微生物检验实验室文件控制研究
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摘要
目的深入调研文件控制的管理现状。方法分析实验室在文件的理解、获取和执行方面存在的问题,结合工作实际,查阅文件管理方面的文献,采取分类管理、文件跟踪等措施,增强文件的执行力。结果分析对比现有标准对于文件控制的相关条款,总结了相关著作对于文件控制的理解和做法;结合档案管理的理论,对于文件控制提出一种设想。结论提出了使用分类标记、跟踪监督促的方法促进文件控制的管理工作。
Objective To deeply investigate the current state of management of document control. Methods The problems of laboratory document about understanding, acquisition and execution were analyzed. Combining the application of actual work and consulting literature about document management, the execution of document was enhanced according to classified management and trace file and so on. Results Through the analysis and contrast of relevant terms in the current standard, the experience of document control in literature was summarized. Base on the theory of archives management, an idea of document control was put forward.Conclusion The use of classification management and tracking supervision to promote the management of document control is proposed.
Objective To deeply investigate the current state of management of document control. Methods The problems of laboratory document about understanding, acquisition and execution were analyzed. Combining the application of actual work and consulting literature about document management, the execution of document was enhanced according to classified management and trace file and so on. Results Through the analysis and contrast of relevant terms in the current standard, the experience of document control in literature was summarized. Base on the theory of archives management, an idea of document control was put forward.Conclusion The use of classification management and tracking supervision to promote the management of document control is proposed.
引文
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[3]郝凤,王毓芳.质量管理体系文件编写与运行参考[M].北京:中国计量出版社,2002.Hao F,Wang YF.Quality management system documentation and operation reference[M].Beijing:China Metrology Publishing House,2002.
[4]中国实验室国家认可委员会组.中国实验室注册评审员培训教程[M].北京:中国计量出版社,1997.China Laboratory National Accreditation Committee.China laboratory registration reviewer training course[M].Beijing:China Metrology Publishing House,1997.
[5]GB/T 19023-2003质量管理体系文件指南[S].GB/T 19023-2003 Guidelines for quality management system documentation[S].
[6]雷质文.食品微生物实验室质量管理手册(第二版)[M].北京:中国标准出版社,2018.Lei ZW.Food microbiology laboratory quality management manual 2nd Ed[M].Beijing:China Standard Press,1997.
[7]刘卓慧.实验室资质认定工作指南第1版[M].北京:中国计量出版社,2006.Liu ZH.Laboratory qualification certification work guide 1st Ed[M].Beijing:China Metrology Publishing House,2006.
[8]GB/T 27405-2008实验室质量控制规范食品微生物检测[S].GB/T 27405-2008 Criterion on quality control of laboratoriesMicrobiological testing of food[S].
[9]ISO/IEC 17025-2005检测和校准实验室的能力的通用要求[S].ISO/IEC 17025-2005 Accreditation criteria for the competence of testing and calibration laboratories[S].
[10]GB/T 19001-2016质量管理体系要求[S].GB/T 19001-2016 Quality management systems-Requirements[S].
[11]黎淦平,刘宜仲,刘永梅.“两个规范”与ISO9001:2008及ISO/IEC17025:2005质量管理体系的融合[J].中国卫生质量管理,2014,21(1):94-96.Li JP,Liu YZ,Liu YM.Integration of ISO9001:2008 and ISO/IEC17025:2005 Quality management systems and the"Two Stander"[J].Chin Health Qual Manag,2014,21(1):94-96.
[12]韩文芳.浅析ISO17025与ISO9001标准的联系和区别[J].市场周刊(理论研究),2013,(5):141-142,49.Han WF.Analysis of the connection and difference between ISO17025 and ISO 9001 standard[J].Market Wkly(Theor Res),2013,(5):141-142,49.
[13]鄢国强.ISO/IEC 17025:2017条款阐释[EB/OL].http://www.gqyan.com/files/201805092017.pdf.2018-07-19.Yan GQ.ISO/IEC 17025:2017 Terms Interpretation[EB/OL].http://www.gqyan.com/files/201805092017.pdf.2018-07-19.
[14]雷质文.食品微生物实验室质量管理手册[M].北京:中国标准出版社,2006.Lei ZW.Food microbiology laboratory quality management manual[M].Beijing:China Standard Press,2006.
[15]FDA.CFSAN Laboratory quality manual,3th Ed[M].2009.
[16]World Health Organization.Document control[EB/OL].https://www.who.int/ihr/training/laboratory_quality/Ap24_Doc_control.doc?ua=1.2015-08-13.
[17]俞君立,陈树年.文献分类学[M].武汉:武汉大学出版社,2001.Yu JL,Chen SN.Document taxonomy[M].Wuhan:Wuhan University Press,2001.
[18]邓绍兴,陈智为.档案管理学[M].北京:北京师范大学出版社,1990.Deng SX.Chen ZW.Archive management[M].Beijing:Beijing Normal University Press,1990.
[19]黎海生,胡大春,赵晓丽,等.临床实验室质量管理体系文件的控制实践[J].国际检验医学杂志,2016,37(16):2352-2354.Li HS,Hu DC,Zhao XL,et al.Control practice of clinical laboratory quality management system documents[J].Int J Lab Med,2016,37(16):2352-2354.
[20]中国食品药品检定研究院起草组.药品质量控制实验室质量管理规范(征求意见稿)[EB/OL].http://www.nifdc.org.cn/directory/web/WS02/images/1365734660083.pdf.Drafting Group of China Food and Drug Control Research Institute.Quality control standards for pharmaceutical quality control laboratories(draft for comment)[EB/OL].http://www.nifdc.org.cn/directory/web/WS02/images/1365734660083.pdf.
[21]GB/T 7072-2002信息分类和编码的基本原则与方法[S].GB/T 7072-2002 Basic principles and methods for information classifying and coding[S].
[22]焦红艳,安小米.文件管理国际标准ISO15489的内容及特点[J].中国档案,2002,(12):37-38.Jiao HY,An XM.Content and characteristics of ISO15489[J].China Arch,2002,(12):37-38.
[23]王卓.CNAS-CL01中“记录的控制”要素的理解和实施[J].中国计量,2017,(1):56-59,110.Wang Z.Interpretation and practice about control of records in CNAS-CL01[J].China Metrol,2017,(1):56-59,110.
[24]王娜,张勤,田晓苇.实验室认可制度下体系文件档案的管理[J].中国检验检测,2019,27(1):43-46.Wang N,Zhang Q,Tian XW.The management of system files under laboratory accreditation system[J].China Insp Body Lab,2019,27(1):43-46.
[25]肖镜,王青,陈旻,等.药品检验机构实验室文件控制的研究[J].中国卫生质量管理,2016,23(2):76-79.Xiao J,Wang Q,Chen M,et al.Laboratory document control in pharmaceutical inspection institutions[J].Chin Health Qual Manag,2016,23(2):76-79.
[26]田丽娜,彭靖,夏静,等.食品检测企业基于质量体系的文件管理浅谈[J].现代食品,2018,(11):5-8.Tian LN,Pen J,Xia J,et al.Document management of food inspection enterprises based on quality system[J].Mod Food,2018,(11):5-8.
[27]程红革,韦汝珍,陈晓丽,等.医学实验室质量管理体系文件的控制[J].国际检验医学杂志,2014,35(4):507-509.Cheng HG,Wei RZ,Chen XL,et al.Quality management system documentation control in medical laboratory[J].Int J Lab Med,2014,35(4):507-509.
[28]周颖,张镝.论实验室管理体系文件的改进和控制[J].检验医学与临床,2008,(7):442-443.Zhou Y,Zhang D.Improvement and control of laboratory management system files[J].Lab Med Clin,2008,(7):442-443.
[29]唐宇,肖智.企业文件化信息流的管理与控制-文件控制中心的设立及其情报工作思考[J].图书情报工作,2010,54(S1):241-245,306.Tang Y,Xiao Z.Management and control of enterprise documented information flow-Thoughts on the Establishment of document control center and its intelligence work[J].Lib Inform Serv,2010,54(S1):241-245,306.
[30]陈惠,吴建明,吴昌永.实验室文件控制管理创新与实践[J].现代测量与实验室管理,2011,19(6):36-37.Chen H,Wu JM,Wu CY.Laboratory document control management innovation and practice[J].Adv Meas Lab Manag,2011,19(6):36-37.
[31]GB/T 14805-2007用于行政、商业和运输业电子数据交换的应用级语法规则[S].GB/T 14805-2007 Electronic data interchange for administration,commerce and transport(EDIFACT)-Application level syntax rules[S].
[32]World Health Organization.Laboratory quality management system:Handbook[Z].2011.
[33]GB/T 26162.1-2010信息与文献文件管理第1部分:通则[S].GB/T 26162.1-2010 Information and documentation-Records management-Part1:General[S].
[34]World Health Organization.Document management[EB/OL].[2015-08-13].https://www.who.int/ihr/training/laboratory_quality/Ap22_Doc_management.doc?ua=1.2015-08-13.
[35]Good Documentation Practice(GDP).Guideline[EB/OL].[2018-02-01].http://www.ipa-india.org/static-files/pdf/event/ipf2018-presentation22.pdf.2018-02-01.
[36]John WS.The laboratory quality assurance system:A manual of quality procedures and forms[M].Ratliff TA,2005.
[37]张莉,杨德忠,阮桂平,等.管理体系文件理解、获取和执行存在的问题及改进建议[J].中国药事,2018,32(12):1624-1627.Zhang L,Yang DZ,Ruan GP,et al.On the understanding acquisition and implementation of management system documents[J].Chin Pharm Affa,2018,32(12):1624-1627.
[38]Clinical and Laboratory Standards Institute.Laboratory documents:Development and control.Approved guideline,5th Ed[M].2006.
[39]DA/T 22-2015归档文件整理规则[S].DA/T 22-2015 The arrangement rule of archival documents[S].
[40]GB/T 27703-2011信息与文献图书馆和档案馆的文献保存要求[S].GB/T 27703-2011 Information and documentation-Document storage requirements for archive and library materials[S].
[41]WHO.Laboratory biosafety manual[EB/OL].http://apps.who.int/medicinedocs/s16535zh/s16535zh.pdf.
[42]CNAS-CL 09检测和校准实验室能力认可准则在微生物检测领域的应用说明[S].CNAS-CL 09 Guidance on the application of testing and calibration laboratory competence accreditation criteria in the field of microbiological testing[S].
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