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世界中医药学会联合会中医药机构评估办法
【发布时间】:2012-11-26         【来源】:本站

世界中医药学会联合会中医药机构评估办法

世界中联第三届第三次理事会讨论通过

第一章  总则


第一条 根据《世界中医药学会联合会章程》第二章第五条,世界中医药学会联合会(以下简称世界中联)开展中医药机构评估,旨在促进中医药机构的规范化管理,提高服务质量,保障消费者安全。
第二条 为明确世界中联中医药机构评估活动的范围、程序、方法等要求,特制定本办法。
第三条 本办法适用于世界中联依据相关标准及标准实施细则在世界中联会员单位范围内开展的中医药机构评估活动。

第二章  组织机构


第四条 世界中联中医药机构评估工作由世界中联秘书处组织实施。
第五条 世界中联秘书处可单独开展,或根据需要与有关国家或地区的权威机构合作开展评估工作。
第六条 世界中联秘书处职责:
(一) 严格按照世界中联发布的相关标准、标准实施细则及本办法开展评估工作;
(二) 筛选、审查合作机构的资质并监督其开展工作;
(三) 对世界中联聘请的评估人员及合作机构的评估人员进行资格审查和培训;
(四) 建立世界中联中医药机构评估专家库;
(五) 对有需求的申请参评机构进行培训和改进指导;
(六) 对评估证书和标牌的使用情况进行监督;
(七) 受理有关的申诉和投诉。
第七条 评估专家应具有长期从事中医药临床、质量管理、标准化等相关领域工作的经验,熟悉世界中联相关标准、标准实施细则、本办法和世界中联的相关规定。
第八条 评估中的现场评估阶段由从评估专家库中挑选出的评估专家组成现场评估小组完成。
第九条 现场评估小组的评估专家选择应充分考虑以下原则:
(一) 无利益相关:不应与申请参评机构有业务往来或其他利益相关。
(二) 专业互补:评估小组应由中医药临床、质量管理、标准化等不同专业背景的专家组成。

第三章  评估程序


第十条   世界中联中医药机构评估分为提交申请、文件评估、现场评估、颁发证书和标牌四个阶段。
第十一条   世界中联各国会员单位所属中医药机构可自愿向世界中联秘书处提交申请。申请机构应如实填写评估申请表,并按照评估申请表中的说明,提交相关的证明材料。
第十二条   提交申请阶段指自世界中联秘书处收到申请机构提交的《世界中医药学会联合会中医药机构评估申请表》开始,到申请机构收到世界中联秘书处反馈的受理意见的过程。
第十三条   文件评估阶段是指自世界中联秘书处受理评估申请,开始审核,完成文件评估报告,到申请机构收到世界中联秘书处正式反馈的文件审核意见的过程。
第十四条   在文件评估期间,世界中联秘书处可根据需要聘请相关专家协助文件评估。
第十五条   在文件评估期间,世界中联秘书处可根据需要向申请机构核实相关信息和文件,或要求申请机构提供相关补充材料。
第十六条   现场评估阶段指自世界中联秘书处向申请机构发出现场评估通知,到世界中联秘书处收到现场评估小组提交的评估报告的过程。
第十七条   现场评估小组应在规定的时间完成现场评估并向世界中联秘书处提交现场评估报告。评估报告应有明确的评估结论。评估结论分为达标、整改后达标或不达标。世界中联秘书处审查评估报告,并报由世界中联秘书长会讨论通过。
第十八条   现场评估结论为整改后达标的,申请机构应根据整改意见在规定时间内完成整改,并申请重新进行现场评估。
第十九条   颁发证书和标牌阶段指世界中联秘书处向世界中联秘书长会讨论通过评估的机构颁发世界中联中医药机构评估证书和标牌的过程。

第四章 通过评估资格的保持


第二十条   为保持通过评估的资格,通过评估的机构应接受年审和复审。年审为文件审核,通过评估的机构应按照要求提供相应文件,积极配合年审工作。复审每3年一次,由2-3名评估专家组成的复审评估小组实施现场复审。
第二十一条   年审或复审未通过者,应立即停止使用评估证书和标牌,并依照要求进行整改,直至通过。
第二十二条 通过评估的机构信息、年审及复审结果应及时在世界中联官方网站上公布。
第二十三条 通过评估的机构发生重大变化时,如停止营业、更换负责人、变更营业场所、较大幅度地变化管理流程等,应及时向世界中联世界中联秘书处提交书面的说明。

第五章  评估证书和标牌


第二十四条   世界中联中医药机构评估证书和标牌由世界中联世界中联秘书处负责设计、制作和颁发。其样式可根据各国家或地区的审美需要设计,设计风格应庄重、简洁、大方。
第二十五条 评估证书和标牌上应包含该机构的名称、地址、实施评估的机构的名称、依据的标准、适用范围、发证日期、有效时间和证书编码。
第二十六条 评估证书和标牌仅限在通过评估的机构内部、网站或非治疗效果宣传的相关宣传材料中使用。
第二十七条  评估证书和标牌仅表示经过世界中联组织的中医药机构评估,认为本机构符合世界中联相关标准的要求。世界中联对该机构提供的服务或产品的质量及安全性不作保证。
第二十八条 以下情况发生时,世界中联有权暂停或终止评估证书和标牌的使用权:
(一) 申请机构在评估过程中提供了不准确、不真实的信息;
(二) 通过评估的机构超时间、超范围或不恰当地使用评估证书和标牌;
(三) 通过评估的机构发生了重大变动,这些变动已经影响到了已通过的评估的适用性。

第六章  合作机制


第二十九条  世界中联秘书处可根据需要与相关机构合作,宣传、组织和实施评估工作。世界中联秘书处应严格审查合作机构资质的合法性和权威性。
第三十条   世界中联秘书处可与世界中联会员单位、各国中医药学会、协会及相关中医药团体等机构广泛合作开展中医药机构评估的宣传和组织工作。
第三十一条  世界中联秘书处可根据需要,在条件允许的情况下,与具有实施评估的能力、权威性和相关资质的,与被评估机构无利益相关的第三方机构合作实施评估。合作形式可为联合或委托:
联合的合作形式是指世界中联秘书处与相关机构联合开展评估,双方共同颁发评估证书。
委托的合作形式是指世界中联根据需要委托相关机构承担世界中联中医药机构评估工作的某个或某些环节。
第三十二条 合作机构应严格按照世界中联秘书处的授权范围开展工作。
第三十三条 合作实施评估的机构的职责:
(一) 按照世界中联的要求,真实、完整地提供本机构的信息;
(二) 严格按照世界中联相关标准、标准实施细则、本办法及世界中联的要求开展评估工作;
(三) 配合世界中联对本机构相关评估人员进行培训;
(四) 配合世界中联收集、整理所在国家或地区中医药医、教、研机构和从业人员发展情况和管理规范;
(五) 积极宣传世界中联中医药机构评估活动;
(六) 在世界中联指导下,对申请参评的机构进行培训和改进指导;
(七) 协助世界中联对评估证书和标牌的使用情况进行监督;
(八) 受理有关的申诉和投诉,并提出处理意见,及时向世界中联上报批准。

第七章 罚则

第三十四条 申请评估的机构提供的信息不准确、不真实,通过评估的机构未按照要求使用评估证书和标牌,或有重大变动时未及时向世界中联秘书处报告,将被暂停或终止使用评估证书和标牌。
第三十五条 合作机构未按照协议的约定履行其职责或超出协议约定的范围开展工作的,世界中联秘书处将暂停或终止与其的合作关系,并依法追究其相关责任。
第三十六条 参加评估的专家未严格按照世界中联相关标准、标准实施细则和本办法的要求开展工作,世界中联秘书处将取消其评估专家资格并追究相关责任。

第八章  其他事项


第三十七条 申请参评的机构应向世界中联缴纳评估费用。
第三十八条 世界中联秘书处负责制定世界中医药学会联合会中医药机构评估细则。
第三十九条  本办法及评估细则的解释权归世界中联。
第四十条  本办法自发布之日起开始实施。

世界中医药学会联合会
二〇一二年十一月二十日

Rules of Traditional Chinese Medicine Institutions Assessment

of World Federation of Chinese Medicine Societies

CHAPTER ONE  GENERAL RULES


Article 1. According to the Article 5, Chapter 2 of the constitution of World Federation of Chinese Medicine Societies, World Federation of Chinese Medicine Societies (WFCMS for short) conducts assessment of TCM institutions in order to advance the regulated management of institutions, to promote the service quality and to guarantee safety of consumers.
Article 2. The rules are formulated to define the scope, procedure, method, etc of TCM institutions of WFCMS.
Article 3. The rules are applied to the TCM institutions assessment which is conducted within member societies of WFCMS by relevant standards and regulation details for implementing the standards.

CHAPTER TWO  ORGANIZATION

Article 4. WFCMS assessment of TCM institutions is organized and implemented by the secretariat of WFCMS.
Article 5. The secretariat may conduct the assessment alone or together with relevant national or regional authorities according to practical need.
Article 6. Duties of the secretariat of WFCMS in the assessment are:
1. To conduct assessment by strictly observing relevant standards, regulation details for implementing the standards and the rules itself issued by WFCMS.
2. To screen cooperative institutions of WFCMS, to exam their qualification and to supervise their work.
3. To conduct qualification examination and provide trainings to staffs who are employed by WFCMS and who belong to cooperative institutions of WFCMS for the assessment.
4. To establish think tank of TCM institution assessment of WFCMS.
5. To provide training and instructions for improvement to institutions those apply for such assessment.
6. To supervise the utilization of assessment certificate and board.
7. To receive relevant appeals and complaints.
Article 7. Experts of the assessment shall have long-term experience in the fields like TCM clinical research, quality management, standardization, etc. They shall be familiar with relevant standards, regulation details for implementing the standards, the rules itself and relevant regulations of WFCMS.
Article 8. The assessment in the phase of scene assessment is to be implemented by a scene assessment team consisted of experts of assessment selected from the think tank.
Article 9. The selection of experts of assessment of the scene assessment team shall take full consideration of the principles below:
1. Not involved in business. Experts shall not be involved with TCM institutions to be assessed in business or other profitable aspects.
2. Complementarity of specialties. The scene assessment team shall be comprised of experts from different specialties, such as TCM clinical research, quality management and standardization.

CHAPTER THREE  THE PROCEDURE OF ASSESSMENT


Article 10. The assessment of TCM institution of WFCMS is divided into four phases: application submit, documents assessment, scene assessment and issue of certificate and board.
Article 11. TCM institutions affiliated with member societies of WFCMS may voluntarily submit application to the secretariat of WFCMS. Applying institutions shall complete application form practically and submit relevant credentials by the instruction in the application form.
Article 12. The phase of application submit indicates a period of time, started with the secretariat of WFCMS’ receiving ‘The Application Form for TCM Institutions Assessment of World Federation of Chinese Medicine Societies’ submitted by a applying institution, ended with the applying institutions’ receiving of the reply from the secretariat of WFCMS.
Article 13. The phase of documents assessment indicates a period of time, when the secretariat of WFCMS accepts the application for assessment, exams the application, produces a report of documents assessment, and then formally reply to the applying institution with the opinion on the document examination until the latter one receives the reply.
Article 14. In the period of documents assessment, the secretariat of WFCMS may employ relevant experts to assist the assessment according to practical need.
Article 15. In the period of documents assessment, the secretariat of WFCMS may verify relevant information and documents from the applying institution according to practical need, or ask for complementary materials from the applying institution.
Article 16. Scene assessment indicates a period of time, started with the secretariat of WFCMS’ sending notice of scene assessment to the applying institution, ended with the secretariat of WFCMS’ receiving the scene assessment report submitted by the scene assessment team.
Article 17. Scene assessment team shall complete scene assessment and submit a report of the scene assessment to the secretariat of WFCMS in due time. The report shall have a clear conclusion of the assessment and the conclusion is categorized into three: up to standard, up to standard through improvement and not up to standard. The secretariat of WFCMS exams the report and submits it to the meeting of secretary-generals of WFCMS for discussion and approval.
Article 18. Applying institution which is estimated as ‘up to standard through improvement’ shall complete the improvement according to opinions of improvement in due time and then apply for a new scene assessment.
Article 19.The phase of issue of certificate and board indicates a period of time when the secretariat of WFCMS issues the certificate and board of assessment of TCM institutions of WFCMS to institutions whose applications have passed the discussion in the meeting of secretary-generals of WFCMS.

CHAPTER FOUR  MAINTENANCE OF ASSESSED QUALIFICATION


Article 20. Institutions those have passed the assessment shall receive annual verification and re-verification regularly. Annual verification is to be carried out in the way of documents verification. Institutions shall provide required relevant documents and actively assist the annual verification. Re-verification is conducted once every three years and carried out in the way of scene verification by a re-verification team consisted of 2-3 assessment experts.
Article 21.The institutions those fail to pass the annual verification or re-verification shall be deprived of the right to use the assessment certificate and board immediately and conduct improvements according to requirement till they pass the verification.
Article22. The information, annual verification and re-verification results of institutions which pass TCM assessment shall be published on the official website of WFCMS as soon as possible.
Article 23. When institutions which have passed the assessment undergo major changes, such as closure of business, change of chiefs, change of location or major changes of managerial procedure, etc, they shall submit a written statement to the secretariat of WFCMS as soon as possible.


 CHAPTER FIVE  ASSESSMENT CERTIFICATE AND BOARD


Article 24.The design, manufacturing and awarding of the assessment certificate and board shall be conducted by the secretariat of WFCMS. Its pattern should be designed in accordance with sense of beauty of different countries and regions and the style should be serious, succinct and unaffected.
Article 25. Name and address of assessed institution, name of assessing institution, standards of invoking, application scope, date of issue, expiration and certificate code shall be included in the certificate and board of assessment.
Article 26. The assessment certificate and board shall only be used within the institution, on the website of the institution and in disseminating materials related to non-treatment efficacy dissemination.
Article 27. The issue of certificate and board only indicates that the institution has reached relevant standards of WFCMS after the TCM institution assessment organized by WFCMS. However, WFCMS does not guarantee the quality and security of service and products provided by the institution.
Article 28. In the following circumstances, WFCMS have the right to suspend or stop the right of using assessment certificate and board of assessed institutions:
1. Applying institutions provide inaccurate or untrue information in the period of assessment.
2. Institutions which have passed the assessment use the certificate and board beyond the period of expiration, beyond application scope or in an unappropriate way.
3. Institutions those have passed the assessment undergo major changes, which have affected the application of the assessment.


 CHAPTER SIX  COOPERATION MECHANISM


Article 29.The secretariat of WFCMS may cooperate with relevant institutions to conduct publicity, to organize and to implement the assessment. The secretariat of WFCMS shall strictly review the legality and authoritativity of the cooperation institutions.
Article 30. The secretariat of WFCMS may widely cooperate with institutions such as member societies of WFCMS, TCM societies, association and relevant TCM institutions of all countries to conduct publicity and organization of the assessment of TCM institutions.
Article 31. The secretariat of WFCMS may cooperate with third party institutions to conduct the assessment if necessary and possibly. Such institution shall have the capability, authoritativity and relevant aptitude to conduct the assessment and has no relative interest with the applying institution. The cooperation may be realized in the ways of collaboration or commission.
Collaboration indicates that the secretariat of WFCMS collaborates with relevant institutions to conduct the assessment and issues the certificate together.
Commission indicates that the secretariat of WFCMS commissions relevant institutions to undertake certain part or parts of the assessment of WFCMS.
Article 32. Cooperation institutions shall conduct work within the scope of authorization of the secretariat of WFCMS.
Article 33. Duties of the cooperation institution for assessment are:
1. To provide factual and integral information of itself according to the requirement of WFCMS.
2. To conduct the assessment according to relevant standards, regulation details for implementing the standards, the rules itself and requirements of WFCMS.
3. To coordinate with WFCMS for training assessing staffs of institutions.
4. To coordinate with WFCMS to collect the information of development and management regulations of medical, education and research institutions and practitioners in the field of TCM in the country and region of the institutions.
5. To publicize the TCM institution assessment of WFCMS actively.
6. To give instruction of training and improvement to applying institutions under the instruction of WFCMS.
7. To assist WFCMS for supervising the utilization of assessment certificate and board.
8. To receive relevant appeals and complaints, to propose and to report to WFCMS for approval timely.

CHAPTER SEVEN  RULES OF PUNISHMENT


Article 34. Applying institutions those provide inaccurate and untrue information, institutions those fail to use assessment certificate and board in accordance with requirement after they have passed the assessment, or institutions those undergo major changes but fail to report them to the secretariat of WFCMS, will be suspended or deprived of the right of using assessment certificate and board.
Article 35. The secretariat of WFCMS will suspend or terminate the cooperation of institutions which fail to carry out their duties in accordance with the agreement, or whose behaviours exceed the scope of the agreement. WFCMS will make them legally accountable in accordance with law.
Article 36. The secretariat of WFCMS will remove the assessment right of experts who participate in the assessment but fail to do their work in strict accordance with relevant standards, regulation details for implementing standards of WFCMS and the rules itself, and make the experts legally accountable.


CHAPTER EIGHT  OTHER REGULATIONS


Article 37. Applying institutions shall pay the fee for the assessment to WFCMS.
Article 38. The secretariat of WFCMS is responsible for the formulation of regulation details of TCM institution of World Federation of Chinese Medicine Society.
Article 39. The power of interpretation of the rules and regulation details of assessment owes to WFCMS.
Article 40. The rules go into effect since the date of issue.


World Federation of Chinese Medicine Societies


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