Quiz requirements ISO 19443 version 2018

1/86

1. A design and development process shall be established, implemented and maintained

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2. A documented information to control external processes shall be maintained

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3. A member of the management shall be appointed as management representative

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4. A register to determine the risks when selecting suppliers shall be maintained

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5. A review of product and service requirements shall be conducted

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6. A risk management process shall be established

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7. Actions to address risks and opportunities shall be planned

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8/86

8. Changes for production or service provision shall be reviewed and controlled

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9. Changes shall be planned

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10. Changes to the quality management system shall be managed to ensure nuclear safety is not compromised

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11. Competence shall also address qualification of person(s) when necessary

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12. Continual improvement shall encompass nuclear safety culture

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13. Control of monitoring and measuring equipment shall be determined

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14. Controlled conditions shall take into account the graded approach outputs

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15/86

15. Criteria for the evaluation, selection and monitoring of performance of external providers shall be determined and applied

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16/86

16. Customer perception of the degree to which their needs shall be monitored

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17/86

17. Design and development changes shall be controlled

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18/86

18. Design and development shall be planned

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19/86

19. Determination and provisions of resources shall ensure that nuclear safety is not compromised

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Quiz requirements ISO 19443 version 2018

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20. Documents of external origin shall be approved

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21. External and internal issues shall be determined

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Quiz requirements ISO 19443 version 2018

22/86

22. Externally provided processes, products and services shall be controlled

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23/86

23. For items and activities, the organization shall grade the application of requirements

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24/86

24. For ITNS items and activities, monitoring and measurement intended for product acceptance shall be performed by competent persons different from those who performed the work

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25. Information communicated to external providers shall be adequate

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26. Infrastructure needed to achieve product conformity shall be monitored

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27. Interested parties shall be determined

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28/86

28. Internal and external communication needs shall be determined

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29/86

29. Internal audits shall be conducted at planned intervals

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30/86

30. Measuring equipment shall be calibrated or verified

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Quiz requirements ISO 19443 version 2018

31/86

31. Monitoring and measurement data shall be analyzed and evaluated

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32/86

32. Nonconforming outputs shall be identified and controlled

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33/86

33. Nonconformities shall be controlled

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34/86

34. Nuclear safety shall receive the attention warranted by its significance

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35/86

35. Opportunities for improvement shall be determined

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36/86

36. Organizational knowledge shall be determined

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37/86

37. Outputs shall be preserved during production and service provision

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38/86

38. Personnel shall be made aware

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Quiz requirements ISO 19443 version 2018

39/86

39. Persons involved in the realization of ITNS products or services shall be trained on the importance of their tasks, including the potential nuclear safety consequences of errors in their activities

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40/86

40. Planned arrangements to verify that the product and service requirements have been met shall be implemented

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41/86

41. Post-delivery requirements shall be met

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Quiz requirements ISO 19443 version 2018

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42. Process mapping shall be established and documented

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Quiz requirements ISO 19443 version 2018

43/86

43. Production and service provision shall be implemented under controlled conditions

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44/86

44. Property belonging to customers or external providers shall be respected

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45. Quality objectives shall be established

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Quiz requirements ISO 19443 version 2018

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46. Requirements for products and services shall be defined

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47/86

47. Resources needed for monitoring and measurement shall be provided

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48/86

48. Resources needed for the management of the QMS shall be provided

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49/86

49. The audit program shall be planned, implemented and maintained

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50/86

50. The design and development process shall be controlled

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51. The following also applies nuclear safety culture aspects

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52/86

52. The necessary competence of personnel shall be determined

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53. The necessary documented information shall be controlled

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54/86

54. The necessary process environment shall be provided

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55. The necessary process infrastructure shall be provided

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56/86

56. The necessary processes shall be planned and controlled

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57/86

57. The organization shall be responsible for the conformity of all externally provided processes, products and/or services

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58. The organization shall break down ITNS products and services into items and activities

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59. The organization shall communicate to external providers its requirements for passing down relevant requirements to all levels of its supply chain

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60. The organization shall ensure an appropriate nuclear safety culture

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61. The organization shall ensure that all required documented information is present at delivery

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Quiz requirements ISO 19443 version 2018

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62. The organization shall ensure that design and development outputs specify the conditions under which commercial grade items or activities can be used as ITNS items or activities

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63. The organization shall prevent CFS items at all levels of operations including selection of external providers

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64. The organization shall provide adequate resources for improvement plans

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65. The organization shall share with its customer and disseminate to its supply chain organizations relevant learning from experience

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66/86

66. The performance and the effectiveness of the QMS shall be evaluated

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67/86

67. The processes needed for the QMS shall be determined

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68. The quality manual shall be established and maintained

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69. The quality policy shall be available, communicated, understood and applied

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70. The result of evaluation of external providers shall be valid for a limited period of time and a stated scope

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71. The risks and opportunities that need to be addressed shall be determined

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72. The scope of the QMS shall be determined

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73. The suitability, adequacy and effectiveness of the QMS shall be continually improved

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74. The unique identification of the outputs shall be controlled when traceability is a requirement

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75/86

75. Top management shall appoint a member of the organization's management who has the organizational independence and authority to manage nuclear safety and quality issues

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76. Top management shall appoint a member of the organization's management who has unrestricted access to top management

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77. Top management shall demonstrate leadership

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Quiz requirements ISO 19443 version 2018

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78. Top management shall demonstrate leadership and commitment with respect to customer focus

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79/86

79. Top management shall ensure that nuclear safety is taken into account in decision making and is not compromised by any decision taken

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80/86

80. Top management shall ensure that the responsibilities and authorities are assigned, understood and implemented

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81/86

81. Top management shall establish, implement and maintain a quality policy that includes appropriate nuclear safety considerations

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82/86

82. Top management shall establish, implement and maintain a quality policy that includes a commitment to ensure that nuclear safety is not compromised by other priorities

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83. Top management shall manage the quality policy

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84. Top management shall review the QMS

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85/86

85. Top management shall take accountability for the effectiveness of the QMS

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86/86

86. Where design tools (e.g. computation codes or computerized models) are used, the organization shall demonstrate that these are fit for purpose

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Quiz requirements ISO 19443 version 2018