ISO9001-8.3.2

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8.3.2 设计和开发策划
在确定设计和开发的各个阶段和控制时，组织应考虑：
a）设计和开发活动的性质、持续时间和复杂程度；
b）所需的过程阶段，包括适用的设计和开发评审；
c）所需的设计和开发验证、确认活动；
d）设计和开发过程涉及的职责和权限；
e）产品和服务的设计和开发所需的内部、外部资源；
f）设计和开发过程参与人员之间接口的控制需求；
g）顾客及使用者参与设计和开发过程的需求；
h）对后续产品和服务提供的要求；
i）顾客和其他有关相关方所期望的对设计和开发过程的控制水平；
j）证实已经满足设计和开发要求所需的成文信息

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8.3.2 Design and Development Planning

When determining the various stages and controls of design and development, organizations should consider:

a) The nature, duration, and complexity of design and development activities;

b) The required process stages, including applicable design and development reviews;

c) Required design and development verification and confirmation activities;

d) Responsibilities and authorities involved in the design and development process;

e) Internal and external resources required for the design and development of products and services;

f) Control requirements for interfaces between personnel involved in the design and development process;

g) The need for customers and users to participate in the design and development process;

h) Requirements for the provision of subsequent products and services;

i) The level of control expected by customers and other relevant parties over the design and development process;

j) Documented information required to confirm that design and development requirements have been met

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b）、c）必要的阶段包括：
——评审，即针对策划输出如“新产品研发计划书”的基本评审或详细评审，即评价总体思路、过程、资源、职责分配、资金投入等的充分性、适宜性与可实施性，亦即这个新产品研发计划能够圆满完成吗？
——验证，即设计和开发的最终输出能够满足输入的要求吗？，例如这个输出为非常详细的新产品生产方案，包括原料及其配方、工艺及其控制参数、过程产品标准及其检测计划、产品包装与标签等，能够全部实现原先输入（即“概括性初步要求”）吗？
——确认，即最终试验、试制的产品或推出的供测试用服务是否已经达到预先设定的要求，即“概括性初步要求”吗？
d）谁来做，即设计和开发过程所有阶段的负责及参与协助人员的责任和权限；
e）内外部资源可包括：组织的核心人才与技术、产品配方与工艺、知识产权，设备与设施（诸如中小型试验装备），来自客户或外部供方的支持、临时人员聘用、相关的规范或标准；
f）设计和开发所涉及人员的过程或工作衔接口与沟通机制，诸如会议、备忘录、活动小结，以及信息共享的方式与途径；

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b) The necessary stages include:

——Review refers to the basic or detailed review of the planning output, such as the "New Product R&D Plan", which evaluates the adequacy, suitability, and feasibility of the overall idea, process, resources, responsibility allocation, and fund investment. Is this new product R&D plan able to be successfully completed?

——Can the final output of design and development meet the input requirements?, For example, can this output be a very detailed production plan for a new product, including raw materials and their formulas, processes and control parameters, process product standards and testing plans, product packaging and labeling, etc., all of which can achieve the original input (i.e., "general preliminary requirements")?

——Have the final test, trial produced product, or launched trial service met the pre-set requirements, i.e. the "general preliminary requirements"?

d) Who will do it, that is, the responsibility and authority of all stages of the design and development process, as well as the participation and assistance personnel;

e) Internal and external resources can include: the organization's core talents and technology, product formulas and processes, intellectual property, equipment and facilities (such as small and medium-sized experimental equipment), support from customers or external suppliers, temporary personnel employment, and relevant norms or standards;

f) The process or job title interface and communication mechanism of personnel involved in design and development, such as meetings, memorandums, activity summaries, and ways and means of information sharing;