1. Personnel working in the organization which has implemented ISO9001 Quality Management System, need to
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Correct Answer:
be competent on the basis of education, training, skills, experience
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2.
Special Instructions:The following question may have more than one correct answer options
The top management of the organization must ensure that:
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Correct Answer:
Quality Policy is stated
Quality Objectives are defined and established
Effective Quality Management System is established, implemented and maintained
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3. How many mandatory documented procedures are required by ISO9001 Quality Management System?
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Correct Answer:
6
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4. The ISO9001 standard requires that a Management Representative should be:
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Correct Answer:
A member of the management of the organization
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5. ISO9001 Quality Management System specifies the creation of a documented statement of the organization's:
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Correct Answer:
Quality Policy
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6. Which clause of ISO9001 requires that a documented procedure be established for conducting Internal Audits:
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Correct Answer:
Clause 8.2.2
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7. According to one of the principles of Quality Management System, Continual Improvement should be a permanent objective of the organization.
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Correct Answer:
True
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8. Quality Manual need not be documented for the Quality Management System of an organization:
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Correct Answer:
False
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9. ISO 9001:2000 requirements for the purchasing process do not specify:
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Correct Answer:
the goods and services to be purchased by the customer
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10. All purchased products could be verified by:
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Correct Answer:
Any one or more of the above
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11. Guidelines for performance improvement of the Quality Management System are provided in which standard:
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Correct Answer:
ISO9004
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12. Which concept makes PDCA cycle a key element of ISO9001:2008?
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Correct Answer:
Continual improvement
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13. The ISO9000 family of standards has been published by:
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Correct Answer:
International Organization for Standardization
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14. Responsibility and Authority of various functionaries in the organization need not be defined and communicated within the organization.
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Correct Answer:
False
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15. Which clause of ISO9001:2008 specifies the requirement for a Quality Policy?
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Correct Answer:
Management responsibility 5.3
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16. Documented procedure needs to be established for conducting Internal Audits:
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Correct Answer:
True
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17. Which clause of ISO9001 makes it mandatory to have Documented Procedure for Document Control?
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Correct Answer:
Clause 4.2.3
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18. The external auditor must review the management review documentation
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Correct Answer:
during every audit
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19. The operational technique or activity required to fulfill quality requirements is:
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Correct Answer:
Quality control
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20. The existing ISO 9001:2000 certification will stand invalid
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Correct Answer:
2 years after publication of ISO9001:2008
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21. What clause of ISO9001:2008 makes it mandatory to maintain the records of Management Review
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Correct Answer:
Clause 5.6
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22.
Special Instructions:The following question may have more than one correct answer options
The role of top management, as required by ISO9001 is to provide leadership and take actions which create an environment where:
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Correct Answer:
People are fully involved
Quality Management System can operate effectively,
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23. A non-conforming product
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Correct Answer:
can be reworked to meet the specifications
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24. Which clause of ISO 9001:2008 refers to the working conditions and is used to ensure that the product manufacturing requirements are being met?
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Correct Answer:
clause 6.3
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25. What needs to be ensured prior to their communication to the supplier.
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Correct Answer:
Price
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26. _________ is applied to corrective and preventive actions to prevent a problem from re-occuring.
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Correct Answer:
Root Cause Analysis
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27. The Technical Committee which considers, drafts and finalizes the International Quality Management System, ISO9001, is :
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Correct Answer:
ISO/TC176
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28. All ISO 9001:2000 certifications need to be revised to ISO 9001:2008 certifications by the end of:
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Correct Answer:
2010
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29. Which clause of ISO9001:2008 requires the statement of Quality Policy in the Quality Management System?
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Correct Answer:
Clause 5.3
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30. The purpose of conducting Management Review is to
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Correct Answer:
ensure effectiveness of the Quality Management System
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31. Under which clause of ISO9001, it is mandatory to identify Customer property?
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Correct Answer:
Clause 7.5.4
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32. Follow-up audit, after Internal Audit observation of non-conformity
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Correct Answer:
is required to verify the effectiveness of the corrective action
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33. ISO9001 does not recommend application of PDCA Methodology to all determined processes.
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Correct Answer:
False
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34. Product realization does not include:
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monitoring and measurement of processes
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35.
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Following are the current editions of the family of ISO9000 standards:
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Correct Answer:
ISO9004:2002
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36. Records provide evidence of conformity to requirements and effective operation of Quality Management System
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Correct Answer:
True
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37. Resource management includes:
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Correct Answer:
a process of determining whether resources are sufficient to meet customer requirements
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38. Special Instructions:The following question may have more than one correct answer options Quality Objectives should be:
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Correct Answer:
Measurable Consistent with Quality Policy
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39. ____________ is the written authorization for using materials that do not confirm to the quality requirements.
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Correct Answer:
concession waiver
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40. In a four tier pyramid concept of documentation for ISO9001:2008 guidelines, what is included in the tier three documents?
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Correct Answer:
Work instructions, reference documents/charts and instructional computer screens
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41. Necessary competence of the personnel working in the organization which has implemented ISO9001 is determined by:
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Correct Answer:
Quality Auditor
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42. __________ is required for periodically keeping the system revitalized.
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Correct Answer:
surveillance audit
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43. Which of the following clause makes it mandatory to maintain the Records of Preventive Actions taken?
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Correct Answer:
Clause 8.5.3
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44. The number of Quality Management System principles on which ISO9001 is based is:
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Correct Answer:
Eight
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45. According to ISO9001, top management does not include:
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Correct Answer:
ISO auditor
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46. According to ISO9001 standards, ensuring consumer focus throughout the organization is the responsibility of:
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Correct Answer:
Top management
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47. Internal audits need to be conducted:
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Correct Answer:
At planned interval
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48. The ISO members who have one vote each, irrespective to the strength of the economy are grouped as:
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full members
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49. The organization actually responsible for Design and Development of product can claim exclusion of Clause 7.3 of the standard ISO9001.
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Correct Answer:
False
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50. What needs to be planned and developed for product provision or provision of service, as required by ISO9001?
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Correct Answer:
Manufacturing Processes
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51. Guidelines for 'performance improvement' based upon the quality management principles are included in:
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Correct Answer:
ISO 9004
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52. ISO9001 promotes adoption of the following approach while developing, implementing and improving the effectiveness of the Quality Management System
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Correct Answer:
Process based
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53. During an audit, which step is used to check if a product meets the initial product specification requirements?
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Correct Answer:
product validation
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54. Appropriate records of education, training, skills and experience of the employees of the organization should be maintained by:
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Correct Answer:
personnel department
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55. In PDCA cycle P stands for Plan, D stands for Do, A stands for Act. What does C stand for?
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Correct Answer:
Check
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56. Which ISO standard sets guidelines for auditing Quality Management Systems and Environmental Management Systems?
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Correct Answer:
ISO 19011:2002
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57. Monitoring and measurement equipment must be calibrated or validated
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Correct Answer:
before using the equipment
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58. According to ISO specifications, customer property, if any, either used for production or incorporation
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Correct Answer:
must be identified prior to use
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59. According to ISO9001 specifications, the product status needs to be identified:
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Correct Answer:
suitably throughout production process
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60. An activity of using resources to transform inputs into outputs is called:
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Correct Answer:
Process
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61. The work that the organization goes through to develop, manufacture, and deliver the finished goods or services is called
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Correct Answer:
product realization
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62. Out of the given quality management principles, which one emphasizes on understanding & meeting current and future needs of the customers?
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Correct Answer:
Customer focus
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63. ________ is required to analyze and compare the adequacy of the system resources in order to improve and achieve product quality.
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Correct Answer:
quality audit
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64. ISO9001 can be applied to any organization irrespective of its size, structure and nature of the product.
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Correct Answer:
True
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65.
Special Instructions:The following question may have more than one correct answer options
ISO9001 certified organization is permitted to use an approved logo of the certifying body on its following items:
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Correct Answer:
Stationery
Advertising Material
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66.
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Documented procedure for control of records must define controls for their:
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identification
storage and protection
retention and retrieval
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67. In case any element cannot be applied to an ISO system due to the nature of an organization, it can be considered for exclusion as per:
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Correct Answer:
Clause 7
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68. ___________ is the technical committee of Environmental Management Systems.
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Correct Answer:
ISO/TC 207
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69.
Special Instructions:The following question may have more than one correct answer options
According to ISO9001, Monitoring and Measurement is required for:
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Correct Answer:
Process
Product
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70. Out of the given quality management principles, which one emphasizes on understanding & meeting requirements, and also obtaining effective results?
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Correct Answer:
process approach
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71. ISO9001 aims to enhance the satisfaction of :
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Correct Answer:
Customers
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72. Whose satisfaction is necessarily to be monitored and measured?
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Correct Answer:
Customer
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73. The ISO 9001 standard requires an organization to review its quality management system at planned intervals. What "inputs" shall management review records include?
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Correct Answer:
changes that could affect the quality management system
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74. Although ISO does not perform certification, what committee has produced a number of standards that relate to the certification process?
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Correct Answer:
CASCO (Committee on Conformity Assessment)
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75. The ISO 9001 standard requires "document procedures" to how many specific elements in an organization's quality management system?
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Correct Answer:
6
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76. The ISO 9001 standard requires an organization to identify what by suitable means throughout its realization?
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Correct Answer:
product
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77. The ISO 9001 standard requires an organization to review requirements related to product prior to supplying the product. What should this review include?
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Correct Answer:
changes to orders
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78. Conformity assessment is the process used to show that a product, service or system meets specified requirements. The main forms of conformity assessment are certification, inspection and what?
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Correct Answer:
testing
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79. The organization is required by the ISO 9001 standard to collect and analyze appropriate data to demonstrate effectiveness of the quality management system. This analysis of data shall include:
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Correct Answer:
customer satisfaction data
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80. The ISO 9001 standard requires an organization to identify, verify, protect and safeguard what?
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Correct Answer:
customer property provided for use
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81. Certification is performed by external certification bodies, which are largely private. When choosing a certification body it is a good idea to:
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Correct Answer:
bear in mind that the cheapest could be more costly in the long run if its auditing is below standard
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82. How does an organization verify purchased product required by the ISO 9001 standard?
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Correct Answer:
the organization shall establish and implement inspection activities
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83. The ISO 9001 standard requires an organization to determine post-delivery activities related to product. This might include:
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Correct Answer:
final disposal
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84. The ISO 9001 standard requires control of production and service provisions under controlled conditions. Controlled conditions shall include:
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Correct Answer:
the availability of work instructions
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85. The model of a process-based quality management system illustrates process linkages based on the ISO 9001 standard clauses 4 - 8. What process plays a significant role in determining inputs?
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Correct Answer:
Customer Requirements
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86. How does top management provide evidence of its commitment to meet the requirements of the ISO 9001 standard?
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Correct Answer:
by ensuring the availability of resources
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87. Confirmation of the ability of computer software to satisfy the intended application would typically include:
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Correct Answer:
its verification and configuration management to maintain its suitability for use
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88. A review of the design and development of product is required by the ISO 9001 standard. The review shall:
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Correct Answer:
identify any problems and propose necessary actions
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89. What should an organization do if a piece of measuring equipment is found out of conformance to requirements?
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Correct Answer:
assess and record the validity of the previous measuring results
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90. During the design and development planning within the ISO 9001 standard requirements, the organization is required to determine what?
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Correct Answer:
the responsibilities and authorities for design and development
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91. Preservation of product per the ISO 9001 standard includes:
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Correct Answer:
handling, packaging, and storage
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92. The ISO 9001 standard requires the organization to determine and provide the resources needed to enhance customer satisfaction by meeting:
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Correct Answer:
customer requirements
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93. The ISO 9001 standard requires an organization to take action to eliminate the causes of potential nonconformities. What is this called?
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Correct Answer:
preventive action
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94. A documented procedure for preventive actions shall be established to define requirements for what?
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Correct Answer:
determining potential nonconformities and their causes
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95. Who is responsible for establishing the quality policy of an organization?
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Correct Answer:
top management
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96. Which should an organization use to continually improve the effectiveness of the quality management system per the ISO 9001 standard?
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97. Under 4.0, the ISO 9001 standard requires an organization to monitor, measure and analyze processes to determine if they are:
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Correct Answer:
effective
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98. How should auditors conduct internal audits per the ISO 9001 standard?
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Correct Answer:
Auditors shall not audit own work
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99. The recommendations for improvement is considered an input for what?
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Correct Answer:
management review
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100. When monitoring and measuring product, what type of records shall be maintained by the organization per ISO 9001?
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Correct Answer:
evidence of conformity with the acceptance criteria
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101. The organization is required to determine and provide the resources needed to enhance customer satisfaction by what?
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Correct Answer:
meeting customer requirements
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102. The ISO 9001 standard requires an organization to implement effective arrangements for communicating what to customers?
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Correct Answer:
enquiries, contracts, or order handling including amendments
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103. The organization is required to conduct a review prior to the commitment to supply a product to the customer and shall ensure that the organization has the ability to meet what?
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Correct Answer:
the defined requirements
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104. Design and Development of product requires planning per the ISO 9001 standard. What should the organization determine during planning of design and development?
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Correct Answer:
the design and development stages
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105. ISO 9001 requires an organization to implement a quality management system to demonstrate:
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Correct Answer:
the organization's ability to consistently provide product that meets customer requirements
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106. The ISO 9001 standard requires top management to ensure that appropriate communication processes are established within the organization and that communication takes place regarding what?
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Correct Answer:
the effectiveness of the quality management system
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107. The ISO 9001 standard requires an organization to plan and implement the monitoring, measurement, analysis and improvement of processes needed to what?
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Correct Answer:
continually improve the effectiveness of the quality management system
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108. What purpose would an organization seek an ISO 9001 certification?
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Correct Answer:
To provide the organization's customers assurance of consistent, good quality products or services
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109. The ISO 9001 standard can be applied to:
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Correct Answer:
any organization, large or small, whatever its product or service and regardless of its sector of activity.
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110. Clause 7.0 of the ISO 9001 standard is Product Realization. The standard requires a organization to plan and develop the processes needed for product realization. What does planning product realization include?
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Correct Answer:
the need to determine the required monitoring activities specific to the product
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111. An organization must perform what to check how its quality management system is working?
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Correct Answer:
internal audits
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112. Per the ISO 9001 standard, documents required by the organization's quality management system shall be:
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Correct Answer:
controlled
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113. The ISO 9001 standard refers to a methodology as PDCA. What does PDCA stand for?
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Correct Answer:
Plan, Do, Check, Act
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114. Per the ISO 9001 standard, an organization is required to plan an audit program that considers the results of what?
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Correct Answer:
previous audits
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115. How does an organization monitor and measure customer satisfaction?
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Correct Answer:
customer data on delivered product quality
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116. The ISO 9001 standard requires a organization to determine and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes what?
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Correct Answer:
software and hardware
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117. The ISO 9001 standard requires an organization to ensure records of evidence of conformity are what?
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Correct Answer:
legible, readily identifiable and retrievable
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118. The ISO 9001 standard promotes the adoption of a process approach because:
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Correct Answer:
this approach enhances customer satisfaction by meeting customer requirements
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119. The ISO 9001 standard requires an organization to take action to eliminate the causes of nonconformities in order to what?
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Correct Answer:
prevent recurrence
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120. Audits are a vital part of ISO 9001's management system approach as they enable the organization to:
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Correct Answer:
check how far their achievements meet their objectives
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121. The ISO 9001 standard requires a organization to ensure its personnel are aware of what?
Answer
Correct Answer:
the established quality objectives
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122. Who should the Management Representative be of an organization?
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Correct Answer:
member of the organization's management
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123. ISO 9001 is considered compatible with what other ISO standard?
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Correct Answer:
ISO 14001
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124. Under 4.0, the ISO 9001 standard requires an organization to control required documents. One of these controls is:
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Correct Answer:
to ensure changes and current revision status of documents are identified
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125. The ISO 9001 standard requires an organization to review its quality management system at planned intervals. Why?
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Correct Answer:
to ensure its continuing effectiveness
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126. The ISO 9001 standard requires the organization to provide training, where applicable, or take other actions to achieve the necessary what?
Answer
Correct Answer:
competence
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127. The ISO 9001 standard requires the output from the management review shall include any decisions and actions related to what?
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Correct Answer:
improvement of product related to customer requirements
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128. Why would an organization implement a quality management system that meets ISO 9001 standard requirements?
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Correct Answer:
to improve the efficiency and effectiveness of company operations
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129. When nonconforming product is corrected, it shall be subject to what?
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Correct Answer:
re-verification to demonstrate conformity to the requirements
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130. How does an organization become ISO 9001 certified?
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Correct Answer:
Through an independent certification body that determines the product, service or system in question meets ISO 9001 standard requirements
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131. The required documentation for the ISO 9001 standard can be:
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Correct Answer:
in any form or type of medium
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132. How does the ISO 9001 standard define an "outsourced process?"
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Correct Answer:
a process that the organization needs for the quality management system and which the organization chooses to have performed by an external party
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133. What does product design and development verification of the ISO 9001 standard require?
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Correct Answer:
to ensure the outputs have met the input requirements of the design and development
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134. The ISO 9001 standard requires an organization to apply suitable methods for monitoring and measuring the quality management system processes and shall demonstrate the ability to achieve planned results. When planned results are not achieved, what should happen?
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Correct Answer:
correction and corrective action shall be taken
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135. An organization shall conduct internal audits when?
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Correct Answer:
determined planned intervals
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136. The ISO 9001 standard requires top management of an organization to ensure the quality policy includes what?
Answer
Correct Answer:
a commitment to continually improve the effectiveness of the quality management system
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137. The ISO 9001 standard requires an organization to establish processes to ensure that monitoring and measuring equipment is controlled. This includes:
Answer
Correct Answer:
measuring equipment shall be calibrated and/or verified
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138. The ISO 9001 standard requires an organization to establish a quality manual that includes:
Answer
Correct Answer:
a justification of any exclusions to the requirements of the standard
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139. Clause 4.2 of the ISO 9001 standard requires a organization's quality management system to include a: