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华中科技大学硕士学位论文
摘要
随着科技的发展、政策的推动、以及人类对健康期望值的提升，医疗器械行业
正在以史无前例的速度不断发展。新技术推动新产品不断推向市场，给病人带来更
好的治疗，给企业带来商机。这种背景下，如何将新产品平稳快速的提供给市场，
抢占先机成为各企业必须重视的紧迫问题。QS集团在骨科行业历史悠久，是全球骨
科行业的标杆企业。QS公司遇到的问题，在行业内很具有代表性。
本文首先回顾了医疗器械行业的发展状况。从QS公司的实际情况出发，着眼于
QS公司新产品导入过程的质量管理策略，通过仔细分析新产品导入过程的质量管理
现状，结合法规要求，指出了全面质量计划、工艺开发管理、风险管理和项目交接
方面的问题，并应用全面质量管理的思想，制定了相应的改进方案和实施保障措施。
在风险管理方面，一种创新性的过程失效模式与效应分析工作模式被提出，对改善
风险管理效果是一次有益的尝试。对改进方案实施的保障工作，本文从推动自上而
下的变革的角度做了分析和阐述，强调了管理层的深度参与和推动对推行变革的重
要作用，介绍了QS公司的流程改进模型及其运作过程，还介绍了QS公司在鼓励全体
员工参与变革、广泛收集员工意见、持续创新、改进流程方面的系统建设。最后，
对实施效果进行了总结。
关键词：新产品导入；质量管理；风险管理
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华中科技大学硕士学位论文
Abstract
The medical device industry is growing faster than ever before, driven by technology,
policy, and human expectations for health. New technologies are pushing new products
into themarket, bringing better treatmentto patients andbusiness opportunities to
companies. In this context, how to smoothly and quickly provide new products to the
market has become an urgent issue that enterprises must pay attention to. QS Group has a
long history and is a benchmark enterprisein the global orthopaedic industry. QS's
problems are typical in the industry.
This thesis reviews the development of medical device industry. Then starting from
the actual situation of QS company, focusing on quality management strategy of new
product introduction process, by carefully analyzing the current situation of new product
introduction, takingthe regulatory requirementsunder consideration, pointsout the
comprehensive quality planning, process development and management, risk management
and project hand-over issues, and apply the thought of total quality management. The
corresponding improvement plan and implementation measures have been formulated. In
the aspect of risk management, an innovative working mode of process failure mode and
effect analysis is proposed, which is a beneficial attempt to improve the effect of risk
management.Thisthesisanalyzesandexpoundstheguaranteeworkofthe
implementation of the improvement plan from the perspective of promoting the top-down
change, emphasizes the importance of management engagement on the implementation of
the change, and introduces the process improvement model of QS company.It also
introduces the mechanism of QS company in encouraging all employees to participate in
the change, collectingemployees' opinions extensively,continuously innovating and
improving the process. Finally, the effect of implementation is summarized.
Key words: New Product Introduction, Quality Management, Risk Management
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