GB/T19001: 2016 6.1应对风险措施

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在策划质量管理体系时，组织应考虑到4.1所提及的因素和4.2所提及的要求，并确定需要应对的风险和机遇，以”。

此句应翻译为“在策划质量管理体系时，组织应考虑到4.1所提及的因素和4.2所提及的要求，然后确定需要应对的风险和机遇，以”。在确定质量管理体系的风险和机遇时，应当考虑内外部因素（4.1）和相关方的要求（4.2）。

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When planning a quality management system, the organization should consider the factors mentioned in 4.1 and the requirements mentioned in 4.2, and determine the risks and opportunities that need to be addressed.
When planning a quality management system, the organization should consider the factors mentioned in 4.1 and the requirements mentioned in 4.2, and then determine the risks and opportunities that need to be addressed. When determining the risks and opportunities of the quality management system, internal and external factors (4.1) and the requirements of relevant parties (4.2) should be considered.

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确定需要应对的风险和机遇时，

可以使用SWOT、PESTLE、FMEA(失效模式与影响分析)、FMECA(失效模式、影响及危害性分析)、HACCP(危害分析及关键控制点）等分析工具。


由组织自己决定采用何种方法和工具。组织的运营规模和复杂性不大时，可以使用较简单的方法，例如：头脑风暴、SWIFT（结构性假设技术）、假设分析（如果….…会怎么样)、结果/概率矩阵等。

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SWOT, PESTLE, FMEA (Failure mode and effects analysis), FMECA (failure mode, impact and criticality analysis), HACCP (hazard analysis and critical control points) and other analysis tools can be used to determine the risks and opportunities to be addressed.
It is up to the organization to decide which methods and tools to use.

When the operational scale and complexity of an organization are not significant, simpler methods can be used, such as brainstorming, SWIFT (Structural Hypothesis Technique), hypothesis analysis (what would happen if...), result/probability matrix, etc.

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质量管理体系不能达成其目标的风险的例子包括：过程、产品和服务不能满足其要求；组织不能实现顾客满意等。

机遇的例子包括：开发新客户的可能性；新产品或服务的需求潜力；将新产品或服务引入市场的可能性；通过新技术的采用修改或取代过程使其变得更有效率的需求潜力等。

“确保质量管理体系能够实现其预期结果”。例如：过程、产品和服务不能满足其要求的风险(可通过监视、测量、验证、产品和服务的放行等活动或过程来应对该风险)。

“增强有利影响”。例如：改进其活动的效率的机会；开发或采用新技术的机会等。

“预防或减少不利影响”。例如：潜在不合格或其它潜在不期望情况发生的风险(可通过采取预防措施来应对该风险）。

“实现改进”。例如：改进产品和服务的符合性的机会；增强顾客满意的机会等

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Examples of risks where the quality management system cannot achieve its objectives include: processes, products, and services cannot meet their requirements; The organization is unable to achieve customer satisfaction, etc.



Examples of opportunities include the possibility of developing new customers; The potential demand for new products or services; The possibility of introducing new products or services into the market; The potential demand for making new technologies more efficient through the adoption, modification, or replacement process.



Ensure that the quality management system can achieve its expected results. For example, the risk of processes, products, and services not meeting their requirements (which can be addressed through activities or processes such as monitoring, measurement, verification, and release of products and services).



Enhance favorable impact. For example, opportunities to improve the efficiency of their activities; Opportunities for developing or adopting new technologies, etc.



Prevent or reduce adverse effects. For example, the risk of potential nonconformities or other unexpected situations (which can be addressed by taking preventive measures).



Implement improvements. For example, opportunities to improve the compliance of products and services; Opportunities to enhance customer satisfaction, etc