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所在平台: Udemy |
课程主页: https://www.udemy.com/course/iso-134852016-medical-devices-qms-self-assessment-test/
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**Coursera 课程总结：ISO 13485:2016 医疗器械质量管理体系自我评估测试** 本课程是一项基于 ISO 13485:2016 标准的自我评估测试，适用于所有参与医疗器械生命周期（包括设计开发、生产、储存分发、安装维修等）的组织和个人。无论您是否已参加过 ISO 13485 培训，本测试都旨在帮助您检查和验证您对该国际标准的理解程度。 测试内容涵盖 ISO 13485:2016 标准的以下关键部分： * **第一章 范围 (Scope)** * **第二章 规范性引用文件 (Normative References)** * **第三章 术语和定义 (Terms and Definitions)** * **第四章 质量管理体系 (Quality Management System)** * **第五章 管理职责 (Management Responsibility)** * **第六章 资源管理 (Resource Management)** * **第七章 产品实现 (Product Realization)** * **第八章 测量、分析和改进 (Measurement, Analysis and Improvement)** 通过完成测试，您可以识别自己在特定领域或条款上的知识盲点，从而有针对性地进行学习和提升。掌握 ISO 13485:2016 标准的知识将为您的简历增添重要的砝码。 **请注意：** ISO 13485:2016 医疗器械 质量管理体系 用于法规的要求 是国际标准化组织 (ISO) 的版权保护文件，本课程不允许分享或复制。请从 ISO 商店或其授权商店购买正本。
The ISO 13485:2016 international standard is relevant to organizations that are involved in the life-cycle of medical devices, be it design and development, production, storage and distribution, installation and servicing, or other relevant activities. If you are working in such an organization, it is important to have a certain level of understanding of this international standard. As such, this knowledge will add valuable credentials to your resume.Regardless of whether you have attended any ISO 13485 training, this self-assessment test serves as a tool for you to check and validate your knowledge of ISO 13485. Upon completion of the test, you may find yourself lack of knowledge in certain areas or clauses. With this information, you can then focus your learning on these areas or clauses.The composition of the test includes:Clause 1 ScopeClause 2 Normative ReferencesClause 3 Terms and DefinitionsClause 4 Quality Management SystemClause 5 Management ResponsibilityClause 6 Resource ManagementClause 7 Product RealizationClause 8 Measurement, Analysis and ImprovementPlease note that the international standard - ISO 13485:2016 Medical Devices - Quality Management System - Requirements for Regulatory Purpose is a copyright protected document of International Organization for Standardization (ISO). Hence, we are not permitted to share or reproduce for you. Please purchase a copy from ISO store or its authorized stores.
