ISO 9001:2008 质量管理体系 要求

标准编号：ISO 9001:2008

中文名称：质量管理体系 要求

英文名称：Quality management systems — Requirements

发布日期：2008-11

标准范围

ISO 9001:2008规定了组织质量管理体系的要求需要证明其有能力始终如一地提供符合客户和适用法律法规要求的产品，以及旨在通过系统的有效应用来提高客户满意度，包括系统的持续改进流程以及确保符合客户和适用的法律法规要求。ISO 9001:2008的所有要求都是通用的，旨在适用于所有组织，无论其类型、规模和提供的产品如何。如果由于组织及其产品的性质而无法应用ISO 9001:2008的任何要求，则可以考虑排除。在排除的情况下，符合ISO 9001的声明:除非这些排除仅限于第7条中的要求，并且此类排除不影响组织提供满足客户和适用法律法规要求的产品的能力或责任。

ISO 9001:2008 specifies requirements for a quality management system where an organization

• needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
• 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 statutory and regulatory requirements.

All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.Where exclusions are made, claims of conformity to ISO 9001:2008 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 statutory and regulatory requirements.

标准预览图