CNCA-C11-01与ISO 9001的成文信息要求分析

Analysis of the Requirements of Documented Information in CNCA-C11-01 and ISO 9001

《强制性认证实施规则汽车产品》(CNCA-C11-01:2014)附件5与ISO 9001均对企业保持/保留成文信息提出了要求,根据ISO 9001对成文信息的定义,结合汽车产品强制性产品认证(CCC)制度及质量管理体系的不同要求,重点对《强制性产品认证实施规则工厂质量保证能力要求》(CNCA-00C-005:2014)中的附件5-1《生产一致性审查要求》、附件5-2《工厂质量保证能力及生产条件审查要求》及ISO 9001:2015《质量管理体系要求》中的成文信息要求进行了梳理、对比及分析。

The Annex 5 of CNCA-C11-01:2014,Compulsory Certification Implementation Rules for Automobile Products and ISO 9001 both require enterprises to maintain or retain documented information.According to the definition of documented information in ISO 9001,combined with the different requirements of the Compulsory Certification of Automobile Products(CCC) system and the quality management system,the paper compares and analyzes the documented information requirements in Annex 5-1,Production Consistency Review Requirements,Annex 5-2,Factory Quality Assurance Ability and Production Conditions Review Requirements,and ISO 9001:2015,Quality Management System Requirements.