GB/T19001-2016质量管理体系及其过程

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1.条款4.4.1的意图是确定质量管理体系所需的过程，特别是考虑其在组织中的应用。

条款4.4.1是建立、实施、保持和持续改进其绩效的总体思路，也是实施质量管理体系必然的逻辑步骤，因此a）至h》条款的识别和确定使得QMS自始至终完全纳入组织的经营管理之中

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The intention of clause 4.4.1 is to determine the processes required for the quality management system, especially considering its application in the organization.

Clause 4.4.1 is the overall approach to establish, implement, maintain, and continuously improve its performance, and is also an inevitable logical step in implementing a quality management system. Therefore, the identification and determination of clauses a) to h enable QMS to be fully integrated into the organization's business management from beginning to end

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2.条款4.4.1f要求组织在确定质量管理体系所需的过程及其在整个组织内的应用时，应按照条款6.1的要求应对风险和机遇

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Clause 4.4.1f requires organizations to address risks and opportunities in accordance with the requirements of Clause 6.1 when determining the processes required for the quality management system and its application throughout the organization

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(1）质量管理体系的目的是向组织的顾客提供信任，即让顾客相信组织能够稳定交付符合要求的产品和服务。

为此，本标准要求组织证明其有能力满足顾客和相关法律法规的要求

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(1) The purpose of a quality management system is to provide trust to the organization's customers, that is, to make them believe that the organization can stably deliver products and services that meet the requirements.
Therefore, this standard requires organizations to demonstrate their ability to meet the requirements of customers and relevant laws and regulations

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（2）组织的经营管理方法不是唯一的。

GB/T19001提供了可供组织使用的良好管理实践的框架，闸明了质量管理体系需包含的一系列要求，但并没有提供满足这些要求的具体方法。
因此，在满足GB/T19001的要求方面，标准为组织提供了很大的自由空间。

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(2) The management methods of an organization are not unique.
GB/T19001 provides a framework for good management practices that organizations can use, clarifying the series of requirements that a quality management system needs to include, but does not provide specific methods to meet these requirements.

Therefore, in meeting the requirements of GB/T19001, standards provide organizations with a great deal of freedom.

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（3）组织应根据其实际的业务活动建立质量管理体系，特别是初次建立质量管理体系的组织需要对那些未达到标准要求的地方进行改进。

标准4.4条款对组织策划、设计、建立和运行一个符合GB/T19001要求并寻求认证十分重要