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所在平台: Udemy |
课程主页: https://www.udemy.com/course/internal-audit-on-medical-device-qms-iso-13485-2016/
课程评论：没有评论
课程名称：医疗设备质量管理体系内部审核 - ISO 13485:2016 课程概述： 医疗设备质量管理体系内部审核 - ISO 13485:2016 是由Stendard Academy创建的一门课程，旨在帮助学员掌握成为ISO 13485:2016标准内部审核员所需的技能。课程将涵盖审计的一般原则，并逐步解读该标准的所有条款，以便全面了解如何实施审核。我们将通过一次全面的模拟审核，运用我们精心编制的审核清单，彻底评估每一条标准，帮助学员深刻理解审核的过程。 ISO 13485:2016标准为医疗设备开发和质量管理体系（QMS）设定了要求，是医疗设备开发公司的重要标准。该标准不仅是普遍的监管要求，遵循它还能提供一个支持优质产品和过程的质量管理框架。尽管您可能已经对ISO 13485:2016标准有了较好的理解，但根据该标准进行审核则涉及到更高的严格性。 本课程将帮助您学习以下内容： - 审计的一般概念和原则 - 如何建立和准备审核 - 如何根据编制的清单进行模拟审核 - 审核结果报告 - 审核后活动和纠正及预防措施（CAPA）规划 为了方便学习，我们还汇编了一份审核清单，将作为模拟审核的基础。这份清单经过我们的团队根据ISO 13485:2016的要求整理，完整的清单也同步了美国FDA 21 CFR Part 820的相关要求。您可以在课程第3.2节下载Audit Checklist.pdf，并根据自身组织的需要进行调整。 您成功进行ISO 13485:2016医疗设备开发和质量管理体系的内部审核之旅触手可及，我们欢迎您加入Stendard Academy。我们将质量置于业务的核心，助您简化审核过程！
Internal audit on Medical Device QMS - ISO 13485:2016 is another course created by Stendard Academy to help you gain the skills, and learn how to be an internal auditor for the ISO 13485:2016 standard.In the course, we will cover the general principles of auditing, and walk through all the clauses in this standard, to provide a holistic picture of how audits are and can be performed. This will be done as part of a comprehensive mock audit, performed according to an audit checklist we crafted to thoroughly assess each line in the standard.The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS). It is an essential standard for medical device development companies. Besides being a common regulatory requirement, this standard, when adhered to, provides a Quality Management framework that supports quality products and processes.You may already have a good understanding of the ISO 13485:2016 standard. However, performing an audit according to the standard is a different matter, with the rigour expected.Learning these principles and knowing the documents and records required will be useful should you be in a position that requires you to be prepared for external audits, as similar principles apply.This course has been broken down into:General concepts and principles of auditingEstablishing and preparing for the auditPerforming the audit (How to conduct a mock audit based on compiled checklist?)Reporting the audit resultsPost-audit activities and CAPA planningFor the purpose of this course, we have also compiled a checklist that we would base our mock audit on. This checklist was put together by our team at Stendard in accordance to ISO 13485:2016. The full checklist is available and you will note that we synced it with requirements according to US FDA 21 CFR Part 820 as well. You can download the Audit Checklist.pdf in Section 3.2. and adapt it for your own organisation's usage. Your journey to successfully conducting an internal audit based on requirements of ISO 13485:2016 for Medical Device Development and QMS is only clicks away. We welcome onboard the Stendard Academy, we put quality at the centre of your business and make it easier!
