质量管理体系–要求

3.3、关键特性

是一种属性或特性，其变化将对产品装配,成形，功能，性能 ,使用寿命或可制造性产生重大影响，因而要求特定的措施对其变化进行控制。

3.4、产品安全性

产品能够履行其设计或预期目的而不会对人员伤害或者财产损坏造成不可接受的风险的一种状态。

3.5、特殊要求

由顾客识别或组织自己确定的要求,这些要求有无法满足的高风险,因而要求它们包含在运营风险管理过程中.确定特殊要求的因素包括产品或过程的复杂性,过去的经验以及产品或过程的成熟性.特殊要求的例子包括顾客提出的已接近业界能力极限的性能要求,或是由组织按自身技术或过程能力极限确定的要求。

注：特殊要求（3.5）和关键项目（3.2），连同关键特性（3.3）一起是相互关联的。

特殊要求是在确定和评审与产品有关的要求时识别的（见8.2.1和8.2.2）。特殊要求可能要求识别关键项目。设计输出（见8.3.5）可能包括识别要求特定的措施以确保其充分管理的关键项目。一些关键项目由于需要对其变化进行控制会被进行一步归类为关键特性。

3.3、Key Characteristic

An attribute or feature whose variation has a significant effect on product fit, form, function, performance, service life, or producibility, that requires specific actions for the purpose of controlling variation.

3.4、Product Safety

The state in which a product is able to perform to its designed or intended purpose without causing unacceptable risk of harm to persons or damage to property.

3.5、Special Requirements

Those requirements identified by the customer, or determined by the organization, which have high risks of not being met, thus requiring their inclusion in the operational risk management process. Factors used in the determination of special requirements include product or process complexity, past experience, and product or process maturity. Examples of special requirements include performance requirements imposed by the customer that are at the limit of the industry’s capability, or requirements determined by the organization to be at the limit of its technical or process capabilities.

NOTE: Special requirements (3.5) and critical items (3.2), along with key characteristics (3.3), are interrelated.

Special requirements are identified when determining and reviewing requirements related to the product (see 8.2.2 and 8.2.3). Special requirements can require the identification of critical items. Design output (see 8.3.5) can include identification of critical items that require specific actions to ensure they are adequately managed. Some critical items will be further classified as key characteristics because their variation needs to be controlled.