judging safety related compliance claims

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  • 8/13/2019 Judging Safety Related Compliance Claims

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    F

    8 A C (/)

    8.1 E

    9.1

    9.2 A

    9.3 E

    9.4 E

    10.1

    10.2 A

    11.1 11.2 CC

    12.1 CC A

    12.2 CC C &

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    10.1 D

    A Organisation that is separate and distinct, bymanagement and other resources, from the

    organisations responsible for the activities that take

    place during the development lifecycle of the Entity thatis subject of the SRCC

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    A D Department that is separate and distinct from thedepartments responsible for the activities

    which take place during the development lifecycle of theEntity that is subject of the SRCC.

    A Person who is separate and distinct from the activities

    which take place during the development lifecycle of theEntity that is the subject of the SRCC, and does nothave direct responsibility for those activities.

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    10.3 C

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    11 C 11.1 C

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