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Tenacore's Successful ISO 13485:2016 Recertification Audit with Greenlight Guru's eQMS
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
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。
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。
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。
运营影响
数量效益
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