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Multiple
Choices:
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
6. A process that the
organization needs for its quality management system and which the organization
chooses to have performed by an external party, is
a) Outsourced process
b) Internal process
c) External process
d) None
7. To determine how all of the
process relate to each other, process must be
a) Mapped
b) Flowcharted
c) Both (a) & (b)
d) None
8. The term “quality” can be used
with adjective such as
a) Poor
b) Good
c) Excellent
d) All above
9. Which clause requires the
organization to identify and prepare documents necessary for effective planning,
operation, and control of its processes?
a) Clause 3.2
b) Clause 1.4
c) Clause 4.2.1d
d) Clause 2.4e
10. There is no requirement to
create a documented procedure for describing the process of creating a quality
policy in
a) Clause 4.2.3
b) Clause 8.5.2
c) Clause 5.3
d) Clause 7.1
11. The extent of quality
management system documentation dependent on the
a) Size & type of
organization
b) Complexity & interaction
of the organization’s process
c) Competency of the
organization’s people
d) All above
12. According to clause 3.7.2,
the document is defines as
a) Information and supporting
medium
b) Product
c) Report
d) Data
13. Top management is required to
ensure that customer requirements are
a) Determined
b) Understood
c) Met
d) All above
14. According to clause 3.3.5,
the “customer” term is defined as
a) Organization or person that
receives product
b) A person that sells a product
c) Purchaser
d) None
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
19. According to clause 5.2, who
is responsible to ensure that customer requirements are determined and met with
the aim of enhancing customer satisfaction?
a) Top management
b) Employees of the organization
c) Low level manager
d) None
20. An activity defined in clause
3.8.7 undertaken to determine the suitability, adequacy & effectiveness of
the subject matter to achieve established objective, is
a) Process
b) Procedure
c) Review
d) Requirement
21. Clause, which requires that
personnel are competent, is
a) Clause 6.2.4
b) Clause 6.2.1
c) Clause 5.2.3
d) Clause 6.5
22. According to clause 3.1.6,
competency is defined as
a) Demonstrated ability to apply
knowledge and skills
b) To compare with other
organization
c) Improvement in quality
d) None
23. The records that are created
by the activities to ensure competency may need to be enrolled per clause
4.2.2, which is related to
a) Control of documents
b) Control of records
c) Quality Management System
d) Monitoring & Measurement
24. The organization need to
identify what classroom training, seminars, on-the-job, or other training is necessary
so that
a) Top managers involved in
Quality Management System is competent
b) Low level managers involved in
Quality Management System is competent
c) Every employee involved in
Quality Management System is competent
d) All above
25. From the following in which
part it is common practice to conduct training evaluation?
a) Evaluation of the training
immediately upon completion
b) Evaluation of the training
received several weeks after the training
c) Evaluation of the skills
developed several months after the training
d) All above
26. Which clause defines the
infrastructure as system of facilities, equipment & services needed for 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
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
31. The planning for realization
processes covered in _________________ should define the records the
organization will keep during the process of determining customer requirements.
a) Clause 7.5
b) Clause 7.1
c) Clause 8.3
d) Clause 2.8
32. The obligation assumed by the
organization includes not only the products defined but also ancillary items
such as
a) Conformance to stated delivery
dates
b) Adherence to referenced
external standards
c) Compliance with the commercial
terms & condition applicable to the order, contract, quote or tender
d) All above
33. According which clause, the
organizations have the ability to meet requirements?
a) Clause 6.2.2
b) Clause 7.2.2
c) Clause 8.2.2
d) Clause 5.2.2
34. A critical activity generally
involves several functions & levels in an organization, is
a) Sell the product
b) Improve the quality
c) Determination of customer
requirements
d) None
35. The arrangement identified
& implemented should be appropriate for the organization in terms of
a) Its products
b) Its orders
c) Its contracts
d) All above
36. Clause, which applies to all
product type, to all market sectors, and to organization of all sizes, is
a) Clause 7.2.1
b) Clause 6.5.2
c) Clause 3.5.3
d) Clause 2.6.2
37. The intent of clause ____________
is to make sure that the organization plans and controls design and development
projects.
a) Clause 6.4
b) Clause 7.2.1
c) Clause 7.3.1
d) Clause 5.4.2
38. If the design and development
processes are planned and controlled well, then the projects will be completed
a) On time
b) Within budget
c) Both (a) & (b)
d) None
39. The output from the design
and development process is expected to include an information that relates to
a) Producing
b) Creating
c) Manufacturing
d) Processing
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
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
44. Which statement is true?
a) Validation is usually
performed after successful design & development verification
b) Verification is usually
performed after successful design & development validation
c) Validation & verification
both are same
d) Validation & verification
both are performed simultaneously
45. Which clause requires that
the organization shall ensure that purchased product conforms to specified
purchase requirements?
a) Clause 8.2.1
b) Clause 7.4.1
c) Clause 6.5.2
d) Clause 4.4.1
46. Clause 7.4.1 requires records
of the results of supplier evaluations and subsequent follow-up actions, with
specific reference to
a) Clause 5.2
b) Clause 4.2.4
c) Clause 5.3.1
d) Clause 7.2.1
47. Clause, which requires the
organization defined a process for verifying that purchased product conforms to
defined requirements, is
a) Clause 7.4.3
b) Clause 7.4.2
c) Clause 7.4.1
d) Clause 7.4.5
48. Clause, which requires to
pertain when verification activities are to be performed at the supplier’s premises,
is
a) Clause 7.4.3
b) Clause 7.4.2
c) Clause 7.4.1
d) Clause 7.4.5
49. Which clause requires a
process to ensure that purchasing documents adequacy state all of the requirements
for the items to be purchased?
a) Clause 7.4.1
b) Clause 7.4.2
c) Clause 7.4.3
d) Clause 7.4.4
50. If purchased material has
high actual potential impact on either the final product on the realization
processes, then
a) No need to control it
b) Less control is required
c) More robust control is
required
d) None
51. Determination the nature of
the control is the responsibility of
a) Suppliers
b) Customers
c) Employees
d) Organization
52. Which clause addresses the
processes necessary for an organization to produce and deliver product &
services?
a) Clause 6.4.1
b) Clause 5.2.3
c) Clause 7.5.1
d) Clause 7.2.3
53. Documentation requirements
for the overall quality management system are stated in
a) Clause 4
b) Clause 5
c) Clause 6
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
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
59. Clause, which provides the
framework for the establishment and maintenance of a measurement system, is
a) Clause 7.1
b) Clause 6.5
c) Clause 7.6
d) Clause 5.6
60. According to clause 8.1
‘Measurement, Analysis & Improvement’, from the following which is the responsibility
of the organization?
a) What it needs to monitor &
measure
b) Where to monitor & measure
c) What analysis should be
performed
d) All above
61. Which clause monitored the
customer satisfaction information?
a) Clause 7.2.1
b) Clause 8.2.1
c) Clause 8.2.5
d) Clause 6.2.4
62. Internal audit of the quality
management system remains grouped with clauses for monitoring information
relation to __________________.
a) Customer requirements
b) Customer perceptions
c) Customer satisfaction
d) All above
63. Clause 8.4,
______________________, of ISO 9001:2008, which could be a source of information
in identifying the key process to monitor.
a) Monitoring & measurement
b) Control of records
c) Analysis of data
d) Customer satisfaction
64. When process monitoring or
measurements indicate that the desired results are not being achieved, the
process may need ________________ to identify and eliminate root causes.
a) Corrective action
b) Reproduction
c) Modification
d) Perceptive action
65. Monitoring & Measurement
of a product is related to
a) Clause 8.2.4
b) Clause 7.2.4
c) Clause 6.2.1
d) Clause 7.3.2
66. For purchased material,
clause ___________, ‘verification of purchased product’, requires the organization
to identify and implement verification activities.
a) Clause 7.5.1
b) Clause 8.2.3
c) Clause 8.2.4
d) Clause 7.4.3
67. Which clause requires
establishing process to ensure that product that does not confirm to requirement
is identified and controlled to prevent unintended use or delivery?
a) Clause 8.2
b) Clause 8.3
c) Clause 7.5
d) Clause 6.4
68. Is services are the product
of an organization, clause 8.3 may have ___________ applicability.
a) Limited
b) Unlimited
c) Complete
d) Less
69. A(n) _______________ shall be
established to define the controls & related responsibilities andnauthorities
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
73. The clause, which requires
the organization to collect & analyze appropriate data to determine the
suitability & effectiveness
of the quality management system, is
a) Clause 8.1
b) Clause 8.2
c) Clause 8.3
d) Clause 8.4
74. Clauses, which are linked in
the sense that the organization should function on a closed-loop bases, are
a) Clauses 5, 6 and 7
b) Clauses 6,7 and 8
c) Clauses 5,7 and 8
d) Clauses 4,5 and 6
75. The _______________ is a
powerful tool for driving continual improvement.
a) QMS
b) Analysis of Data
c) Modify data
d) Improvement
76. Collecting of data without
developing the data into useful information is a (n) _______________ of
organizational resources.
a) Product
b) Service
c) Tool
d) Waste
77. The purpose of analysis is to
convert data into
a) Usable information
b) Relevant information
c) Product
d) None
78. The organization should
seriously consider documenting expectation for continual improvement at least
in the area of data related to
a) Customer satisfaction
b) Conforming to product
requirements
c) Opportunities for preventive
action
d) All above
79. The appropriate information
on customer satisfaction on and/ or dissatisfaction may depend upon the
______________ of an organization relationship with its customer.
a) Nature
b) Behavior
c) Service
d) All above
80. The organization shall
continually improve the effectiveness of the QMS through the use of the
a) Quality policy
b) Quality objectives
c) Audit results
d) All above
81. The setting of objectives
consistent with a quality policy containing a commitment to continual improvement
of the effectiveness of the QMS is required in
a) Clause 5.4.1
b) Clause 5.4.3
c) Clause 5.4.4
d) Clause 6.2.1
82. The intent of clause
_____________ is to achieve 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
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
87. Which clause requires records
of preventive action results with specific reference to clause 4.2.4 for
control of records generated?
a) Clause 8.4.1
b) Clause 7.2.4
c) Clause 8.5.2
d) Clause 8.5.3
88. The success or failure of the
Quality Management System implementation depends on
a) How the requirements are
implemented
b) The process used for
implementation
c) The midset of top managers
& other employees
d) All above
89. Planning for continual
improvement described in ISO 9001:2008,
a) Clause 5.4.2
b) Clause 8.1
c) Both (a) & (b)
d) None
90. Active and serious management
review of the entire loop required in
a) Clause 4.2
b) Clause 5.6
c) Clause 7.2
d) Clause 8.6
91. A desired result is achieved
more efficiently when activities and related resources are manage as
a
a) Process
b) Project
c) Individual work
d) Plan
92. A process is nothing more
than a collection of
a) Related activities
b) Interrelated activities
c) Modules
d) Individual task
93. ___________________ provide
requirements to the process and feedback how well those requirements have been
met.
a) Consumers
b) Customers
c) Suppliers
d) Managers
94. A system is a collection of
_________________ with a common set of objectives & outputs.
a) Interrelated process
b) Interrelated activities
c) Hardware
d) Software
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
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
