8.5.1、生产和服务提供的控制
组织应在受控条件下进行生产和服务提供。
适用时，受控条件应包括：
a）可获得成文信息，以规定以下内容：
1）拟生产的产品、提供的服务或进行的活动的特性；
2）拟获得的结果。
注 1：确定产品和服务特征的成文信息包括图纸、零件清单、材料和工艺规范。
注 2：活动执行和结果取得的成文信息包括过程流程图、控制计划，生产文件（如：制造计划、路线图、流程卡、工作指令和工艺卡）和验证文件。
b）可获得和使用适宜的监视和测量资源；
c）在适当阶段实施监视和测量活动，以验证是否符合过程或输出的控制准则以及产品和服务的接收准则；
1）确保为接收产品而进行的监视和测量活动的成文信息包括了：
—— 接收和拒收准则；
—— 按顺序进行验证操作；
—— 保留测量的结果（至少表明接收或拒收）；
—— 要求的任何特定的监视和测量设备及其相关的使用说明；
2）当使用抽样检验作为产品接收的方法时，应基于被广泛认可的统计学原理来制定抽样计划，并该抽样计划应适合实际使用（例如按照产品的重要性和过程的能力匹配相应的抽样计划）。
d）使用适宜的基础设施和环境来运行过程；
注：适宜的基础设施可以包括产品专用工具（如型架、夹具、模具）和软件程序。
e）配备胜任的人员，包括所要求的资格；
f）若输出结果不能由后续的监视或测量加以验证，应对生产和服务提供过程实现策划结果的能力进行确认，并定期再确认；
注：这些过程也被称为特殊过程（见8.5.1.2）。
g）采取措施防止人为错误；
h）实施放行、交付和交付后的活动；
i）工艺准则的建立（如书面标准、代表性样本、插图）；
j）在生产中对所有产品负责（如零件数量、分作业指令、不合格品）；
k）按建立的过程，控制和监视已识别的关键项目，包括关键特性；
l）确定方法来测量可变数据（如工具，在线探测，检验设备）；
m）在后续阶段不能进行足够验证时，识别过程中的检验/验证点；
k）可得到所有生产和检验/验证操作已按计划完成的证据，或者另外文件批准和授权；
l）提供预防、检测和去除外来物；
m）对会影响产品要求符合性的公用设施和供给物（如水、压缩空气、电及化学产品）进行监视和控制，
q）在所有要求的测量和监视活动完成前，产品被放行到后道工序，应对其进行标识和记录，做到如果后来发现产品不符合要求，能够对其进行召回和更换。
n) 报废的结果（例如材料、组件、设备、产品）
8.5.1、Control of Production and Service Provision
The organization shall implement production and service provision under controlled conditions. Controlled conditions shall include, as applicable:
a. the availability of documented information that defines:
1.the characteristics of the products to be produced, the services to be provided, or the activities to be performed;
2.the results to be achieved;
NOTE 1: Documented information that defines characteristics of products and services can include digital product definition data, drawings, parts lists, materials, and process specifications.
NOTE 2: Documented information for activities to be performed and results to be achieved can include process flow charts, control plans, documents (e.g., travelers, routers, work orders), and verification documents.
b. the availability and use of suitable monitoring and measuring resources;
c. the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met;
1.ensuring that documented information for monitoring and measurement activity for product acceptance includes:
—— criteria for acceptance and rejection;
—— where in the sequence verification operations are to be performed;
—— measurement results to be retained (at a minimum an indication of acceptance or rejection);
—— any specific monitoring and measurement equipment required and instructions associated with their use;
2. ensuring that when sampling is used as a means of product acceptance, the sampling plan is justified on the basis of recognized statistical principles and appropriate for use.
d. the use of suitable infrastructure and environment for the operation of processes;
NOTE: Suitable infrastructure can include product specific tools (e.g., jigs, fixtures, molds) and software programs.
e. the appointment of competent persons, including any required qualification;
f. the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;
g. the implementation of actions to prevent human error;
h. the implementation of release, delivery, and post-delivery activities;
i. The establishment of criteria for workmanship (e.g., written standards, representative samples, illustrations);
j. the accountability for all products (e.g., parts quantities, split orders, nonconforming product);
k. the availability of evidence that all production and inspection/verification operations have been completed as planned, or as otherwise documented and authorized;
l. the provision for the prevention, detection, and removal of foreign objects;
m. the control and monitoring of utilities and supplies (e.g., water, compressed air, electricity, chemical products) to the extent they affect conformity to product requirements (see 7.1.3);n. the consequences of obsolescence (e.g., materials, components, equipment, products).
