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ISO 9001:2008
English – Chinese Bilingual
Quality management system – Requirement
质量管理体系 – 要求
Copyright reserved, for reference to Intertek systems certification customers only

ISO 9001:2008

0.1 General

The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by
a) its organizational 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 and organizational structure.
a) 组织的业务环境、该环境的变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,
e) 所采用的过程,
f) 组织的规模和组织结构。

It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.

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.

This International Standard can be used by internal and external parties, including certification bodies, to assess theorganization's ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization's own requirements.

The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.
本标准的制定已经考虑了ISO 9000和ISO 9004中所阐明的质量管理原则。

0.2 Process approach

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