This document contains 73 multiple choice questions related to ISO 9001:2008 quality management system requirements. The questions cover topics such as process approach, documentation requirements, management responsibility, resource management, product realization, measurement analysis and improvement. The document provides the questions and answer options, but no answers. It directs the reader to contact the given email address and phone number if they need an answer sheet for this question paper.

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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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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.

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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
Need Answer Sheet of this Question paper, contact
aravind.banakar@gmail.com
www.mbacasestudyanswers.com
ARAVIND – 09901366442 – 09902787224