ISO9001-GBT19001-2015FDIS中英文对照版(7)

The organization shall conduct a review before committing to supply products and services to a customer, to include:

The customer’s requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements.

NOTE In some situations, such as internet sales, a formal review is impractical for each order.

Instead, the review can cover relevant product information, such as catalogues or advertising material.

8.2.3.1组织应确保其有能力满足提供给顾客的产品和服务的要求，组织应在向顾客承诺提供产品和服务之前实施评审，包括：

a) requirements specified by the customer, including the requirements for delivery and post-delivery activities;

a) 顾客规定的要求，包括交付和交付后活动的要求；

b) requirements not stated by the customer, but necessary for the specified or intended use, when known;

b) 顾客虽然没有明示，但规定用途或已知的预期用途所必需的要求；

c) requirements specified by the organization;

c) 组织规定的要求；

d) statutory and regulatory requirements applicable to the products and services;

d) 适用于产品和服务的法律法规要求；

e) contract or order requirements differing from those previously expressed.

e) 与以前表述不一致的合同或订单的要求。

and shall ensure contract or order requirements differing from those previously defined are resolved.

组织应确保与以前规定不一致的合同或订单要求已得到解决。

The organization shall ensure that contract or order requirements differing from those previously defined are resolved.

顾客没有提供其要求的文件化说明时，组织应在接受前对顾客要求进行确认。

8.2.3.2 The organization shall retain documented information, as applicable:

a) on the results of the review;

b) on any new requirements for the products and services.

8.2.3.2 适用时，组织应保留以下方面的文件化信息：

a) 评审结果；

b) 产品和服务的任何新要求。

8.2.4Change to requirements for products and services产品和服务要求的变更【7.2.2】

The organization shall ensure that relevant documented information is amended, and that relevant

persons are made aware of the changed requirements, when the requirements for products and services are changed.

若产品和服务要求发生变更，组织应确保相关的文件化信息得到修改，并确保相关人员知道已变更的要求。

8.3 Design and development of products and services 产品和服务的设计和开发【7.3】

8.3.1 General 总则【7.3.1】

The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.

组织应建立、实施和保持设计和开发过程，以适用于确保后续的产品和服务的提供。

8.3.2 Design and development planning 设计和开发的策划【7.3.1】

Design and development planning In determining the stages and controls for design and development, the organization shall consider:

在确定设计和开发的阶段和控制时，组织应考虑：

a) the nature, duration and complexity of the design and development activities;

a) 设计和开发活动的性质、持续时间和复杂性；

b) the required process stages, including applicable design and development reviews;

b) 所需的过程阶段，包括适用的设计和开发评审；

c) the required design and development verification and validation activities;

c) 所需的设计和开发的验证和确认；

d) the responsibilities and authorities involved in the design and development process;

d) 设计和开发过程涉及的职责和权限；

e) the internal and external resource needs for the design and development of products and services; e) 产品和服务的设计和开发所需的内部和外部资源；

f) the need to control interfaces between persons involved in the design and development process; f) 控制设计和开发过程涉及的个人之间的接口的需求；

g) the need for involvement of customers and users in the design and development process;

g) 顾客和用户参与设计和开发过程的需求；

h) the requirements for subsequent provision of products and services;

h) 后续的产品和服务提供的要求；

i) the level of control expected for the design and development process by customers and other

relevant interested parties;

i) 顾客和其他有关相关方对设计和开发过程所期望的控制程度；

j) the documented information needed to demonstrate that design and development requirements have been met.

j) 证实设计和开发要求已得到满足所需的文件化信息。

8.3.3 Design and development Inputs 设计和开发的输入【7.3.2】

The organization shall determine the requirements essential for the specific types of products and services to be designed and developed.

The organization shall consider:

The organization shall determine:

a) requirements essential for the specific type of products and services being designed and developed, including, as applicable, functional and performance requirements;

组织应确定有关设计和开发的产品和服务的具体类型的基本要求，组织应考虑：

a) functional and performance requirements;

a) 功能和性能要求；

b) information derived from previous similar design and development activities;

b) 来自以前类似设计和开发活动的信息；

c) statutory and regulatory requirements;

c) 法律法规要求；

d) standards or codes of practice that the organization has committed to implement;

d) 组织承诺执行的标准或行业规则；

e) potential consequences of failure due to the nature of the products and services.

产品和服务的设计和开发的内部和外部需要

e) the potential consequences of failure due to the nature of the products and services;

Inputs shall be adequate for design and development purposes, complete and unambiguous.

输入应满足设计和开发目的，完整并且清楚。

Conflicting design and development inputs shall be resolved.

设计和开发输入的矛盾应予以解决。

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