GB/T19001-2016质量管理体系及其过程

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(3) Organizations should establish a quality management system based on their actual business activities, especially those who establish a quality management system for the first time need to improve those areas that do not meet the standard requirements.
Standard 4.4 clause is crucial for organizational planning, design, establishment, and operation to meet the requirements of GB/T19001 and seek certification

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（4）一个能够完成自身质量职能的组织，客观上就存在一个质量管理体系，但并非每一个管理体系在达成组织的目标方面都是充分有效的。

每一个组织的产品和服务可以有不同的特性，不同的客户和相关方也会有不同的需求，组织应建立并有效地运行其质量管理体系，并与组织的其他管理体系相互协调配合，通过管理体系的整合和有效运行实现组织的目标。


还需要认识到，不是所有的系统、过程和活动都可以被预先确定，因此，组织及其质量管理体系应具有应变能力以适应变化的环境

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(4) An organization that can fulfill its own quality function objectively has a quality management system, but not every management system is fully effective in achieving organizational goals. Each organization's products and services can have different characteristics, and different customers and stakeholders may have different needs.
The organization should establish and effectively operate its quality management system, coordinate and cooperate with other management systems of the organization, and achieve the organization's goals through the integration and effective operation of the management system.

It is also necessary to recognize that not all systems, processes and activities can be predetermined. Therefore, the organization and its quality management system should have the ability to adapt to the changing environment

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（1）采用质量管理体系是组织的一项战略性决策，它关系到组织的全体员工及有关的相关方的利益，对组织的总体业绩有着重要的影响，关系到组织的生存和发展，因此它要求组织的最高管理者亲自承担责任。

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(1) The adoption of a quality management system is a strategic decision of an organization, which concerns the interests of all employees and relevant parties, has a significant impact on the overall performance of the organization, and is related to the survival and development of the organization.
Therefore, it requires the top management of the organization to personally take responsibility.

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（2）质量管理具有整体性、关联性、有序性和动态性的特性。

（3）不同组织的管理体系各有不同，质量管理体系的建立和实施应遵循其内在的规律，应用适合组织的方法建立和实施适合组织的体系是确保体系的符合性、有效性和持续有效运行的关键

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(2) Quality management has the characteristics of integrity, relevance, orderliness, and dynamism.

(3) The management systems of different organizations vary, and the establishment and implementation of quality management systems should follow their inherent laws.

Applying methods suitable for the organization to establish and implement a system suitable for the organization is the key to ensuring the compliance, effectiveness, and continuous effective operation of the system

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（1）确定这些过程所需的输入和预期的输出

通常质量管理体系的过程包括管理活动、支持过程、运作过程，对于产品和服务提供过程还应该进一步展开，包括产品实现的策划、识别和评审产品要求、设计和开发、采购、生产和服务提供等过程。每一个组织的生产流程或服务流程几乎都是不同的，如同样是机械制造企业，有的有转造、锻造等毛坏生产过程，有的则没有，也可能采用外包的方式。对过程的适当展开，是对过程实施控制的前提。

（2）确定这些过程的顺序和相互作用识别过程并确定过程顺序，可便于确定过程的输入和输出、本过程与哪些过程有相互关系。通常过程流程图是识别顺序的较好方法。

（3）确定和应用所需的准则和方法（包括监视、测量和相关绩效指标），以确保这些过程的有效运行和有效控制。确定确保过程有效运行的准则和方法，即是对每个过程应符合的要求或过程标准的确定。通过对准则的确定，来实现每个过程预期的结果。

（4）确定这些过程所需的资源并确保其可获得组织需要确定过程所需资源方面的信息：每个过程需要哪些资源？—为确保资源可获得需要哪些方面的信息沟通？需要收集哪些数据?

（5）分配这些过程的职责和权限对职责和权限的规定和沟通，是体系和过程得以运行的组织保证。有效的分配组织职责和权限也是组织质量管理体系策划中必须解决的工作。

（6）按照条款6.1的要求应对风险和机遇基于风险的思维是实现质量管理体系有效性的基础。根据6.1的要求，将基于风险的思维融入整个质量管理体系的策划和实施中。

（7）评价这些过程，实施所需的变更，以确保实现这些过程的预期结果评价过程是确保质量管理体系有效性的重要活动，通过评价为针对过程运行中的问题采取措施和改进提供依据。

（8）改进过程和质量管理体系组织需要为改进过程和质量管理体系进行策划并实施：

如何改进过程？

需要采取哪些措施?

——各项改进的措施实施了吗？

——措施的实施是否有效

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(1) Determine the inputs and expected outputs required for these processes

The process of a quality management system usually includes management activities, support processes, and operational processes. The process of providing products and services should also be further expanded, including the planning, identification and review of product requirements, design and development, procurement, production, and service provision of product realization. The production process or service process of each organization is almost different. For example, as a mechanical manufacturing enterprise, some have production processes such as remanufacturing and forging, while others do not. Outsourcing may also be used. The appropriate deployment of the process is a prerequisite for implementing control over the process.

(2) Identifying the sequence and interaction of these processes and determining the sequence of processes can facilitate the identification of the inputs and outputs of the process, as well as the relationships between this process and which processes. Generally, Process flow diagram is a better method to identify the sequence.

(3) Determine and apply the necessary criteria and methods (including monitoring, measurement, and related performance indicators) to ensure the effective operation and control of these processes. The determination of criteria and methods to ensure the effective operation of processes is the determination of the requirements or process standards that each process should meet. By determining the criteria, the expected results of each process are achieved.

(4) Determine the resources required for these processes and ensure that they have access to information about the resources required for the organization's processes: What resources are required for each process What aspects of information communication are needed to ensure resource availability? What data needs to be collected?

(5) The allocation of responsibilities and authorities for these processes, as well as the regulation and communication of responsibilities and authorities, is the organizational guarantee for the operation of the system and processes. Effective allocation of organizational responsibilities and authorities is also a necessary task in the planning of an organizational quality management system.

(6) Addressing risks and opportunities in accordance with the requirements of clause 6.1 is the foundation for achieving the effectiveness of the quality management system through risk based thinking. According to the requirements of 6.1, integrate risk based thinking into the planning and implementation of the entire quality management system.

(7) Evaluating these processes and implementing necessary changes to ensure the expected results of these processes is an important activity to ensure the effectiveness of the quality management system. Through evaluation, measures and improvements are taken to address issues in process operation.

(8) The organization needs to plan and implement the improvement process and quality management system:

How to improve the process?

What measures need to be taken?

——Have all improvement measures been implemented?

——Is the implementation of measures effective