品质管理系统要求.pdf

ISO 9001:2000 2000.12.15 Quality management systems – Requirements 品質管理系統 -- 要求 1 Scope 1 範圍 1.1 General 1.1 通則 This International Standard specifies requirements for 當組織有下列要求時，本國際標準界定其品質管理 a quality management system where an organization 系統的需求： a) needs to demonstrate its ability to consistently a) 需要展現其能力足以穩定地提供符合客戶及適 删除的内容: 須 provide product that meets customer and 用法規要求之產品，和 applicable regulatory requirements, and b) aims to enhance customer satisfaction through the b) 透過系統的有效運用，包括持續改善系統之過程 effective application of the system, including 與保證符合客戶及適當法規要求，以增進客戶滿 processes for continual improvement of the system 意。 and the assurance of conformity to customer and applicable regulatory requirements. NOTE In this International Standard, the term 備註 在本國際標準中，”產品”一詞適用於預期提 “product” applies to the product intended for, 供予顧客或其所需要之產品。 or required by, a customer. 1.2 Application 1.2 應用 All requirements of this International Standard are 此國際標準的所有要求乃通用性要求且期望能適 generic and are intended to be applicable to all 用於所有組織，無論其行業、規模及所提供的產品。 organizations, regardless of type, size and product provided. 本國際標準的任何要求若因組織或產品之特性而 Were any requirement(s) of this international Standard 無法適用時可考慮予以排除。 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. 當本國際標準的任何要求被排除時，則組織不得宣