实验室标准化和质量保证

Laboratory Standardization and Quality Assurance

实验室标准化和质量保证是提高实验室工作质量的两个互补的概念。标准化包括由政府机构认可的检验方法，操作规范和参考材料，参考材料是依据准确性和一致性的概念建立的。仅有标准化还不能确保优质的分析效果，必须要有质量保证措施。通过一系列活动提供分析的可信性，使实验室工作符合医生的期望，这些活动包括内部质量控制和室间质量评估。用法规和行政手段对所有活动进行管理、加上工作人员的认识和能动性、富有实现优质工作质量的精神才能保持高质量的服务。

Abstract Labratory standardization and quality assurance are complementary concepts for improving health laboratory services.Standardization includes the specification of methods and processes and their approvement by an official body and the provision of officially recognized reference materials. Reference materials are established according to the accuracy concept or consensus concept.Good analytical practice cannot be guaranted by standardization only,but it should be ensured by quality assurance,that is by systematic actions to provide adequate confidence that the laboratory service will meet the expectations of the user,Such actions include internal quality control and external quality assessment.While the actions may be introduced by regulatory and administrative means the high quality of service will be maintained by the consciousness and motivation of the staff and a spirit towards good working practice.