ISO 9001 QMS LATC Specimen Exam Paper-01

For ISO 9001:2015 QMS Lead Auditor Training Course-VILT

Name of Delegate: ___________________________________

Date of Examination: ________________

Instructions:

1) Duration of Exam: 2 hours. If the delegate’s native language is NOT English, the
delegate may have an additional 30 minutes. Any delegate with medical disability
may get an additional 20 minutes.
2) No extra time allowed for reading the examination paper
3) This examination is OPEN BOOK, and proctored over Live-Video
4) An unmarked copy of ISO 9001:2015 and a hard-copy of Dictionary may be used
by the delegates. All other material should be outside the Examination premises
5) Delegates are required to endeavor to respond to all sections and all questions

6) This exam paper contains space for answers as well; Delegate's

answers must be written on this Exam paper itself. Delegates may
write on the reverse side of a page if necessary. No additional/loose
sheets will be supplied/accepted.

7) Please observe the Action Verb such as Describe, List, Illustrate, State etc., and
respond accordingly

Total marks scored: ________ out of 90

Result: Pass/Fail
Name of Scorer: __________________

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 1

PART 1 – Five questions, two marks for each question – maximum 10 marks

(Statements in italics are for reference only, and are not part of the expected answer)

1.1 ISO 9001 requires that the audits be objective and impartial. DESCRIBE your

understanding of objectivity and impartiality. Ref: ISO 19011 (2 marks)

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1.2 EXPLAIN the likely consequences of an auditor not being diplomatic during an
audit. Ref: ISO 19011 (2 marks)

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QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 2

1.3 GIVE four examples of evidence which demonstrates that an organization is
managing its QMS legal compliance in conformity with ISO 9001. (2 marks)

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1.4 IDENTIFY two ways in which an auditor can verify that agreed corrective actions
have been effectively implemented. (2 marks)

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1.5 IDENTIFY whether each of the four statements below is TRUE or FALSE by circling
the correct response. (2 marks)

a) The organization must consider the results of analysis and evaluation, and the
outputs from management review, to determine if there are needs or opportunities that
shall be addressed as part of continual improvement (TRUE/FALSE)

b) Management review must be conducted atleast twice a year (TRUE/FALSE)

c) Auditors must identify the root cause of any nonconformity which they report
(TRUE/FALSE)

d) The expectations of interested parties must be considered within the scope of the
QMS (TRUE/FALSE)

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 3

PART-2 – Four questions worth five marks each – maximum 20 marks

(2.1 a) LIST six responsibilities of Audit Team Leader when conducting an external
audit (3 marks)

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(2.1.b) An auditor conducting a third-party audit finds a critical operational hazard

which has not been addressed in QMS. State how the auditor should respond. (2 marks)
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QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 4

2.2 You are the audit team leader conducting a QMS Stage-1 certification audit on site
by yourself in an organization. At the initial meeting, you are presented with a high-end
handheld computer containing the company’s soft-copies of QMS manual and
procedures. The QMS manager indicates that the laptop is a token of business goodwill
for you to use during the audit and keep it for yourself after the audit. DESCRIBE how
you would respond to this situation. (5 marks)

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2.3 You are the audit team leader in a Stage-2 QMS certification audit of a large
computer company manufacturing personal computers, network systems, routers etc.,
wishing to gain ISO 9001 certification. You are required to form the audit team; LIST
five factors you would consider when selecting individual members of that team as per
ISO 19011 > Clause 7. (5 marks)

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QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 5

2.4 At the Opening Meeting of the Stage-2 certification audit, the Quality manager
informs you as auditor, that a recent internal audit has found many nonconformities
relating to many issues in the Design Division. Corrective action has already been
planned. The manager therefore suggests that doing the audit in the Design Division
would not add value, and requests if you, as auditor, could exempt the Design Division
from the Audit Plan, and spend that time in the Laboratory as there has been an
increase in minor accidents recently.

OUTLINE five issues you would include in the response which you would give to this
request. (5 marks)

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QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 6

PART-3 – Three questions worth ten marks each – maximum 30 marks

Note to markers: Marks should be given for alternative answers that are logically
presented and comply with the requirements of ISO 9001.

3.1 A Turbine installation company has been certified to ISO 9001 for more than a year.
Two months back, the company had a fatal accident involving someone working between
two generators. Next week is the 1st surveillance audit and you are the sole auditor
conducting the audit. EXPLAIN what you would wish to examine by listing at least 10
issues for investigation making reference to relevant clauses of ISO 9001. (10 marks)

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QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 7

3.2 Based on clause 10.2 of ISO 9001, DESCRIBE, in terms of a sequence or illustrate
using a diagram, the corrective action process starting from a non-conformity being
raised by an auditor till closure of nonconformity.

IDENTIFY the audit party (Auditor or Auditee) responsible for each element of the
process (10 marks)

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QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 8

3.3 A requirement of ISO 9001 (Clause 5.1) is that top management demonstrates
leadership in support of the QMS. PREPARE an Audit checklist of at least ten
checkpoints to determine whether the organization conforms to this requirement. (10
marks)

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QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 9

Part-4: Three questions worth 10 marks each – maximum 30 marks

Questions in this section are intended to evaluate the delegate’s ability to analyze audit
situations, evaluate audit evidence, and apply knowledge of the audit criteria.

Delegates are required to either:

• (A) Complete the nonconformity report template.

Marking scheme for a nonconformity:

o For correctly identifying the scenario as a nonconformity (2 marks)

o For a clear description of the nonconformity (3 marks)
o For correctly quoting relevant evidence (3 marks)
o For correctly identifying the relevant ISO 9001 requirement (1 mark)
o Overall clarity of the nonconformity report (1 mark)

If delegates raise a nonconformity report when there is no nonconformity, 0 (zero)

marks will be awarded.

OR

• (B) Complete the audit investigation template, clearly describing:

o the reason(s) for choosing there is no sufficient evidence to report the findings
as nonconformity (2 marks)
o How the delegate would investigate to determine conformity or otherwise, by
furnishing audit trails the delegate would follow and clear examples of audit
evidence

o If delegates complete the audit investigation template for a situation where

there is evidence that nonconformity exists, a maximum of 7 marks may be
awarded as follows:

▪ providing a valid reason why there is insufficient evidence for a nonconformity (2

marks)
▪ Providing relevant audit trails as indicated above. (5 marks)

Marks will be awarded where the audit investigation trails are appropriate to the
situation, and would furnish further evidence of conformity or otherwise.

If a delegate responds with a NC Report for a scenario which is in fact an audit

investigation, Scorer provides Zero marks.

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 10

4.1 – Audit Scenario 1:

As an auditor from a certification body, you are in the pantry/kitchen of an

Administrative Office of large library. In the kitchen, you observe that a clear dark-
violet colored liquid is stored in an unmarked/unlabeled transparent container
placed just adjacent to food items. You query the kitchen manager what the liquid
is and the kitchen manager responds that it is a chemical for unclogging the waste-
drains as and when they get blocked. When you ask why it is kept on the food shelf
you are responded that it is not usually kept there, but it is not an issue since
everyone who accesses the kitchen knows what it is.

You speak to different/select personnel in the kitchen, and their responses do not
indicate you that they know what it is for or why it is there or how to use it. The
records of training for kitchen establish that that contract workers are deployed in
the kitchen for few days in a week. The Manager states that there are no
procedures or work instructions or risk assessments for the storage and use of the
unclogging liquid since people who are kitchen know what it is.

As an auditor, you are aware that using chemicals or other hazardous substances at
work can put peoples’ health and safety at risk, and that the regulatory stipulations
requires employers to control storage and use of hazardous substances to prevent
inadvertent use.

QMS AUDIT - NONCONFORMITY REPORT 1

1) Nonconformity (2 marks for identifying the scenario as a nonconformity)

2) Description of the nonconformity (3 marks for describing the NC)

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QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 11

3) Objective Evidence (3 marks for identifying the evidence)

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4. ISO 9001 clause and requirement: (only one clause/Sub-clause to be written)

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Remarks: 1 mark for clause and requirement plus 1 mark for unambiguous/clear
response

OR

QMS Audit Investigation Template -1

1. Audit investigation: (2 marks)

There is no sufficient evidence to report nonconformity.

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2. Points of Audit investigation and evidence sought: (4 audit trails, each

audit trail, 2 marks)
I. ---------------------------------------------------------------------------------

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QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 12

 ------------------------------------------------------------------------ (2 marks)

II. ---------------------------------------------------------------------------------

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III. ---------------------------------------------------------------------------------

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IV. ---------------------------------------------------------------------------------

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1.

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 13

4.2– Audit scenario 2:

In an audit, during lunch in the cafeteria of an engineering company, you as auditor

observe a signage which reads “Please drop your suggestions in the box below” but
the suggestion box is missing. On continuing with the audit, you ask the Cafeteria
Supervisor about the missing suggestion box. He responds that the process has
changed; suggestions are now sought only by mail by Quality Manager.

When auditing Quality Manager later, you ask about the emails related to
suggestions. He responds that only three suggestions have been received in the past
one month. It relates to poor air-conditioning, delayed service in cafeteria, and delay
in providing the food. Such suggestions are sent to Administration Manager to whom
the Cafeteria Supervisor reports to with cc: to the complainant.

When asked further on same topic, the Quality manager responded that the
suggestion box was removed since the consumption of food in cafeteria has been
very low in the past 6 months. He also added that emails were introduced to promote
more suggestions, and meet the requirements of the QMS.

QMS AUDIT - NONCONFORMITY REPORT 2

1) Nonconformity (2 marks for identifying the scenario as a nonconformity)

2) Description of the nonconformity (3 marks for describing the NC)

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3) Objective Evidence (3 marks for identifying the evidence)

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QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 14

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4. ISO 9001 clause and requirement: (only one clause/Sub-clause to be written)

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Remarks: 1 mark for clause and requirement plus 1 mark for unambiguous/clear
response

OR

Audit investigation-2:

There is no sufficient evidence to report nonconformity. (2 marks)

Points of Audit investigation and evidence : (4 audit trails – 8 marks)

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QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 15

 4.3 Audit scenario 3:

As an auditor from a certification body auditing a precision engineering company, you

review the records of incident reporting process, and note that there were 14
incidents reported where workers/visitors were found smoking near workplace,
workers entering restricted area, welders not wearing welding shield while welding,
nurses in company-clinic not wearing PPE etc.,

Your observations and available documented information retained indicated that the
personnel were unaware that Incident Reporting is in place. You ask a representative
of top management how the personnel are informed of any QMS issues relevant to
them. He replied stating that all QMS issues are addressed in weekly ‘Stand-Up
Meetings’. These meetings are held every Tuesday morning and all personnel
irrespective of level/function must attend. You ask to see the Agenda and Minutes of
these meetings, and the samples you review cover the only typical topics of
workshop meeting such as availability of welding rods, readiness of lathes, canteen
timings etc.,

You inquire how the company ensures all personnel attend, and are told that it’s not
necessary for any records to be kept since it is a standard practice for over 10 years
for all personnel to attend. When asked how they ensure those personnel who are
not able to attend these meetings because of other shift-duties, illness or holidays
etc. he stated that ‘there is no formal arrangements, but it is expected that Division
managers to appraise all personnel when they return to work’.

QMS AUDIT - NONCONFORMITY REPORT 3

1. Nonconformity (2 marks for identifying the scenario as a nonconformity)

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2. Description of nonconformity (3 marks for describing the NC)

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QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 16

 3. Objective Evidence (3 marks for identifying the evidence)

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4. ISO 9001 clause and requirement:

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(OR)

Audit investigation-3:

There is no sufficient evidence to report nonconformity.

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Points of Audit investigation and evidence: (4 audit trails = 8 marks)

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END OF SPECIMEN EXAM PAPER

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper 17