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所在平台: Udemy |
课程主页: https://www.udemy.com/course/iso-134852016-mdqms-self-assessment-for-lead-auditor/
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课程名称：ISO 13485:2016 医疗器械质量管理体系自我评估与主审员培训 课程概述： ISO 13485:2016是适用于参与医疗器械生命周期的组织的国际标准。如果您在这样的组织工作，可能会被选中参与审核，这是ISO 13485:2016医疗器械行业质量管理体系中最重要的过程之一。为了开展有效的审核，需要具备能力的审计员来规划、准备、实施和报告审核。本自我评估测试专门设计为工具，帮助您检查和验证对ISO 13485:2016、ISO 9000:2015和ISO 19011:2018的知识。一些用户可能会发现此测试对准备实际的ISO 13485:2016主审员考试非常有用，因为试卷设计包含了与主审员考试相似的要素。 测试内容包括： - 第一部分：了解术语、定义和质量管理原则 - 第二部分：了解ISO 19011:2018管理体系审核 - 第三部分：熟悉ISO 13485:2016的要求 - 第四部分：识别审核场景中的不符合项 - 第五部分：识别最合适的不符合项对应的ISO 13485:2016要求 - 第六部分：识别最合适的ISO 13485:2016审计记录要求 请注意，国际标准ISO 9000:2015、ISO 13485:2016和ISO 19011:2018是国际标准化组织（ISO）的受版权保护文件，因此我们无法分享或复制这些文件。建议您通过ISO商店或其授权商店购买副本。
The ISO 13485:2016 international standard is relevant to organizations that are involved in the life-cycle of medical devices. If you are working in such an organization, you may be selected to be involved in auditing, which is one of the most important processes in ISO 13485:2016 quality management system for medical device industry. In order to have an effective audit, we need competent auditors to plan, prepare, conduct and report on the audit.This self-assessment test is specifically designed to serve as a tool for you to check and validate your knowledge of ISO 13485:2016, ISO 9000:2015 and ISO 19011:2018. Some users may find this test useful in preparing for the actual ISO 13485:2016 Lead Auditor Exam, as the papers are designed to include similar elements of the Lead Auditor Exam.The composition of the test includes:Paper 1 - Understanding the terms, definitions and quality management principlesPaper 2 - Understanding ISO 19011:2018 management system auditPaper 3 - Familiarizing with ISO 13485:2016 requirementsPaper 4 - Identifying the nonconformities from audit scenariosPaper 5 - Identifying the most suitable ISO 13485:2016 requirement for nonconformityPaper 6 - Identifying the most suitable ISO 13485:2016 requirement for audit trailPlease note that these international standard - ISO 9000:2015, ISO 13485:2016 and ISO 19011:2018 are copyright protected documents 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.
