ISO13485认证 新版ISO13485:2016认证标准实施参考
ISO13485 certification of the new version of ISO13485:2016 certification standards for reference
对于新版标准的实施安排，建议企业按以下步骤。
For the implementation of the new standard arrangements, the proposed enterprise according to the following steps.
先行培训，对于其中的技术要求要深入理解，如设计验证的样本量的合理性，如体系软件应用确认要求，等等。
Prior training, for which the technical requirements to be in-depth understanding, such as the rationality of the sample size of the design validation, such as the application of system software to confirm the requirements, and so on.
其次，进行差距分析，选择适用的标准，法规和技术支持体系的变化实施，相对来讲体系运行的支持性文件和欧美有很多的指南可以帮助企业实施体系里的要求，如统计工具的导入，如AAMI TIR 36的引入，如风险工具的选择和优化，等等。
Secondly, gap analysis, choose the applicable standards, changes in the implementation of regulations and technical support system, relatively speaking, operation system supporting documents and Europe and the United States have many guide can help the enterprise to implement the system requirements, such as the introduction of statistical tools, such as AAMI TIR 36 introduced, such as the selection and optimization of risk, and so on.
再就是进行体系改动项目计划的策划和实施，并适当进行内审和管理评审，如果有不符合要求的就采取纠正预防措施了，直至差距关闭。
Then the system changes the planning and implementation of the project plan, and appropriate internal audit and management review, if there is no requirement to take corrective and preventive measures, until the gap closed.
总之，新标准的要求更实际，更科学，更明确，更广泛地协调了法规要求，最大限度地降低了风险，确保医疗器械的安全和性能功能的有效，为将来新技术应用和法规审核提供了更好的一致性。
In short, the requirements of the new standard is more practical, more scientific, more clear, more widely coordinated regulatory requirements, maximize lowers the risk of ensure medical safety and performance of the functions of, for the future of application of new technology and regulations audit provides better consistency.
ISO13485 ISO13485认证 ISO13485质量管理体系 ISO13485最新版本 ISO134852012 ISO13485/' target='_blank'>ISO13485标准下载
ISO13485 ISO13485 certification ISO134852012 quality management system ISO13485 the latest version of ISO13485 ISO13485 standard download