Quality management systems - Requirements (ISO 9001:2008)
质量管理体系.要求(ISO 9001-2008)
发布日期:
2008-11-17
本标准与ISO 9001:2008ISO 9001:2008相同,ISO 9001:2008规定了质量管理体系的要求,其中组织需要证明其能够始终如一地提供满足客户和适用法律法规要求的产品,并通过有效应用该体系来提高客户满意度,包括持续改进体系的过程,以及确保符合客户和适用法律法规要求的过程。
ISO 9001:2008的所有要求都是通用的,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,可以考虑将其排除在外。如果存在例外情况,则不接受符合ISO 9001:2008的声明,除非这些例外情况仅限于第7条中的要求,且此类例外情况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。
This standard is identical toISO 9001:2008ISO 9001:2008 specifies requirements for a quality management system where an organizationneeds to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, andaims 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.