基于检测/校准功能的实验室质量管理体系建设案例研究

Case Study of Testing /Calibration Based Laboratory Quality Management System Construction

以某国有大型企业检测中心质量管理体系建设为案例,分析了实验室现状与体系建立要因,通过理顺职责与定义职能,确定了及时准确、科学公正、优质高效的质量方针和检测/校准准确率≥99.5%、客户满意度≥99%、设备周检率100%的检测/校准质量目标.充分考虑ISO17025标准的要求,兼顾ISO10012、ISO9001以及职业健康安全管理体系,特别是资质认定的相关要求,统筹兼顾,严格整合,设计了由质量手册、程序文件、作业指导书、质量记录和计划组成的4个层次构架的文件体系,尽量做到一套文件多个体系通用.采用实验室质量活动的过程控制方法建立了一套控制流程.通过实验室管理体系实施及适宜性有效性验证,取得了ILAS-MRA/CNAS国际互认联合标识使用协议权、提高了检测/校准结果权威性.

In the case of quality management system in a large state-owned enterprise test center, the laboratory status and the main factors for establishing the system were analyzed. The quality policy,, in terms of accurate and timely, scientific and fair,quality and efficient, and quality objectives with testing/calibration accuracy ≥ 99.5%, customer satisfaction ≥99% and equipment inspection rate 100% are determined by responsibilities and functions definition. Based on the ISO17025 and taking account of ISO10012, ISO9001 and OHSMS 18001, a system of documentation is designed, which consists of four levels such as quality manual, procedure direc-tion, operation instruction and quality plan and record. The objective of this file can be applied in multiple sys-tem. A set of procedures is constructed by process control in laboratory quality activities. Though laboratory management system implementation as well as suitability and effectiveness validation, the power of ILAC-MRA/ CNAS is authorized, and the authority of testing/calibration result is improved greatly.