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- Responsible for nonconforming product review. 负责组织不合格品评审。
- Responsible for organization of nonconforming product review. 负责组织采购产品的不合格品评审。
- Be authorized to disposition nonconforming product and material. 授权处理不合格产品与材料。
- Unlike rework, repair can affect or change parts of the nonconforming product. 返工与返修不同，返修可影响或改变不合格产品的某些部分。
- Unlike rework, repair can affect or change parts of the nonconforming product. 返修与返工不同，返修可影响或改变不合格产品的某些部分。
- Scrap:action on a nonconforming product to preclude its originally intended use. EXAMPLE Recycling, destruction. 报废：为避免不合格产品原有的预期用途而对其所采取的措施。示例：回收、销毁。
- Obsolete product shall be controlled in a similar manner to nonconforming product. 应以对待不合格品的类似方法控制过期产品。
- The manufacturer shall ensure that nonconforming product is accepted by concession only if regulatory requirements are met. 制造业者应确保不合格医疗器材产品系能在符合法规要求之原则下予以特采。
- Product with unidentified or suspect status shall be classified as nonconforming product (see 7. 不确定或可疑状态的产品,必须按不合格产品对待(见7。
- This element shall apply to suspect material or product (see Glossary) as well as nonconforming product. 此要素必须适用于可疑的材料或产品（见术语）和不合格品。
- The controls and related responsibilities and authorities for ealing with nonconforming product shall be defined in a documented procedure. 不合格品控制以及不合格品处置的有关职责和权限应在形成文件的程序中作出规定。
- The organization shall deal with nonconforming product by taking action to preclude its original intended use or application. 组织应采取方法处置不合格品;如采取措施防止其原预计的使用或应用.
- To control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected. 在缺陷或不满意状况被矫正前,控制不合格产品被进一步加工、交货或安装。
- Customers shall be informed promptly in the event that nonconforming product has been shipped. 当发生不合格产品被发运时,必须立即通知顾客。
- Where the product fails to pass any inspection and/or test, the procedures for control of nonconforming product shall apply. 若产品未能通过任何检验或测试,则应引用不合格品之控制程序予以处理。
- When nonconforming product is corrected it shall be subject to re?verification to demonstrate conformity to the requirements. 在不合格品得到纠正之后，必须对其再次进行验证，以证实符合要求。
- The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in documented procedure. 所要求的活动，包括审查和解决不合格品的责任和权限应于书面程序内界定。
- When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. 应对纠正后的产品再次进行验证,以证实符合要求。
- The supplier shall quantify and analyze nonconforming product and establish a prioritized reduction plan. Progress toward the plan should be tracked. 供方必须量化和分析不合格品，并建立优先减少计划。必须跟踪计划的进展情况。
- The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. 不合格品的管制及处理的责任与授权，应被定义于文件化程序中。
