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09 SOLUTION - Specimen Exam Paper - ISO 9001-QMS LATC V 1.0
09 SOLUTION - Specimen Exam Paper - ISO 9001-QMS LATC V 1.0
Instructions:
7) Please observe the Action Verb such as Describe, List, Illustrate, State etc.,
and respond accordingly
(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:
(1 mark)
1.2 EXPLAIN the likely consequences of an auditor not being diplomatic during
an audit. (2 marks)
Suggestive solution:
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.
Suggestive solution:
1.4 IDENTIFY two ways in which an auditor can verify that agreed corrective
actions have been effectively implemented. (2 marks)
Suggestive solution:
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)
c) Auditors must identify the root cause of any nonconformity which they report
(TRUE/FALSE)
2.1 a) LIST six responsibilities of the Audit Team Leader when conducting an
external audit (3 marks)
(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)
2.2 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)
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)
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)
• 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.
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)
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)
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.
OR
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.
Solution – Nonconformity
The system failed to identify all the hazards or take into consideration the
legal requirements with regard to hazardous substances.
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
NOTE: 1 mark for clause and requirement plus 1 mark for unambiguous/clear
response
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:
NOTE:
Deduction of 0.5 mark for each point if the clause reference is missing.
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
The organisation has failed to implement effective procedures that inform staff of
QMS issues they need knowledge of to ensure their personal safety.
Note: