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Working Regulation for Formulation and Publication of Standards

【Release time】:Jun,19th,2014    【Source】:WFCMS Secretariat

Foreword.. 8
Introduction.. 10
1 Scope.. 12
2 Structure and Responsibilities of Technical Organization.. 13
2.1 Department of International Standardization (DIS) of WFCMS. 13
2.2 Standardization Construction Committee (SCC)13
2.3 Technical Committee (TC) and Professional Standard Inspecting Committee (PSIC)13
2.4 Working Group(WG)14
2.5 Member. 14
3 Formulation and Publication Procedures. 15
3.1 Formulating Development Plan.. 15
3.2 New Proposal (NP)15
3.3 Project Acceptance. 16
3.4 Launching Preparation.. 16
3.5 Preparation of Draft Document. 17
3.6 Procedure of Approval. 18
3.7 Publication.. 18
3.8 Revision.. 18
 
Foreword
This Regulation describes the technical procedures for the formulation and publication for World Federation of Chinese Medicine Societies (WFCMS) standard.
The standard was proposed by and under the jurisdiction of WFCMS.
The standard was drafted by the Secretariat of the World Federation of Chinese Medicine Societies.
Chief author: Li Zhenji
Co-authors:
The People’s Republic of China:He Xingdong, Jiang Zaizeng, Deng Liangyue, Fang Shuting, Shi Baoquan, Zhang Lin, Huang Jianyin, Xu Chunbo, Guo Chen’guang, Wang Guanying, Wang Jinyu, Wang Yiyi, Wang Kui, Zhu Xiaolei, Zhang Xiangyong, Guan Tao, Li Hebai, Qin Shukun, Gong Shuqin, He Suqing, Wang Yafeng, Chen Lixin, Wang Bingqi
Singapore: Teo Eng Kiat
The United States of America: Tian Xiaoming, David Molony, Angela Tu Ying
Canada: Steven K.H. Aung
The Kingdom of Netherlands: Dong Zhilin
The United Kingdom of Great Britain and Northern Ireland: Manfong Mei
Portugal: Pedro Choy
Austria: Andreas Bayer
Italy: Carlo Maria Giovanardi
Australia: Tzi Chiang Lin
Spain: Ramon Maria Calduch
Introduction
Standardization is a strategic choice for enhancing modernization of Chinese Medicine. It is WFCMS’ core commissions to study, formulate, promulgate and promote International Organizational Standards of Chinese Medicine, which is urgently needed in the international information communication, medical service, talent cultivation, scientific research, management regulation.
International standard, in broad sense, includes standards formulated by international standardization organizations like ISOITU, international organizational standards formulated by standardization-related international organizations, and standards formulated by regional standardization institutions. Whereas, in narrow sense, International standard indicates ISOITU standards and those of other international organizations which are recognized and promulgated on the standard list of ISO. WFCMS standard belongs to international organizational standard.
In order to standardize the work of formulation and publication of International Organizational Standards of Chinese Medicine, an International Standardization Conference of Chinese Medicine was held during the WFCMS Establishment Congress. The proposal of formulating Working Regulation for Formulation and Publication of Standard was raised by representatives from WFCMS member societies. Afterwards, with reference to Procedures for the Technical Work of ISO/IEC Directives, the secretariat drafted the regulation on the principle of high quality, scientificity, objectivity, fairness, impartiality. Simplification and revision was made to the Procedures for the technical work of ISO/IEC Directives so as to comply with the characteristic of international standardization of Chinese Medicine and that of our organization. Eventually, a tryout version took into form after a series of discussion on Chairpersons’ Meeting and Council Board Meeting, during which extensive solicitation of opinions was made. The tryout version was released on WFCMS website in 2006 and served as a ground for standardization work of WFCMS.
Under the guidance of the tryout regulation, the International Standard Chinese-English Basic Nomenclature of Chinese Medicine was formulated and promulgated, and several first working drafts, committee drafts, final draft standards were prepared. During the process of formulating international organizational standard of Chinese Medicine, WFCMS perfected the organization structure of standardization with its Standardization Construction Committee officially registered in State Administration of TCM and Civil Affair Ministry, PRC., and have its technical organizational structure and responsibilities defined. With the commbination of Chinese Medicine characteristics and general rules of international standard formulation, the accumulation of precious experiences, and the command of working procedures of international standardization, WFCMS officially promulgates the regulation as a standard making amendments to the tryout version.
 1 Scope
This Regulation describes the technical procedures for formulation and publication of International Organizational Standards of Chinese Medicine (IOSCM).
This Regulation is applicable to formulation and publication for WFCMS standard.
2 Structure and Responsibilities of Technical Organization
As the consultive and decision-making organ of WFCMS, the major responsibilities of Standardization Construction Committee lie in the following areas: conducting scientific research, carrying out academic exchange, reasoning and examining draft of administrative and programming standard on commission, drafting comprehensive standard, cultivating professionals on standardization construction, studying the promotion strategy for international standardization, and raising suggestion on formulation, revision, publication and promotion of international organizational standards. The working fruits are submitted to the Department of International Standardization in forms of suggestion, research report, examining report, and final draft Standard.