ISO10012测量管理体系及在医疗测量设备管理中的应用

介绍ISO10012标准,及其在医院内测量设备管理中的应用.     

医院推行ISO9000族标准的三个关键点

结合医疗行业特点,在医院推行ISO9000族标准的过程中,明确了对质量管理体系的认识定位,确立了医院、职能科室及业务科室的目标确立、体系策划、文件培训、质量考核、经济奖惩过程,建立了文件的分层次管理模式,确保相关过程质量,这对于即将引入和正在引入ISO9000标准的医院具有一定的参考意义.     

ISO 9001可能给医院带来什么

面临日益激烈的市场竞争,如何立足医疗质量,提高综合竞争力,是医疗机构不断探索、实践的重头戏.ISO 9000族质量管理体系标准的引进,提出了一个经营性的质量观,为与医疗改革配套的医院质量管理提供了一个崭新的思路、一个有较强操作性的方法.     

ISO9001:2000质量管理体系在医院管理中的实践

在推行ISO9001：2000质量管理体系过程中我们注重把握以患者为关注焦点,强调领导的质量职责,把服务与资源作为过程管理,进行持续改进,给医院的管理注入了新的活力.     

ISO9001过程方法在规范药品效期管理中的应用

运用ISO9001过程方法对药品效期管理进行描述和管理，达到规范药品效期管理的目的，结果表明ISO9001可规范药品效期管理，减少药品损耗，保障患者用药安全。     

药品审评检查机构质量管理体系建设实践探索

目的:贯彻国务院强化质量管理、落实全国药监部门完善自身质量管理体系工作部署,梳理山东省药品审评检查机构质量管理体系建设情况,总结经验、查找不足,加强审评检查质量管理。方法:调研药品审评检查机构导入质量管理体系的现实意义,剖析山东省药品审评检查机构质量管理体系建设的实践经验,思考存在的问题。结果:行之有效的质量管理体系对药品审评检查机构规范化建设和药品审评检查发展起到了积极的推动作用。结论:药品审评检查机构推进质量管理体系建设,对规范自身建设、提高工作质量、降低业务风险、服务医药产业发展具有重要作用,也是必然要求,药品审评检查机构质量管理体系需要持续改进,逐渐与国际接轨。     

Gentamicin and leucine inhalable powder: What about antipseudomonal activity and permeation through cystic fibrosis mucus?

The aim of this study was to evaluate the permeation properties of gentamicin (G) in a novel dry powder form for inhalation through an artificial mucus model. Moreover, since respiratory infections sustained by Pseudomonas are a major cause of sickness and death in CF patients, the susceptibility of P. aeruginosa to engineered G powders was investigated.     

Chemical,physical, and in vitro characterization of research cigarettes containing denicotinized tobacco

The use of very low nicotine tobacco cigarettes is currently being investigated as a possible harm reduction strategy. Here, we report the smoke chemistry, toxicity, and physical characteristics of very low nicotine cigarettes that were made using blended tobacco processed through a supercritical CO₂ fluid extraction, which resulted in elimination of 96% of nicotine content (denicotinized (denic) tobacco). Three types of test cigarettes (TCs) were manufactured with tobacco filler containing 100% denic tobacco (TC100), 50% denic tobacco and 50% unextracted tobacco (TC50/50), and 100% unextracted tobacco (TC0). Mainstream smoke (MS) was generated for measurement of 46 analytes and cytotoxicity and mutagenicity determination. Analysis of physical characteristics of TCs demonstrated they were well made with <5% variability among cigarettes for most parameters measured. We observed significant changes in the levels of smoke constituents, including decreases in formaldehyde, nitrosamines, and phenol, and increases in aliphatic hydrocarbons, aliphatic nitrogen compounds, aromatic amines, halogen compounds, and metals. Use of denic tobacco resulted in changes in the chemical composition of MS, but these changes did not modify biological activity as measured in the mutagenicity and cytotoxicity assays.     

浅析ISO/IEC17025:2005

2005年5月15日,国际标准化组织(ISO)和国际电工委员会(IEC)联合发布了ISO/IEC17025:2005《检测和校准实验室能力的通用要求》,取代ISO/IEC17025:1999.CNAL依据等同采用ISO/IEC17025:2005原则,于2005年9月1日正式颁布实施《检测和校准实验室认可准则》(CNAL/AC01:2005),取代CNAL/AC01:2003《检测和校准实验室认可准则》(等同ISO/IEC17025:1999).