SOLUTION

ISO 9001:2015 QMS LAC Specimen Exam Paper-01

For ISO 9001:2015 QMS Lead Auditor 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 additional 30 minutes. Any delegate with medical
disability may get 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 questions

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

answers must be written on this Exam paper itself. Delegate 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 SOLUTION 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 ISO 9001:2015 audits to be objective and impartial.
DESCRIBE your understanding of objectivity and impartiality in this
context. (2 marks)

Suggestive solution:

Objectivity: Auditors should gather fact-based evidence that is traceable and

verifiable. No assumptions or hear-say to be considered as Objective Evidence

(1 mark)

Impartiality: Auditors should perform without partiality or bias, including in the

process of collecting of data, and analysis of evidence. Or, that auditor is free from
a conflict of interest (1 mark)

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

Suggestive solution:

Being undiplomatic is considered as rude or disrespectful to the auditee, and can

cause the auditee to be offended, lead to raising a a complaint. It could also lead
to a complete withdrawal of co-operation and hence the audit opportunity.

It is also possible that it might cause the auditee to be not so keen to respond
proactively to queries, and hence limiting the overall effectiveness of the audit.

1.3 GIVE four examples of evidence which demonstrates that an organisation is

managing its QMS legal compliance in conformity with ISO 9001. (2 marks)

Suggestive solution:

• A process to determine & have access to up-to-date legal requirements

• A list of legislative, regulatory & other requirements
• A link between its QMS risks and the appropriate legislation
• A register of applicable legislation
• Access to a competent specialist, expertise or advice
• Evidence of compliance checking

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper SOLUTION 2

 • A process for periodic evaluation of legislative compliance and associated
retained documented information to evidence such evaluations
• QMS Objectives have taken legal requirements into account
• Appropriate operational controls are in place
• Reviews are in place to assess changing legislative or other requirements

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

Suggestive solution:

 Acceptance in writing from auditor

 Evaluation of submitted evidence
 Verification of corrective action at the audit location or virtual audit
 Results of audit follow-up
 Photographic evidence (for simple NCs which do not require site visit for
carrying audit follow-up)

All of above must demonstrate that the corrective action has been implemented
and authenticated as ‘effective, not just the remark of ‘implemented corrective
action’.

1.5 IDENTIFY whether each of the four statements below is TRUE (T) or FALSE
(F) by circling the correct letter. (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 SOLUTION 3

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

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

2.1. a) Suggestive solution: (Any six)

• Initial communication with the auditee

• Confirm the audit objective, its scope and the audit criteria
• Pre-audit visit (or Stage 1 audit or document review)
• Confirm and agree date/s of audit
• Evaluate and select audit team and any technical expert as required
• Assign tasks to audit team members as necessary
• Chair the opening meeting
• Managing the audit; keeping to the audit programme and timing
• Invite feedback from team at auditors meeting(s)
• Chair the closing meeting
• Inform auditee management of audit findings and recommendations
• Encourage queries from Auditee management
• Manage preparation and distribution of audit report
• Review any corrective actions taken
• Arrange for a re-visit as necessary
• Closure of audit
• Distribution of audit documentation in accordance with the client’s
requirements
• Responding to any query the client may have post-audit

(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)

2.1. b) Suggestive solution:

• Make a note of the details of the situation.

• Check with the relevant auditee whether or not the related risk has been
identified/determined.
• Raise an NCR against 6.1. - if the risk has not been identified or if the
organisation has no established process for ‘action to address risks and
opportunities’.

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 • Check the competence of the personnel responsible for managing risks that
completed the risk identification in the area in which the hazard was found
• Review any documented information relating to the area in which the
risk/hazard was identified to determine whether there have been any other
significant omissions.
• Check how long the hazard has been present. If this is a new hazard
determine why the hazard was not identified.

2.2 You are the audit team leader conducting a QMS Stage-1 certification audit on
site by yourself in an organisation. 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 computer is a token of
business relationship 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)

2.2) Suggestive Solution:

Thank the QMS manager, and the auditee management very sincerely for the
generous gift, but express in clear terms that such a generous gift would be
viewed by the certification body as an inducement to the auditor. And, express it is
not ethical to accept gifts of this nature. Highlight that auditors must be impartial
and independent every moment in accordance with accreditation standards such as
ISO 17021 and auditors’ professional code of conduct. Advise the QMS manager
that there is no intent to disrespect by refusing the gift but express the trust that
the company will understand the auditor’s position. Emphasize the fact that the
acceptance or negating the gift will not affect your conduct of the audit in any
manner.

Note to Scorer: The core focus of this question is the need for the auditor to act
with integrity, recognize and manage cultural and social issues and maintain an
effective but independent relationship with the client. 1 mark for each underlined
issue to a maximum of 5 marks. Award 0 marks if the gift is to be accepted.

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. (5 marks)

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2.3) Suggestive solution:

1. Individual auditors should have no conflicts of interest such as prior

consultancy within recent years.
2. Maturity as a currently experienced auditor – are they competent to work
alone or require supervision?
3. Knowledge and experience of the computer industry and specifically the
manufacture of hardware.
4. QA systems related to computer industry, if any.
5. Auditors should be certified and/or have the approval of the certification body
6. appropriate competence including education and training is required.
7. Relevant personal skills and attributes to ensure a successful audit.
8. Geographical proximity to the audit location may be a factor.
9. Ideally should be fluent in the audit language.
10. Knowledge of ISO 9001 and its interpretation in the computer manufacturing
sector
11. Knowledge of relevant local and national QMS legislation/regulations
12. Will technical expertise be required requiring specialist advice and guidance?
13. Will the team as a whole possess the overall competencies required for
effective completion of the audit and is it likely they will work effectively
together?

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
Design Division would not add value, and requests if you, as auditor, could exempt
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)

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper SOLUTION 6

2.4) Suggestive solution:

• An external audit needs to cover all the processes associated with the scope of
the management system and the audit criteria. (2 marks)
• If Purchase Division is not included, it will not be possible to make a
recommendation on certification.
• An audit of Purchase Division now could confirm the accuracy of the recent
internal audit findings.
• The audit criteria for internal audit may be different from the audit criteria of
this audit
• All issues must be independently verified by the auditor
• The opening meeting is not the place to try to alter the agreed schedule of the
audit plan
• An external audit of Purchase Division now may identify other findings that may
need to be addressed for system improvement.
• The audit can address/include a review of planned corrective action.
• The fact that internal audits have been carried out and corrective actions
identified may well provide positive evidence of system conformity, rather than
be seen to be a defect or a problem.

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper SOLUTION 7

 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 in a confined space. 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)

3.1) Suggestive solution: (An audit checklist with 10 issues is also acceptable)

• Has the organization’s assessment of risk been reviewed post-accident?

(10.2.c)
• If the organization’s assessment of risk has been changed, has the new
assessment been communicated? (10.2)
• Have new controls been implemented? (8.1.1.b)
• Have people been trained in the new controls? (7.2.b)
• Did the company follow due legal process for reporting the fatal accident
(6.1.4.a.2)
• Review the process (es) for ‘Action to address risks and opportunities’ (6.1.)
• Confirm application of the appropriate process(es) to verify if hazards
associated with confined space working have been identified and assessed to
be significant. (6.1)
• Look for process(es) relating to eliminating hazards and reducing QMS risks:
were they applied in this case? (8.1.2)
• Have these arrangements taken full consideration of legal requirements? (9.3)
• Has the adequacy of the process(es) been reviewed following the incident?
(10.2)
• Look at performance monitoring and measurement (9.1.1)
• Look at incident/hazard statistics, is there analysis & evaluation of data?
(9.1.1)
• Look at incident/hazard reports for establishment of root cause (10.2)
• Look at corrective actions based on incident investigation reports (10.2)
• Look at the process for evaluating the effectiveness of corrective actions (10.2)
• Confirm effective Emergency Preparedness and Response Plans are in place as
a part of Risk management initiative: were the plans applied and effective for
this incident? (6.1)

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper SOLUTION 8

3.2 With reference to the requirements of 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 through to close of
subject-nonconformity. IDENTIFY the audit party (Auditor or Auditee) responsible
for each element of the process (10 marks)

3.2) Suggestive solution: (A Flowchart is also acceptable)

1. NCR raised - Auditor

2. Review the nonconformity, Determination of root cause/s – Auditee
3. Finalize actions to ensure that nonconformity does not recur – Auditee
4. A decision (after evaluation of the need or as part of the evaluation process)
to take action or not – Auditee
5. Provide timeline for each set of activity, and sum it up to indicate the
probable time required for completing corrective action, by generating a CAP,
Corrective Action Plan - Auditee
6. Forward CAP to auditor – Auditee
7. Approve or reject CAP – Auditor (If rejected go back to Step 2 above –
Auditee)
8. Once approved by auditor, Implement action needed – Auditee
9. Record results of action taken – Auditee
10. Review effectiveness of action taken – Auditee
11. Inform auditor for Audit Follow-up - Auditee
12. Verify effective corrective action – Auditor
13. Close audit - Auditor
14. Make changes to a) Management system related documented information
such as procedures, controls etc., b) Risk management - Auditee

3.3 A requirement of ISO 9001 (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 organisation conforms to this requirement.
(10 marks)

3.3) Suggestive Solution: (An audit checklist is expected for this question)

1. How does the Top Management take accountability for effectiveness of QMS ?
(5.1.a)

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper SOLUTION 9

2. How are the Quality Policy and Quality Objectives established for QMS?
(5.1.b)
3. How the Top Management ensures the integration of the quality management
system requirements into the organization’s QMS? (5.1.c)
4. How the Top Management promotes the use of the process approach and risk-
based thinking? (5.1.d)
5. How the Top Management ensures QMS achieves its intended results? (5.1.g)
6. How promoting improvement is managed t Top Management level? (5.1.j)
7. How the requirements of customer and applicable statutory and regulatory
requirements are determined, understood and consistently met? (5.1.2.a)
8. Towards ensuring the focus on enhancing customer satisfaction is maintained,
please Top Management’s leadership and commitment? (5.1.2.c)
9. How risks and opportunities are determined, understood and consistently
met? (5.1.2.b)
10. How top management engages, directs and supports persons to contribute to
the effectiveness of QMS? (5.1.1.h)

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper SOLUTION 10

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
appropriately.

Delegates are required to either:

• 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)

Note to marker: if students raise a nonconformity report when there is no

nonconformity, 0 (zero) marks will be awarded.

OR

• 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 the delegate would look for, and for what purpose.(8
marks)

Note to marker: If delegates complete the audit investigation template for a

situation where there is evidence that a 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)

Note to marker: Marks should only be awarded where the audit investigation trails
are appropriate to the situation, and would furnish further evidence of conformity
or otherwise.

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper SOLUTION 11

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.

Solution – Nonconformity

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)

The system failed to identify all the hazards or take into consideration the
legal requirements with regard to hazardous substances.

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

The dark violet colored unclogging liquid is stored on the food shelf in an
unmarked container. There is neither risk assessment relating to the
identified hazard nor any valid procedure/work instruction/signage. Various

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper SOLUTION 12

 personnel available in the kitchen who were interviewed were not aware of
what the fluid was, what is its use or its storage instructions.

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

written)

6.1. Actions to address risks and opportunities

Remarks: Alternatively, 6.1.2, or 8.1.1b or 7.3.e is acceptable

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

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper SOLUTION 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.

Solution – No nonconformity

Audit investigation:

There is no sufficient evidence to report nonconformity.

There is a need to further investigate the Quality manager’s response to the

emails, discussion with Administration Manager, and whether any follow up action
took place or not to decide whether this scenario is a conformity or otherwise. (2
marks)

Points of Audit investigation and evidence sought: (4 audit trails)

1. Establish if there has been a wider awareness to increase understanding of

the suggestion scheme and how to report concerns (5.4) (2 marks)
2. Establish whether all personnel have access to email during working hours
(7.1) (2 marks)
3. Review the methods of communicating processes and establish if staff
understood how to report incidents (7.4.2) (2 marks)
4. Determine how the manager sees her responsibilities in QMS, and
demonstrates a focus on continual improvement (10.3) (2 marks)

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper SOLUTION 14

 5. Determine whether any other documented information exists in relation to
the concerns (7.5.1.b) (2 marks)

NOTE:

Deduction of 0.5 mark for each point if the clause reference is missing.

If nonconformity is raised, 0 marks will be awarded.

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper SOLUTION 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’.

Solution – Nonconformity

QMS AUDIT - NONCONFORMITY REPORT 3

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

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

The organisation has failed to implement effective procedures that inform staff of
QMS issues they need knowledge of to ensure their personal safety.

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

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper SOLUTION 16

Several workers had not been informed of radiation work that was being carried
out and had entered a radiation-controlled area.

4. ISO 9001 clause and requirement:

7.4.2 - The organization shall internally communicate information relevant to the

QMS among the various levels and functions of the organization

Note:

Clause 7.2.d or 8.1.b is also acceptable

END OF SPECIMEN EXAM PAPER-SOLUTION

QMSLAV 1.0 ISO 9001:2015 QMS LAC_Specimen Exam Paper SOLUTION 17