AS9100C：2009_中英文对照(7)

客批准的特殊过程资源；

AS9100C

e. Define the process, responsibilities and authority for the e) 对于批准状态决定、批准状态更改以及根据

供应商批准状态对供应商进行控制使用的条approval status decision, changes of the approval status

件确定过程、职责和权力。 and conditions for a controlled use of suppliers depending on the supplier’s approval status, and

f. determine and manage the risk when selecting and using f) 选择和使用供应商时，确定和管理风险(见

7.1.2)。 suppliers (see 7.1.2).

sources,

7.4.2 Purchasing information

Purchasing information shall describe the product to be purchased, including where appropriate

a) requirements for approval of product, procedures, processes and equipment,

b) requirements for qualification of personnel,

c) quality management system requirements,

d) the identification and revision status of specifications, drawings, process requirements, inspection/verification instructions and other relevant technical data,

e) requirements for design, test, inspection, verification (including production process verification), use of statistical techniques for product acceptance, and related instructions for acceptance by the organization, and as applicable critical items including key characteristics,

f) requirements for test specimens (e.g., production method, number, storage conditions) for design approval, inspection/verification, investigation or auditing,

g) requirements regarding the need for the supplier to - notify the organization of nonconforming product,

- obtain organization approval for nonconforming product

disposition,

- notify the organization of changes in product and/or

process, change of suppliers, changes of manufacturing facility location and, where required, obtain organization approval, and

- flow down to the supply chain the applicable requirements

including customer requirements,

h) records retention requirements, and

i) right of access by the organization, their customer and regulatory authorities to the applicable areas of all facilities, at any level of the supply chain, involved in the order and to all applicable records,

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

7.4.2 采购信息

采购信息应表述拟采购的产品，适当时包括：

a) 产品、程序、过程和设备的批准要求；

b) 人员资格的要求；

c) 质量管理体系的要求；

d) 规范、图样、过程要求、检验/验证说明书和其他有关的技术资料的标识和修订状态；

e）组织的设计、试验、检验、验证的要求（包括生产过程的验证），用于产品接收的统计技术的使用，和有关组织接收的指导书，以及适用的关键项目包括关键特性；

f）用于设计批准、检验/验证、调查或审核的

试验样件的要求（例如，生产方法，数量。储存条件）。

g)需要考虑对供应商的下述要求： -向组织通报不合格产品，

-不合格品处理得到组织批准；

-将产品和/或过程的更改，供应商更改，生产设施地点更改应报告组织，织，并且在要求时获得组织的批准；

-向供应链传达适用要求，包括顾客要求；

h) 记录保存要求；

i) 组织及其顾客,和法规性机构可接触涉及订

单的任何层次的供应链所有设施的适用区域,和所有适用记录的权利。

在与供方沟通前，组织应确保所规定的采购要求是充分与适宜的。

AS9100C

7.4.3 Verification of Purchased Product

The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

NOTE 1 Customer verification activities performed at any level of the supply chain should not be used by the organization or the supplier as evidence of effective control of quality and does not absolve the organization of its responsibility to provide acceptable product and comply with all requirements.

NOTE 2 Verification activities can include

a. obtaining objective evidence of the conformity of the

product from suppliers (e.g., accompanying documentation, certificate of conformity, test reports, statistical records, process control records),

b. inspection and audit at the supplier’s premises,

c. review of the required documentation,

d. inspection of products upon receipt, and

e. delegation of verification to the supplier or supplier

certification.

Where purchased product is released for production use pending completion of all required verification activities, it shall be identified and recorded to allow recall and replacement if it is subsequently found that the product does not meet requirements.

Where the organization delegates verification activities to the supplier, the requirements for delegation shall be defined and a register of delegations maintained.

Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision

The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable

a) the availability of information that describes the characteristics of the product,

NOTE This information can include drawings, parts lists,

7.4.3 采购产品的验证

组织应确定并实施检验或其他必要的活动，以确保采购的产品满足规定的采购要求。

注1 组织或供方不应该把顾客对任何层次的供应链所做的验证活动用作质量有效控制的证据，据，也不能免除组织提供可接受产品和符合所有要求的责任。

注2验证活动可以包括

a) 从供应商处获得产品符合性的客观证据（如

随产品文件，合格证明，试验报告，统计记录，过程控制记录）；

b) 在供应商处的检验和 …… 此处隐藏：4725字，全部文档内容请下载后查看。喜欢就下载吧 ……