风险管理对医疗器械的应用174p.pptVIP

* PDCA循环 与质量体系的协调 * 如何定义？ 合法是最低底线。 欧盟MDD指令，明示的准则：符合标准的要求 Article 3 Essential requirements The devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned. Article 5 Reference to standards 1. Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonized standards the references of which have been publishes in the Official Journal of the European Communities; Member States shall publish the references of such national standards. 2. For the purposes of this Directive, reference to harmonized standards also includes the monographs of the European Pharmacopoeia notably on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, the references of which have been published in the Official Journal of the European Communities. 3. If a Member State or the Commission considers that the harmonized standards do not entirely meet the essential requirements referred to in Article 3, the measures to be taken by the Member States with regard to these standards and the publication referred to in paragraph 1 of this Article shall be adopted by the procedure defined in Article 6 (2). * PHA 初始危害识别 ISO 13485 的应用要求 ISO 13485 USA China Canada EU Japan Australia CMDCAS cGMP EN ISO 13485 GMP QSR ISO 13485 以过程为基础的质量管理模式 质量管理模式 要求 管理职责 测量、 分析和改进 资源管理 产品实现 输入 输出 产品 满意 顾客 (ISO9001) 和其它相关利益方 (ISO 9004) 质量管理体系的持续改进 顾客 (ISO9001) 和其它相关利益方 (ISO 9004) RM ISO 13485对风险管理的要求 7.1 产品实现的策划 组织应策划和开发产品实现所需的过程。产品策划应与质量管理体系其他过程的要求相一致。 在对产品实现进行策划时，组织应确定以下方面的适当内容： a) 产品的质量目标和要求； b) 针对产品确定过程、文件和资源的需求； c) 产品所要求的验证、确认、监视、检验和试验活动，以及 产品接收准则； d) 为实现过程及其产品满足要求提供需要的记录。 策划的输出形式应适合于组织的运作方式 组织应在产品实现全过程中，建立风险管理的形成文件的要求。应保持风险管理引起的记录。 注1：对应用于特定的产品、项目或合同的质量管理体系的过程 （包括产品过程）和