ISO9001:2015-8.3.3

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8.3.3设计和开发输入

组织应针对所设计和开发的具体类型的产品和服务，确定必需的要求。组织应考虑：

a）功能和性能要求；

b）来源于以前类似设计和开发活动的信息；

c）法律法规要求；

d）组织承诺实施的标准或行业规范；

e）由产品和服务性质所导致的潜在的失效后果。

针对设计和开发的目的，输入应是充分和适宜的，且应完整、清楚。

相互矛盾的设计和开发输入应得到解决。

组织应保留有关设计和开发输入的成文信息。

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8.3.3 Design and development inputs



The organization should determine the necessary requirements for the specific types of products and services designed and developed. Organizations should consider:



a) Functional and performance requirements;



b) Information sourced from previous similar design and development activities;



c) Legal and regulatory requirements;



d) The standards or industry norms that the organization promises to implement;



e) Potential failure consequences caused by the nature of the product and service.



For the purpose of design and development, input should be sufficient and appropriate, and should be complete and clear.



Conflicting design and development inputs should be addressed.



Organizations should retain written information about design and development inputs.

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与产品或服务直接相关的法规标准要求，例如《产品质量法》、《食品安全法》、《药品管理法》、产品标准（国家标准、国家推荐标准、行业标准、地区标准），或者与产品与服务生产、提供相关的环境、设备设备、工艺等相关的法规、良好操作规范、行业指南等，例如饭店的卫生要求与人员健康要求（如取得餐饮从业健康证）、服务场所的消防要求

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Regulatory and standard requirements directly related to products or services, such as the Product Quality Law, Food Safety Law, Drug Management Law, product standards (national standards, national recommended standards, industry standards, regional standards), or regulations, good operating practices, industry guidelines, etc. related to the production and provision of products and services, the environment, equipment, processes, etc, For example, the hygiene requirements of restaurants and personnel health requirements (such as obtaining a catering health certificate), and the fire protection requirements of service venues

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由产品或服务性质带来的失败的潜在后果，例如运输或旅游公司对于新旅游线路或运输线路，如果缺乏（在考虑路况、天气或气候、司机熟悉程度等前提下的）道路交通安全策划，可能导致事故；新设计服装不料上不稳定染料可导致褪色或转移，能够导致顾客满意度下降。

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The potential consequences of failure caused by the nature of the product or service, such as the lack of road traffic safety planning (taking into account road conditions, weather or climate, driver familiarity, etc.) by transportation or tourism companies for new tourism routes or transportation routes, which may lead to accidents; Unstable dyes on newly designed clothing can cause fading or transfer, which can lead to a decrease in customer satisfaction.