BSI医疗器械质量管理体系认证.pdfVIP

Quality Management System Certification 质量管理体系认证 Understanding Medical Device Quality Management System (QMS) certification 了解医疗器械质量管理体系（QMS）认证 Updated March 2016 2016年3月更新 The medical device manufacturing sector is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place onto the market, medical devices that are safeand fit for their intended purpose. ISO 13485:2016 was published in March 2016. Go to our revision page to find out differences between ISO 13485:2003 and the new standard. /ISO13485revision 医疗器械的制造业是监管最为严格的行业之一，必须满足质量体系和产品的要求。法规要求旨在确保医疗器在设计、 生产和投放市场中的安全性并满足预期用途。 ISO 13485:2016于2016年3月发布。访问BSI官网（/ISO13485revision） ，了解ISO 13485:2016与 ISO 13485:2003之间的区别。 The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a quality management system(QMS). Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. ISO 13485是满足质量管理体系全面要求的有效解决方案。对于制造商来说，采用ISO 13485 具有重要的现实意义， 这不仅是履行法规和责任的承诺，也是确保医疗器械具备安全性和质量的保障。 What is ISO 13485? 什么是 ISO 13485？ ISO 13485 is a stand-alone QMS standard, derived from ISO 13485系独立的QMS标准，源于国际公认的 ISO 9000 the internationally recognized and accepted ISO 9000 质量管理标准系列。ISO 13485对旧版 ISO 9001 和 quality management standard series. ISO 13485 adapts ISO 9000:2008基于流程的模型进行了改编，使之符合医 the previous version of ISO 9001, ISO 9000:2008 疗器械制造的监管环境。虽然ISO 13485是基于ISO 9001 process-based model for a regulated medical device 的计划、执行、检查、行动（PDCA）的流