Tenacore 利用 Greenlight Guru 的 eQMS 成功通过了 ISO 13485:2016 再认证审核
技术
- 平台即服务 (PaaS) - 应用开发平台
- 平台即服务 (PaaS) - 设备管理平台
适用行业
- 设备与机械
- 医疗保健和医院
适用功能
- 维护
- 质量保证
用例
- 虚拟培训
- 视觉质量检测
服务
- 测试与认证
- 培训
关于客户
Tenacore, LLC 成立于 2000 年，总部位于加利福尼亚州科斯塔梅萨，是美国领先的 ISO 13485:2016 认证医疗设备维修和服务公司之一。该公司经营多种服务线，包括患者监护、外科、呼吸和液体输送设备。 Tenacore 的使命以患者安全和质量为中心，旨在为医院和诊所提供服务和生命周期解决方案，以延长一流医疗设备的使用寿命。该公司拥有超过 100 家医疗设备客户，并且不断扩大其全国覆盖范围。
挑战
Tenacore 是美国领先的 ISO 13485:2016 认证医疗设备维修和服务公司，其纸质质量管理体系 (QMS) 面临着重大挑战。随着公司不断扩大规模并管理 100 多种医疗设备，纸质 QMS 变得越来越难以管理。获取原始设备制造商 (OEM) 文件、更新技术手册以及管理和鉴定供应商以满足 Tenacore 的高质量标准等关键任务变得异常困难。基于纸张的系统还阻碍了跨团队协作并导致流程效率低下。
解决方案
为了克服这些挑战，Tenacore 采用了 Greenlight Guru 易于使用的电子质量管理系统 (eQMS)。该平台为 Tenacore 提供了继续扩展操作所需的可追溯性。基于云的平台使团队可以在任何地方工作，从而简化了流程。 Greenlight Guru 基于任务的 QMS 流程方法促进了质量和产品开发团队之间的协作，使他们能够更快地推进项目。 eQMS 还允许 Tenacore 跨平台链接和参考信息，确保更好地连接流程和文档。在购买 Greenlight Guru 后的 10 个月内，Tenacore 将其整个质量管理体系从纸质文件中迁移出来。
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