Examination Paper of ISO 9001 : 2008
1
IIBM Institute of Business
Management
IIBM
Institute of Business Management
Examination
Paper MM.100
ISO:
9001: 2008
Guidelines for paper
• Total No. of Questions is 100.
• The minimum passing marks is 50%.
• Each Question carries 1 mark.
• Answer all the Questions.
Multiple
Choices: Total Marks: 100
1. A desired result is
achieved more efficiently when activities & related resources are managed
as a
a) Program
b) Process
c) Aim
d) Project
2. An advantage of process approach
is
a) Internal working
b) External management
c) Ongoing control
d) None
3. A quality management
system has confirmed to ISO 9001:2008 is aimed to achieve
a) Minimum quality
b) Best quality
c) Maximum profit
d) Customer satisfaction
4. If exclusions are not
limited to requirements with clause 7, then which action is taken against
claims of confirmed
a) Claims of conformity to
this international standard are not acceptable
b) Claims of conformity to
this international standard are acceptable
c) Modify those exclusions
d) None
5. Whenever the term
“product” is used, it can also mean
a) Cost
b) Quality
c) Profit
d) Service
……………………………………….
15. Clause, which requires
that top management establish the quality policy is
a) Clause 5.3
b) Clause 5.1
c) Clause 3.2
d) Clause 4.3
16. Once the policy is
established the organization must _________________ it.
a) Deploy
b) Implement
c) Recreate
d) Verify
17. The quality policy
describes overall interactions and direction of an organization related to
quality as formally expressed
by top management. This definition is defined by
a) Clause 3.2.4
b) Clause 3.3.1
c) Clause 3.1.1
d) Clause 3.2.7
18. Clause, which requires
management of change so that the integrity of the quality management
system is maintained when the
system is change, is
a) Clause 3.2.4
b) Clause 5.4.2
c) Clause 3.2.1
d) Clause 4.5.3
…………………………..
the operation of an
organization?
a) Clause 3.6.1
b) Clause 3.3.3
c) Clause 3.3.1
d) Clause 3.3.2
Examination Paper of ISO 9001 : 2008
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IIBM Institute of Business
Management
27. The work environment of
an organization can be considered to be a combination of
a) Internal & external
events
b) Human & process
c) Customers & consumers
d) Human & physical
factors
28. Which physical factor can
affect the work environment?
a) Heat
b) Hygiene
c) Humidity
d) All above
29. From the following which
clause provides the essence of the use of the process approach?
a) Clause 4.1
b) Clause 8.1
c) Clause 7.1
d) All above
30. According to clause
3.4.2, the product is defined as
a) Result of a process
b) A service
c) Software
d) Hardware
………………………………….
40. According to clause
4.2.2, inputs relating to product requirements shall be determined and records
maintained. These inputs
shall include
a) Functional and performance
requirements
b) Applicable statuary &
regulatory requirements
c) Where applicable,
information derived form previous similar designs
d) All above
Examination Paper of ISO 9001 : 2008
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IIBM Institute of Business
Management
41. Which clause defines the
requirements specification for new product & maintains the records?
a) Clause 7.3.2
b) Clause 8.7.2
c) Clause 6.4.1
d) Clause 5.4.3
42. Which work should not
begin until a document exits in form acceptable to all who have
responsibility for
contributing to product specification?
a) Designing
b) Development
c) Production
d) Selling
43. Design and development
output be provided in a way that can be used for
a) Identification
b) Justification
c) Validation
d) Verification
……………………………………..
d) Clause 7
54. The focus of clause
7.5.1, ‘control of production and service provision’, is the key concept that
processed need to be carried
out under
a) Uncontrolled conditions
b) Controlled conditions
c) Both (a) & (b)
d) None
Examination Paper of ISO 9001 : 2008
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IIBM Institute of Business
Management
55. If changes are made to
process equipment, the product design, the materials used to produce the
product or to other
significant factors such as new personnel, then the process often requires
a) Reevaluation
b) Revalidation
c) Reproduction
d) Recertification
56. Validation should be
carried out at appropriate ________________ to respond to changes in
market requirements,
regulations, or standard in addition to assuring the continued acceptable
performance of processes.
a) Intervals
b) Checkouts
c) Positions
d) Timings
57. Which one is true?
a) Identification and
traceability are same
b) Identification and
traceability are not same
c) Identification and
traceability are not related
d) Identification and
traceability are separate bur related issues
58. Identification and
traceability is related to
a) Clause 7.5.3
b) Clause 7.5.2
c) Clause 8.2.1
d) Clause 7.5.1
………………………………
68. Is services are the
product of an organization, clause 8.3 may have ___________ applicability.
a) Limited
b) Unlimited
c) Complete
d) Less
Examination Paper of ISO 9001 : 2008
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IIBM Institute of Business
Management
69. A(n) _______________
shall be established to define the controls & related responsibilities and
authorities for dealing with
non conforming product.
a) Documented procedure
b) Report
c) File
d) Information
70. When nonconforming
product is corrected it shall be subject to _________________ to
demonstrate conformity to the
requirements.
a) Revalidation
b) Re verification
c) Review
d) Implement
71. The organization should
consider documenting a process for addressing situations in which
_____________ is detected
after delivery to or use by a customer has occurred.
a) Nonconformity product
b) Conformity product
c) Both (a) & (b)
d) None
72. The analysis of data
shall provide information relating to
a) Customer satisfaction
b) Conformity to product
requirements
c) Suppliers
d) All above
………………………………………
an integrated improvement
mentality
throughout the organization.
a) Clause 8.5.4
b) Clause 8.4.1
c) Clause 8.5.1
d) Clause 8.3.2
Examination Paper of ISO 9001 : 2008
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IIBM Institute of Business
Management
83. ________________ involves
the taking action to eliminate the causes of nonconformities.
a) Corrective action
b) Preventive action
c) Improvement
d) Analysis of data
84. Clause, which is related
to requirements for customer communications states that arrangement
must be made with customer
relating to complains, is
a) Clause 8.3
b) Clause 8.5.2
c) Clause 7.2.3
d) Clause 6.2.1
85. In preventive action the
organization is required to identify how it will eliminate the “causes” of
potential nonconformities in
order to prevent their
a) Resources
b) Occurrence
c) Visibility
d) None
86. FMECA stands for
a) Failure modes, effect, and
critical analysis
b) Failure modes, eliminate
and cancel analysis
c) Foreign money exchange and
complete association
d) None
…………………………………………
95. The approach in which
audits all of the process, each major process can be ensure compliance
with ISO 9001:2008 called
a) Horizontal audit
b) Vertical audit
c) Both (a) & (b)
d) None
96. Vertical audits can be
used for ________________ areas that have major parts of the overall
system.
a) Process
b) Planning
c) Functional
d) Improvement
Examination Paper of ISO 9001 : 2008
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IIBM Institute of Business
Management
97. In which sector ISO 9001
certification is frequently used to increase confidence in the products &
services provided by
certified organization?
a) Private
b) Public
c) Both (a) & (b)
d) None
98. The key objective of the
ISO/IEC sector policy is
a) Maximize the use of
generic QMS international standards
b) Support international
trade & remove trade barriers
c) Support developing
countries
d) All above
99. Records of audits and
their results are described in
a) Clause 8.2.2
b) Clause 8.2.4
c) Clause 7.5
d) Clause 8.3.4
100. The basis used for
calibration is defined in
a) Clause 7.3
b) Clause 7.6a
c) Clause 7.5.2a
d) Clause 7.3.4
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