1前言质量体系是为实施质量管理所需的组织结构、程序、过程和资源，而文件化的质量体系是企业质量体系结构是否有效的关键；质量体系文件是质量体系的表征；是开展质量管理和质量保证活动的基本法规、依据和见证的一系列文件。由于我国企业管理的现状和管理的思维的误区，因而 1 Foreword The quality system is the organizational structure, procedures, processes, and resources needed to implement quality management. The documented quality system is the key to the effectiveness of the company’s quality system structure. The quality system documentation is a representation of the quality system; it is the development of quality management. And the basic regulations, basis, and testimony of the quality assurance activities. Due to the current situation of enterprise management in our country and the misunderstanding of management thinking,