ISO9001认证标准理解 产品和服务的设计和开发的总则

ISO 9001 standard is the general principle for understanding the design and development of products and services

前言

preface

从今天开始分享产品和服务的设计和开发的内容。这部分内容标准将其分为总则、设计和开发策划、设计和开发输入、设计和开发控制、设计和开发输出、设计和开发更改六部分。今天分享的内容为“产品和服务的设计和开发的总则”。

Starting today, share the design and development of products and services. This part is divided into six parts: general, design and development planning, design and development input, design and development control, design and development output, design and development change. The content shared today is "general principles for the design and development of products and services".

标准内容

Standard content

标准《质量管理体系-要求 GB/T 19001-2016》条款8.3.1 总则的内容为“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”。

The content of article 8.3.1 of the standard "quality management system - requirements GB / T 19001-2016" is "the organization shall establish, implement and maintain appropriate design and development process to ensure the provision of subsequent products and services".

标准解读

Standard interpretation

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。本条本条旨在确保组织建立、实施和保持设计和开发过程,以确保其产品和服务满足要求。设计和开发过程既包括产品和服务的设计和开发还包括产品和服务提供过程的设计和开发。

The organization shall establish, implement and maintain appropriate design and development processes to ensure the subsequent provision of products and services. This article aims to ensure that the organization establishes, implements and maintains the design and development process to ensure that its products and services meet the requirements. The design and development process includes not only the design and development of products and services, but also the design and development of product and service provision process.

产品和服务的设计和开发条款，不同的组织有不同考虑。每个组织在确定质量管理体系的范围时,就应考虑《质量管理体系 要求GB/T 19001-2016》在本组织的适用性。有的组织可能需要考虑所有的设计和开发要求,而另外一些组织仅需考虑某些要求,如设计开发更改或顾客沟通等。在某些情况下,基于质量管理体系范围、顾客或法律法规要求或最佳经营实践,组织可能决定将设计和开发要求用于运行过程。

Different organizations have different considerations about the design and development terms of products and services. When determining the scope of quality management system, each organization should consider the applicability of "quality management system requirements GB / T 19001-2016" in the organization. Some organizations may need to consider all design and development requirements, while others only need to consider certain requirements, such as design and development changes or customer communication. In some cases, the organization may decide to apply design and development requirements to operational processes based on the scope of the quality management system, customer or regulatory requirements, or best business practices.

产品和服务设计开发的具体内容,即设计和开发策划、设计和开发输入、设计和开发控制、设计和开发输出、设计和开发更改将会在后续进行分享。一般来讲，设计和开发，不仅包括产品和服务的设计和开发，也包括产品和服务过程的设计和开发。

The specific contents of product and service design and development, namely design and development planning, design and development input, design and development control, design and development output, design and development changes, will be shared in the future. Generally speaking, design and development includes not only the design and development of products and services, but also the design and development of product and service process.