ISO: 9001: 2008 - 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
- 1. Need Answer Sheet of this Question paper, contact aravind.banakar@gmail.com www.mbacasestudyanswers.com ARAVIND – 09901366442 – 09902787224 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