每个制造商应当建立和维护一个描述或包括设计和开发活动以及定期实施职责的策划书。
Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation.
策划书应当界定和描述内部为设计开发所设定的不同组别或活动之间的联系，这些活动包括输入、产生结果等。
The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process.
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