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1. | The organization shall determine, provide and maintain the infrastructure needed to achieve conformity |
| 组织应确定提供和维护为实现产品符合性所需的基础设施. |
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2. | The organization shall determine and manage the work environment needed to achieve conformity to product |
| 组织应确定和管理为实现产品符合性所需的工作环境。 |
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