质量体系，生产，法规及其他适当的人员应参加对元器件，装置及工艺设计文档的评审及评估。
Quality system, production, regulatory, and other appropriate personnel should participate in the review, evaluation, and documentation of the components, device, and process design.
质量体系回顾的日期和结果应做成文档保存。
The dates and results of quality system reviews shall be documented.
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