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所在平台: Udemy |
课程主页: https://www.udemy.com/course/iso-134852016-medical-device-internal-auditor-training/
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课程名称：ISO 13485:2016 医疗器械内部审计员培训 课程概述：ISO 13485:2016 医疗器械内部审计员培训课程旨在为参与者提供进行有效内部审计所需的知识和技能，以确保质量管理体系（QMS）符合ISO 13485:2016标准。该培训帮助医疗器械组织满足监管要求和客户需求，同时着重关注产品质量和患者安全。通过理论授课、实际案例分析和实践练习的结合，学习者将掌握审计计划、执行、报告和后续措施的专业技能。本课程遵循ISO 19011：管理体系审计指南的原则，强调基于风险的思维、过程审计和合规性。 适合人群：本课程适合以下人员： - 质量保证（QA）和监管事务（RA）专业人士 - 内部审计员及合规官 - 医疗器械制造商及供应商 - 生产及运营经理 - 工程师及研发专业人员 - 顾问及监管专家 - 任何参与ISO 13485合规及QMS审计的人士 课程要求：无需先前的审计经验，但基本了解ISO 13485:2016标准是有益的。 课程形式： - 交付方式：在线自学 - 课程时长：2-3天（提供灵活学习选项） - 培训材料：课程幻灯片、审计模板 该课程旨在帮助参与者提升评估、改进和维护符合ISO 13485标准的QMS流程的能力。
The ISO 13485:2016 Medical Device Internal Auditor Training course is designed to provide participants with the knowledge and skills required to conduct effective internal audits of a Quality Management System (QMS) in compliance with ISO 13485:2016. This training ensures that medical device organizations meet regulatory and customer requirements while maintaining a strong focus on product quality and patient safety.Through a combination of theoretical instruction, real-world case studies, and hands-on exercises, learners will develop expertise in audit planning, execution, reporting, and follow-up actions. The course follows the principles of ISO 19011: Guidelines for Auditing Management Systems and emphasizes risk-based thinking, process auditing, and regulatory compliance.This training is ideal for professionals working in quality assurance, regulatory affairs, manufacturing, and compliance roles, helping them enhance their ability to evaluate, improve, and maintain ISO 13485-compliant QMS processes.Who Should Take This Course?This course is designed for:- Quality Assurance (QA) & Regulatory Affairs (RA) Professionals- Internal Auditors & Compliance Officers- Medical Device Manufacturers & Suppliers- Production & Operations Managers- Engineers & R & D Professionals- Consultants & Regulatory Specialists- Anyone involved in ISO 13485 compliance & QMS auditingNo prior auditing experience is required, but a basic understanding of ISO 13485:2016 is beneficial.Course FormatDelivery Mode: Online / Self-PacedDuration: 2-3 Days (Flexible Learning Options Available)Training Materials: Course slides, audit templates
