【中英文对照版】强制性产品认证机构和实验室管理办法(2022修订).docx

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1、强制性产品认证机构和实验室 管理办法（2004年6月23日国家质量 监督检验检疫总局令第65号 公布根据2022年9月29日 国家市场监督管理总局令第 61号修订）第一章总则第一条为规范强制性产 品认证机构、实验室的管理， 合理利用社会资源，保证强制 性产品认证制度的有效实施， 根据中华人民共和国认证认 可条例（以下简称条例）的 知!史.生II克木力注.强制性产品认证机构和实验室管理办法(2022修订)Measures for the Administration of Compulsory ProductCertification Institutions and Laboratories

2、(2022 Revision)【制定机关】国家市场监督管理总局【发文字号】国家市场监督管理总局令第61号【公布日期】【施行日期】【效力位阶】部门规章【法规类别】认证认可综合规定Issuing authority： Instrumentalities of the State Council,AII Administrations,State Administration for Market RegulationDocument Number： Order No. 61 of the State Administration for Market RegulationDate issued：

3、09-29-2022Effective date： 11-01-2022Level of Authority： Departmental RulesArea of Law： Standardization Administration, Certification and AccreditationMeasures for the Administration of Compulsory Product Certification Institutions and Laboratories(Issued by Order No. 65 of the State Administration f

4、or Market Regulation on June 23, 2004; and revised by Order No. 61 of the State Administration for Market Regulation on September 29, 2022)Chapter I General ProvisionsArticle 1 The present Measures are formulated in accordance with the Certification and Accreditation Regulation of the Peoples Republ

5、ic of China (hereinafter referred to as the Regulation) for the purpose of regulating the administration on compulsory product certification institutions and lahnratnrioe makinn i iqo nf cnnial rnem irroc nrnnnrk/品认证机构、实验室（以下简 称指定的认证机构、实验室） 应当在指定范围内按照认证基 本规范和认证规则的要求为认 证委托人提供服务，不得转让 或者变相转让指定的认证、检 测业务

6、。第二十四条指定的认证 机构、实验室应当制订管理制 度和程序，对强制性产品认证、 检测活动和自愿性产品认证、 委托检测活动明确区分，不得 利用其指定的资格，开发或者 从事自愿性产品认证以及检测 业务。第二十五条指定的认证 机构在对外宣传中应当严格区 分强制性产品认证业务与自愿 性产品认证业务。第二十六条指定的认证 机构应当与指定的实验室签署 书面协议，明确各自的权利义 务和法律责任，并保证其使用 的实验室的检测活动符合国家 强制性产品认证规范和认证规 则的要求，保证其使用的实验 室（包括同一法人内的）享有 平等权利和履行同等义务。第二十七条指定的认证木n物立哈宝头1同一不注A nvF.Stat

7、e Administration for Market Regulation (hereinafter referred to as the designated certification institutions and laboratories) shall provide services to the agent of certification within the designated scope in accordance with the basic standards for certification and the requirements of certificati

8、on rules, and shall not transfer or transfer in disguised form the designated certification and testing business.Article 24 The designated certification institutions and laboratories shall formulate management systems and procedures to clearly differentiate between the activities of compulsory produ

9、ct certification and testing, and of voluntary product certification, inspection by entrustment and testing by entrustment, and shall not develop or undertake the voluntary product certification business and testing business by making use of their designated qualifications.Article 25 The designated

10、certification institutions shall strictly differentiate between the compulsory product certification business and the voluntary product certification business in the publicity.Article 26 A designated certification body shall sign written agreement with the designated laboratory, clarifying the right

11、s and obligations and legal liabilities of each of them, and ensure that testing activities of the laboratory it uses may correspond with the requirements of the national standards for compulsory product certification and the certification rules, and ensure that the laboratory (including those in th

12、e same legal person) it uses may enjoy the equal rights and perform the equal obligations.Article 27 In case the designated certification body, lahnrQtnrx/ aro tho aama local narcnn tho rlocinnatorl指定的机构应当制订相关管理 制度并保证其持续有效运行， 保证认证、检测活动独立实施, 保证认证人员、检测人员独立 开展活动。第二十八条指定的认证 机构、实验室应当在指定的业 务范围内从事强制性产品认证 活

13、动，保证为认证委托人提供 及时、有效的认证、检测服务, 不得歧视、刁难认证委托人， 不得牟取不当利益。第二十九条指定的认证 机构、实验室开展国际互认活 动，应当依法在国家市场监督 管理总局或者经授权的国务院 有关部门对外签署的国际互认 协议框架内进行。第三十条指定的机构应 当按照国家市场监督管理总局 的规定和要求，及时提供强制 性产品认证、检测的信息，配 合市场监督管理部门开展的强 制性产品认证监督检查工作。第五章监督检查第三十一条国家市场监 督管理总局对指定的认证机 珈立哈也每生世衿一出生甘日institution shall formulate relevant management sy

14、stems and ensure their sustainable and effective operation, and ensure that the activities of certification and testing may be carried out independently, as well as ensure that the certification personnel and testing personnel may carry out activities independently.Article 28 The designated certific

15、ation institutions and laboratories shall undertake compulsory product certification activities within the designated business scope, and ensure to provide certification and testing services in time and effectively to the certification agent, and may not discriminate or create difficulties for the c

16、ertification agent or seek for unjust interests.Article 29 The designated certification institutions and laboratories shall carry out international mutual recognition activities within the framework of the international mutual recognition agreement concluded by the State Administration for Market Re

17、gulation or the relevant authorized departments of the State Council.Article 30 The designated institutions shall provide information on compulsory product certification and testing in time according to the provisions and requirements of the State Administration for Market Regulation, and cooperate

18、with the market regulatory department in their carrying out of the work of supervision over compulsory product certification.Chapter V Supervision and InspectionArticle 31 The State Administration for Market Regulation shall make periodical supervision and ineno+inn nn tho rlocinnatnrl ror+ifiratinn

19、 inc+iti itinnc监督检查。第三十二条指定的认证 机构、实验室应当于每年2月 15日前向国家市场监督管理 总局上报其上一年度从事强制 性产品认证活动的工作报告， 年度工作报告包括内部审核和 管理评审等，接受国家市场监 督管理总局就有关事项的询 问。第三十三条国家市场监 督管理总局对指定的认证机 构、实验室的认证、检测工作 的质量进行不定期调查，并征 求有关认证委托人和认证证书 持有人的意见和建议。第三十四条国家市场监 督管理总局对指定的认证机 构、实验室的技术能力、服务 质量、工作效率、工作人员职 业道德以及认证基本规范和认 证规则的执行等情况组织进行 同行评议，并公布评议结果。第

20、三十五条国家市场监 督管理总局应当对指定的认证 机构、实验室的认证、检测活 动以及认证结果进行专项抽 查，并公布抽查结果。筌二干六名在向的他和and laboratories once a year.Article 32 The designated certification institutions and laboratories shall submit the work report of the previous year on their undertaking of compulsory product certification activities to the State

21、 Administration for Market Regulation before February 15 every year and accept the inquiry of the State Administration for Market Regulation on the relevant matters concerned. The annual work report shall include the internal auditing and examination on management.Article 33 The State Administration

22、 for Market Regulation shall make non-periodical investigation into the quality of the work of certification and testing of the designated certification institutions and laboratories, and solicit opinions and suggestions of the relevant certificate agents and holders of certification certificate.Art

23、icle 34 The State Administration for Market Regulation shall organize the peer review on such conditions of the designated certification institutions and laboratories as the technical ability, service quality, work efficiency, professional ethics of the staff members and the implementation of the ba

24、sic certification regulations and certification rules, and publicize the result of the review.Article 35 The State Administration for Market Regulation shall make special spot-check on the certification and testing activities and the certification results of the designated certification institutions

25、 and laboratories, and publicize the result of the spot-check.Avticla QC An/ ontitv/ nr inrli/irli iqI mo/ ronnrt tho anteof the designated certification institutions and laboratories and the acts in the designation work that are in violation of laws and regulations to the market regulatory departme

26、nt.个人对指定的认证机构、实验 室以及指定工作中的违法、违 规行为可以向市场监督管理部 门举报。Chapter VI Penalties第六章罚则Article 37 In case any designated certification body or laboratory has any of the following circumstances, it shall be ordered to correct and fined RMB 20 thousand Yuan up to 30 thousand Yuan:第三十七条指定的认证 机构、实验室有下列情形之一 的，责令改正，并处

27、以2万元 以上3万元以下罚款：(1) Lacking the necessary management systems and procedures for differentiating between the compulsory product certification and testing activities and the voluntary product certification and entrusted testing activities.（一）缺乏必要的管理制度和 程序区分强制性产品认证、检 测活动与自愿性产品认证、委 托检测活动的；(2) Promoting a

28、nd popularizing voluntary product certification business by making use of the compulsory product certification business.（二）利用强制性产品认证业 务宣传、推广自愿性产品认证 业务的；(3) Failing to provide certification and testing services to the certification agents in time and effectively, or purposely postponing or discrimina

29、ting or creating difficulties for the certification agents, and seeking for unjust interests.（三）未向认证委托人提供及 时、有效的认证、检测服务， 故意拖延的或者歧视、刁难认 证委托人，并牟取不当利益的;(4) Failing to cooperate in the activities of law enforcement supervision and inspection or refusing to provide the relevant information.（四）对执法监督检查活动不

30、予配合，拒不提供相关信息的;(5) Failing to submit the annual work report as required or to provide information of compulsory product certification and testing.（五）未按照要求提交年度工 作报告或者提供强制性产品认 证、检测信息的。Article 38 If any designated certification institution or laboratory no longer meets the designated conditions, the Sta

31、te Administration for Market Regulation shall revoke the designation to it.第三十八条指定的认证 机构、实验室不再具备指定条 件情况的，国家市场监督管理 总局撤销对其的指定。Article 39 In case any designated certification body or laboratory is revoked of designation due to issuing of false certificate and other illegal acts, it may not apply for de

32、signation within 3 years from the date of being revoked of designation.第三十九条指定的认证 机构、实验室因出具虚假证明 等违法行为被撤销指定的，其 自被撤销指定之日起3年内不 得申请指定。Article 40 The relevant provisions of the Regulation shall be followed in punishing other illegal acts in violation of the provisions of the Regulation.第四十条对于其他违反 条例规定的违法

33、行为，依照条 例的有关规定予以处罚。Chapter VII Supplementary Provisions第七章附则Article 41 The power to interpret the present Measures shall remain with the State Administration for Market Regulation.第四十一条本办法由国 家市场监督管理总局负责解 释。Article 42 The present Measures shall come into force as of August 1,2004.第四十二条本办法自 2004年8月1日起施

34、行。and ensuring the effective implementation of the compulsory product certification system.Article 2 For the purposes of these Measures, “compulsory product certification institutions and laboratories* means the certification institutions and laboratories undertaking compulsory product certification

35、 and relevant activities.第二条 本办法所称的强 制性产品认证机构、实验室是 指从事强制性产品认证以及相 关活动的认证机构、实验室。Article 3 The present Measures shall be applicable to the designation of and supervision over the compulsory product certification institutions and laboratories within the territory of the Peoples Republic of China.第三条本办法适

36、用于中 华人民共和国境内的强制性产 品认证机构、实验室的指定和 监督管理。Article 4 The state implements designation system on the compulsory product certification institutions and laboratories.第四条国家对强制性产 品认证机构、实验室实行指定 制度。Article 5 The State Administration for Market Regulation shall be responsible for the work of establishment, implem

37、entation of and supervision over the compulsory product certification institutions and laboratories.第五条国家市场监督管 理总局负责强制性产品认证机 构、实验室指定制度的建立、 实施及其监督管理工作。Article 6 The compulsory product certification institutions and laboratories shall meet and have the conditions and abilities as prescribed in the Reg

38、ulation and other laws and administrative regulations, and may not undertake compulsory product certification activities and testing activities in relation to the compulsory product certification until they are designated by the State Administration for Market Regulation.第六条强制性产品认证 机构、实验室应当符合条例及 其他法

39、律、行政法规规定的条 件和能力，经国家市场监督管 理总局指定后，方可从事强制 性产品认证活动和从事与强制 性产品认证有关的检测活动。Article 7 The principle of proper use of resources and actual needs, fair competition, openness and justness, and convenience and effectiveness shall be followed for the designated work of the compulsory product certification institut

40、ions and laboratories.第七条强制性产品认证 机构、实验室的指定工作遵循 资源合理利用和实际需要、公 平竞争、公开公正和便利、有 效的原则。Article 8 In case the compulsory product certification institutions and laboratories are the same one legal person, their qualifications of undertaking compulsory product certification and testing activities in relation

41、to the certification shall be designated separately.第八条认证机构、实验 室为同一法人时，其从事强制 性产品认证以及与认证有关的 检测活动的资格应当分别指 定。Chapter II Designation Conditions第二章指定条件Article 9 The following conditions shall be met for a certification body that applies for undertaking activities of compulsory product certification:第九条申请

42、从事强制性 产品认证活动的认证机构应当 具备下列条件：(1) Being established according to the provisions of the Regulation, and having experiences of certification in the corresponding fields for over two years or having issued more than 20 certification certificates of the relevant products.（一）依照条例规定设立，具 有相应领域2年以上认证经历 或者颁发相关产

43、品认证证书 20份以上；(2) Conforming to the general requirements of national standards on the technical capability of certification institutions.（二）符合国家标准中对认证 机构技术能力的通用要求；(3) Having no illicit records within 6 months before the application.（三）在申请前6个月内无不 良记录；(A Thn nati iro nf Innal norcnn rnne+iti itinn nf nr

44、nnnrtv/（I7U、木如物的注人枇话 有right and organization structure of the body can ensure the objectiveness and fairness of its compulsory certification activities.权构成和组织结构等能够保证 其强制性认证活动的客观公 正；(5) Having technology and management ability which will enable it to undertake compulsory product certification activit

45、ies justly, independently and effectively.（五）具备能够公正、独立和 有效地从事强制性产品认证活 动的技术与管理能力；(6) Having resources of testing and inspection, which meet the requirements for undertaking compulsory product certification activities and may be dispatched and used independently; and having certification personnel mee

46、ting the requirements of the Regulation and stable financial resources fitting in with the work task of compulsory product certification.（六）具备从事强制性产品认 证活动所需要并且可以独立调 配使用的检测、检查资源，拥 有与强制性产品认证工作任务 相适应的符合条例规定的认证 人员和稳定的财力资源。Article 10 A laboratory applying for undertaking activities of compulsory products

47、 certification and testing (hereinafter referred to as the laboratory) shall meet the following requirements:第十条申请从事强制性 产品认证检测活动的实验室 （以下简称实验室），应当具 备下列条件：(1) Having the basic conditions and abilities as prescribed by laws and administrative regulations, which have been accredited according to law.（一）

48、具有法律、行政法规规 定的基本条件和能力，并经依 法认定；(2) Having testing experiences of the relevant fields, and having undertaken testing work for more than two years or having issued more than 20 testing reports of the relevant fields.（二）具有相关领域检测经验, 从事检测工作2年以上或者对 外出具相关领域检测报告20 份以上；(3) Conforming to the general requirements of national standards on the technical capability of laboratories.（三）符合国家标准中对实验 室技术能力的通用