Management and Development of Health-related Standards in Nations and Organizations: An Evidence-based Review

HE Hongfeng; TIAN Qiannan; ZHOU Qi; ZHAO Junxian; SU Renfeng; LI Zhewei; LIU Hui; YANG Nan; CHEN Yaolong; WU Liqun; WANG Xiaohui

doi:10.12290/xhyxzz.2023-0449

Volume 15 Issue 1

Jan. 2024

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Medical Journal of Peking Union Medical College Hospital > 2024 > 15(1): 202-210. > DOI: 10.12290/xhyxzz.2023-0449

HE Hongfeng, TIAN Qiannan, ZHOU Qi, ZHAO Junxian, SU Renfeng, LI Zhewei, LIU Hui, YANG Nan, CHEN Yaolong, WU Liqun, WANG Xiaohui. Management and Development of Health-related Standards in Nations and Organizations: An Evidence-based Review[J]. Medical Journal of Peking Union Medical College Hospital, 2024, 15(1): 202-210. DOI: 10.12290/xhyxzz.2023-0449

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Management and Development of Health-related Standards in Nations and Organizations: An Evidence-based Review

HE Hongfeng¹,
TIAN Qiannan³,
ZHOU Qi²,
ZHAO Junxian¹,
SU Renfeng¹,
LI Zhewei¹,
LIU Hui²,
YANG Nan³,
CHEN Yaolong^{1, 2, 4, 5, 6},
WU Liqun^3, ,,
WANG Xiaohui^1, ,

1.
School of Public Health, Lanzhou University, Lanzhou 730000, China
2.
Evidence-based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China
3.
Shenzhen Health Development Research and Data Management Center, Shenzhen 518028, China
4.
Research Unit of Evidence-based Evaluation and Guidelines, Chinese Academy of Medical Sciences, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China
5.
WHO Collaborating Center for Guideline Implementation and Knowledge Translation, Lanzhou 730000, China
6.
Institute of Health Data Science, Lanzhou University, Lanzhou 730000, China

Funds:

Sanming Project of Medicine in Shenzhen SZSM202111001

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Corresponding author:
WU Liqun, E-mail: 57128241@qq.com

WANG Xiaohui, E-mail: wangxiaohui@lzu.edu.cn
Received Date: September 22, 2023
Accepted Date: November 28, 2023
Available Online: December 12, 2023
Issue Publish Date: January 29, 2024

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Objective To promote the development of high-quality health standards in China and summarize the characteristics of global health standards management systems and development processes.
Methods We conducted a systematic search of relevant databases and the websites of standardization institutions. A descriptive method was used to analyze the basic characteristics of the standard management systems and development processes.
Results The majority of the investigated countries and organizations primarily implement voluntary standards, with the exception of Chinese and the European Committee for Standardization that enforce compulsory standards. All countries and organizations have health standards at the national, group, and enterprise levels. In China and Japan, standards authorities are subordinate to the government, while in other countries or organizations, they operate as independent civil societies. The development process for health standards generally involves five stages: "Project/Proposal → Draft → Enquiry → Review → Publication". However, the specific steps in the development of health standards vary across different countries and organizations. Furthermore, China ranks high in the number of both standards and health standards issued, but the proportion of health standards is only 2.06%.
Conclusions There are significant differences between China and other countries in terms of the management system and development process of health standards. To promote the management and development of high-quality health standards in China, we recommend promoting the coordination mechanism for standard development, increasing efforts to publicize standards and evaluate the implementation effect, strengthening the construction of personnel for the development of health standards, optimizing the efficiency of standard development and improving the internationalization level of health standards.
- hygiene and health standards,
- standard system,
- standard development,
- scoping review

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[1]	中华人民共和国国家卫生健康委员会. 国家卫生健康委关于印发"十四五"卫生健康标准化工作规划的通知[EB/OL]. (2022-01-11)[2023-08-31]. http://www.gov.cn/zhengce/zhengceku/2022-01/27/content_5670684.htm. National Health Commission of the People's Republic of China. Notice of the national health commission on issuing the 14th Five Year Plan for health standardization work[EB/OL]. (2022-01-11)[2023-08-31]. http://www.gov.cn/zhengce/zhengceku/2022-01/27/content_5670684.htm.
[2]	全国标准信息公共服务平台[DB/OL]. [2023-08-31]. https://std.samr.gov.cn/. National standard information public service platform[DB/OL]. [2023-08-31]. https://std.samr.gov.cn/.
[3]	中华人民共和国国务院办公厅. 国务院办公厅关于印发"十四五"国民健康规划的通知[EB/OL]. (2022-05-20)[2023-08-31]. http://www.gov.cn/zhengce/content/2022-05/20/content_5691424.htm. General Office of the State Council of the People's Republic of China. Notice of the General Office of the State Council on issuing the national health plan for the 14th Five Year Plan[EB/OL]. (2022-05-20)[2023-08-31]. http://www.gov.cn/zhengce/content/2022-05/20/content_5691424.htm.
[4]	李俊, 王强, 黄超, 等. 对我国医疗卫生标准工作的思考[J]. 中国卫生标准管理, 2020, 11(7): 4-7. DOI: 10.3969/j.issn.1674-9316.2020.07.002 Li J, Wang Q, Huang C, et al. Thoughts on the work of medical and health standards in China[J]. Chin Health Stand Manag, 2020, 11(7): 4-7. DOI: 10.3969/j.issn.1674-9316.2020.07.002
[5]	刘苏苏, 茅宁莹. 江苏省卫生地方标准工作现状分析[J]. 中国卫生质量管理, 2021, 28(7): 22-24. Liu S S, Mao N Y. Status analysis of health local standards in Jiangsu province[J]. Chin Health Qual Manag, 2021, 28(7): 22-24.
[6]	吕兰婷, 张子墨. 我国医疗卫生标准管理的现状研究[J]. 中国卫生事业管理, 2019, 36(4): 258-260. Lyu L T, Zhang Z M. Studying on the status of medical and health standard management in China[J]. Chin Health Serv Manag, 2019, 36(4): 258-260.
[7]	吴士勇, 李岳峰. 国内外卫生健康信息标准管理机制比较分析[J]. 中国卫生信息管理杂志, 2021, 18(1): 41-49. Wu S Y, Li Y F. Comparative analysis of management mechanism of health information standard at home and abroad[J]. Chin J Health Inform Manag, 2021, 18(1): 41-49.
[8]	郑和辉, 程义斌. 发达国家团体标准体系对我国卫生标准化建设的启示[J]. 环境卫生学杂志, 2020, 10(5): 486-489. Zheng H H, Cheng Y B. Implication for construction of Chinese health standardization system based on group standard system in developed countries[J]. J Environ Hyg, 2020, 10(5): 486-489.
[9]	黄超, 孔东池, 程书栋, 等. 国内外对标准定义和类型的比较和思考[J]. 中国卫生标准管理, 2020, 11(7): 1-3. DOI: 10.3969/j.issn.1674-9316.2020.07.001 Huang C, Kong D C, Cheng S D, et al. Comparison and reflection on the definition and types of standard at home and abroad[J]. Chin Health Stand Manag, 2020, 11(7): 1-3. DOI: 10.3969/j.issn.1674-9316.2020.07.001
[10]	杨辉. 美国标准化管理体制对我国的启示[J]. 世界贸易组织动态与研究, 2006(5): 37-39. Yang H. To gain the enlightenment from American adminis-trative system of standardization[J]. J Shanghai Univer Inter Bus Econom, 2006(5): 37-39.
[11]	廖丽, 程虹, 刘芸. 美国标准化管理体制及对中国的借鉴[J]. 管理学报, 2013, 10(12): 1805-1809. Liao L, Cheng H, Liu Y. United States standardization system and its references giving for China[J]. Chin J Manag, 2013, 10(12): 1805-1809.
[12]	国内外环境卫生标准体系研究[J]. 中国卫生标准管理, 2013, 4(增刊7): 36-41. Research on the environmental hygiene standard system at home and abroad[J]. Chin Health Stand Manag, 2013, 4(S7): 36-41.
[13]	孙乃玲, 郑彬, 余宁乐, 等. 国内外公共卫生领域标准化工作管理体制比较与思考[J]. 中华流行病学杂志, 2021, 42(5): 928-934. DOI: 10.3760/cma.j.cn112338-20201231-01456 Sun N L, Zheng B, Yu N L, et al. Comparison and reflection of standardization of public health management system both at home and abroad[J]. Chin J Epidem, 2021, 42(5): 928-934. DOI: 10.3760/cma.j.cn112338-20201231-01456
[14]	中华人民共和国国家卫生健康委员会. 国家卫生健康委关于印发卫生健康标准管理办法的通知[EB/OL]. (2019-07-04)[2023-08-31]. http://www.nhc.gov.cn/fzs/s3581p/201907/429b93973e0145888a4860c9658ac482.shtml. National Health Commission of the People's Republic of China. Notice of the National Health Commission on issuing the management measures for health standards[EB/OL]. (2019-07-04)[2023-08-31]. http://www.nhc.gov.cn/fzs/s3581p/201907/429b93973e0145888a4860c9658ac482.shtml.
[15]	全国人民代表大会. 中华人民共和国标准化法[EB/OL]. (2017-11-04)[2023-08-31]. http://www.npc.gov.cn/npc/c2/c30834/201905/t20190521_278360.html.
[16]	吴焱, 王文君, 聂婕, 等. 澳大利亚标准国际化工作探析[J]. 标准科学, 2022(9): 105-110. Wu Y, Wang W J, Nie J, et al. Analysis of the internationalization of Australian standards[J]. Stand Sci, 2022(9): 105-110.
[17]	张彦, 刘春青. 澳大利亚标准化管理体制机制研究[J]. 标准科学, 2018(4): 24-29. Zhang Y, Liu C Q. Analysis of Australian standardization management mechanism[J]. Stand Sci, 2018(4): 24-29.
[18]	Standards Australia. Standards development process[EB/OL]. (2023-02-12)[2023-08-31]. https://www.standards.org.au/standards-development/developing-standards/process.
[19]	Standards Australia. Standardisation guide 001: preparing standards[EB/OL]. (2023-06-25)[2023-08-31]. https://www.standards.org.au/getmedia/180f17a5-dc80-40d4-a2a8-2eab138cef0c/SG-001-Preparing-Standards.pdf.aspx.
[20]	郭鶱, 刘晶, 肖承翔, 等. 国内外标准化组织体系对比分析及思考[J]. 中国标准化, 2016(2): 51-57. Guo X, Liu J, Xiao C X, et al. Comparative analysis on the domestic and International Standardization Organization systems[J]. Chin Stand, 2016(2): 51-57.
[21]	DIN Deutsches Institut für Normung e. V. A brief introduc-tion to standards[EB/OL]. [2023-08-31]. https://www.din.de/en/about-standards/a-brief-introduction-to-standards.
[22]	DIN Deutsches Institut für Normung e. V. DIN German institute for standardization Berlin[EB/OL]. [2023-08-31]. https://www.din.de/resource/blob/66170/0ad27759be047557cf7654e1f4df824d/din-satzung-en-data.pdf.
[23]	刘辉, 王益谊, 付强. 美国自愿性标准体系评析[J]. 中国标准化, 2014(3): 83-86. Liu H, Wang Y Y, Fu Q. Analysis of America's voluntary standards system[J]. Chin Stand, 2014(3): 83-86.
[24]	杨辉. 发达国家标准化管理体制对我国的启示[J]. 机械工业标准化与质量, 2005(5): 9-11. Yang H. Drawing great inspiration from the standardization management system of developed countries[J]. Jixie Gongye Biaozhunhua Yu Zhiliang, 2005(5): 9-11.
[25]	American National Standards Institute. American National Standards (ANS) introduction[EB/OL]. (2023-11-20)[2023-08-31]. https://www.ansi.org/american-national-standards/ans-introduction/overview.
[26]	American National Standards Institute. ANSI essential requirements: due process requirements for American National Standards[EB/OL]. [2023-08-31]. https://share.ansi.org/Shared%20Documents/About%20ANSI/Current_Ver-sions_Proc_Docs_for_Website/ER_Pro_current.pdf.
[27]	黄灿艺. 日本标准化管理体制对我国的启示[J]. 山东纺织经济, 2009(4): 96-97. Huang C Y. The inspiration of Japanese standardization management system for our country[J]. Shandong Textil Econom, 2009(4): 96-97.
[28]	杨安怀. 日本标准化制度的发展变化及给我们的启示[J]. 现代日本经济, 2005(1): 17-22. Yang A H. The history of Japan's standardization system and its enlightenment for China[J]. Xiandai Riben Jingji, 2005(1): 17-22.
[29]	李佳, 王益谊. 日本标准化体制机制研究[J]. 标准科学, 2021(1): 142-147. Li J, Wang Y Y. Study on the institutional mechanism of standardization in Japan[J]. Stand Sci, 2021(1): 142-147.
[30]	许柏, 杜东博, 刘晶, 等. 日本标准化战略发展历程与最新进展[J]. 标准科学, 2018(10): 6-10. Xu B, Du D B, Liu J, et al. Development history and latest progress of Japan standardization strategy[J]. Stand Sci, 2018(10): 6-10.
[31]	Japanese Industrial Standards Committee. Flowchart of JIS development[EB/OL]. (2022-03-27)[2023-08-31]. https://www.jisc.go.jp/eng/jis-act/flow-dev.html.
[32]	Japanese Standards Association. Reserach and development[EB/OL]. [2023-08-31]. https://www.jsa.or.jp/en/en_about02/.
[33]	British Standards Institution. A standard for standards-principles of standardization: BS 0: 2011[S]. London: BSI, 2011.
[34]	British Standards Institution. Beginner's guide to standards[M/OL]. (2023-02-04)[2023-08-31]. https://www.bsigroup.com/en-GB/standards/explore-standards/the-power-of-standards/beginners-guide-to-standards/.
[35]	CEN-CENELEC. European standards[EB/OL]. [2023-08-31]. https://www.cencenelec.eu/european-standardization/european-standards/.
[36]	European Commission. Standardisation requests[EB/OL]. [2023-08-31]. https://single-market-economy.ec.europa.eu/single-market/european-standards/standardisation-requests_en.
[37]	董文芳. ISO(国际标准化组织)标准制定简介[J]. 广东橡胶, 2018(11): 25-29. Dong W F. Introduction to the development of ISO (International Organization for Standardization) standards[J]. Guangdong Rubber, 2018(11): 25-29.
[38]	方祖梅, 吴路易. 国际标准制定过程简述[J]. 福建质量技术监督, 2015(7): 60-61. Fang Z M, Wu L Y. Overview of the process of developing international standards[J]. Fujian Zhiliang Jishu Jiandu, 2015(7): 60-61.
[39]	International Organization for Standardization. Guidance on new work[M]. Geneva: IOS, 2019.
[40]	庞亚男, 郑彬. 我国卫生标准与世界卫生组织指南制定与管理的对比[J]. 中国卫生标准管理, 2018, 9(9): 5-10. Pang Y N, Zheng B. Comparison between the formulation and management of China's health standards and WHO guidelines[J]. Chin Health Stand Manag, 2018, 9(9): 5-10.
[41]	World Health Organization. About us[EB/OL]. [2023-07-31]. https://www.who.int/groups/guidelines-review-committee/about.
[42]	World Health Organization. WHO guidelines[EB/OL]. [2023-03-01]. https://www.who.int/publications/who-guidelines.
[43]	中国共产党中央委员会, 中华人民共和国国务院. 中共中央国务院印发《国家标准化发展纲要》[EB/OL]. (2021-10-10)[2023-08-31]. http://www.gov.cn/zhengce/2021-10/10/content_5641727.htm. Central Committee of the CPC, State Council of the PRC. The Central Committee of the Communist Party of China and the State Council have issued the National Standardization Development Outline[EB/OL]. (2021-10-10)[2023-08-31]. http://www.gov.cn/zhengce/2021-10/10/content_5641727.htm.
[44]	高建华, 于建平, 苏宁. 我国卫生健康相关标准现状与分析[C]//第十六届中国标准化论坛论文集. 北京: 中国标准化协会, 2019: 657-662. Gao J H, Yu J P, Su N. Current situation and analysis of health and hygiene related standards in China[C]//Proceedings of the 16th China Standardization Forum. Beijing: China Association for Standardization, 2019: 657-662.
[45]	高建华, 于建平, 苏宁, 等. 基于标准信息服务平台的我国卫生健康相关标准分析[J]. 首都公共卫生, 2020, 14(1): 40-42. Gao J H, Yu J P, Su N, et al. Analysis on the current status of health standards based on service platform for standards information in China[J]. Capital J Public Health, 2020, 14(1): 40-42.
[46]	徐佳南. 我国卫生健康标准制修订管理现状研究[J]. 江苏卫生事业管理, 2020, 31(9): 1116-1118. Xu J N. A study on the current situation of revision and management of health standards in China[J]. Jiangsu Healthc Administ, 2020, 31(9): 1116-1118.
[47]	中国国家标准化管理委员会. 中国标准化发展年度报告(2022年)[EB/OL]. (2023-04-25)[2023-08-31]. https://www.sac.gov.cn/xw/bzhdt/art/2023/art_af1d9fd607e14496b216587fee4ec4c0.html. Standardization Administration of China. Annual report on standardization development in China (2022)[EB/OL]. (2023-04-25)[2023-08-31]. https://www.sac.gov.cn/xw/bzhdt/art/2023/art_af1d9fd607e14496b216587fee4ec4c0.html.

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