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所在平台: Udemy |
课程主页: https://www.udemy.com/course/iso-134852016-a-practical-guide-to-implementation/
课程评论：没有评论
课程名称：ISO 13485:2016 - 实施的实用指南 课程概述：ISO 13485:2016 - 实施的实用指南课程旨在帮助希望进入或改善医疗器械行业合规性的专业人士和企业。该课程提供逐步的实用方法，帮助制定和维护符合ISO 13485标准的质量管理体系（QMS），确保医疗器械制造商、供应商和服务提供商能够满足欧盟、美国及全球市场的监管要求。课程重点关注医疗器械供应商的实际审计要点，特别是那些生产子组件而不直接向医院交付的供应商。课程内容涵盖供应商资格认证与批准、基于风险的审计、过程验证（IQ、OQ、PQ）、材料可追溯性、变更控制及纠正和预防措施（CAPA）管理等关键主题。此外，课程还强调良好文件管理规范（GDP）、良好生产规范（GMP）以及监管要求（如FDA 21 CFR Part 820、EU MDR 和 ISO 14971 风险管理）的重要性。 参与者将学习如何在合格供应商名单（ASL）中管理供应商、实施关键零件可追溯性（COC/COA），并通过有效的内部和供应商审计保持合规性。课程包括现实案例研究，展示组织如何成功获得ISO 13485认证和国际医疗器械销售的监管批准。课程结束时，参与者将掌握有效实施和维护ISO 13485合规所需的知识和工具，能够通过审计，确保其产品符合医疗行业的最高质量和监管标准。
The ISO 13485:2016 - A Practical Guide to Implementation and Compliance course is designed for professionals and businesses looking to enter or improve their compliance within the medical device industry. This course provides a step-by-step practical approach to implementing and maintaining an ISO 13485-compliant Quality Management System (QMS), ensuring that medical device manufacturers, suppliers, and service providers meet regulatory requirements in the EU, U.S., and global markets.This training focuses on practical audit points for medical device suppliers, particularly those producing subcomponents and not delivering directly to hospitals. It covers essential topics such as supplier qualification and approval, risk-based auditing, process validation (IQ, OQ, PQ), material traceability, change control, and CAPA management. The course also emphasizes the importance of Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and regulatory requirements (FDA 21 CFR Part 820, EU MDR, and ISO 14971 risk management).Participants will learn how to qualify suppliers, manage Approved Supplier Lists (ASL), implement critical part traceability (COC/COA), and maintain compliance through effective internal and supplier audits. The course includes real-world case studies demonstrating how organizations successfully achieve ISO 13485 certification and regulatory approval for selling medical devices internationally.By the end of this course, learners will have the knowledge and tools to effectively implement and maintain ISO 13485 compliance, pass audits, and ensure their products meet the highest quality and regulatory standards in the medical industry.
