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AS9100D

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

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AS9100D

2       A preservation of product process shall be established

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3/113

AS9100D

3       A process for configuration management shall be planned, implemented and controlled

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4/113

AS9100D

4       A process for managing operational risks to the achievement of applicable requirements shall be planned, implemented and controlled

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AS9100D

5       A process for the recall of monitoring and measuring equipment shall be established, implemented and maintained

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AS9100D

6       A process to plan and control the temporary or permanent transfer of work shall be established, implemented and maintained

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AS9100D

7       A process with criteria for notifying its customer, about changes that affect customer requirements, shall be

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AS9100D

8       A production change control process shall be established

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AS9100D

9       A representative item from the first production run of a new part or assembly shall be used to verify production processes

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10/113

AS9100D

10      A review of product and service requirements shall be conducted

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AS9100D

11      Actions to address risks and opportunities shall be planned

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AS9100D

12      All documented information required to accompany the products and services shall be present at delivery

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13/113

AS9100D

13      Appropriate action including investigation and reporting shall be taken when problems are detected after delivery

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AS9100D

14      Changes for production or service provision shall be reviewed and controlled

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AS9100D

15      Changes shall be planned

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AS9100D

16      Controlled conditions shall include the control and monitoring of identified critical items, including key characteristics

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AS9100D

17      Controlled conditions shall include the establishment of criteria for workmanship

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18/113

AS9100D

18      Controlled conditions shall include the provision for the prevention, detection and removal of foreign objects

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19/113

AS9100D

19      Counterfeit or suspect counterfeit parts shall be controlled

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20/113

AS9100D

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

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AS9100D

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

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AS9100D

22      Data protection processes shall be defined when documented information is managed electronically

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23/113

AS9100D

23      Decisions and actions related to risks identified shall be included in the outputs of the management review

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24/113

AS9100D

24      Design and development changes shall be controlled

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AS9100D

25      Design and development changes shall be controlled according to the configuration management process requirements

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AS9100D

26      Design and development outputs shall specify, as applicable, any critical items, including any key characteristics

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27/113

AS9100D

27      Design and development shall be planned

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AS9100D

28      Documented information on control of monitoring and measuring equipment shall be maintained

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AS9100D

29      Documented information on control of outsourced processes shall be maintained

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AS9100D

30      Documented information on control of product safety shall be maintained

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AS9100D

31      Documented information on planning of realization processes shall be maintained

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AS9100D

32      Documented information on prevention of counterfeit parts shall be maintained

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AS9100D

33      Documented information that defines the nonconformity and corrective action management processes shall be maintained

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AS9100D

34      Documents of external origin shall be approved

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AS9100D

35      External and internal issues shall be determined

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AS9100D

36      Externally provided processes, products and services shall be controlled

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37/113

AS9100D

37      Information communicated to external providers shall be adequate

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38/113

AS9100D

38      Infrastructure needed to achieve product conformity shall be monitored

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AS9100D

39      Interested parties shall be determined

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AS9100D

40      Internal and external communication needs shall be determined

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AS9100D

41      Internal audits shall be conducted at planned intervals

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AS9100D

42      Measuring equipment shall be calibrated or verified

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AS9100D

43      Monitoring and measurement data shall be analyzed and evaluated

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AS9100D

44      Nonconforming outputs shall be identified and controlled

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AS9100D

45      Nonconformities shall be controlled

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AS9100D

46      On-time delivery of products and services shall be met

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AS9100D

47      On-time delivery performance shall be taken into consideration in the management review

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48/113

AS9100D

48      Operational risks shall be identified

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AS9100D

49      Opportunities for improvement shall be determined

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AS9100D

50      Organizational knowledge shall be determined

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AS9100D

51      Outputs shall be preserved during production and service provision

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AS9100D

52      Personnel shall be made aware

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53/113

AS9100D

53      Personnel shall be made aware of the QMS documented information, its contribution to product or service conformity, its contribution to product safety and the importance of ethical behavior

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54/113

AS9100D

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

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AS9100D

55      Plans that address deficiencies identified shall be developed and implemented

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56/113

AS9100D

56      Post-delivery requirements shall be met

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57/113

AS9100D

57      Prevention of the unintended use of obsolete documented information shall be controlled

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58/113

AS9100D

58      Process mapping shall be established and documented

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59/113

AS9100D

59      Processes for the prevention of counterfeit or suspect counterfeit part use shall be planned, implemented and controlled

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60/113

AS9100D

60      Product or service conformity and on-time delivery performance shall be measured

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61/113

AS9100D

61      Production and service provision shall be implemented under controlled conditions

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62/113

AS9100D

62      Production process verification activities shall be implemented

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63/113

AS9100D

63      Property belonging to customers or external providers shall be respected

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64/113

AS9100D

64      Quality objectives shall be established

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65/113

AS9100D

65      Requirements for products and services shall be defined

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66/113

AS9100D

66      Requirements for the need to implement a QMS shall be communicated to external providers

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67/113

AS9100D

67      Resources needed for monitoring and measurement shall be provided

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68/113

AS9100D

68      Resources needed for the management of the QMS shall be provided

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69/113

AS9100D

69      Special requirements of the products and services shall be determined

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70/113

AS9100D

70      Special requirements, critical items or key characteristics shall be communicated to external providers

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71/113

AS9100D

71      Storage requirements for production equipment or tooling in storage shall be defined

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72/113

AS9100D

72      The audit program shall be planned, implemented and maintained

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73/113

AS9100D

73      The controls needed to prevent the delivery of nonconforming products and services to the customer shall be established

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74/113

AS9100D

74      The design and development effort shall be divided into distinct activities, when appropriate

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75/113

AS9100D

75      The design and development process shall be controlled

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76/113

AS9100D

76      The design and development process shall be controlled to ensure that progression to the next stage is authorized

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77/113

AS9100D

77      The external provider’s delegated verification activities shall be periodically monitored

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78/113

AS9100D

78      The identification of the configuration of the products and services shall be maintained

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79/113

AS9100D

79      The implementation of improvement activities and evaluation the effectiveness of the results shall be monitored

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80/113

AS9100D

80      The management representative who have the organizational freedom and unrestricted access to top management shall be appointed

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AS9100D

81      The necessary competence of personnel shall be determined

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82/113

AS9100D

82      The necessary documented information shall be controlled

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83/113

AS9100D

83      The necessary process environment shall be provided

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84/113

AS9100D

84      The necessary process infrastructure shall be provided

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85/113

AS9100D

85      The necessary processes shall be planned and controlled

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86/113

AS9100D

86      The nonconformity control process shall be maintained as documented information

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87/113

AS9100D

87      The performance and the effectiveness of the QMS shall be evaluated

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88/113

AS9100D

88      The performance of the external provider shall be periodically

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89/113

AS9100D

89      The preservation of outputs shall also include provisions for prevention, detection and removal of foreign objects

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90/113

AS9100D

90      The process and resources to support the use and maintenance of the products and services shall be determined

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91/113

AS9100D

91      The processes and controls needed to manage critical items shall be determined

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92/113

AS9100D

92      The processes needed for the QMS shall be determined

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93/113

AS9100D

93      The processes needed to assure product safety shall be planned, implemented and controlled

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94/113

AS9100D

94      The products and services to be obtained from external providers shall be determined

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95/113

AS9100D

95      The QMS shall also address customer and applicable statutory and regulatory requirements

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96/113

AS9100D

96      The quality manual shall be approved by top management

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97/113

AS9100D

97      The quality policy shall be available, communicated, understood and applied

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98/113

AS9100D

98      The recommendations of ISO 10007 shall be implemented for configuration management

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99/113

AS9100D

99      The responsibility for the conformity of all externally provided processes, products and services, including from sources defined by the customer, shall be assumed by the organization

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100/113

AS9100D

100     The risks and opportunities that need to be addressed shall be determined

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101/113

AS9100D

101     The risks associated with external provision of processes, products and services, as well as the selection and use of external providers shall be identified and managed

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102/113

AS9100D

102     The scope of the QMS shall be determined

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103/113

AS9100D

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

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104/113

AS9100D

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

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105/113

AS9100D

105     Top management shall demonstrate leadership

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106/113

AS9100D

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

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107/113

AS9100D

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

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108/113

AS9100D

108     Top management shall manage the quality policy

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109/113

AS9100D

109     Top management shall review the QMS

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110/113

AS9100D

110     Top management shall take accountability for the effectiveness of the QMS

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111/113

AS9100D

111     Verification activities of external providers shall be performed according to the risks identified

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112/113

AS9100D

112     When a nonconformity occurs and it is determined that the external provider is responsible the organization shall flow down corrective action requirements to the external provider

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113/113

AS9100D

113     When tests are necessary for verification and validation, these tests shall be planned, controlled, reviewed and documented

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AS9100D

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