CNCA-00C-005 强制性产品认证实施规则工厂质量保证能力要.doc

2014年第1号 国家认监委关于发布工厂质量保证能力要求 等强制性产品认证实施规则的公告 为进一步促进强制性产品认证实施科学、规范、有效，根据《中华人民共和国认证认可条例》和《强制性产品认证管理规定》以及《国家认监委关于明确强制性产品认证实施规则类文件调整方案及要求的通知》（国认证〔2013〕39号），我委制定了两个强制性产品认证通用实施规则：《强制性产品认证实施规则工厂质量保证能力要求》，用于规范指导强制性产品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；《强制性产品认证实施规则工厂检查通用要求》，用于规范指导强制性产品认证指定认证机构工厂检查工作实施的一致性，现予以发布。 上述两个通用实施规则与后续发布的具体产品认证实施规则配套使用，于2014年9月1日起实施。 特此公告。 附件：1.《强制性产品认证实施规则工厂质量保证能力要 求》（编号：CNCA-00C-005） 2.《强制性产品认证实施规则工厂检查通用要求》 （编号：CNCA-00C-006） 国家认监委 2014年1月2日 附件1 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，