国务院


中华人民共和国标准化法实施条例(附英文)

1990年4月6日，国务院

第一章 总则
第一条 根据《中华人民共和国标准化法》（以下简称《标准化法》）的规定，制定本条例。
第二条 对下列需要统一的技术要求，应当制定标准：
（一）工业产品的品种、规格、质量、等级或者安全、卫生要求；
（二）工业产品的设计、生产、试验、检验、包装、储存、运输、使用的方法或者生产、储存、运输过程中的安全、卫生要求；
（三）有关环境保护的各项技术要求和检验方法；
（四）建设工程的勘察、设计、施工、验收的技术要求和方法；
（五）有关工业生产、工程建设和环境保护的技术术语、符号、代号、制图方法、互换配合要求；
（六）农业（含林业、牧业、渔业，下同）产品（含种子、种苗、种畜、种禽，下同）的品种、规格、质量、等级、检验、包装、储存、运输以及生产技术、管理技术的要求；
（七）信息、能源、资源、交通运输的技术要求。
第三条 国家有计划地发展标准化事业。标准化工作应当纳入各级国民经济和社会发展计划。
第四条 国家鼓励采用国际标准和国外先进标准，积极参与制定国际标准。

第二章 标准化工作的管理
第五条 标准化工作的任务是制定标准、组织实施标准和对标准的实施进行监督。
第六条 国务院标准化行政主管部门统一管理全国标准化工作，履行下列职责：
（一）组织贯彻国家有关标准化工作的法律、法规、方针、政策；
（二）组织制定全国标准化工作规划、计划；
（三）组织制定国家标准；
（四）指导国务院有关行政主管部门和省、自治区、直辖市人民政府标准化行政主管部门的标准化工作，协调和处理有关标准化工作问题；
（五）组织实施标准；
（六）对标准的实施情况进行监督检查；
（七）统一管理全国的产品质量认证工作；
（八）统一负责对有关国际标准化组织的业务联系。
第七条 国务院有关行政主管部门分工管理本部门、本行业的标准化工作，履行下列职责：
（一）贯彻国家标准化工作的法律、法规、方针、政策，并制定在本部门、本行业实施的具体办法；
（二）制定本部门、本行业的标准化工作规划、计划；
（三）承担国家下达的草拟国家标准的任务，组织制定行业标准；
（四）指导省、自治区、直辖市有关行政主管部门的标准化工作；
（五）组织本部门、本行业实施标准；
（六）对标准实施情况进行监督检查；
（七）经国务院标准化行政主管部门授权，分工管理本行业的产品质量认证工作。
第八条 省、自治区、直辖市人民政府标准化行政主管部门统一管理本行政区域的标准化工作，履行下列职责：
（一）贯彻国家标准化工作的法律、法规、方针、政策，并制定在本行政区域实施的具体办法；
（二）制定地方标准化工作规划、计划；
（三）组织制定地方标准；
（四）指导本行政区域有关行政主管部门的标准化工作，协调和处理有关标准化工作问题；
（五）在本行政区域组织实施标准；
（六）对标准实施情况进行监督检查。
第九条 省、自治区、直辖市有关行政主管部门分工管理本行政区域内本部门、本行业的标准化工作，履行下列职责：
（一）贯彻国家和本部门、本行业、本行政区域标准化工作的法律、法规、方针、政策，并制定实施的具体办法；
（二）制定本行政区域内本部门、本行业的标准化工作规划、计划；
（三）承担省、自治区、直辖市人民政府下达的草拟地方标准的任务；
（四）在本行政区域内组织本部门、本行业实施标准；
（五）对标准实施情况进行监督检查。
第十条 市、县标准化行政主管部门和有关行政主管部门的职责分工，由省、自治区、直辖市人民政府规定。

第三章 标准的制定
第十一条 对需要在全国范围内统一的下列技术要求，应当制定国家标准（含标准样品的制作）：
（一）互换配合、通用技术语言要求；
（二）保障人体健康和人身、财产安全的技术要求；
（三）基本原料、燃料、材料的技术要求；
（四）通用基础件的技术要求；
（五）通用的试验、检验方法；
（六）通用的管理技术要求；
（七）工程建设的重要技术要求；
（八）国家需要控制的其他重要产品的技术要求。
第十二条 国家标准由国务院标准化行政主管部门编制计划，组织草拟，统一审批、编号、发布。
工程建设、药品、食品卫生、兽药、环境保护的国家标准，分别由国务院工程建设主管部门、卫生主管部门、农业主管部门、环境保护主管部门组织草拟、审批；其编号、发布办法由国务院标准化行政主管部门会同国务院有关行政主管部门制定。
法律对国家标准的制定另有规定的，依照法律的规定执行。
第十三条 对没有国家标准而又需要在全国某个行业范围内统一的技术要求，可以制定行业标准（含标准样品的制作）。制定行业标准的项目由国务院有关行政主管部门确定。
第十四条 行业标准由国务院有关行政主管部门编制计划，组织草拟，统一审批、编号、发布，并报国务院标准化行政主管部门备案。
行业标准在相应的国家标准实施后，自行废止。
第十五条 对没有国家标准和行业标准而又需要在省、自治区、直辖市范围内统一的工业产品的安全、卫生要求，可以制定地方标准。制定地方标准的项目，由省、自治区、直辖市人民政府标准化行政主管部门确定。
第十六条 地方标准由省、自治区、直辖市人民政府标准化行政主管部门编制计划，组织草拟，统一审批、编号、发布，并报国务院标准化行政主管部门和国务院有关行政主管部门备案。
法律对地方标准的制定另有规定的，依照法律的规定执行。
地方标准在相应的国家标准或行业标准实施后，自行废止。
第十七条 企业生产的产品没有国家标准、行业标准和地方标准的，应当制定相应的企业标准，作为组织生产的依据。企业标准由企业组织制定（农业企业标准制定办法另定），并按省、自治区、直辖市人民政府的规定备案。
对已有国家标准、行业标准或者地方标准的，鼓励企业制定严于国家标准、行业标准或者地方标准要求的企业标准，在企业内部适用。
第十八条 国家标准、行业标准分为强制性标准和推荐性标准。
下列标准属于强制性标准：
（一）药品标准，食品卫生标准，兽药标准；
（二）产品及产品生产、储运和使用中的安全、卫生标准，劳动安全、卫生标准，运输安全标准；
（三）工程建设的质量、安全、卫生标准及国家需要控制的其他工程建设标准；
（四）环境保护的污染物排放标准和环境质量标准；
（五）重要的通用技术术语、符号、代号和制图方法；
（六）通用的试验、检验方法标准；
（七）互换配合标准；
（八）国家需要控制的重要产品质量标准。
国家需要控制的重要产品目录由国务院标准化行政主管部门会同国务院有关行政主管部门确定。
强制性标准以外的标准是推荐性标准。
省、自治区、直辖市人民政府标准化行政主管部门制定的工业产品的安全、卫生要求的地方标准，在本行政区域内是强制性标准。
第十九条 制定标准应当发挥行业协会、科学技术研究机构和学术团体的作用。
制定国家标准、行业标准和地方标准的部门应当组织由用户、生产单位、行业协会、科学技术研究机构、学术团体及有关部门的专家组成标准化技术委员会，负责标准草拟和参加标准草案的技术审查工作。未组成标准化技术委员会的，可以由标准化技术归口单位负责标准草拟和参加标准草案的技术审查工作。
制定企业标准应当充分听取使用单位、科学技术研究机构的意见。
第二十条 标准实施后，制定标准的部门应当根据科学技术的发展和经济建设的需要适时进行复审。标准复审周期一般不超过五年。
第二十一条 国家标准、行业标准和地方标准的代号、编号办法，由国务院标准化行政主管部门统一规定。
企业标准的代号、编号方法，由国务院标准化行政主管部门会同国务院有关行政主管部门规定。
第二十二条 标准的出版、发行办法，由制定标准的部门规定。

第四章 标准的实施与监督
第二十三条 从事科研、生产、经营的单位和个人，必须严格执行强制性标准。不符合强制性标准的产品，禁止生产、销售和进口。
第二十四条 企业生产执行国家标准、行业标准、地方标准或企业标准，应当在产品或其说明书、包装物上标注所执行标准的代号、编号、名称。
第二十五条 出口产品的技术要求由合同双方约定。
出口产品在国内销售时，属于我国强制性标准管理范围的，必须符合强制性标准的要求。
第二十六条 企业研制新产品、改进产品、进行技术改造，应当符合标准化要求。
第二十七条 国务院标准化行政主管部门组织或授权国务院有关行政主管部门建立行业认证机构，进行产品质量认证工作。
第二十八条 国务院标准化行政主管部门统一负责全国标准实施的监督。国务院有关行政主管部门分工负责本部门、本行业的标准实施的监督。
省、自治区、直辖市标准化行政主管部门统一负责本行政区域内的标准实施的监督。省、自治区、直辖市人民政府有关行政主管部门分工负责本行政区域内本部门、本行业的标准实施的监督。
市、县标准化行政主管部门和有关行政主管部门，按照省、自治区、直辖市人民政府规定的各自的职责，负责本行政区域内的标准实施的监督。
第二十九条 县级以上人民政府标准化行政主管部门，可以根据需要设置检验机构，或者授权其他单位的检验机构，对产品是否符合标准进行检验和承担其他标准实施的监督检验任务。检验机构的设置应当合理布局，充分利用现有力量。
国家检验机构由国务院标准化行政主管部门会同国务院有关行政主管部门规划、审查。地方检验机构由省、自治区、直辖市人民政府标准化行政主管部门会同省级有关行政主管部门规划、审查。
处理有关产品是否符合标准的争议，以本条规定的检验机构的检验数据为准。
第三十条 国务院有关行政主管部门可以根据需要和国家有关规定设立检验机构，负责本行业、本部门的检验工作。
第三十一条 国家机关、社会团体、企业事业单位及全体公民均有权检举、揭发违反强制性标准的行为。

第五章 法律责任
第三十二条 违反《标准化法》和本条例有关规定，有下列情形之一的，由标准化行政主管部门或有关行政主管部门在各自的职权范围内责令限期改进，并可通报批评或给予责任者行政处分：
（一）企业未按规定制定标准作为组织生产依据的；
（二）企业未按规定要求将产品标准上报备案的；
（三）企业的产品未按规定附有标识或与其标识不符的；
（四）企业研制新产品、改进产品、进行技术改造，不符合标准化要求的；
（五）科研、设计、生产中违反有关强制性标准规定的。
第三十三条 生产不符合强制性标准的产品的，应当责令其停止生产，并没收产品，监督销毁或作必要技术处理；处以该批产品货值金额百分之二十至百分之五十的罚款；对有关责任者处以五千元以下罚款。
销售不符合强制性标准的商品的，应当责令其停止销售，并限期追回已售出的商品，监督销毁或作必要技术处理；没收违法所得；处以该批商品货值金额百分之十至百分之二十的罚款；对有关责任者处以五千元以下罚款。
进口不符合强制性标准的产品的，应当封存并没收该产品，监督销毁或作必要技术处理；处以进口产品货值金额百分之二十至百分之五十的罚款；对有关责任者给予行政处分，并可处以五千元以下罚款。
本条规定的责令停止生产、行政处分，由有关行政主管部门决定；其他行政处罚由标准化行政主管部门和工商行政管理部门依据职权决定。
第三十四条 生产、销售、进口不符合强制性标准的产品，造成严重后果，构成犯罪的，由司法机关依法追究直接责任人员的刑事责任。
第三十五条 获得认证证书的产品不符合认证标准而使用认证标志出厂销售的，由标准化行政主管部门责令其停止销售，并处以违法所得二倍以下的罚款；情节严重的，由认证部门撤销其认证证书。
第三十六条 产品未经认证或者认证不合格而擅自使用认证标志出厂销售的，由标准化行政主管部门责令其停止销售，处以违法所得三倍以下的罚款，并对单位负责人处以五千元以下罚款。
第三十七条 当事人对没收产品、没收违法所得和罚款的处罚不服的，可以在接到处罚通知之日起十五日内，向作出处罚决定的机关的上一级机关申请复议；对复议决定不服的，可以在接到复议决定之日起十五日内，向人民法院起诉。当事人也可以在接到处罚通知之日起十五日内，直接向人民法院起诉。当事人逾期不申请复议或者不向人民法院起诉又不履行处罚决定的，由作出处罚决定的机关申请人民法院强制执行。
第三十八条 本条例第三十二条至第三十六条规定的处罚不免除由此产生的对他人的损害赔偿责任。受到损害的有权要求责任人赔偿损失。赔偿责任和赔偿金额纠纷可以由有关行政主管部门处理，当事人也可以直接向人民法院起诉。
第三十九条 标准化工作的监督、检验、管理人员有下列行为之一的，由有关主管部门给予行政处分，构成犯罪的，由司法机关依法追究刑事责任：
（一）违反本条例规定，工作失误，造成损失的；
（二）伪造、篡改检验数据的；
（三）徇私舞弊、滥用职权、索贿受贿的。
第四十条 罚没收入全部上缴财政。对单位的罚款，一律从其自有资金中支付，不得列入成本。对责任人的罚款，不得从公款中核销。

第六章 附则
第四十一条 军用标准化管理条例，由国务院、中央军委另行制定。
第四十二条 工程建设标准化管理规定，由国务院工程建设主管部门依据《标准化法》和本条例的有关规定另行制定，报国务院批准后实施。
第四十三条 本条例由国家技术监督局负责解释。
第四十四条 本条例自发布之日起施行。(附英文)

REGULATIONS FOR THE IMPLEMENTATION OF THE STANDARDIZATION LAW OFTHE PEOPLE'S REPUBLIC OF CHINA

Important Notice: (注意事项)
英文本源自中华人民共和国务院法制局编译, 中国法制出版社出版的《中华人民
共和国涉外法规汇编》(1991年7月版).
当发生歧意时, 应以法律法规颁布单位发布的中文原文为准.
This English document is coming from the "LAWS AND REGULATIONS OF THE
PEOPLE'S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7)
which is compiled by the Brueau of Legislative Affairs of the State
Council of the People's Republic of China, and is published by the China
Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.

Whole Document (法规全文)
REGULATIONS FOR THE IMPLEMENTATION OF THE STANDARDIZATION LAW OF
THE PEOPLE'S REPUBLIC OF CHINA
(Promulgated by Decree No. 53 of the State Council of the People's
Republic of China on April 6, 1990 and effective as of the date of
promulgation)

Chapter I General Provisions
Article 1
These Regulations are formulated in accordance with the provisions of the
Standardization Law of the People's Republic of China (hereinafter
referred to as the Standardization Law).
Article 2
Standards should be formulated for the following technical requirements
that need to be unified:
(1) varieties, specifications, quality and grades of industrial products
or requirements pertinent to safety and hygiene;
(2) methods for design, production, experimentation, examination, packing,
storage, transportation and utilization of industrial products or
requirements pertinent to safety and hygiene in the course of production,
storage and transportation;
(3) various technical requirements and methods for examination concerning
environmental protection;
(4) technical requirements and methods for surveying, designing,
construction and examination and acceptance in building projects;
(5) technical terms, symbols, codes, drafting methods and requirements for
conversion and coordination concerning industrial production, project
construction and environmental protection;
(6) varieties, specifications, quality, grades, examination, packing,
storage, transportation and requirements for production technology and
management expertise concerning agricultural products (including seeds,
seedlings, breeding stock and breeding poultry and those in forestry,
animal husbandry and fishery; the same below);
(7) technical requirements concerning information, energy, resources, and
transport.
Article 3
The State develops standardization undertakings in a planned way.
Standardization work should be included in the plans for national economic
and social development at the various levels.
Article 4
The State encourages the adoption of international standards and advanced
standards abroad and takes an active part in the formulation of
international standards.

Chapter II Administration of Standardization Work
Article 5
The task for those who are in charge of standardization work is:
formulating standards, organizing the implementation of standards and
exercising supervision over the implementation of standards.
Article 6
The competent department in charge of standardization under the State
Council exercises unified leadership over the standardization work
throughout the country, and it performs the following duties:
(1) organizing the implementation of the State's laws, regulations,
policies and measures concerning standardization;
(2) organizing the formulation of programmes and plans concerning
standardization work in the whole country;
(3) organizing the formulation of national standards;
(4) providing guidance to the relevant competent departments under the
State Council and administrative departments for standardization work in
the people's governments in the provinces, autonomous regions and the
municipalities directly under the Central Government in their
standardization work, and coordinating work in this field and dealing with
problems arising therein;
(5) organizing the implementation of standards;
(6) conducting supervision over and inspection on the implementation of
standards;
(7) exercising unified leadership over attestation of product quality in
the whole country;
(8) taking overall responsibility for professional contacts with the
relevant international standardization organizations.
Article 7
The relevant competent departments under the State Council are responsible
for the standardization work in their own departments or trades. They
shall perform the following duties:
(1) implementing the State's laws, regulations, policies and measures
concerning standardization work and formulating specific procedures for
their implementation in their departments and trades;
(2) formulating programmes and plans concerning standardization work in
their departments and trades;
(3) undertaking tasks assigned by the State of drafting state standards
and organizing the formulation of the standards in their respective
trades;
(4) providing guidance to the relevant competent authorities in the
provinces, autonomous regions and municipalities directly under the
Central Government in their standardization work;
(5) organizing the implementation of the standards in their departments
and trades;
(6) conducting supervision over and inspection on the implementation of
standards;
(7) taking charge of attestation of product quality in their own trades on
the authorization from the competent department in charge of
standardization under the State Council.
Article 8
The administrative departments for standardization in the people's
governments in the provinces, autonomous regions and municipalities
directly under the Central Government exercise unified leadership over
standardization work in their respective administrative regions, and shall
perform the following duties:
(1) implementing the State's laws, regulations, policies and measures
concerning standardization work and formulating specific procedures for
their implementation in their respective administrative regions;
(2) formulating local programmes and plans concerning standardization
work;
(3) organizing the formulation of local standards;
(4) providing guidance to the relevant administrative authorities in their
own administrative regions in their standardization work, and coordinating
work in this field and dealing with problems arising therein;
(5) organizing the implementation of the standards in their respective
administrative regions;
(6) conducting supervision over and inspection on the implementation of
the standards.
Article 9
The relevant competent administrative authorities in the provinces,
autonomous regions and municipalities directly under the Central
Government are responsible for the standardization work in their own
departments and trades in the respective administrative regions, and shall
perform the following duties:
(1) implementing the laws, regulations, policies and measures concerning
standardization work formulated by the State and their respective
departments, trades and administrative regions and formulating specific
procedures for their implementation;
(2) formulating programmes and plans concerning standardization work for
their own departments and trades in the respective administrative regions;
(3) undertaking the tasks of drafting local standards assigned by the
people's governments in the provinces, autonomous regions and
municipalities directly under the Central Government;
(4) organizing the implementation of the standards in their own
departments and trades in the respective administrative regions;
(5) conducting supervision over and inspection on the implementation of
the standards.
Article 10
The division of the duties of the administrative departments in charge of
standardization and the relevant competent administrative authorities in
municipalities and counties shall be stipulated by the people's
governments in the provinces, autonomous regions and municipalities
directly under the Central Government.

Chapter III The Formulation of Standards
Article 11
National standards (including making sample standards) should be
formulated for the following technical requirements that need to be
unified throughout the country:
(1) requirements for standardizing commonly used technical terms;
(2) technical requirements for guaranteeing human health and personal and
property safety;
(3) technical requirements for essential raw materials, fuels and
processed materials;
(4) technical requirements for commonly used basic spare parts;
(5) commonly used methods of experimentation and examination;
(6) technical requirements for commonly used management expertise;
(7) important technical requirements in project construction;
(8) technical requirements for the other important products that must be
controlled by the State.
Article 12
In formulating national standards, the administrative department in charge
of standardization under the State Council shall be responsible for making
plans, organizing drafting, examination and approval, numbering and
promulgation. In formulating national standards for project construction,
pharmaceuticals, food hygiene, veterinary medicine and environmental
protection, the competent departments in charge of project construction,
public health, agriculture and environmental protection under the State
Council shall be responsible for organizing drafting and examination and
approval in their respective departments. The procedures for numbering and
promulgation shall be formulated by the administrative department in
charge of standardization under the State Council in conjunction with the
relevant competent departments under the State Council.
Where there are, in law, provisions different from those above for the
formulation of national standards, those provisions in law shall prevail.
Article 13
If there are no national standards for those technical requirements which
need to be standardized for certain trades throughout the country, trade
standards (including the making of sample standards) may be formulated.
Items of trade standards to be formulated shall be determined by the
relevant competent administrative departments under the State Council.
Article 14
In formulating trade standards, the relevant competent administrative
departments under the State Council shall be responsible for drawing up
plans, organizing drafting, examination and approval, numbering and
promulgation and they should report to the administrative department in
charge of standardization under the State Council for the record.
Trade standards shall be null and void automatically after the
corresponding national standards have taken effect.
Article 15
Local standards may be formulated for the safety and sanitation
requirements for industrial goods which need to be unified in the
provinces, autonomous regions and municipalities directly under the
Central Government, in the absence of national standards or trade
standards for them. Items of local standards to be formulated shall be
determined by the administrative departments for standardization of the
people's governments in the provinces, autonomous regions and
municipalities directly under the Central Government.
Article 16
In formulating local standards, the administrative departments for
standardization of the people's governments in the provinces, autonomous
regions and municipalities directly under the Central Government shall be
responsible for drawing up plans, organizing drafting, examination and
approval, numbering and promulgation, and they should report to the
administrative department in charge of standardization under the State
Council and the relevant competent departments under the Council for the
record. Where there are, in law, provisions different from those above
for the formulation of local standards, those provisions in law shall
prevail.
Local standards shall be null and void automatically after the
corresponding national standards or trade standards go into effect.
Article 17
In the absence of national standards, trade standards and local standards
for certain products, the enterprises producing such products shall
formulate their own standards as the basis for organizing production.
Enterprise standards shall be formulated by the relevant enterprises
themselves (procedures for formulating standards for agricultural
enterprises shall be provided for separately), and shall be filed for the
record in accordance with the provisions of the people's governments in
the provinces, autonomous regions and municipalities directly under the
Central Government.
Where there are already national standards, trade standards and local
standards, enterprises should be encouraged to formulate enterprise
standards which are stricter than the corresponding national, trade or
local standards and apply them within their enterprises.
Article 18
National standards and trade standards are divided into compulsory
standards and recommendatory standards.
The following standards belong in the compulsory category:
(1) standards for pharmaceuticals, food hygiene and veterinary medicine;
(2) safety and hygiene standards for products and the production, storage
and transportation and utilization of products; standards for the safety
of labour and hygiene standards and safety standards for transportation;
(3) quality, safety and sanitation standards for project construction and
other standards for project construction that must be controlled by the
State;
(4) standards for the discharge of pollutants concerning environmental
protection and standards for environmental quality;
(5) important technical terms, symbols, codes and drafting methods in
common use;
(6) standards for commonly used methods of experimentation and
examination;
(7) standards for conversion and coordination;
(8) quality standards for the important products which need to be
controlled by the State. The catalogue of the important products which
need to be controlled by the State shall be fixed by the administrative
department for standardization under the State Council in conjunction with
the relevant competent administrative departments under the State Council.
Those standards which are not compulsory are recommendatory standards.
The local standards for safety and hygiene requirements for industrial
products formulated by the administrative departments in charge of
standardization of the people's governments in the provinces, autonomous
regions and municipalities directly under the Central Government are
compulsory standards in their respective administrative regions.
Article 19
Trade associations, research institutions for science and technology, and
academic organizations should be given a role to play in formulating
standards. The departments responsible for formulating national, trade
and local standards should set up standardization technical committees
consisting of experts from users, production units, trade associations,
research institutions for science and technology, academic organizations
and the departments concerned, which shall be responsible for drafting
standards and examining the technical aspects of the drafts. Where
standardization technical committees have not been set up, the units
charged with specific responsibility for standardization technology may
take charge of drafting standards and examining the technical aspects of
the drafts.
It is necessary to heed fully the opinions of the users and research
institutions for science and technology in formulating enterprise
standards.
Article 20
After standards go into effect, the departments which formulated the
standards shall carry out timely reexaminations in light of the
development of science and technology and the needs of economic
construction. Normally, reexamination should be conducted every five
years, at the longest.
Article 21
The procedures of coding and numbering for national, trade and local
standards shall be provided for by the administrative department in charge
of standardization under the State Council.
The procedures of coding and numbering for enterprise standards shall be
provided for by the administrative department in charge of standardization
under the State Council in conjunction with the relevant competent
administrative departments under the State Council.
Article 22
The procedures of publication and distribution of standards shall be
stipulated by the departments which have formulated the standards.

Chapter IV Implementation and Supervision Concerning Standards
Article 23
Any units and individuals that are engaged in scientific research,
production and operation must strictly implement compulsory standards. The
products which do not measure up to compulsory standards may not be
allowed to be produced, marketed or imported.
Article 24
Enterprises may go by the national, trade and local standards or
enterprise standards in production. The codes, serial numbers and names of
the standards should be marked on their products, or written in the
technical manuals or on the packages.
Article 25
The technical requirements for export products shall be agreed upon by the
two contracting parties.
When those export products which should be subject to compulsory standards
of China are sold at domestic markets, they must meet the requirements of
the relevant compulsory standards.
Article 26
Enterprises should meet standardization requirements in developing new
products, improving products or carrying out technical innovations.
Article 27
The administrative department in charge of standardization under the State
Council organizes or authorizes the relevant competent departments under
the State Council to set up trade attestation agencies for carrying out
product quality attestation.
Article 28
The administrative department in charge of standardization under the State
Council shall be responsible for the supervision over the implementation
of standards throughout the country. The relevant administrative
departments under the State Council shall be responsible for the
supervision over the implementation of the standards in their respective
departments and trades.
The administration departments for standardization in the provinces,
autonomous regions and municipalities directly under the Central
Government shall be responsible for the supervision over the
implementation of the standards in their respective administrative areas.
The relevant administrative authorities in the people's governments in the
provinces, autonomous regions and municipalities directly under the
Central Government shall be responsible for the supervision over the
implementation of the standards in their departments and trades in the
respective administrative areas.
The administrative departments for standardization and the relevant
administrative authorities in municipalities and counties shall be
responsible for the supervision over the implementation of the standards
in their respective administrative areas according to the duties assigned
to them by the people's governments of the provinces, autonomous regions
and municipalities directly under the Central Government.
Article 29
The administrative departments in charge of standardization in the
people's governments above county level may, according to their needs, set
up examination agencies or authorize the examination agencies of other
units to ensure products are up to the standards and undertake other tasks
of supervision and examination concerning the implementation of standards
in setting up examination agencies, attention should be paid to a rational
geographical allocation and making full use of the available personnel and
facilities.
The establishment of state examination agencies shall be planned and
examined by the administrative department in charge of standardization
under the State Council in conjunction with the relevant administrative
departments under the State Council. The establishment of local
examination agencies shall be planned and examined by the administrative
departments in charge of standardization in the people's governments of
the provinces, autonomous regions and municipalities directly under the
Central Government in conjunction with the relevant administrative
authorities at provincial level. The data provided by the examination
agencies stipulated in this Article shall be taken as the criterion in
solving disputes over whether certain products are up to the relevant

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国家中医药管理局办公室


国家中医药管理局办公室关于印发《国家中医重点专科协作组管理工作方案》的通知

国中医药办医政发〔2012〕38号


各省、自治区、直辖市卫生厅局、中医药管理局，新疆生产建设兵团卫生局，中国中医科学院，北京中医药大学：
为加强国家中医重点专科建设，规范国家中医重点专科协作组管理，确保国家中医重点专科协作组各项工作切实取得成效，我局组织制定了《国家中医重点专科协作组管理工作方案》。现印发给你们，请遵照执行。



二○一二年七月九日



国家中医重点专科协作组管理工作方案


为进一步加强国家中医重点专科协作组的管理，促进国家中医重点专科协作组各项工作规范有序地开展，现制定国家中医重点专科协作组管理工作方案。
一、 国家中医重点专科协作组组织
国家中医重点专科协作组范围包括国家中医重点专科、重点专科建设项目、重点专科培育项目、重点专科协作组成员单位（以下简称重点专科）。
（一）重点专科协作组组织
所有国家中医重点专科按专业类别划分成29个重点专科协作组。各重点专科协作组设置组长单位、工作委员会和专家指导委员会。
1．重点专科协作组组长单位
①重点专科协作组组长单位的设置
各重点专科协作组设组长单位3-5个，每个组长单位按优势病种确定分工，其中一个组长单位作为总牵头单位，负责协作组全面工作。每个组长单位确定组长1名。
②重点专科协作组组长单位的产生
组长单位由各重点专科协作组成员单位充分酝酿、推选后提出建议名单报重点专科项目办公室，重点专科项目办公室根据建议单位的工作表现提出意见报国家中医药管理局医政司，医政司审核后确定组长单位名单。
③重点专科协作组组长单位的工作原则
各组长单位和组长之间按照民主协商的原则开展工作。
2．重点专科协作组工作委员会
各重点专科协作组成立工作委员会，原则上由重点专科协作组组长和优势病种协作组组长组成，主任委员由专科协作组牵头单位的组长担任。各协作组的重要活动和重大事项由工作委员会协商决定。各工作委员会根据协作组实际工作需要，不定期召开委员会工作会议。
3．重点专科协作组专家指导委员会
各重点专科协作组成立专家指导委员会，由本专业内具有较高理论和技术水平并享有较高威望的专家组成。专家委员会对重点专科协作组工作提供技术支持和专业咨询，并根据工作需要参加诊疗方案和临床路径审定、专科建设督导、检查评估等工作。
（二）中医优势病种协作组组织
各重点专科协作组按照各专业中医优势病种划分成若干个优势病种协作组，各重点专科根据医院本专科特色优势和本专业确定的优势病种情况，本着自愿原则选择参加1-3个优势病种协作组。每个优势病种协作组成员单位原则上不少于10个。各中医优势病种协作组设置组长单位。
1．中医优势病种协作组组长单位的设置
各中医优势病种协作组设组长单位1个，组长单位确定组长1名。
2．中医优势病种协作组组长单位的产生
中医优势病种协作组组长单位由所在重点专科协作组组长单位根据各中医优势病种协作组成员单位意见提出推荐名单，重点专科项目办公室根据推荐单位的工作表现提出意见报国家中医药管理局医政司，医政司审核后确定组长单位名单。
3．中医优势病种协作组组长单位的工作原则
组长单位和组长在开展工作过程中要坚持民主原则，充分发扬学术民主，调动协作组各成员单位的积极性，共同做好协作组各项工作。
二、国家中医重点专科协作组主要任务
（一）开展优势病种中医临床诊疗方案的梳理、验证、制定、提高工作。
1．遴选中医优势病种
中医优势病种是指运用中医药技术方法能够基本治愈的病种和在疾病某个环节上运用中医药技术方法能够解决某些临床问题的病种。
中医优势病种名单由各重点专科协作组研究提出并报国家中医药管理局重点专科项目办公室，项目办公室审核提出意见后报国家中医药管理局医政司审定。
2．梳理中医优势病种临床诊疗方案
优势病种协作组各成员单位在认真梳理本医院临床实际应用的、有效的诊疗方法的基础上，形成本医院的优势病种临床诊疗方案。
3．验证中医优势病种临床诊疗方案
优势病种协作组组织各成员单位依据《中医优势病种临床验证工作方案》的要求，确定验证的临床诊疗方案，制定验证工作方案，对诊疗方案中的各种治疗方法的临床疗效和安全性开展临床验证工作。
4．制定中医优势病种临床诊疗方案
优势病种协作组根据临床验证的结果，综合确有疗效的中医诊疗方法，制定该优势病种的中医临床诊疗方案。
5．提高中医优势病种临床诊疗方案
优势病种协作组在协作组范围内广泛应用中医临床诊疗方案，在此基础上定期进行疗效分析和评价，不断优化、提高中医优势病种临床诊疗方案。
（二）开展优势病种中医临床路径制定和试点工作
1．制定优势病种中医临床路径
在中医优势病种临床诊疗方案的基础上，筛选适合中医临床路径管理的病种，制定中医优势病种临床路径。
2．开展优势病种中医临床路径试点
优势病种协作组依据《中医临床路径管理试点工作方案》，在重点专科协作组范围内开展优势病种中医临床路径试点工作。
试点结束后，对优势病种中医临床路径的实施情况进行总结，针对试点过程中存在的问题提出改进措施，不断修改和完善中医优势病种临床路径和临床路径实施方案。
（三）梳理优势病种中医治疗难点并联合攻关
各优势病种协作组针对患者亟需解决的临床问题（如患者最痛苦的症状等）提出中医治疗难点，在优势病种协作组范围内通过临床协作等多种方式，开展联合攻关，不断解决中医治疗难点，提高中医临床疗效。
（四）加强专科人才队伍建设
各重点专科协作组和优势病种协作组通过开展中医诊疗方案的梳理、验证、制定、提高以及组织学术交流、联合攻关、进修学习等多种形式，培养专科人才，逐步形成中医观念牢固、技术水平高、临床疗效好、创新能力强的专科人才队伍。
（五）向社会广泛宣传中医优势病种的临床疗效
各优势病种协作组在国家中医药管理局的统一部署下，对优势病种进行广泛的社会宣传。充分利用平面媒体、视频、网络等技术手段以及新闻发布、资料发放、电视专题片等形式，宣传介绍中医药的治疗效果和优势，提高老百姓对中医药的认知度。
三、国家中医重点专科协作组工作职责
（一）国家中医药管理局医政司职责
国家中医药管理局医政司负责对重点专科协作组的管理、监督和指导。
（二）国家中医药管理局重点专科项目办公室职责
由中华中医药学会医院管理分会和中国中医药科技开发交流中心组建国家中医药管理局重点专科项目办公室，负责协作组日常工作的组织实施和管理，包括规划和组建协作组、制定协作组管理工作方案、布置协作组年度工作任务并督促落实、对协作组开展绩效考核等。
（三）重点专科协作组组长职责
1．正确理解和把握重点专科各项工作内容和要求，贯彻落实国家中医药管理局关于专科建设的工作思路和政策措施。
2．提出本专科中医优势病种建议名单，推荐优势病种协作组组长候选单位和候选人。
3．协调召开本重点专科协作组工作会议，制定本重点专科协作组年度工作计划。
4．审核各优势病种中医临床路径、临床诊疗方案培训讲义和宣传材料。
5．督促和指导各优势病种协作组完成协作组各项工作任务。
（四）优势病种协作组组长职责
1．组织本协作组成员单位进行优势病种中医诊疗方案的梳理、验证、制定、提高工作。
2．开展中医临床路径和诊疗方案的试点培训工作。
3．起草中医临床路径和诊疗方案培训讲义。
4．提出中医治疗难点、解决方案并实施。
5．组织本协作组各成员单位完成协作组各项工作任务。
（五） 重点专科职责
1．参与优势病种中医诊疗方案的梳理、验证、制定、提高和临床路径的起草工作。
2．参与中医临床路径和诊疗方案的试点工作。
3．参与中医优势病种中医治疗难点的解决。
4．建立视频网络平台。
5．按照要求完成协作组各项工作任务。
四、国家中医重点专科协作组考核
（一）考核范围
考核范围包括各重点专科协作组组长单位和组长、各优势病种协作组组长单位和组长、各重点专科。
（二）考核原则
本着客观公正、民主公开、注重实绩的原则，上级考核与民主评议相结合，年度考核与平时表现相结合，对协作组工作情况进行准确评价。
（三）考核内容
主要考核年度工作安排和要求的完成情况。
（四）考核组织实施
考核工作由国家中医药管理局重点专科项目办公室负责。对协作组组长和优势病种协作组组长的考核通过对协作组日常工作的考察和协作组全体成员单位的评价两种形式进行。对协作组日常工作的考察依据《国家中医重点专科协作组工作绩效考核细则》、《优势病种协作组工作绩效考核细则》进行，协作组全体成员单位的评价一般每年度开展一次。对重点专科的考核由国家中医药管理局重点专科项目办公室、协作组组长单位、优势病种协作组组长单位进行综合考核。考核结果分为优、中、差三个等次。
（五）考核结果应用
国家中医药管理局重点专科项目办公室将考核结果上报国家中医药管理局医政司，医政司依据考核结果，对组长单位和组长实行动态管理。对考核结果为“优”的组长单位和组长予以表扬；对考核结果为“中”的组长单位和组长进行督促整改；对考核结果为“差”的组长单位和组长予以警告并限期整改，整改后工作仍不力的予以调整。