Once the policy is established the organization must _________________ it. a) Deploy b) Implement c) Recreate d) Verify
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ISO: 9001: 2008
Multiple Choices :
Q1. A desired
result is achieved more efficiently when activities & related resources are
managed as a
a) Program
b) Process
c) Aim
d) Project
Q2. An
advantage of process approach is
a) Internal working
b) External
management
c) Ongoing control
d) None
Q3. 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
Q4. 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
Q5. Whenever
the term “product” is used, it can also mean
a) Cost
b) Quality
c) Profit
d) Service
Q6. 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
Q7. To
determine how all of the process relate to each other, process must be
a) Mapped
b) Flowcharted
c) Both (a) &
(b)
d) None
Q8. The term
“quality” can be used with adjective such as
a) Poor
b) Good
c) Excellent
d) All above
Q9. 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
Q10. 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
Q11. 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
Q12. According
to clause 3.7.2, the document is defines as
a) Information and
supporting medium
b) Product
c) Report
d) Data
Q13. Top
management is required to ensure that customer requirements are
a) Determined
b) Understood
c) Met
d) All above
Q14. 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
Q15. 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
Q16. Once the
policy is established the organization must _________________ it.
a) Deploy
b) Implement
c) Recreate
d) Verify
Q17. 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
Q18. 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
Q19. 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
Q20. 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
Q21. 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
Q22. 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
Q23. 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
Q24. 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
Q25. 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
Q26. 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
Q27. 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
Q28. Which
physical factor can affect the work environment?
a) Heat
b) Hygiene
c) Humidity
d) All above
Q29. 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
Q30. According
to clause 3.4.2, the product is defined as
a) Result of a
process
b) A service
c) Software
d) Hardware
Q31. 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
Q32. 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
Q33. 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
Q34. 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
Q35. 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
Q36. 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
Q37. 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
Q38. 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
Q39. 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
Q40. 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
Q41. 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
Q42. 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
Q43. Design and
development output be provided in a way that can be used for
a) Identification
b) Justification
c) Validation
d) Verification
Q44. 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
Q45. 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
Q46. 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
Q47. 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
Q48. 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
Q49. 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
Q50. 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
Q51. Determination
the nature of the control is the responsibility of
a) Suppliers
b) Customers
c) Employees
d) Organization
Q52. 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
Q53. Documentation
requirements for the overall quality management system are stated in
a) Clause 4
b) Clause 5
c) Clause 6
d) Clause 7
Q54. 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
Q55. 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
Q56. 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
Q57. 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
Q58. 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
Q59. 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
Q60. 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
Q61. 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
Q62. 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
Q63. 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
Q64. 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
Q65. 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
Q66. 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
Q67. 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
Q68. Is
services are the product of an organization, clause 8.3 may have ___________
applicability.
a) Limited
b) Unlimited
c) Complete
Q69. 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
Q70. 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
Q71. 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
Q72. The
analysis of data shall provide information relating to
a) Customer
satisfaction
b) Conformity to
product requirements
c) Suppliers
d) All above
Q73. 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
Q74. 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
Q75. The
_______________ is a powerful tool for driving continual improvement.
a) QMS
b) Analysis of Data
c) Modify data
d) Improvement
Q76. Collecting
of data without developing the data into useful information is a (n)
_______________ of organizational resources.
a) Product
b) Service
c) Tool
d) Waste
Q77. The
purpose of analysis is to convert data into
a) Usable
information
b) Relevant
information
c) Product
d) None
Q78. 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
Q79. 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
Q80. 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
Q81. 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
Q82. 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
Q83. ________________
involves the taking action to eliminate the causes of nonconformities.
a) Corrective action
b) Preventive action
c) Improvement
d) Analysis of data
Q84. 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
Q85. 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
Q86. 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
Q87. 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
Q88. 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
Q89. Planning
for continual improvement described in ISO 9001:2008,
a) Clause 5.4.2
b) Clause 8.1
c) Both (a) &
(b)
d) None
Q90. 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
Q91. 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
Q92. A process
is nothing more than a collection of
a) Related
activities
b) Interrelated
activities
c) Modules
d) Individual task
Q93. ___________________
provide requirements to the process and feedback how well those requirements
have been met.
a) Consumers
b) Customers
c) Suppliers
d) Managers
Q94. A system
is a collection of _________________ with a common set of objectives &
outputs.
a) Interrelated
process
b) Interrelated
activities
c) Hardware
d) Software
Q95. 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
Q96. Vertical
audits can be used for ________________ areas that have major parts of the
overall system.
a) Process
b) Planning
c) Functional
d) Improvement
Q97. 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
Q98. 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
Q99. 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
Q100. 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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