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工厂质量保证能力要求和工厂检查通用要求
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标准要求起关键作用的元器件、零部件、
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