引入质量管理体系 提高技术监测能力

为提高技术监测能力，建立以顾客为关注焦点的科学、高效的北京市药品安全性信息监测与服务体系，北京市药品不良反应监测中心引入了ISO9001质量管理体系。该体系提出了明确的管理方针与质量控制目标，制定了8个程序文件、19个工作规范与技术标准及16项管理制度，并由此派生出13个产品。通过质量认证工作与药品安全性监管工作的结合，强化了药／械安全性信息服务的管理，规范了监测行为，提高了监测能力，为深入开展药／械安全性监管工作打下了基础。

The Application of ISO9001 Quality Management System to Improve the Technical Ability for ADR Monitoring

In order to improve the technical ability for ADR monitoring, Beijing Center for ADR Monitoring applied the ISO9001 Quality Management System to establish a scientific and efficient quality management system which focused On customer＇s COncerns. Quality policies and 0bjectives have been estab-lished, which serve as the basis for 8 procedure documentations, 19 practice criterions, 16 regulations and 13 productions. All of these policies and procedures have Strengthened the management of drug safety monitoring system and improved the technical ability.