宿迁摆地摊需要食品经营许可证吗

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宿迁摆地摊需要食品经营许可证吗

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宿迁摆地摊需要食品经营许可证吗

发表于 2024-02-23 11:19:59 浏览：0

宿迁摆地摊需要食品经营许可证吗

　　摆地摊是否需要食品经营许可证，取决于当地的法规和规定。

　　一般来说，对于食品销售和餐饮服务活动，食品经营许可证是必须的。但是，对于流动摊贩，一些地方可能会实行登记制或备案制，而不是要求他们必须获得食品经营许可证。

　　因此，如果你打算摆地摊并销售食品，最好先向当地的市场监管部门咨询是否需要办理食品经营许可证。同时，无论是否需要许可证，都应确保食品的卫生和安全，以维护公众的健康。

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title	'{fenzhan}医疗器械经营许可证现场核查重点：仓储与质量管理体系搭建'
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description	'医疗器械经营许可证现场核查是确保企业合规经营的关键环节，仓储管理与质量管理体系是两大核心审查内容。2024年《医疗器械经营监督管理办法》修订后，核查标准进一步细化。本文结合最新法规与实操案例，梳理现场核查要点及体系搭建策略，助力企业高效通过审核。一、仓储管理现场核查重点1. 场地合规性分区管理：必须设置待验区、合格品区、不合格品区、退货区（分区标'
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content	'<p style="margin-top: 8px; margin-bottom: 12px; padding: 0px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-stretch: inherit; font-size: 16px; line-height: 1.75; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);">医疗器械经营许可证现场核查是确保企业合规经营的关键环节，仓储管理与质量管理体系是两大核心审查内容。2024年《医疗器械经营监督管理办法》修订后，核查标准进一步细化。本文结合最新法规与实操案例，梳理现场核查要点及体系搭建策略，助力企业高效通过审核。</p><hr style="margin-top: 24px; margin-bottom: 24px; border-top-color: rgba(0, 0, 0, 0.08); background: none rgb(252, 252, 252); color: rgba(0, 0, 0, 0.9); font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-size: 16px;"><h4 style="margin: 16px 0px 8px; padding: 0px; font-size: 14px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-weight: 600; font-stretch: inherit; line-height: 1.5; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">一、仓储管理现场核查重点</span></h4><h5 style="margin: 16px 0px 8px; padding: 0px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-weight: 600; font-stretch: inherit; font-size: 16px; line-height: 1.5; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">1. 场地合规性</span></h5><ul style="margin: 8px 0px 16px 16px; padding: 0px; list-style: none; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-stretch: inherit; font-size: 16px; line-height: inherit; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">分区管理</span>：<ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">必须设置<span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">待验区、合格品区、不合格品区、退货区</span>（分区标识清晰，物理隔离）；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">需配备专用<span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">冷链仓储区</span>（冷库、冷藏车、保温箱等），温度实时监控并记录。</li></ul></li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">面积匹配</span>：<ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">仓储面积与经营规模匹配（如经营二类器械需≥50㎡，冷链产品需额外增加冷库面积）；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">不得与非医疗器械产品混放（如药品与器械需分库或分区分架）。</li></ul></li></ul><h5 style="margin: 16px 0px 8px; padding: 0px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-weight: 600; font-stretch: inherit; font-size: 16px; line-height: 1.5; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">2. 温湿度控制</span></h5><ul style="margin: 8px 0px 16px 16px; padding: 0px; list-style: none; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-stretch: inherit; font-size: 16px; line-height: inherit; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">设备要求</span>：<ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">配备温湿度自动监测设备（精度±0.5℃），数据存储≥3年；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">冷库需双电路供电或备用发电机组（断电报警装置启动时间≤2分钟）。</li></ul></li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">监控记录</span>：<ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">温湿度数据每30分钟自动记录一次，异常波动需留存调查处理报告；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">冷链产品需记录运输全程温度（从发货到收货，温度偏差≤2℃）。</li></ul></li></ul><h5 style="margin: 16px 0px 8px; padding: 0px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-weight: 600; font-stretch: inherit; font-size: 16px; line-height: 1.5; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">3. 库存与效期管理</span></h5><ul style="margin: 8px 0px 16px 16px; padding: 0px; list-style: none; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-stretch: inherit; font-size: 16px; line-height: inherit; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">信息化系统</span>：<ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">使用医疗器械GSP管理软件（支持效期预警、近效期产品自动锁定）；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">库存记录与实物一致（现场抽查误差率≤0.1%）。</li></ul></li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">近效期产品</span>：<ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">设置独立<span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">近效期专区</span>，有效期≤6个月的产品需明显标识；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">不得销售过期产品，销毁记录需留存（视频+纸质签字）。</li></ul></li></ul><hr style="margin-top: 24px; margin-bottom: 24px; border-top-color: rgba(0, 0, 0, 0.08); background: none rgb(252, 252, 252); color: rgba(0, 0, 0, 0.9); font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-size: 16px;"><h4 style="margin: 16px 0px 8px; padding: 0px; font-size: 14px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-weight: 600; font-stretch: inherit; line-height: 1.5; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">二、质量管理体系核查重点</span></h4><h5 style="margin: 16px 0px 8px; padding: 0px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-weight: 600; font-stretch: inherit; font-size: 16px; line-height: 1.5; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">1. 制度文件完整性</span></h5><ul style="margin: 8px 0px 16px 16px; padding: 0px; list-style: none; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-stretch: inherit; font-size: 16px; line-height: inherit; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">核心文件清单</span>：<ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">《质量管理制度》（含采购、验收、储存、销售、售后服务全流程）；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">《不合格医疗器械处理程序》《追溯与召回制度》《风险防控预案》。</li></ul></li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">文件管控要求</span>：<ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">制度文件需经法定代表人签批，修订后重新培训并记录；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">现场随机抽查员工对制度的熟悉程度（回答正确率≥90%）。</li></ul></li></ul><h5 style="margin: 16px 0px 8px; padding: 0px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-weight: 600; font-stretch: inherit; font-size: 16px; line-height: 1.5; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">2. 人员与培训</span></h5><ul style="margin: 8px 0px 16px 16px; padding: 0px; list-style: none; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-stretch: inherit; font-size: 16px; line-height: inherit; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">关键岗位资质</span>：<ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">质量负责人需具备医疗器械相关专业大专以上学历，3年以上从业经验；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">验收、养护人员需接受省级药监部门培训并持证。</li></ul></li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">培训记录</span>：<ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">年度培训计划及执行记录（含GSP法规、产品知识、操作技能）；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">培训考核试卷存档（得分≥80分为合格）。</li></ul></li></ul><h5 style="margin: 16px 0px 8px; padding: 0px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-weight: 600; font-stretch: inherit; font-size: 16px; line-height: 1.5; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">3. 采购与验收流程</span></h5><ul style="margin: 8px 0px 16px 16px; padding: 0px; list-style: none; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-stretch: inherit; font-size: 16px; line-height: inherit; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">供应商管理</span>：<ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">供应商档案需包含《医疗器械生产/经营许可证》《产品注册证》；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">首次采购需签署质量协议（明确质量责任与退换货条款）。</li></ul></li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">验收标准</span>：<ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">到货查验产品标签、说明书、合格证、运输温度记录；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">冷链产品需在30分钟内完成入库验收（留存开箱视频）。</li></ul></li></ul><h5 style="margin: 16px 0px 8px; padding: 0px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-weight: 600; font-stretch: inherit; font-size: 16px; line-height: 1.5; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">4. 追溯与风险控制</span></h5><ul style="margin: 8px 0px 16px 16px; padding: 0px; list-style: none; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-stretch: inherit; font-size: 16px; line-height: inherit; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">追溯系统</span>：<ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">使用UDI（医疗器械唯一标识）系统，实现“一物一码”追溯；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">销售记录需包含产品名称、规格、批号、生产企业和购货者信息。</li></ul></li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">风险处置</span>：<ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">建立《不良事件监测与报告制度》，发现风险产品24小时内上报；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">每季度模拟召回演练，记录响应时间与处置效果。</li></ul></li></ul><hr style="margin-top: 24px; margin-bottom: 24px; border-top-color: rgba(0, 0, 0, 0.08); background: none rgb(252, 252, 252); color: rgba(0, 0, 0, 0.9); font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-size: 16px;"><h4 style="margin: 16px 0px 8px; padding: 0px; font-size: 14px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-weight: 600; font-stretch: inherit; line-height: 1.5; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">三、常见问题与整改方案</span></h4><ol style="margin: 8px 0px 16px 16px; padding: 0px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-stretch: inherit; font-size: 16px; line-height: inherit; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; list-style-position: initial; list-style-image: initial; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; line-height: 1.75; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word; display: inline;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">仓储分区不达标</span></p><ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: disc; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">问题</span>：合格区与不合格区仅用标识牌区分，无物理隔离。</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">整改</span>：加装隔断墙或货架隔离，设置独立门禁系统。</li></ul></li><li style="margin: 4px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; line-height: 1.75; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word; display: inline;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">温湿度数据造假</span></p><ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: disc; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">问题</span>：手工记录代替自动监测，数据不连续。</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">解决</span>：采购合规温湿度监测设备（推荐品牌：德图、欧姆龙）。</li></ul></li><li style="margin: 4px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; line-height: 1.75; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word; display: inline;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">质量文件缺失</span></p><ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: disc; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">问题</span>：未建立追溯与召回制度，无法提供演练记录。</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">整改</span>：委托第三方机构（如SGS、华测）编制体系文件并辅导实施。</li></ul></li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; line-height: 1.75; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word; display: inline;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">人员资质不符</span></p><ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: disc; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">问题</span>：质量负责人学历或经验不达标。</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">解决</span>：招聘持证人员或安排现有人员参加学历提升课程。</li></ul></li></ol><hr style="margin-top: 24px; margin-bottom: 24px; border-top-color: rgba(0, 0, 0, 0.08); background: none rgb(252, 252, 252); color: rgba(0, 0, 0, 0.9); font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-size: 16px;"><h4 style="margin: 16px 0px 8px; padding: 0px; font-size: 14px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-weight: 600; font-stretch: inherit; line-height: 1.5; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">四、体系搭建与优化建议</span></h4><ol style="margin: 8px 0px 16px 16px; padding: 0px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-stretch: inherit; font-size: 16px; line-height: inherit; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; list-style-position: initial; list-style-image: initial; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; line-height: 1.75; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word; display: inline;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">仓储设计策略</span></p><ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: disc; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">布局优化</span>：按“出入库动线最短”原则设计货架位置，减少搬运损耗；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">技术赋能</span>：使用AGV无人搬运车、智能拣货系统提升效率。</li></ul></li><li style="margin: 4px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; line-height: 1.75; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word; display: inline;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">质量管理工具</span></p><ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: disc; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">信息化系统</span>：选择与药监局数据接口兼容的GSP软件（如用友、金蝶）；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">风险预警</span>：设置近效期、高投诉产品自动预警阈值。</li></ul></li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; line-height: 1.75; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word; display: inline;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">持续改进机制</span></p><ul style="margin-top: 4px; margin-right: 0px; margin-left: 16px; padding: 0px; list-style: disc; border: 0px; font: inherit; vertical-align: baseline;"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">内审管理</span>：每半年开展一次内部审核，留存《不符合项整改报告》；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">管理评审</span>：年度评审会由法定代表人主持，评估体系有效性。</li></ul></li></ol><hr style="margin-top: 24px; margin-bottom: 24px; border-top-color: rgba(0, 0, 0, 0.08); background: none rgb(252, 252, 252); color: rgba(0, 0, 0, 0.9); font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-size: 16px;"><h4 style="margin: 16px 0px 8px; padding: 0px; font-size: 14px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-weight: 600; font-stretch: inherit; line-height: 1.5; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">结语</span></h4><p style="margin-top: 8px; margin-bottom: 8px; padding: 0px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-stretch: inherit; font-size: 16px; line-height: 1.75; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);">医疗器械经营现场核查的核心是<span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">“硬件合规、数据可溯、体系健全”</span>。企业需重点关注：</p><ol style="margin: 8px 0px 16px 16px; padding: 0px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-stretch: inherit; font-size: 16px; line-height: inherit; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; list-style-position: initial; list-style-image: initial; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">硬件兜底</span>：仓储分区、温湿度设备等必须100%达标；</li><li style="margin: 4px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">数据真实</span>：杜绝手工篡改，全程自动化记录；</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">动态合规</span>：定期更新制度文件，匹配法规变化。</li></ol><p style="margin-top: 8px; margin-bottom: 8px; padding: 0px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-stretch: inherit; font-size: 16px; line-height: 1.75; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><span style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: 600; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline;">政策依据与工具</span>：</p><ul style="margin: 8px 0px 16px 16px; padding: 0px; list-style: none; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-stretch: inherit; font-size: 16px; line-height: inherit; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);"><li style="margin: 0px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">《医疗器械经营质量管理规范》（2024年修订）</li><li style="margin: 4px 0px 4px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">国家药监局GSP信息化系统对接标准</li><li style="margin: 4px 0px 0px 4px; padding: 0px; list-style: none; border: 0px; font: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word;">UDI数据库查询平台：<span class="hyc-common-markdown__link" style="margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; cursor: pointer; color: rgb(0, 108, 69);"><span class="hyc-common-markdown__link__content" style="margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline;">http://udi.nmpa.gov.cn</span><svg class="hyc-common-icon" width="12" height="12" viewBox="0 0 14 14" fill="none" xmlns="http://www.w3.org/2000/svg"><path d="M5.94622 3.83398L10.2319 3.83398M10.2319 3.83398C10.2319 5.97684 10.2319 8.1197 10.2319 8.1197M10.2319 3.83398L4.23193 9.83398" stroke-linecap="round" stroke-linejoin="round" stroke="currentColor"></path><path d="M7.23193 0.833984H3.23193C2.12736 0.833984 1.23193 1.72941 1.23193 2.83398V6.83398" stroke-linecap="round" stroke="currentColor"></path><path d="M7.23193 12.834L11.2319 12.834C12.3365 12.834 13.2319 11.9386 13.2319 10.834L13.2319 6.83398" stroke-linecap="round" stroke="currentColor"></path></svg></span></li></ul><p style="margin-top: 8px; margin-bottom: 0px; padding: 0px; border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-variant-alternates: inherit; font-stretch: inherit; font-size: 16px; line-height: 1.75; font-family: "PingFang SC", -apple-system, BlinkMacSystemFont, "Segoe UI", Roboto, Ubuntu, "Helvetica Neue", Helvetica, Arial, "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", "Source Han Sans CN", sans-serif; font-optical-sizing: inherit; font-kerning: inherit; font-feature-settings: inherit; font-variation-settings: inherit; vertical-align: baseline; word-break: break-word; overflow-wrap: break-word; color: rgba(0, 0, 0, 0.9); background-color: rgb(252, 252, 252);">（附：现场核查自检表可私信获取，含100项核查要点与评分标准。）</p>'
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meta_title	'河北省医疗器械经营许可证现场核查重点：仓储与质量管理体系搭建_【乐财汇】'
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'displayorder' => '0', 'tid' => '1', 'content' => '', 'mid' => 'fenzhan', 'pcatpost' => 0, 'topid' => '3', 'catids' => array ( 0 => '21', ), 'is_post' => 1, 'url' => 'http://www.58lecaihui.com/index.php?s=fenzhan&c=category&id=21', 'total' => '请使用count标签查询', 'field' => array ( ), ), 22 => array ( 'id' => '22', 'pid' => '3', 'pids' => '0,3', 'name' => 'icp许可证', 'dirname' => 'icpxukezheng', 'pdirname' => 'xukezhengshenpi/', 'child' => 0, 'disabled' => '0', 'ismain' => 1, 'childids' => 22, 'thumb' => '', 'show' => '1', 'setting' => array ( 'disabled' => '0', 'linkurl' => '', 'getchild' => '0', 'notedit' => '0', 'seo' => array ( ), 'template' => array ( 'pagesize' => '20', 'mpagesize' => '20', 'page' => '', 'list' => 'list.html', 'category' => 'category.html', 'search' => 'search.html', 'show' => 'show.html', ), 'cat_field' => NULL, 'module_field' => NULL, 'html' => 1, 'urlrule' => 0, ), 'displayorder' => '0', 'tid' => '1', 'content' => '', 'mid' => 'fenzhan', 'pcatpost' => 0, 'topid' => '3', 'catids' => array ( 0 => '22', ), 'is_post' => 1, 'url' => 'http://www.58lecaihui.com/index.php?s=fenzhan&c=category&id=22', 'total' => '请使用count标签查询', 'field' => array ( ), ), 23 => array ( 'id' => '23', 'pid' => '3', 'pids' => '0,3', 'name' => '进出口贸易许可证', 'dirname' => 'jinchukoumaoyixukezheng', 'pdirname' => 'xukezhengshenpi/', 'child' => 0, 'disabled' => '0', 'ismain' => 1, 'childids' => 23, 'thumb' => '', 'show' => '1', 'setting' => array ( 'disabled' => '0', 'linkurl' => '', 'getchild' => '0', 'notedit' => '0', 'seo' => array ( ), 'template' => array ( 'pagesize' => '20', 'mpagesize' => '20', 'page' => '', 'list' => 'list.html', 'category' => 'category.html', 'search' => 'search.html', 'show' => 'show.html', ), 'cat_field' => NULL, 'module_field' => NULL, 'html' => 1, 'urlrule' => 0, ), 'displayorder' => '0', 'tid' => '1', 'content' => '', 'mid' => 'fenzhan', 'pcatpost' => 0, 'topid' => '3', 'catids' => array ( 0 => '23', ), 'is_post' => 1, 'url' => 'http://www.58lecaihui.com/index.php?s=fenzhan&c=category&id=23', 'total' => '请使用count标签查询', 'field' => array ( ), ), 24 => array ( 'id' => '24', 'pid' => '3', 'pids' => '0,3', 'name' => '商品流通许可证', 'dirname' => 'shangpinliutongxukezheng', 'pdirname' => 'xukezhengshenpi/', 'child' => 0, 'disabled' => '0', 'ismain' => 1, 'childids' => 24, 'thumb' => '', 'show' => '1', 'setting' => array ( 'disabled' => '0', 'linkurl' => '', 'getchild' => '0', 'notedit' => '0', 'seo' => array ( ), 'template' => array ( 'pagesize' => '20', 'mpagesize' => '20', 'page' => '', 'list' => 'list.html', 'category' => 'category.html', 'search' => 'search.html', 'show' => 'show.html', ), 'cat_field' => NULL, 'module_field' => NULL, 'html' => 1, 'urlrule' => 0, ), 'displayorder' => '0', 'tid' => '1', 'content' => '', 'mid' => 'fenzhan', 'pcatpost' => 0, 'topid' => '3', 'catids' => array ( 0 => '24', ), 'is_post' => 1, 'url' => 'http://www.58lecaihui.com/index.php?s=fenzhan&c=category&id=24', 'total' => '请使用count标签查询', 'field' => array ( ), ), 25 => array ( 'id' => '25', 'pid' => '3', 'pids' => '0,3', 'name' => '劳务派遣许可证', 'dirname' => 'laowupaiqianxukezheng', 'pdirname' => 'xukezhengshenpi/', 'child' => 0, 'disabled' => '0', 'ismain' => 1, 'childids' => 25, 'thumb' => '', 'show' => '1', 'setting' => array ( 'disabled' => '0', 'linkurl' => '', 'getchild' => '0', 'notedit' => '0', 'seo' => array ( ), 'template' => array ( 'pagesize' => '20', 'mpagesize' => '20', 'page' => '', 'list' => 'list.html', 'category' => 'category.html', 'search' => 'search.html', 'show' => 'show.html', ), 'cat_field' => NULL, 'module_field' => NULL, 'html' => 1, 'urlrule' => 0, ), 'displayorder' => '0', 'tid' => '1', 'content' => '', 'mid' => 'fenzhan', 'pcatpost' => 0, 'topid' => '3', 'catids' => array ( 0 => '25', ), 'is_post' => 1, 'url' => 'http://www.58lecaihui.com/index.php?s=fenzhan&c=category&id=25', 'total' => '请使用count标签查询', 'field' => array ( ), ), 26 => array ( 'id' => '26', 'pid' => '3', 'pids' => '0,3', 'name' => '危化品许可证', 'dirname' => 'weihuapinxukezheng', 'pdirname' => 'xukezhengshenpi/', 'child' => 0, 'disabled' => '0', 'ismain' => 1, 'childids' => 26, 'thumb' => '', 'show' => '1', 'setting' => array ( 'disabled' => '0', 'linkurl' => '', 'getchild' => '0', 'notedit' => '0', 'seo' => array ( ), 'template' => array ( 'pagesize' => '20', 'mpagesize' => '20', 'page' => '', 'list' => 'list.html', 'category' => 'category.html', 'search' => 'search.html', 'show' => 'show.html', ), 'cat_field' => NULL, 'module_field' => NULL, 'html' => 1, 'urlrule' => 0, ), 'displayorder' => '0', 'tid' => '1', 'content' => '', 'mid' => 'fenzhan', 'pcatpost' => 0, 'topid' => '3', 'catids' => array ( 0 => '26', ), 'is_post' => 1, 'url' => 'http://www.58lecaihui.com/index.php?s=fenzhan&c=category&id=26', 'total' => '请使用count标签查询', 'field' => array ( ), ), )
urlrule	'/index.php?s=fenzhan&c=show&id=4064&page=[page]'
fix_html_now_url	''
my_web_url	'http://hebeisheng.58lecaihui.com/index.php?c=show&id=4064'
get	array ( 'c' => 'show', 'id' => '4064', 's' => 'fenzhan', )

Files ( 155 )

App.php	FCPATH/CodeIgniter72/Config/App.php
Auto.php	FCPATH/App/Module/Config/Auto.php
Autoload.php	FCPATH/CodeIgniter72/Config/Autoload.php
Cache.php	FCPATH/CodeIgniter72/Config/Cache.php
Cache.php	FCPATH/CodeIgniter72/Extend/Cache.php
Cache.php	FCPATH/Fcms/Library/Cache.php
Category.php	FCPATH/App/Module/Action/Category.php
CodeIgniter.php	FCPATH/CodeIgniter72/Extend/CodeIgniter.php
Constants.php	FCPATH/CodeIgniter72/Config/Constants.php
Content.php	APPPATH/Models/Content.php
Content.php	FCPATH/App/Module/Models/Content.php
Content.php	FCPATH/Fcms/Model/Content.php
ContentSecurityPolicy.php	FCPATH/CodeIgniter72/Config/ContentSecurityPolicy.php
Controller.php	FCPATH/CodeIgniter72/Extend/Controller.php
Database.php	FCPATH/CodeIgniter72/Config/Database.php
Date.php	FCPATH/Fcms/Field/Date.php
Editor.php	FCPATH/Fcms/Field/Editor.php
Exceptions.php	FCPATH/CodeIgniter72/Config/Exceptions.php
Exceptions.php	FCPATH/CodeIgniter72/Extend/Exceptions.php
Field.php	FCPATH/Fcms/Library/Field.php
File.php	FCPATH/Fcms/Field/File.php
Filters.php	FCPATH/CodeIgniter72/Config/Filters.php
Helper.php	FCPATH/Fcms/Core/Helper.php
Hook.php	FCPATH/CodeIgniter72/Extend/Hook.php
Hooks.php	FCPATH/App/Chtml/Config/Hooks.php
Hooks.php	FCPATH/App/Module/Config/Hooks.php
Hooks.php	FCPATH/Fcms/Core/Hooks.php
Init.php	APPPATH/Config/Init.php
Init.php	FCPATH/CodeIgniter72/Init.php
Init.php	FCPATH/Fcms/Init.php
Input.php	FCPATH/Fcms/Library/Input.php
Kint.php	FCPATH/CodeIgniter72/Config/Kint.php
Lang.php	FCPATH/Fcms/Library/Lang.php
Linkages.php	FCPATH/Fcms/Field/Linkages.php
Logger.php	FCPATH/CodeIgniter72/Config/Logger.php
Member.php	FCPATH/Fcms/Model/Member.php
Model.php	FCPATH/CodeIgniter72/Extend/Model.php
Model.php	FCPATH/Fcms/Core/Model.php
Module.php	FCPATH/App/Module/Action/Module.php
Module.php	FCPATH/App/Module/Extends/Home/Module.php
Modules.php	FCPATH/CodeIgniter72/Config/Modules.php
Mwhere.php	APPPATH/Config/Mwhere.php
Paths.php	FCPATH/CodeIgniter72/Config/Paths.php
Phpcmf.php	FCPATH/Fcms/Core/Phpcmf.php
Request.php	FCPATH/CodeIgniter72/Extend/Request.php
Router.php	FCPATH/Fcms/Library/Router.php
Routes.php	APPPATH/Config/Routes.php
Routes.php	FCPATH/CodeIgniter72/Config/Routes.php
Routes.php	FCPATH/CodeIgniter72/Extend/Routes.php
Routes.php	FCPATH/Fcms/Config/Routes.php
Security.php	FCPATH/Fcms/Library/Security.php
Seo.php	FCPATH/Fcms/Library/Seo.php
Service.php	FCPATH/Fcms/Core/Service.php
Services.php	FCPATH/CodeIgniter72/Config/Services.php
Show.php	APPPATH/Controllers/Show.php
Text.php	FCPATH/Fcms/Field/Text.php
Textarea.php	FCPATH/Fcms/Field/Textarea.php
Toolbar.php	FCPATH/CodeIgniter72/Config/Toolbar.php
UserAgents.php	FCPATH/CodeIgniter72/Config/UserAgents.php
Version.php	FCPATH/My/Config/Version.php
View.php	FCPATH/CodeIgniter72/Config/View.php
View.php	FCPATH/CodeIgniter72/Extend/View.php
View.php	FCPATH/Fcms/Core/View.php
custom.php	/www/wwwroot/www.58lecaihui.com/config/custom.php
database.php	/www/wwwroot/www.58lecaihui.com/config/database.php
domain_app.php	/www/wwwroot/www.58lecaihui.com/cache/config/domain_app.php
domain_client.php	/www/wwwroot/www.58lecaihui.com/cache/config/domain_client.php
hooks.php	/www/wwwroot/www.58lecaihui.com/config/hooks.php
index.php	/www/wwwroot/www.58lecaihui.com/fenzhan/pc/index.php
index.php	/www/wwwroot/www.58lecaihui.com/index.php
lang.php	/www/wwwroot/www.58lecaihui.com/api/language/zh-cn/lang.php
site.php	/www/wwwroot/www.58lecaihui.com/cache/config/site.php
system.php	/www/wwwroot/www.58lecaihui.com/cache/config/system.php
template_DS_pc_DS_jizhang_DS_home_DS_fenzhan_DS_fz_footer.html.cache.php	/www/wwwroot/www.58lecaihui.com/cache/template/template_DS_pc_DS_jizhang_DS_home_DS_fenzhan_DS_fz_footer.html.cache.php
template_DS_pc_DS_jizhang_DS_home_DS_fenzhan_DS_fz_header.html.cache.php	/www/wwwroot/www.58lecaihui.com/cache/template/template_DS_pc_DS_jizhang_DS_home_DS_fenzhan_DS_fz_header.html.cache.php
template_DS_pc_DS_jizhang_DS_home_DS_fenzhan_DS_show.html.cache.php	/www/wwwroot/www.58lecaihui.com/cache/template/template_DS_pc_DS_jizhang_DS_home_DS_fenzhan_DS_show.html.cache.php
AutoloadConfig.php	SYSTEMPATH/Config/AutoloadConfig.php
Autoloader.php	SYSTEMPATH/Autoloader/Autoloader.php
BaseBuilder.php	SYSTEMPATH/Database/BaseBuilder.php
BaseCollector.php	SYSTEMPATH/Debug/Toolbar/Collectors/BaseCollector.php
BaseConfig.php	SYSTEMPATH/Config/BaseConfig.php
BaseConnection.php	SYSTEMPATH/Database/BaseConnection.php
BaseHandler.php	SYSTEMPATH/Cache/Handlers/BaseHandler.php
BaseResult.php	SYSTEMPATH/Database/BaseResult.php
BaseService.php	SYSTEMPATH/Config/BaseService.php
Builder.php	SYSTEMPATH/Database/MySQLi/Builder.php
CacheFactory.php	SYSTEMPATH/Cache/CacheFactory.php
CacheInterface.php	SYSTEMPATH/Cache/CacheInterface.php
CliRenderer.php	SYSTEMPATH/ThirdParty/Kint/Renderer/CliRenderer.php
CodeIgniter.php	SYSTEMPATH/CodeIgniter.php
Common.php	SYSTEMPATH/Common.php
Config.php	SYSTEMPATH/Config/Config.php
Config.php	SYSTEMPATH/Database/Config.php
Connection.php	SYSTEMPATH/Database/MySQLi/Connection.php
ConnectionInterface.php	SYSTEMPATH/Database/ConnectionInterface.php
ContentSecurityPolicy.php	SYSTEMPATH/HTTP/ContentSecurityPolicy.php
Controller.php	SYSTEMPATH/Controller.php
Database.php	SYSTEMPATH/Database/Database.php
Database.php	SYSTEMPATH/Debug/Toolbar/Collectors/Database.php
DebugToolbar.php	SYSTEMPATH/Filters/DebugToolbar.php
DotEnv.php	SYSTEMPATH/Config/DotEnv.php
Events.php	SYSTEMPATH/Debug/Toolbar/Collectors/Events.php
Events.php	SYSTEMPATH/Events/Events.php
Exceptions.php	SYSTEMPATH/Debug/Exceptions.php
Factories.php	SYSTEMPATH/Config/Factories.php
Factory.php	SYSTEMPATH/Config/Factory.php
FileHandler.php	SYSTEMPATH/Cache/Handlers/FileHandler.php
FileLocator.php	SYSTEMPATH/Autoloader/FileLocator.php
Files.php	SYSTEMPATH/Debug/Toolbar/Collectors/Files.php
FilterInterface.php	SYSTEMPATH/Filters/FilterInterface.php
Filters.php	SYSTEMPATH/Filters/Filters.php
Header.php	SYSTEMPATH/HTTP/Header.php
IncomingRequest.php	SYSTEMPATH/HTTP/IncomingRequest.php
Kint.php	SYSTEMPATH/ThirdParty/Kint/Kint.php
Logger.php	SYSTEMPATH/Log/Logger.php
LoggerInterface.php	SYSTEMPATH/ThirdParty/PSR/Log/LoggerInterface.php
Logs.php	SYSTEMPATH/Debug/Toolbar/Collectors/Logs.php
Message.php	SYSTEMPATH/HTTP/Message.php
MessageInterface.php	SYSTEMPATH/HTTP/MessageInterface.php
MessageTrait.php	SYSTEMPATH/HTTP/MessageTrait.php
Modules.php	SYSTEMPATH/Modules/Modules.php
Query.php	SYSTEMPATH/Database/Query.php
QueryInterface.php	SYSTEMPATH/Database/QueryInterface.php
Renderer.php	SYSTEMPATH/ThirdParty/Kint/Renderer/Renderer.php
RendererInterface.php	SYSTEMPATH/View/RendererInterface.php
Request.php	SYSTEMPATH/HTTP/Request.php
RequestInterface.php	SYSTEMPATH/HTTP/RequestInterface.php
RequestTrait.php	SYSTEMPATH/HTTP/RequestTrait.php
Response.php	SYSTEMPATH/HTTP/Response.php
ResponseInterface.php	SYSTEMPATH/HTTP/ResponseInterface.php
ResponseTrait.php	SYSTEMPATH/API/ResponseTrait.php
ResponseTrait.php	SYSTEMPATH/HTTP/ResponseTrait.php
Result.php	SYSTEMPATH/Database/MySQLi/Result.php
ResultInterface.php	SYSTEMPATH/Database/ResultInterface.php
RichRenderer.php	SYSTEMPATH/ThirdParty/Kint/Renderer/RichRenderer.php
RouteCollection.php	SYSTEMPATH/Router/RouteCollection.php
RouteCollectionInterface.php	SYSTEMPATH/Router/RouteCollectionInterface.php
Router.php	SYSTEMPATH/Router/Router.php
RouterInterface.php	SYSTEMPATH/Router/RouterInterface.php
Routes.php	SYSTEMPATH/Config/Routes.php
Routes.php	SYSTEMPATH/Debug/Toolbar/Collectors/Routes.php
Services.php	SYSTEMPATH/Config/Services.php
TextRenderer.php	SYSTEMPATH/ThirdParty/Kint/Renderer/TextRenderer.php
Timer.php	SYSTEMPATH/Debug/Timer.php
Timers.php	SYSTEMPATH/Debug/Toolbar/Collectors/Timers.php
Toolbar.php	SYSTEMPATH/Debug/Toolbar.php
URI.php	SYSTEMPATH/HTTP/URI.php
UserAgent.php	SYSTEMPATH/HTTP/UserAgent.php
Utils.php	SYSTEMPATH/ThirdParty/Kint/Utils.php
View.php	SYSTEMPATH/Config/View.php
View.php	SYSTEMPATH/View/View.php
Views.php	SYSTEMPATH/Debug/Toolbar/Collectors/Views.php
init.php	SYSTEMPATH/ThirdParty/Kint/init.php
init_helpers.php	SYSTEMPATH/ThirdParty/Kint/init_helpers.php
url_helper.php	SYSTEMPATH/Helpers/url_helper.php

Routes

File:	/www/wwwroot/www.58lecaihui.com/dayrui/App/Fenzhan/Controllers/Show.php
App:	fenzhan
Controller:	show
Method:	index
URI:	fenzhan/show/index
URL:	http://hebeisheng.58lecaihui.com/index.php?c=show&id=4064

Events

Time	Event Name	Times Called
94.26 ms	pre_system	1
0.94 ms	dbquery	8

History

Datetime	Status	Method	URL	Content-Type	Is AJAX?
2025-04-12 01:38:24	200	GET	http://binzhou.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:23	200	GET	http://hebeisheng.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:22	200	GET	http://jilinsheng.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:21	200	GET	http://zhongwei.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:20	200	GET	http://shandongsheng.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:19	200	GET	http://jining.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:18	200	GET	http://hebeiqu.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:17	200	GET	http://yingkou.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:16	200	GET	http://yingkou.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:15	200	GET	http://haikou.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:14	200	GET	http://songjiangqu.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:13	200	GET	http://yichun371.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:12	200	GET	http://luoyang.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:11	200	GET	http://kaizhouqu.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:10	200	GET	http://shapingbaqu.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:09	200	GET	http://hebeisheng.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:08	200	GET	http://yongan.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:06	200	GET	http://shishi.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:05	200	GET	http://qinghaisheng.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-12 01:38:04	200	GET	http://ningxia.58lecaihui.com/	text/html; charset=UTF-8	No

View Data

Session User Data

Session doesn't seem to be active.

Request ( HTTP/1.1 )

$_GET

c	show
id	4064
s	fenzhan

Headers

User-Agent	Mozilla/5.0 (compatible; SemrushBot/7~bl; +http://www.semrush.com/bot.html)
Connection	close
Accept-Encoding	gzip,deflate
Accept	text/html, application/rss+xml, application/atom+xml, text/xml, text/rss+xml, application/xhtml+xml
Host	hebeisheng.58lecaihui.com

Response ( 200 - OK )

Headers

User-Agent	Mozilla/5.0 (compatible; SemrushBot/7~bl; +http://www.semrush.com/bot.html)
Connection	close
Accept-Encoding	gzip,deflate
Accept	text/html, application/rss+xml, application/atom+xml, text/xml, text/rss+xml, application/xhtml+xml
Host	hebeisheng.58lecaihui.com

System Configuration

Read the CodeIgniter docs...

CodeIgniter Version:	4.0.5
PHP Version:	7.4.33
PHP SAPI:	fpm-fcgi
Environment:	development
Base URL:	http://hebeisheng.58lecaihui.com/
Timezone:	PRC
Locale:	en
Content Security Policy Enabled:	No

宿迁 摆地摊需要食品经营许可证吗

4.0.5

Database (8 Queries across 0 Connection)

Views

运行时间：0.29ms

模板文件

引用提示

模板变量

Files ( 155 )

Routes

Events

History

View Data

Session User Data

Request ( HTTP/1.1 )

$_GET

Headers

Response ( 200 - OK )

Headers

System Configuration

宿迁摆地摊需要食品经营许可证吗