Abstract: To improve the quality control of the product design and development process in ISO9000-certified enterprises, a method for process modeling and controlling was proposed mainly based on supervision of the process documents(design and quality documents). With Quality Function Deployment(QFD)and Work Breakdown Structure(WBS)technologies, the design documents for certain type of products were determined, and a library of meta-documents(documents templates)was created according to various quality documents demanded by ISO9000 quality management system. Based on the process-approach of the ISO9000, the evolution processes of design documents and quality documents, and the multi-documents　 collaborative processes were analyzed, and a hierarchical processes control model was constructed. A process documents based prototype system for product design and development quality control was developed, and the functions such as meta process definition, product-oriented design processes instantiation, product-oriented multi-documents　 collaborative process monitoring and single-document's evolution process monitoring were realized in product design and development process.

Key words: product design, product development, quality management system, quality control, process document, meta-document

摘要： 为提高ISO9000实施企业产品设计开发过程的质量控制水平，提出了以过程文档（设计、质量文档）监控为主线的产品开发过程建模和控制方法；利用质量功能配置和工作分解结构等技术确定某类产品设计开发过程中所需完成的设计文档，并参考ISO9000质量管理体系要求的各种质量文档，建立过程元（模板）文档库；基于ISO9000过程方法，分析了产品开发过程中各种设计、质量文档的单文档演化过程以及多文档协同过程，构建了各种过程文档的分层控制模型。开发了基于过程文档的产品开发质量控制原型系统，实现了产品设计开发的元（模板）过程定义、产品开发过程实例化、产品开发过程多文档协同监控以及单文档演化过程监控等功能。

关键词: 产品设计, 产品开发, 质量管理体系, 质量控制, 过程文档