3C强制性产品认证实施规则工厂质量保证能力要求剖析.docVIP

强制性产品认证实施规则 工厂质量保证能力要求 目 录 0.引言························································5 1.适用范围····················································5 2.术语和定义··················································5 2.1认证技术负责人············································5 2.2认证产品一致性（产品一致性）·······························5 2.3例行检验··················································6 2.4确认检验···················································6 2.5关键件定期确认检验········································6 2.6功能检查···················································6 3.工厂质量保证能力要求········································6 3.1职责和资源·················································7 3.2文件和记录·················································8 3.3采购和关键件控制···········································8 3.4生产过程控制···············································9 3.5例行检验和/或确认检验·····································10 3.6检验试验仪器设备··········································10 3.7不合格品的控制···········································12 3.8内部质量审核·············································12 3.9认证产品的变更及一致性控制·······························12 3.10产品防护与交付··········································13 3.11CCC证书和标志···········································13 0.引言 按照《强制性产品认证管理规定》的要求，生产企业应控制获证产品一致性，其质量保证能力应持续符合认证要求。为规范指导强制性产品认证（以下简称CCC认证）目录内产品生产企业建立确保产品持续符合CCC认证要求的质量保证能力，制定本实施规则。 在认证工作具体实施中，工厂应以保证生产的认证产品与型式试验样品的一致性为目标，根据本实施规则及相应产品认证实施规则/细则的要求，针对产品特性和生产加工特点，建立符合本实施规则要求的质量保证能力。 注：本实施规则中的工厂涉及认证委托人、生产者、生产企业。 1.适用范围 本实施规则规定了工厂质量保证能力的基本要求，同时也是认证机构实施工厂检查的依据之一。 2.术语和定义 2.1认证技术负责人 属于生产者和/或生产企业内部人员，掌握认证依据标准要求，依据产品认证实施规则/细则规定的职责范围，对认证产品变更进行确认批准并承担相应责任的人。 2.2认证产品一致性（产品一致性） 生产的认证产品与型式试验样品保持一致，产品一致性的具体要求由产品认证实施规则/细则规定。 2.3例行检验 为剔除生产过程中偶然性因素造成的不合格品，通常在生产的最终阶段，对认证产品进行的100%检验。例行检验允许用经验证后确定的等效、快速的方法进行。 注：对于特殊产品，例行检验可以按照产品认证实施规则/细则的要求，实施抽样检验。 2.4确认检验 为验证认证产品是否持续符合认证依据标准所进行的抽样检验。 2.5关键件定期确认检验 为验证关键件的质量特性是否持续符合认证依据标准和/或技术要求所进行的定期抽样检验。 注：关键件是对产品满足认证依据标准要求起关键作用的元器件、零部件、原材料等的统称。 2.6功能检查 为判断检验试验仪器设备的预期功能是否满足规定要求所进行的检查。 3.工厂质量保证能力要求 工厂是产品质量的责任主体，其质量