以质量管理的视角探讨医疗器械标准制修订工作流程

Discussing the working process of medical device standard revision from the perspective of quality management

为进一步梳理医疗器械标准制修订工作流程,提高标准制修订的工作质量,本文将质量管理中持续改进的理念贯穿于标准制修订工作全环节,将医疗器械标准制修订工作流程中的主要环节与ISO/IEC 17025中的要素一一对应。医疗器械标准的立项、起草验证、征求意见、技术审查、审核批准和发布、实施和评价、复审和废止可对应质量管理体系中的合同评审、内部审核、技术记录、报告结果、记录控制、外部提供的产品和服务、确保结果有效性、纠正措施和管理评审等要素。标准制修订工作流程和质量管理体系运行有相似之处,可以将确保质量管理体系有效运行的方式方法引申到标准制修订工作中,以实现持续改进,提高标准质量的目标。

In order to further clarify the working process of medical device standard revision and improve the quality of the work,this paper applies the concept of continuous improvement in quality management to the whole process of medical device standard revision,and corresponds the main links in the working process of medical device standard revision to the elements in ISO/IEC 17025.The establishment,drafting,verification,request for comment,inspection,approval and issuing,implementation and evaluation,review and abolishment of medical device standards can be corresponded to contract review,internal audit,results and records control,purchasing services and supplies,ensuring the effectiveness of results,corrective actions and management reviews in the quality management system.The process of standard revision is similar to the operation of the quality management system.The methods to ensure the effectiveness of the quality management system can be extended to the process of standard revision,so as to achieve continuous improvement and improve the quality of standards.