side of discretion, “if in doubt, don't raise an
NCR”. It therefore follows that to raise a nonconformity report when there is not
sufficient objective evidence should be penalised (maximum mark 4 out of 10). However
a report that states clearly the actions that an auditor should take before raising a
nonconformity report could often be supported and be given marks near to the pass
mark (7 out of 10). It could not be given full marks unless there was some obvious
ambiguity in the description of the incident or the student demonstrates logical argument,
knowledge of the subject and the answer shows an ability to make a reasoned judgement.
Reports must be complete, clear and concise and not simply a repetition of the incident.

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 Examination for Auditors of Quality Management Systems

Incident Number 1

Commentary

This incident does not contain sufficient objective evidence to raise a nonconformity report at this
stage. The nonconformity report form should not be used. Below the form there should be reasonable
coverage of what the auditor should do next.

• Check any relevant procedures: do these describe the management review process, and does the
process described comply with procedures? 1 mark
• Interview the managing director (MD): what is their level of involvement in the management
review process and subsequent activities? 2 marks
• Does the summary report submitted to top management include all the inputs to the
management review (5.6.2) 1 mark
• Look for other evidence of top management commitment (5.1) 1 mark
• How do top management communicate information relating to the effectiveness of the quality
management system? (5.5.3), and how does the communication relate to the findings of the
management review? 2 marks
• Is there evidence that the action plan authorised by the MD
a) relates to the review inputs 1 mark
b) will improve the effectiveness of the QMS and product? (5.6.3) 1 mark
• How similar is the final action plan to the recommendations made by the departmental managers’
meeting? 1 mark
• If there are differences, what is the process for reconciling the differences between top
management and departmental management? 1 mark
• Have adequate resources been made available to implement the management review outcomes?
(5.6.3/6.1) 2 marks

Maximum 10 marks
Incorrect grading of incident

If the student raises a non conformity report a maximum of 4 marks may be awarded on condition
that the student clearly states the following.

A An appropriate clause of ISO 9001 is stated, e.g. 5.1d 1 mark

B The NCR is graded as minor 1 mark
C A relevant section of the clause is quoted correctly. 1 mark
D The description of the nonconformity correctly summarises the incident. 1 mark

If the NCR is graded as major then zero marks must be awarded.

Maximum 4 marks

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 Examination for Auditors of Quality Management Systems

Incident number 2

Commentary
The incident contains one nonconformity. Marks for completion of the audit finding form:

Form filling: Note number, name of auditor and date 0.5 mark
Area under review: Internal audits 0.5 mark
Standard and Clause ISO 9001 (8.5.2) 1 mark
Number:
Category: Minor 1 mark
Identifying the evidence: The internal audit resulted in correction, but there is no 3 marks
evidence that the cause of the non conformity was
determined, or that action was taken to prevent its
recurrence. A review of the actions taken failed to identify
that action had not been taken to prevent recurrence of the
problem.
For identifying the The organization shall take action to eliminate the cause of 2 marks
requirement: non conformities in order to prevent recurrence, and shall
review the corrective action taken.
Clarity For producing a clear and unambiguous nonconformity note. 2 marks

Maximum 10 marks

Incorrect grading of incident

If the student does not raise a nonconformity report, but makes a statement in the space below the
report form, a maximum of 7 marks may be awarded on condition that the student clearly states the
following:

• A reason why there is insufficient objective evidence for a deficiency. 3 marks

• Additional information required so that a sound decision could be made. 2 marks
• How this additional information could be obtained. 2 marks

Maximum 7 marks

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 Examination for Auditors of Quality Management Systems

Incident Number 3

Commentary
The incident contains one nonconformity. Marks for completion of the audit finding form:

Form filling: Note number, name of auditor and date 0.5 mark
Area under review: Purchasing 0.5 mark
Standard and Clause ISO 9001 (7.4.1) 1 mark
Number:
Category: Minor 1 mark
Identifying the evidence: A subcontractor of TMX101 items was selected on the basis of 3 marks
price, and no further evaluation of the supplier was made.
For identifying the The organization shall evaluate and select suppliers based on 2 marks
requirement: their ability to supply product in accordance with the
organization’s requirements
Clarity For producing a clear and unambiguous nonconformity note. 2 marks

Maximum 10 marks

Incorrect grading of incident

If the student does not raise a nonconformity report, but makes a statement in the space below the
report form, a maximum of 7 marks may be awarded on condition that the student clearly states the
following:

• A reason why there is insufficient objective evidence for a deficiency. 3 marks

• Additional information required so that a sound decision could be made. 2 marks
• How this additional information could be obtained. 2 marks

Maximum 7 marks

End of examination

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