8.1、运行的策划和控制

为满足提供产品和服务时的要求，并实施第6章所确定的措施，组织应通过以下措施对所需的过程（见4.4）进行策划、实施和控制：

a）确定产品和服务的要求；

注：确定产品和服务的要求应当考虑下述方面：

—— 人员和产品的安全；

——可用性和可检验性

—— 可生产性和可检验性；

—— 可靠性、可用性和可维护性；

—— 使用在产品中的零件和原材料的适宜性；

—— 嵌入式软件的选择和开发；

—— 产品的报废；

—— 预防，探测和移除外来物；

—— 处理，包装和防护；

—— 产品在寿命结束时的回收和最终处理。

b）建立下列内容的准则：

1）过程；

2）产品和服务的接收；

注：根据产品特性并取决于指定条件，统计技术可以用于支持：

—— 设计验证（如：可靠性、可维修性、产品安全）；

—— 过程控制：

·关键特性的选择和验证；

·过程能力测量；

·统计过程控制；

·实验设计；

—— 验证

—— 失效模式、影响和危害性分析。

c）确定所需的资源以使产品和服务符合要求，并且能够按时交付；

d）按照准则实施过程控制；

e）在必要的范围和程度上，确定并保持、保留成文信息，以：

1）确信过程已经按策划进行；

2）证实产品和服务符合要求。

f）确定管理关键项目所需的过程和控制，包括当关键特性已经识别时的生产过程控制；

f）为会受影响的组织职能选取代表参与运行的策划和控制；

h）确定支持产品和服务的使用和维护的过程和资源；

g）确定从外部供方处获取的产品和服务；

h）建立必要的控制以防止交付给顾客不合格的产品和服务。

注：运行的策划和控制有一种实现方法是全程使用整合阶段过程。

当对组织、顾客要求或产品和服务适用时，组织应以一种结构化和受控的方式去策划和管理产品和服务的提供，包括在有资源和时间约束情况下, 预定事件按策划次序执行，并在可接受的风险内满足要求。

注：这些活动通常称为项目策划，项目管理或计划管理。

策划的输出应适合于组织的运行。

注：作为策划的输出，用以描述质量管理系统的过程以及对具体产品、项目或合同所需资源的成文信息称为质量计划。

组织应控制策划的变更，评审非预期变更的后果，必要时，采取措施减轻不利影响。

组织应确保外包过程受控（见8.4）。

组织应建立、实施和保持一个策划和控制临时性或永久性工作转移的过程,以保证持续地符合工作的要求。这个过程应保证工作转移时的影响和风险是在管理。

注：对于控制工作转移从组织到外部供方，或从一个外部供方转移到另一个外部供方，见 8.4。对于从组织的一处设施转移到另一处，或从外部供方转移到组织，见 8.5。

8.1、Operational Planning and Control

The organization shall plan, implement, and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in clause 6, by:

a. determining the requirements for the products and services;

NOTE: Determination of requirements for the products and services should include consideration of:

—— personal and product safety;

—— availability and inspectability;

—— product obsolescence;

—— prevention, detection, and removal of foreign objects;

—— handling, packaging, and preservation;

—— recycling or final disposal of the product at the end of its life.

b. establishing criteria for:

1. the processes;

2. the acceptance of products and services;

NOTE: According to the nature of the product and depending on the specified requirements, statistical techniques can be used to support:

—— process control;

· process capability measurements;

· statistical process control;

· design of experiments;

—— verification.

c. determining the resources needed to achieve conformity to the product and service requirements and to meet on-time delivery of products and services;

d. implementing control of the processes in accordance with the criteria;

e. determining, maintaining, and retaining documented information to the extent necessary:

1. to have confidence that the processes have been carried out as planned;

2. to demonstrate the conformity of products and services to their requirements;

f. engaging representatives of affected organization functions for operational planning and control;

f. determining the products and services to be obtained from external providers;

h. establishing the controls needed to prevent the delivery of nonconforming products and services to the customer.

NOTE: One method to achieve operational planning and control can be through using integrated phased processes.

As appropriate to the organization, customer requirements, and products and services, the organization shall plan and manage product and service provision in a structured and controlled manner including scheduled events performed in a planned sequence to meet requirements at acceptable risk, within resource and schedule constraints.

NOTE: This activity is generally referred to as project planning, project management, or program management.

The output of this planning shall be suitable for the organization's operations.

NOTE: As an output of this planning, documented information specifying the processes of the quality management system and the resources to be applied to a specific product, service, project, or contract can be referred to as a quality plan.

The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.

The organization shall ensure that outsourced processes are controlled (see 8.4).

The organization shall establish, implement, and maintain a process to plan and control the temporary or permanent transfer of work, to ensure the continuing conformity of the work to requirements. The process shall ensure that work transfer impacts and risks are managed.

NOTE: For the control of work transfer from the organization to an external provider, or from an external provider to another external provider, see 8.4. For the control of work transfer from one organization facility to another, or from an external provider to the organization, see 8.5.