组织必需依靠其所有的员工来在每个点上确保质量，一个产品就是在这些点上被定义、设计、实现、配置、评审、测试和发布的。
Organizations must depend on all their employees to ensure quality at every point a product is defined, designed, implemented, configured, reviewed, tested, and shipped.
一次对软件质量的彻底评价，不能只依赖于人控过程，如同行评审及测试用例设计。
A thorough evaluation of application software quality cannot rely solely on human-dependent processes such as peer reviews and test case design.
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，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.
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