GB/T19001: 2015确定体系范围

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“组织应确定质量管理体系的边界和适用性，以确定其范围”。

质量管理体系的范围可能只覆盖组织的一部分，本标准的某些要求也可能不适用于所覆盖的组织部分。

质量管理体系的边界，如：质量管理体系所覆盖的产品和服务类型、质量管理体系所覆盖的部门或职能、质量管理体系所覆盖的场所、质量管理体系所覆盖的分公司、质量管理体系所覆盖的活动或过程

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The organization should determine the boundaries and applicability of the quality management system to determine its scope.






The scope of the quality management system may only cover a part of the organization, and some requirements of this standard may not apply to the covered parts of the organization.






The boundaries of the quality management system, such as the types of products and services covered by the quality management system, the departments or functions covered by the quality management system, the places covered by the quality management system, the subsidiaries covered by the quality management system, and the activities or processes covered by the quality management system

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在确定范围时，组织应考虑：

a)4.1中提及的各种外部和内部因素”。比如：

某产品，其预期销售的区域法规规定必须通过IS09001认证才能上市销售，组织应考虑建立的质量管理体系覆盖该产品；

某产品，大部分竞争对手的同类产品都通过了IS09001认证，组织应考虑建立的质量管理体系覆盖该产品；

某产品，市场对通过了ISO9001认证的同类产品更加认可，组织应考虑建立的质量管理体系覆盖该产品；

某产品，其质量控制绩效较差，组织应考虑建立的质量管理体系覆盖该产品；

某产品，组织不具备设计开发的知识或能力，只有制造的能力，组织应考虑建立的质量管理体系

不覆盖该产品的设计和开发。

“在确定范围时，组织应考虑：b)4.2中提及的相关方的要求”。比如：

某产品，其顾客要求必须通过ISO9001认证，组织应考虑建立的质量管理体系覆盖该产品；

某企业，其销售部门主管要求部门实施符合ISO9001要求的质量管理，以提高部门绩效，组织应考虑建立的质量管理体系覆盖销售部门。

“在确定范围时，组织应考虑：c)组织的产品和服务”。比如：

生产空调的企业，其质量管理体系应覆盖空调产品，而不应该覆盖冰箱或其它；

提供货物运输服务的企业，其质量管理体系应覆盖货物运输服务，而不应该覆盖客运服务或其它

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When determining the scope, the organization should consider various external and internal factors mentioned in section 4.1. For example:



A certain product must pass IS09001 certification in accordance with the regional regulations for expected sales, and the organization should consider establishing a quality management system to cover the product;



A certain product, most of its competitors' similar products have passed IS09001 certification, and the organization should consider establishing a quality management system to cover this product;



A certain product is more recognized by the market for similar products that have passed ISO9001 certification, and the organization should consider establishing a quality management system to cover the product;



A certain product has poor quality control performance, and the organization should consider establishing a quality management system to cover the product;



For a certain product, the organization does not have the knowledge or ability to design and develop, but only has the ability to manufacture. The organization should consider establishing a quality management system



Does not cover the design and development of this product.



When determining the scope, the organization should consider the requirements of the relevant parties mentioned in b) 4.2. For example:



A certain product requires its customers to pass ISO9001 certification, and the organization should consider establishing a quality management system to cover the product;



The sales department manager of a certain enterprise requires the department to implement quality management that meets ISO9001 requirements to improve department performance. The organization should consider establishing a quality management system that covers the sales department.



When determining the scope, the organization should consider: c) the organization's products and services. For example:



Enterprises producing air conditioners should have their quality management system covering air conditioning products, not refrigerators or other products;



Enterprises providing goods transportation services should have their quality management system covering goods transportation services, rather than passenger transportation services or other related services

yaso95

这是自己翻译的吗

hutian02

牛人，建议上传全英文版

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hutian02 发表于 2023-6-25 11:24
牛人，建议上传全英文版

好好学习天天向上