2.强制性产品认证实施规则工厂质量保证能力要求分析.doc

编号：CNCA-00C-005 强制性产品认证实施规则 工厂质量保证能力要求 2014-01-02发布 2014-09-01实施 中国国家认证认可监督管理委员会发布 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