ISO9001-8.3.1

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8.3.1总则

组织应建立、实施和保持适当的设计和开发过程，以确保后续的产品和服务的提供

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8.3.1 General



Organizations should establish, implement, and maintain appropriate design and development processes to ensure the provision of subsequent products and services.

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绝大多数组织，无论制造型组织还是服务型组织，其产品功能、特性、外观或者服务项目、流程等会经常性的发生变化，正如那句管理名言所说的“唯一不变化的就是‘变化’”。

故没有产品或服务更新升级换代的组织几乎是不存在的，致力于建立与实施基于ISO9001:2015标准质量管理体系的组织尤为如此。


在ISO9001质量管理标准发布三十一年以来，不少组织“害怕”这个条款，只要有少许理由就要么删除要么弱化，究其原因，无非两个，其一由于这个设计和开发条款由于为西方人制定，特难理解，也不知道如何做才能符合其要求，其二对组织自身是否有产品或服务的设计和开发还不清楚，不知道有还是没有，如果有又不知道其过程与职责如何界定分配，或者编制不出适合于自身要求而又符合本标准条款要求的所谓《产品（或服务）设计和开发管理程序》或《新产品（或服务）研发（开发）程序》

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The vast majority of organizations, whether manufacturing or service oriented, often experience changes in their product functions, characteristics, appearance, or service items, processes, etc.
As the management saying goes, "The only thing that remains unchanged is' change '.

Therefore, there is almost no organization without product or service updates and upgrades, especially organizations committed to establishing and implementing a quality management system based on the ISO9001:2015 standard.

Since the release of the ISO9001 quality management standard 31 years ago, many organizations have been "afraid" of this clause, either deleting or weakening it with only a few reasons. There are two reasons for this. Firstly, because this design and development clause is formulated for Westerners, it is particularly difficult to understand and do not know how to meet its requirements.
Secondly, it is still unclear whether the organization has its own product or service design and development, I don't know if it exists or not, and if it does, I don't know how to define and allocate its processes and responsibilities, or I can't develop a so-called "Product (or Service) Design and Development Management Procedure" or "New Product (or Service) Research and Development (Development) Procedure" that is suitable for my own requirements and meets the requirements of this standard clause