质量管理体系 - 要求
Quality management systems – Requirements
1范围
1 Scope
通则
1.1 General
本国际标准规定了质量管理体系的各项要求,以满足当组织有下列需求时:
This International Standard specifies requirements for a quality management system where an organization:
a) 须要展现其能力足以稳定地提供符合客户或适当法规要求之产品,和
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
b) 透过体系的有效运用,包括持续改善与保证达成客户和法规要求的流程,达到客户满意
b) aims to achieve 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.
备注:本国际标准中,〝产品〞一词适用于预期提供予顾客或其所需要之产品。
NOTE: In this International Standard, the term “product” applies to the product intended for, or required by, a customer
1.2应用
1.2 Application
此国际标准的所有要求乃通用性要求且期望能适用于所有组织,无论其行业、规模及所提供的产品,
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
本国际标准的任何要求若因组织或产品之特性而无法适用时可考虑予以排除
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.
当本国际标准的任何要求被排除时,则组织不得宣称其符合本国际标准,除非所排除的要求局限于本国际标准的第七章,且不影响组织提供符合客户及适当法规要求产品的能力或责任
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.
2 引用标准
2 Normative reference
本国际标准引用下列标准的内容以构成本国际标准的条款,所引用的标准如具日期版次,则其后之修订或改版均不适用于本国际标准.然而依据本国际标准达成共识之各团体仍应探求使用下列标准档最新版次的可能。引用的标准如未指定日期版次,则应使用最新的引用标准.ISO及IEC会员皆维持有最新有效国际标准的登录清单。
The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.
ISO 9000:2000 质量管理体系 – 原理与词汇
ISO 9000:2000, Quality management systems – Fundamentals and vocabulary.
3 名词与定义
3 Terms and definitions
|