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“不合格品”包括内部产生的，从外部供方接受的，或由客户识别的不合格品和服务。

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以形成文件的信息维持，包含能提供：

—— 规定不合格输出和过程的评审及处置的职责和权限，以及批准作出这些决定的人员的过程。

—— 采取必要的措施，遏制不合格品对其它过程、产品或服务的影响；及时报告已交付给客户和相关方的产品和服务的不合格。

—— 规定交付后发现的不合格产品和服务的，适合于其影响（见10.2）的纠正措施。

注: 相关方要求的不合格产品和服务的通知可以包含：外部供方、内部组织、顾客、分销商和管理当局。

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. 获得有关当局和，适用时，客户对于让步接收的授权。

对不合格品接收进行原样使用或返修的处置仅在以下情况下可以实施：

—— 只有经过负责设计的组织的授权代表，或者受设计组织委托的人员批准后；

如果不合格导致偏离合同要求，经过顾客授权；

处置为报废的产品，必须做出明显和永久性的标记，或进行有效地控制，直至在物理上不可能被使用。

仿冒，或者被怀疑为仿冒件应进行控制以防止在进入供应链。

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、组织应保留下列形成文件的信息，以：

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 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 by a relevant authority and, when applicable, by the customer.

Dispositions of use-as-is or repair for the acceptance of nonconforming products shall only be implemented:

—— after approval by an authorized representative of the organization responsible for design or by persons having delegated authority from the design organization;

—— after authorization by the customer, if the nonconformity results in a departure from the contract requirements.

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.