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所在平台: Udemy |
课程主页: https://www.udemy.com/course/foundation-training-on-iso-13485-awareness/
课程评论：没有评论
**课程名称：** ISO 13485:2016 意识基础培训 **课程概述：** 本课程旨在帮助学员了解ISO 13485标准及其在医疗器械质量管理体系中的应用。学员将学习ISO 13485标准的具体内容、适用范围以及其遵循的核心原则。课程还将阐述ISO 13485与ISO 9001质量管理体系标准的关联性。 此外，本课程将深入讲解ISO 13485质量管理体系的要求，包括医疗器械公司如何进行ISO 13485认证。学员将理解“文件化信息”的含义，掌握ISO 13485标准对文件和记录的要求，并学习控制文件化信息质量管理体系的关键要点。 本培训将提供对ISO 13485文件化信息、认证流程及医疗器械质量管理体系要求的真实理解。通过本课程的学习，学员将获得可立即应用于竞争激烈的医疗器械行业的深入知识，助力其在该领域取得成功。 **课程包含的关键要素：** * ISO 13485:2016 医疗器械质量管理体系概述 * ISO 13485:2016 标准的各项要求 * 文件和记录的控制 * ISO 13485:2016 质量管理体系安装与认证的步骤
ISO 13485 Awareness training course will fulfill your need to know and learn about ISO 13485 standard and the medical devices quality management system. This training course is designed to help participants know what exactly is ISO 13485 standard, where it is applicable and what are the principles on which this standard is based. It helps to understand the relationship between ISO 13485 and ISO 9001 quality management system standards. The course will also help you know ISO 13485 quality management system requirements and the steps need to be taken by medical device companies for ISO 13485 certification. Additionally this course will be helpful to understand the meaning of documented information, the documents and records requirements of ISO 13485 standard and the key points to consider for control of quality management system documented information. All these things will be briefly but effectively covered in the ISO 13485 awareness training course. The training will provide a genuine knowledge of ISO 13485 documented information, certification process steps and ISO 13485 Medical Device Quality Management System requirements. This training will equip you with in-depth knowledge that can be immediately applied to thrive in today's competitive medical device industry.The ISO 13485 training program includes the following key elements:Overview of ISO 13485:2016 Medical Devices Quality Management SystemISO 13485:2016 RequirementsControl of Documents and RecordsSteps for ISO 13485:2016 QMS Installation & Certification.
