Examination Paper of ISO 9001 : 2008
1
IIBM Institute of Business Management
IIBM Institute of Business Management
Examination Paper MM.100
ISO: 9001: 2008
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
5
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
7
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
9
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
11
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
13
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
15
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
1
IIBM Institute of Business Management
IIBM Institute of Business Management
Examination Paper MM.100
ISO: 9001: 2008
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
5
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
7
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
9
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
11
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
13
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
15
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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