8运行

8.1.1、运行风险管理

组织应建立、实施和保持一个过程，用于管理运行风险以实现适用的要求，包括适合于对组织及产品和服务的要求。

a. 运行风险管理的职责分配；

b. 风险准则的确定（如：可能性、后果,风险接受程度）；

c. 在整个运行中风险的识别、评估和沟通；

d. 对于超过确定的风险接受准则时，减轻风险措施的识别、实施和管理，和

e. 减轻风险措施实施后,剩余风险可接受。

注1：当组织质量管理体系策划期间，条款6.1已落实风险和机遇时，本条款（8.1）仅限于产品和服务提供所需的运行过程（条款8）有关的风险。

注2：在航空、航天和国防工业中，风险通常以发生频度和后果严重度来表述。

8.1.1、Operational Risk Management

The organization shall plan, implement, and control a process for managing operational risks to the achievement of applicable requirements, which includes as appropriate to the organization and the products and services:

a. assignment of responsibilities for operational risk management;

b. definition of risk assessment criteria (e.g., likelihood, consequences, risk acceptance);

c. identification, assessment, and communication of risks throughout operations;

d. identification, implementation, and management of actions to mitigate risks that exceed the defined risk acceptance criteria;

e. acceptance of risks remaining after implementation of mitigating actions.

NOTE 1: While clause 6.1 addresses the risks and opportunities when planning for the quality management system of the organization, the scope of this clause (8.1.1) is limited to the risks associated to the operational processes needed for the provision of products and services (clause 8).

NOTE 2: Within the aviation, space, and defense industry, risk is generally expressed in terms of the likelihood of occurrence and the severity of the consequences.