GB／T 3836.21-2022 爆炸性环境第21部分：防爆产品生产质量管理体系的应用

ICS 29.260.20 CCS K 35 中华人民共和国国家标准 GB/T 3836.21—2022 代替 GB/T 3836.21—2017 爆炸性环境 第21部分： 防爆产品生产质量管理体系的应用 Explosive atmospheres— Part 21: Application of quality management systems for Ex Product manufacture (ISO/IEC 80079-34:2018, Explosive atmospheres— Part 34: Application of quality management systems for Ex Product manufacture, MOD) 2022-10-12 发布 2023-05-01 实施 国家市场监督管理总局 国家标准化管理委员会 发布 GB/T 3536.21—2022 目 次 前言 …………………………………………………………………………………………………… Ⅲ 引言 …………………………………………………………………………………………………… V 1 范围 ………………………………………………………………………………………………… 1 2 规范性引用文件 …………………………………………………………………………………… 1 3 术语和定义 ………………………………………………………………………………………… 1 4 组织环境 …………………………………………………………………………………………… 3 4.1 理解组织及其环境 …………………………………………………………………………… 3 4.2 理解相关方的需求和期望 …………………………………………………………………… 3 4.3 确定质量管理体系的范围 …………………………………………………………………… 3 4.4 质量管理体系及其过程 ……………………………………………………………………… 4 5 领导作用 …………………………………………………………………………………………… 4 5.1 领导作用和承诺 ……………………………………………………………………………… 4 5.2 方针 …………………………………………………………………………………………… 5 5.3 组织的岗位、职责和权限 …………………………………………………………………… 5 6 策划 ………………………………………………………………………………………………… 6 6.1 应对风险和机遇的措施 ……………………………………………………………………… 6 6.2 质量目标及其实现的策划 …………………………………………………………………… 7 6.3 变更的策划 …………………………………………………………………………………… 7 7 支持 ………………………………………………………………………………………………… 7 7.1 资源 …………………………………………………………………………………………… 7 7.2 能力 …………………………………………………………………………………………… 9 7.3 意识 …………………………………………………………………………………………… 10 7.4 沟通 …………………………………………………………………………………………… 10 7.5 成文信息 ……………………………………………………………………………………… 10 8 运行 ………………………………………………………………………………………………… 12 8.1 运行的策划和控制 …………………………………………………………………………… 12 8.2 产品和服务的要求 …………………………………………………………………………… 13 8.3 产品和服务的设计和开发 …………………………………………………………………… 14 8.4 外部提供的过程、产品和服务的控制 ……………………………………………………… 16 8.5 生产和服务提供 ……………………………………………………………………………… 19 8.6 产品和服务的放行 …………………………………………………………………………… 21 8.7 不合格输出的控制 …………………………………………………………………………… 21 9 绩效评价 …………………………………………………………………………………………… 22 9.1 监视、测量、分析和评价 …………………………………………………………………… 22 9.2 内部审核 ……………………………………………………………………………………… 23 9.3 管理评审 ……………………………………………………………………………………… 23 GB/T 3836.21—2022 9.3 管理评审 ····························································································································· 24 10 改进 ········································································································································ 25 10.1 总则 ···································································································································· 25 10.2 不合格和纠正措施 ··············································································································· 25 10.3 持续改进 ···························································································································· 25 附录A（资料性） 本文件与GB/T 3836.21—2017的对应关系 ······················································· 26 附录B（资料性） 特定防爆型式和具体防爆产品的相关信息 ······················································· 29 附录C（资料性） 带有不可测通路的元件(作为防爆型式的一部分)验证准则 ································· 43 附录D（资料性） 外部供方的符合性声明 ·················································································· 46 参考文献 ······································································································································ 49