ISO9001質量管理體係標準要素詳解(doc 25頁)

ISO9001質量管理體係標準要素詳解目錄：
1、適用範圍
2、參考標準
3、朮語及定義
4、質量管理係統
5、管理責任
6、資源管理
7 、產品實現
8、量測、分析及改善

ISO9001質量管理體係標準要素詳解內容摘要：
1、Scope
範圍
1.1 General
總則
This International Standard specifies requirements for a quality management system where an organization
本國際標準規定的質量管理體係要求組織﹕
a)needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
需證實其持續提供符合客戶需求及適用法規要求產品的能力。
b)aims to enhance customer satisfaction through the effective application of the system, including
processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
目的在於通過係統的有效運作以達到客戶的滿意﹐包括持續改善係統的流程和確保符合客戶滿及適用法規的需求。
NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.
備注﹕在本國際標準中﹐述語’產品’指的是客戶訂購或客戶需求的產品。
1.2 Application
應用
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
本國際標準規定的是一般和通用的要求﹐適用於所有組織﹐不論其類型﹑規模和提供的產品如何。
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
本國際標準的要求會因組織或產品的特性因素而不適用﹐可以考慮排除。
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
組織可以排除的條款僅限於條款7中的要求﹐並且僅可以排除不影響組織提供符合客戶和適用的法律要求的產品的能力和責任的要求。否則就不能聲稱符合本國際標準。

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