8.7.1、组织应确保对不符合要求的输出进行识别和控制，以防止非预期的使用或交付。
注：术语“不合格输出”包括未经批准的零件、疑似未经批准的零件、假冒的零件以及内部生成的、从外部供方处收到的或顾客识别出的不合格产品或服务。
组织应根据不合格的性质及其对产品和服务符合性的影响采取适当措施。这也适用于在产品交付之后，以及在服务提供期间或之后发现的不合格产品和服务。
组织的不合格控制过程应保持成文信息，其中包括提供：
—— 规定对不合格输出的评审和处置的职责和权限，以及批准人员作出决定的过程；
—— 采取必要的措施，控制不合格在其他过程、产品或服务中的影响；
—— 及时向顾客或相关利益方报告影响到已交付的产品和服务的不合格情况；
—— 在产品和服务交付后发现不合格时，根据其影响程度确定纠正措施，（见 10.2）；
注:要求通知不合格产品和服务的利益相关方可能包括外部供方、内部组织、顾客、分销商和监管机关。
组织应通过下列一种或几种途径处置不合格输出：
a）纠正；
b）隔离、限制、退货或暂停对产品和服务的提供；
c）告知顾客；
d）从顾客（必要时）及有关方面 获得让步接收的授权。
只有在下列情况下，才能以“按现状使用”或“维修”的方式来接受不合格的产品：
—— 经过负责设计产品的组织的授权代表或者是设计组织的委托授权人员批准；
—— 如果不合格导致偏离合同要求，应经过顾客授权批准。
对不合格品的处理方式仅限以下几种：
—— 报废；
—— 拒收，退回供应商处；
—— 拒收，返回生产商进行再确认；
—— 适用时，提交给客户或设计单位两方中的一方，由其做出“按现状使用”的处理决定。
进行报废处理的不合格品，必须做出明显的和永久性的标记，或进行明确的控制，直至在物理上不可能被使用。
应控制假冒的零件或者疑似假冒的零件，防止其再次进入供应链。
对不合格输出进行纠正之后应验证其是否符合要求。
8.7.2、组织应保留下列成文信息：
a）描述不合格；
b）描述所采取的措施；
c）描述获得的让步；
d）识别处置不合格的授权。
8.7.1、The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.
NOTE: The term “nonconforming outputs” includes suspected unapproved, unapproved, counterfeit, and nonconforming product or service generated internally, received from an external provider, or identified by a customer.
The organization shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services. This shall also apply to nonconforming products and services detected after delivery of products, during or after the provision of services.
The organization’s nonconformity control process shall be maintained as documented information including the provisions for:
? defining the responsibility and authority for the review and disposition of nonconforming outputs and the process for approving persons making these decisions;
? taking actions necessary to contain the effect of the nonconformity on other processes, products, or services;
? timely reporting of nonconformities affecting delivered products and services to the customer and to relevant interested parties;
? defining corrective actions for nonconforming products and services detected after delivery, as appropriate to their impacts (see 10.2).
NOTE: Interested parties requiring notification of nonconforming products and services can include external providers, internal organizations, customers, distributors, and regulatory authorities.
The organization shall deal with nonconforming outputs in one or more of the following ways:
a. correction;
b. segregation, containment, return, or suspension of provision of products and services;
c. informing the customer;
d. obtaining authorization for acceptance under concession.
Dispositions of nonconforming product shall be limited to:
? scrap;
? rejection for return to the external provider;
? rejection for revalidation by the manufacturer;
? submittal to either the customer or design authority for use-as-is disposition, as applicable.
Product dispositioned for scrap shall be conspicuously and permanently marked, or positively controlled, until physically rendered unusable.
Counterfeit, or suspect counterfeit, parts shall be controlled to prevent reentry into the supply chain.
Conformity to the requirements shall be verified when nonconforming outputs are corrected.
8.7.2、The organization shall retain documented information that:
a. describes the nonconformity;
b. describes the actions taken;
c. describes any concessions obtained;
d. identifies the authority deciding the action in respect of the nonconformity.
