课程助益：
由于关系到人类本身的健康和安全，全球对医疗器械行业都有严格的要求。在欧洲市场上，医疗器械生产厂商早已被强制要求通过认证机构的CE认证。市场的压力使国内医疗器械企业深入了解这方面的要求成为迫切的需要。
本课程将透彻的讲解医疗器械行业认证要求，使您全面掌握有关ISO 13485：2016的相关要求，有效的进行体系内审工作。
参加对象：
§ 医疗器械行业生产、技术、质量管理、法规注册人员
§ 医疗器械制造行业从事医用电气设备研发、生产、检测技术等医疗器械监管人员
§ 其他需要了解人员
课程大纲：
§ ISO9001: 2015术语和定义
§ ISO9001：2015过程介绍 & 案例分析
§ 医疗器械术语和定义（新旧版术语的差异）
§ EN ISO13485: 2016与医疗器械指令的关系
§ ISO13485:2016 & ISO13485:2003主要差异
§ ISO13485:2016在具体企业应用中的特点
Ø 文件要求
Ø 过程控制
§ 内部审核工作的策划
§ 内部审核技巧
§ 案例分析&分组讨论
§ 内审员考试
Benefits to you and your organisation:
Due to an increasing global awareness to health and safety issues, higher regulatory requirements have been introduced especially to medical equipment manufacturers. In Europe, medical equipment market pressure has prompted Chinese medical equipment manufacturers to fully comprehend according to these requirements. This course provides clear explanations to the newly introduced relevant requirements outlined in ISO 13485:2016 and will equip participants with the tools to effectively implement internal audits.
Objectives:
§ Medical device industry production, technology, quality management, regulatory registration personnel
§ Medical device manufacturing industry engaged in medical electrical equipment research and development, production, testing technology and other medical device supervisors
§ Other Staff who need to learn
Course Outline:
§ ISO9001: 2015 Terms and Definition
§ ISO9001：2015 Process Introduction and Case Analysis
§ Terms and Definition of Medical Devices (Difference of new and previous one)
§ Relationship between EN ISO13485: 2016 and Medical Devices Directives
§ Main Distinction between ISO13485:2016 & ISO13485:2003
§ Application Characteristics of ISO13485:2016 in Enterprises
Ø Documentary Requirements
Ø Process Control
§ Working Plan of Internal Audit
§ Internal Audit Skills
§ Case Analysis and Discussion in groups
§ Examination
Registration
网上注册请填写：姓名，公司名称，职务，邮箱，电话，开发票信息（如需）。
或将以上信息发送至 yhzhao@europeanchamber.com.cn 随后您将收到邮件确认报名及支付事宜。
Registration is required to secure your seat. Please send the following information to Yihan Zhao, yhzhao@europeanchamber.com.cn or you can register online if you are a member.
*Participant Name
*Company Name
*Title
*Contact Email and Mobile phone
*Invoice information: If you need a VAT invoice (fapiao) for reimbursement, please provide us the invoice title, identification number and post address in Chinese.
*If you need a VAT special invoice (fapiao) for reimbursement, please provide a complete information of your company that includes: invoice title, identification number, company phone number, company address, issuing bank, and issuing bank account.
Payment
You should pay at the day of the Training in cash. The European Chamber can give you an official receipt or fapiao, it will be sent to you by posting 10 working days after the event.
Terms & Conditions
Events have limited seating so to ensure your attendance we encourage advance online registration and payment for all events. We cannot guarantee entry to anyone not registered in advance.
Cancellation Policy
If you cannot attend an event for which you have registered, please cancel your registration no later than one business day prior to the event. If you fail to notify us of your cancellation in a timely fashion, you will be charged for event costs.