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Examination Paper

IQA 2015

Paper 1
(ISO 9001: 2015 Internal Auditor Training)

Time Allocated: 60 Minutes

Delegate Name:
Organization Name:
Course Date: Venue:
For office use
Section No. Marks allotted Minimum Pass Marks obtained
marks
1 15 6
2 25 10
3 10 4
Total 50 35
Pass/Fail:
Tutor Name:
Tutor Signature:

QMSIA 2015 Rev.1d (12/2015) Page 1 of 10


INSTRUCTIONS:

This examination paper is in three sections. All questions are to be attempted. The
time allowed is 60 minutes. There is no additional time allowance for reading the
questions. There is a maximum of 50 marks available. The minimum passing marks
is 35.

Your answers must be on the sheets supplied. Additional sheets will not be
accepted.

ISO 9001 always refers to ISO 9001:2015 Quality Management Systems –


Requirements. The word “clause” always refers to a paragraph, section or
requirement of ISO 9001 that is identified by a number, such as 4.2 or 7.1.5.2.

Access to ISO 9001:2015 standard copy, delegate notes and other notes taken
during the training is allowed, but access to other reference material is not
permitted.

Section 1 is worth 15 marks

Question 1, comprises questions which require you to place a circle around the
letter (a, b, c, d or e) to indicate which one you judge to be the correct answer
Question 2, comprises questions which require you to mention True or False against
each statement.
Question 3, comprises questions to indicate the relevant clause from ISO
9001:2015.

Section 2 is worth 25 marks


Comprises questions that require a brief written answer in the space provided.

Section 3 is worth 10 marks


Comprises of situations for which nonconformity may be required and questions
that require a detailed written answer that will normally fill the space provided.

QMSIA 2015 Rev.1d (12/2015) Page 2 of 10


Section 1 — 15 Marks (Each question is worth 5 marks)

1. Circle around the right option.

1.1 “Records, statements of fact or other information, which are relevant to


the audit criteria and verifiable” is a definition of

a. Objective evidence
b. Audit evidence
c. Audit finding
d. Audit
e. None of the above

1.2 The main purpose of an opening meeting during audit is:

a. To explain the audit process.


b. To establish good co-operation and communication with auditee.
c. To explain the scope & purpose of the audit.
d. All of the above
e. None of the above

1.3 Which of the following standard sets out the guidelines for auditing
Management System

a. ISO 9002
b. ISO 9001
c. ISO 19011
d. ISO 9004
e. ISO 9000

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1.4 “Set of interrelated or interacting activities that use inputs to
deliver an intended result” is called –

a. Quality Assurance
b. Quality Management System
c. Process Control
d. Procedure
e. None of the above
1.5 The “Effect of uncertainty” means

a. Risk
b. Non-conformity
c. Process
d. Opportunity
e. None of the above
2. Given below are 5 questions / statements. You are required to state
whether the statement is “TRUE” Or “FALSE” in the space provided.

S. No. Question / Statement T/F


1 The organization shall monitor and review information T
about interested parties and their requirements provided
they are relevant to organization’s QMS.
2 Issues arising from legal, technological, competitive, market, F
cultural, social and economic environments can facilitate
understanding of internal context of the organization.
3 Organization may decide to retain identified risk to their
QMS by informed decision. T
4 Organizational knowledge can be based on both, internal or
external sources. T
5 Documented information on quality objectives is no longer
required to be maintained. F

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3. Mention the Clause no. of ISO 9001:2015 against each statement.

A) The organization shall determine, provide and maintain the infrastructure


necessary for the operation of its processes and to achieve conformity of products
and services.

7.1.3
CLAUSE NO.______________

B) Documented information retained as evidence of conformity shall be


protected from unintended alterations.
7.5.3.2
CLAUSE NO.______________

C) The organization shall ensure that outsourced processes are controlled


8.1
CLAUSE NO.______________

D) Communication with customers shall include obtaining customer feedback


relating to products and services, including customer complaints
8.2.1
CLAUSE NO.______________

E) The organization shall ensure that externally provided processes, products


and services conform to requirements.
.
8.4.1
CLAUSE NO.______________

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Section 2 —25 marks

Attempt all of the following questions. Where appropriate, identify the


relevant requirements of ISO 9001:2015. Each question is worth 5 marks.

1. Mention 5 issues that an auditor may consider discussing with top


management while determining the external context of the organization
Legal issues
___________________________________________________________________

Technological issues
___________________________________________________________________

Competitive issues
___________________________________________________________________

Social issues
___________________________________________________________________

___________________________________________________________________
Cultural issues

___________________________________________________________________

2. State at least 5 audit evidences that could be found during an audit to


demonstrate the effectiveness of clause 10.3 (Continual Improvement) of
ISO 9001:2015.
correction evidences
___________________________________________________________________
corrective action evidences
___________________________________________________________________

continual improvement evidences


___________________________________________________________________

breakthrough change evidences


___________________________________________________________________

innovation and re-organization evidences


___________________________________________________________________

___________________________________________________________________

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3. You are planning for internal audit of the Stores department in a Hospital.
Identify Input/Output/Controls/ Risks that you may require to verify as an
auditor.

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

4. When asked why Finished Goods were being stored outside the warehouse,
the supervisor responds that the warehouse is full, as truck operators are
observing indefinite ‘go slow’ to protest against police harassment in the
city. Mention 5 further audit trails you want to follow as an internal
auditor.

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________
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5. Mention 5 questions that you would ask to the Head of the HR Department
during an internal audit? HR department also deals with training, contractor
management and security.
Mention the relevant clause no. against each question.

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________
Check: Have you mentioned the clause numbers?

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Section 3 —10 Marks

3.1 An incident that occurs during an internal audit of XYZ Ltd is described. It
contains a situation for which a nonconformity report may be required. Examine
the incident carefully then take the following actions:

a. If you think that there is sufficient objective evidence of nonconformity, then


state the nonconformity.

b. If you do not think that there is sufficient objective evidence of nonconformity


then you should state your reasons in the space below the report. You should also
mention 5 audit trails that you want to investigate further.
NOTE: Delegate shall fill up either part a or part b. Zero marks will be given for filling both sections.

INCIDENT: No. 1

During the third internal audit cycle, in the Management Representative


department the auditor observed that all 7 previous NCRs raised during the
second internal audit cycle are not formally closed out.

On enquiring with the MR, he responds that individual departments


implemented correction and corrective action and results are usually discussed
in Management Review Meeting. No other action is usually required.

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a) NC Report

Quality Audit Incident Number …............


NONCONFORMITY REPORT
Company under Audit: XYZ Ltd
Area under review: ISO 9001 Clause Number

………………………………… ……………………………
Category MAJOR* MINOR* *circle the correct one
Nonconformity:

Auditor
OR
b)
________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________
QMSIA 2015 Rev.1d (12/2015) Page 10 of 10

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