文档介绍：ISO 9001:2008
English – Chinese Bilingual
Quality management system – Requirement
质量管理体系–要求
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ISO 9001:2008
Introduction
引言
General
总则
The adoption of a quality management system should be a strategic decision of an
organization. The design and implementation of anization's quality management
system is influenced by
a) anizational environment, changes in that environment, and the risks associated with
that environment,
b) its varying needs,
c) its particular objectives,
d) the products it provides,
e) the processes it employs,
f) its size anizational structure.
采用质量管理体系应当是组织的一项战略性决策。一个组织质量管理体系的设计和和实施受下列因素的影
响响:
a) 组织的业务务环境、该环境的变化化或与该环境有关的风险,
b) 组织的不同需求,
c) 组织的特定目标,
d) 所提供的产品品,
e) 所采用的过程,
f) 组织的规模和和组织结构。
It is not the intent of this International Standard to imply uniformity in the structure of quality
management systems or uniformity of documentation.
统一质量管理体系的结构或文件不是本标准的目的。
The quality management system requirements specified in this International Standard are
complementary to requirements for products. Information marked “NOTE” is for guidance in
understanding or clarifying the associated requirement.
本标准所规定的质量管理体系要求是对产品品要求的补充。“注”是帮助助理解、澄清有关要求的参考性信
息。
This International Standard can be used by internal and external parties, including
certification bodies, to assess anization's ability to meet customer, statutory and
regulatory requirements applicable to the product, and anization's own requirements.
本标准能用于内部和和外部各方(包包括认证机构)评定组织满足顾客要求、适用的产品品的法律法规要求和和
组织自身要求的能力力。
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into
consideration during the development of this International Standard.
本标准的制制定已经考虑了ISO 9000和和ISO 9004中所阐明的质量管理原则。
Process approach
过程方法
This