Regulations of the People’s Republic of China
on Certification and Accreditation
(Adopted at the 18th Executive Meeting of the State Council on August 20, 2003, promulgated by Decree No. 390 of the State Council of the People’s Republic of China on September 3, 2003, and effective as of November 1, 2003)
Chapter I General Provisions
Article 1 These Regulations are formulated for the purposes of regulating certification and accreditation activities, improving quality of products, services and level of management, and promoting economic and social development.
Article 2 The term “certification” in these Regulations means conformity assessment activities by a certification body to verify that a product, service or management system conforms to technical regulations or standards.
The term “accreditation” in these Regulations means conformity assessment activities by an accreditation body to recognize the competence and qualifications to practice of a certification body, inspection body, laboratory or an individual who engages in certification activities such as audit or assessment.
Article 3 Any person who engages in certification and accreditation activities within the territory of the People’s Republic of
Article 4 The State practices a unitary regulatory system for certification and accreditation activities.
The State practices to certification and accreditation a work mechanism in which joint implementation is conducted by relevant sides under unitary supervision, administration and overall coordination of the certification and accreditation regulatory department of the State Council.
Article 5 The certification and accreditation regulatory department of the State Council shall, according to law, strengthen supervision over and administration activities of certification training bodies and certification consultancy bodies.
Article 6 The principles of objectiveness, independency, openness, impartiality and good faith shall be abided by in certification and accreditation activities.
Article 7 The State encourages international mutual recognition in the field of certification and accreditation on the basis of equality and mutual benefit. However, international mutual recognition in the field of certification and accreditation shall not jeopardize the State security or social and public interests.
Article 8 Any body engaged in certification and accreditation activities and its staff members have the obligation to safeguard confidentiality of State secrets and commercial secrets obtained in certification and accreditation activities.
Chapter II Certification Bodies
Article
Any unit or individual shall not engage in certification activities without approval.
Article
(1) having fixed premises and necessary facilities;
(2) having management system that meets the requirements for certification and accreditation;
(3) having a registered capital of not less than 3,000,000 yuan; and
(4) having not less than ten full-time certification personnel in relevant fields.
A certification body to engage in product certification activities is additionally required to have technical competence in testing or inspection commensurate with relevant product certification activities.
Article
(1) the foreign investor is accredited by an accreditation body in his home country or region;
(2) the foreign investor has engaged in certification activities for not less than three years;
The application for, approval and registration of the establishment of a foreign-funded certification body shall be subject to laws, administrative regulations and other relevant provisions of the State on foreign investment.
Article 12 The application and approval procedures for the establishment of a certification body are as follows:
(1) the applicant that is to establish a certification body shall make a written application to the certification and accreditation regulatory department of the State Council and submit proof documents that meet the requirements prescribed in Article 10 of these Regulations;
(2) the certification and accreditation regulatory department of the State Council shall, within 90 days from the date of acceptance of the application for establishing a certification body, decide to approve or disapprove the application; if the application is related to functions and duties of other departments of the State Council, comments shall be solicited from these departments; if the certification and accreditation regulatory department of the State Council decides to approve the application, it shall issue the approval document to the applicant; if the certification and accreditation regulatory department of the State Council decides to disapprove the application, it shall notify the applicant in writing and give the reasons for the disapproval.
(3) the applicant shall then go through the registration formalities according to law by presenting the approval document issued by the certification and accreditation regulatory department of the State Council.
The certification and accreditation regulatory department of the State Council shall publish the directory of certification bodies that are established according to law.
Article
The application for, approval and registration of the establishment of a foreign certification body’s representative office within the territory of the People’s Republic of China shall be subject to laws, administrative regulations and other relevant provisions of the State on foreign investment.
Article
A certification body shall neither accept any financial support that might affect the objectiveness and impartiality of its certification activities, nor engage in any activity such as product development or marketing that might affect the objectiveness and impartiality of its certification activities.
The certification body shall not have any interests relationship with its applicants in assets or management.
Article 15 Any certification personnel, when practicing certification activities, shall practice in one certification body only and shall not practice in two or more certification bodies simultaneously.
Article 16 Any inspection body or laboratory that provides probative data or results to the public shall have the essential facilities and competence required by relevant laws and administrative regulations and it may engage in relevant activities only after such facilities and competence are verified and approved according to law, and the results of the verification and approval shall be published by the certification and accreditation regulatory department of the State Council
Chapter III Certification
Article 17 The State practices and promotes certification of products, services and management systems in light of the need of economic and social development.
Article
In case of a new certification area in which there are no specific certification rules and procedures formulated by the department referred to in the preceding paragraph, a certification body may develop its own specific certification rules and procedures, and shall submit for the record to the certification and accreditation regulatory department of the State Council.
Article 19 Any legal person, organization or individual may voluntarily apply to a certification body established according to law for certification of products, services and management systems.
Article
Article
Article
A certification body, or a certification-related inspection body or laboratory shall make a complete record of the process of certification, inspection or testing, and keep such record on file.
Article
The certification body and its certification personnel shall be responsible for the certification decision.
Article
Article
Article
The pattern, descriptive text or name of the certification mark designed by a certification body shall not violate provisions of laws and administrative regulations, shall not be the same as or similar to the certification mark promoted by the State, and shall not obstruct the administration of public order or do harm to social morality and customs.
Article
Article 28 Where relevant products are subject to compulsory certification as required by the State for the purposes of protection of State security, prevention of deceptive practices, and protection of human life or safety, animal or plant life or health, and the environment, such products may be released from the manufacturer, marketed, imported or used for any commercial purposes only after they are certified and have certification mark displayed.
Article 29 With regard to products subject to compulsory certification, the State shall apply one product catalogue, one set of technical regulations, standards and conformity assessment procedures, one obligatory mark and one structural fee chart.
The unitary product catalogue (hereinafter referred to as the Catalogue) shall be formulated and adjusted by the certification and accreditation regulatory department of the State Council jointly with the relevant departments of the State Council, announced by the certification and accreditation regulatory department of the State Council, and implemented by the certification and accreditation regulatory department of the State Council jointly with relevant sides.
Article 30 Products listed into the Catalogue must be subject to certification by the certification bodies designated by the certification and accreditation regulatory department of the State Council.
The certification marks of products listed into the Catalogue shall be solely governed by the provisions of the certification and accreditation regulatory department of the State Council.
Article 31 Where products listed into the Catalogue come under the catalogue of import-export commodities subject to inspection, the inspection procedures therefor shall be simplified in the import-export commodity inspection.
Article 32 The certification bodies, certification-related inspection bodies and laboratories designated by the certification and accreditation regulatory department of the State Council (hereinafter referred to as the designated certification bodies, inspection bodies and laboratories) to undertake certification of products listed into the Catalogue shall be those that have engaged in the relevant business for a certain length of time without records of malpractice and obtained accreditation in accordance with the provisions of these Regulations, and be competent to engage in relevant certification activities. When designating certification bodies to undertake certification of products listed into the Catalogue, the certification and accreditation regulatory department of the State Council shall ensure that at least two certification bodies that meet the requirements of these Regulations are designated for each field of products listed into the Catalogue.
Before designating the certification bodies, inspection bodies and laboratories referred to in the preceding paragraph, the certification and accreditation regulatory department of the State Council shall publish relevant information and set up a panel composed of experts well-recognized in relevant fields to review the qualifications of the certification bodies, inspection bodies and laboratories that meet the requirements specified in the preceding paragraph and, based on such review and upon consultation with other relevant departments of the State Council, make a decision within the published time limit by following the principles of rational use of resources, fair competition, convenience and effectiveness.
Article 33 The certification and accreditation regulatory department of the State Council shall publish the directory of designated certification bodies, inspection bodies and laboratories as well as their respective designated business scopes.
Without designation, any body shall not engage in certification, certification-related inspection or testing activities of products listed into the Catalogue.
Article 34 Manufacturers, sellers, or importers of products listed into the Catalogue may apply to a designated certification body for the certification on their own initiative.
Article 35 Designated certification bodies, inspection bodies or laboratories shall provide convenient and timely certification, inspection or testing services to applicants within the designated business scopes, and shall not delay, discriminate against applicants, impede or inhibit access by applicants, or seek undue interests.
Designated certification bodies shall not subcontract the designated certification business to other bodies.
Article 36 International mutual recognition activities conducted by designated certification bodies, inspection bodies and laboratories shall be within the framework of the international mutual recognition arrangements concluded by the certification and accreditation regulatory department of the State Council or other departments of the State Council upon authorization.
Chapter IV Accreditation
Article 37 The accreditation body authorized by the certification and accreditation regulatory department of the State Council (hereinafter referred to as the accreditation body) conducts accreditation activities independently.
No unit other than the accreditation body authorized by the certification and accreditation regulatory department of the State Council may engage in accreditation activities directly or in a disguised form; if any other unit does so, its accreditation results shall be invalid.
Article 38 Any certification body, inspection body or laboratory may seek accreditation by the accreditation body to demonstrate that its certification, inspection or testing capability meets the accreditation requirements continuously and steadily.
Article 39 Any individual engaged in certification activities such as audit or assessment shall not engage in related certification activities only after he registers with the accreditation body.
Article 40 The accreditation body shall have a quality system commensurate with its business scope and establish internal audit system to ensure effective implementation of the quality system.
Article 41 The accreditation body may choose or employ individuals to conduct assessment activities in accreditation in light of the needs of accreditation. Such individuals shall be well-recognized experts in relevant fields, be familiar with relevant laws, administrative regulations and accreditation rules and procedures, and have good morality, professional knowledge and competence that are needed for accreditation.
Article 42 Where the accreditation body subcontracts any specific assessment task related to accreditation, the accreditation body shall take responsibility for the assessment decision.
Article 43 The accreditation body shall make publicly available information such as accreditation requirements, accreditation procedures and the structural fee chart.
When accepting an application, the accreditation body shall not set on the applicant any conditions or restrictions irrelevant to accreditation activities.
Article 44 The accreditation body shall, in accordance with national standards and provisions of the certification and accreditation regulatory department of the State Council, complete the assessment of a certification body, an inspection body or a laboratory and make a decision whether or not to grant accreditation within the published time limit, make a complete record of the process of accreditation and keep such record on file. The accreditation body shall ensure the objectiveness, impartiality, integrity and effectiveness of accreditation and take responsibility for accreditation decisions.
The accreditation body shall issue accreditation certificates to accredited certification bodies, inspection bodies and laboratories and publish the directory of such accredited certification bodies, inspection bodies and laboratories.
Article 45 The accreditation body shall, in accordance with national standards and provisions of the certification and accreditation regulatory department of the State Council, evaluate individuals engaged in certification activities such as audit or assessment and register those who are qualified upon examination.
Article 46 The accreditation certificate shall specify the accreditation scope, accreditation criteria, accreditation field, and period of validity.
The format of the accreditation certificate and the pattern of the accreditation mark are subject to the approval of the certification and accreditation regulatory department of the State Council.
Article 47 The accredited body shall use its accreditation certificate and accreditation mark within the accredited scope. If the accredited body improperly uses its accreditation certificate or accreditation mark, the accreditation body shall suspend or even withdraw its accreditation certificate and make such suspension or withdrawal public.
Article 48 The accreditation body shall exercise effective follow-up surveillance over accredited bodies and individuals and conduct regular re-assessment over accredited bodies to verify whether they maintain conformity with the accreditation requirements. If an accredited body or a registered individual is found no longer meeting the accreditation requirements, the accreditation body shall withdraw the accreditation certificate and make such withdrawal public.
The accredited body shall inform the accreditation body in a timely manner of changes in its staff, principal responsible persons, facilities, self-developed specific certification rules and procedures and other changes affecting the conformity with the accreditation requirements.
Article 49 The accreditation body shall not accept any financial support that might affect the objectiveness and impartiality of accreditation activities.
Article
Chapter VI Supervision and Administration
Article 51 The certification and accreditation regulatory department of the State Council may, when exercising supervision of certification bodies, certification-related inspection bodies and laboratories for their conformity with the provisions of these Regulations, takes the form of organizing survey among counterparts, soliciting comments from applicants or certificate holders, conducting sampling examination over certification activities and certification results, or requiring certification bodies, certification-related inspection bodies and laboratories to report on their business activities. Upon finding any violation of these Regulations, the certification and accreditation regulatory department of the State Council shall conduct investigation and make disposition promptly, and inform other relevant departments of the State Council in a timely manner if the case is related to the functions and duties of such departments.
Article 52 The certification and accreditation regulatory department of the State Council shall conduct target supervision over the designated certification bodies, inspection bodies and laboratories by conducting regular or irregular inspection over their certification, inspection and testing activities. A designated certification body, inspection body or laboratory shall regularly submit reports to the certification and accreditation regulatory department of the State Council and take responsibility for the authenticity of the reports. The reports shall include information about the certification, inspection or testing activities of products listed into the Catalogue.
Article 53 The accreditation body shall regularly submit reports to the certification and accreditation regulatory department of the State Council and take responsibility for the authenticity of the reports. The reports shall include information about its implementation of the accreditation system, accreditation activities and performance of its staff.
The certification and accreditation regulatory department of the State Council shall evaluate the reports from the accreditation body and exercise supervision over the accreditation body by taking forms such as reviewing files and documents on accreditation activities or enquiring relevant individuals.
Article 54 The certification and accreditation regulatory department of the State Council may, in light of the needs of supervision and administration of certification and accreditation activities, enquire the principal responsible persons of the accreditation body, certification bodies, inspection bodies or laboratories, carry out investigation and give cautionary advice, and the individuals concerned shall provide active cooperation.
Article 55 The quality and technical supervision departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government and the entry-exit inspection and quarantine agencies established locally by the quality supervision, inspection and quarantine department of the State Council shall exercise supervision and administration of certification activities in accordance with the provisions of these Regulations and within the scope authorized by the certification and accreditation regulatory department of the State Council.
The quality and technical supervision departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government and the entry-exit inspection and quarantine agencies established locally by the quality supervision, inspection and quarantine department of the State Council that are authorized by the certification and accreditation regulatory department of the State Council are collectively referred to as local certification regulatory departments.
Article 56 Any unit or individual has the right to inform the certification and accreditation regulatory department of the State Council or the local certification regulatory departments of any illegal activities in certification and accreditation. The certification and accreditation regulatory department of the State Council and the local certification regulatory departments shall conduct investigation and make disposition in a timely manner, and keep the informant confidential.
Chapter VI Legal Liability
Article 57 Anyone that engages in certification activities without approval or authorization shall be banned and imposed a fine of not less than 100,000 yuan but not more than 500,000 yuan, and the illegal income, if any, shall be confiscated.
Article 58 Where a foreign certification body establishes a representative office within the territory of the People’s Republic of
Where a foreign certification body’s representative office, the establishment of which is approved, engages in certification activities within the territory of the People’s Republic of China, the said representative office shall be ordered to make corrections and be imposed a fine of not less than 100,000 yuan but not more than 500,000 yuan; the illegal income, if any, shall be confiscated; if the circumstances are serious, the approval document shall be revoked and such revocation shall be made public.
Article 59 Where a certification body accepts financial support that might affect the objectiveness and impartiality of certification activities, engages in activities such as product development, or marketing that might affect the objectiveness and impartiality of certification activities, or has interests relationship with its applicants in assets or management, it shall be ordered to suspend its business for rectification; if the circumstances are serious, the approval document shall be revoked and such revocation shall be made public; the illegal income, if any, shall be confiscated; if such act constitutes a crime, criminal liability shall be investigated according to law.
Article 60 Where a certification body comes under any of the following circumstances, it shall be ordered to make corrections and be imposed a fine of not less than 50,000 yuan but not more than 200,000 yuan; the illegal income, if any, shall be confiscated; if the circumstances are serious, it shall be ordered to suspend its business for rectification, or even the approval document shall be revoked and such revocation shall be made public.
(1) conducting certification activities beyond the approved scope;
(2) adding, reducing, or omitting procedures required by the principled certification rules and specific certification rules and procedures；
(3) failing to exercise effective follow-up surveillance of the certified products, services or management systems or failing to suspend or withdraw the certificate and make such suspension or withdrawal public in a timely manner upon finding any failure of certified products, services or management systems in maintaining conformity with the certification requirements;
(4) employing individuals who do not register with the accreditation body to conduct certification activities.
Where a certification-related inspection body or a laboratory adds, reduces or omits procedures required by the principled certification rules and specific certification rules and procedures, punishment shall be imposed thereupon in accordance with the preceding paragraph.
Article 61 Where a certification body comes under any of the following circumstances, it shall be ordered to make corrections within a specified time limit; if it fails to do so, it shall be imposed a fine of not less than 20,000 yuan but not more than 100,000 yuan:
(1) refusing to provide certification services within its business scope on the excuse that the applicant has not sought certification consultation or attended certification training, or setting conditions or restrictions irrelevant to the certification activities on the applicant;
(2) having its own designed pattern, descriptive text or name of the certification mark being the same as or similar to the certification mark promoted by the State, obstructing the administration of public order, or doing harm to social morality and customs;
(3) failing to make publicly available information such as principled certification rules and specific certification rules and procedures, and the structural fee chart.
(4) failing to make a complete record of the process of certification and keep such record on file;
(5) failing to issue the certificate to the certified applicant in a timely manner.
Where a certification-related inspection body or a laboratory fails to make a complete record of the process of certification and keep such record on file, punishment shall be imposed thereupon in accordance with the preceding paragraph.
Article 62 Where a certification body issues a false certification conclusion or a certification conclusion that is highly inconsistent with the facts, its approval document shall be revoked and such revocation shall be made public; the persons in charge bearing direct responsibility and the certification personnel directly responsible therefor shall be disqualified; if such act constitutes a crime, criminal liability shall be investigated according to law; if any damage is thus caused, the certification body shall be liable for the compensation.
Where a designated certification body commits one of the illegal acts prescribed in the preceding paragraph, the designation shall be revoked concurrently.
Article 63 Where certification personnel, when engaging in certification activities, do not practice in one certification body or practice in more than one certification body at the same time, they shall be ordered to make corrections and their practice shall be suspended for not less than six months but not more than two years; if they fail to make corrections, they shall be disqualified.
Article 64 Where a certification body or a certification-related inspection body or laboratory, without designation or authorization, engages in certification or certification-related inspection or testing activities of products listed into the Catalogue, it shall be ordered to make corrections and be imposed a fine of not less than 100,000 yuan but not more than 500,000 yuan; the illegal income, if any, shall be confiscated.
Where a certification body, without designation or authorization, engages in certification of products listed into the Catalogue, its approval document shall be revoked and such revocation shall be made public.
Article 65 Where a designated certification body, inspection body or laboratory engages in certification or certification-related inspection or testing activities of products listed into the Catalogue beyond its designated business scope, it shall be ordered to make corrections and be imposed a fine of not less than 100,000 yuan but not more than 500,000 yuan; the illegal income, if any, shall be confiscated; if the circumstances are serious, the designation shall be revoked or even the approval document shall be revoked and such revocation shall be made public.
Where a designated certification body subcontracts the designated certification business, punishment shall be imposed thereupon in accordance with the preceding paragraph.
Article 66 Where a certification body, inspection body or laboratory obtains accreditation from a foreign accreditation body but fails to make a report to the certification and accreditation regulatory department of the State Council for the record, it shall be given a warning and such warning shall be made public.
Article 67 Where a product listed into the Catalogue, without certification, is released from the manufacturer, marketed, imported or used for any commercial purposes, corrections shall be ordered to be made and a fine of not less than 50,000 yuan but not more than 200,000 yuan shall be imposed; the illegal income, if any, shall be confiscated.
Article 68 Where the accreditation body comes under any of the following circumstances, it shall be ordered to make corrections; if the circumstances are serious, the principal responsible person and persons responsible shall be dismissed from their posts or discharged from employment:
(1) granting accreditation to the body or individual that does not meet the accreditation requirements;
(2) failing to withdraw an accreditation certificate and make the withdrawal public when finding that the accredited body or individual does not meet the accreditation requirements;
(3) accepting financial support that might affect the objectiveness and impartiality of accreditation activities.
The principal responsible person and persons responsible dismissed from their posts or discharged from employment shall not engage in accreditation activities within five years from the date of such dismissal or discharge.
Article 69 Where the accreditation body comes under any of the following circumstances, it shall be ordered to make corrections and its principal responsible person and persons responsible shall be given a warning:
(1) setting on an applicant conditions or restrictions irrelevant to accreditation activities when accepting an application;
(2) failing to complete accreditation activities within the published time limit, or failing to make publicly available information such as accreditation requirements, accreditation procedures and the structural fee chart;
(3) failing to suspend or withdraw the accreditation certificate and make such suspension or withdrawal public in a timely manner, when finding that an accredited body improperly uses the accreditation certificate or the accreditation mark.;
(4) failing to make a complete record of the process of accreditation and keep such record on file.
Article 70 Where the certification and accreditation regulatory department of the State Council or local certification regulatory departments or their staff members abuse their power, commit illegalities for personal interests or by fraudulent means, or neglect their duties by committing any of the following acts, the persons in charge bearing direct responsibility and other persons directly responsible therefor shall be given an administrative sanction of demotion or dismissal from post according to law; if such act constitutes a crime, criminal liability shall be investigated according to law:
(1) Failing to conduct approval and designation in accordance with the requirements or procedures of these Regulations;
(2) Failing to revoke approval document or designation when finding that a certification body no longer meets the requirements for approval and designation in these Regulations;
(3) failing to revoke designation when finding that a designated inspection body or laboratory no longer meets relevant requirements prescribed in these Regulations;
(4) failing to conduct investigation and make disposition when finding that a certification body, certification-related inspection body or laboratory issues false certification conclusion or certification-related inspection or testing conclusion or such conclusion is highly inconsistent with the facts;
(5) failing to conduct investigation and make disposition when finding other illegal acts in certification and accreditation prescribed in these Regulations.
Article 71 Any person who forges, falsely uses, buys or sells certification marks or certificates shall be investigated and dealt with in accordance with the provisions of the Law of the People’s Republic of
Article 72 The administrative penalty prescribed in these Regulations shall be imposed by the certification and accreditation regulatory department of the State Council or its authorized local certification regulatory departments within their respective scope of functions and duties. If laws or other administrative regulations provided otherwise, the provisions of such laws or administrative regulations shall apply.
Article 73 Where any of the certification personnel is disqualified, the accreditation body shall not accept his registration application within five years from the date of the disqualification.
Article 74 Where a certification body fails to conduct effective follow-up surveillance over its certified products, or fails to suspend or withdraw the certificate and require the cease of use of the certification mark in a timely manner when finding that the certified products fail to maintain conformity with the certification requirements, and thus causes damages to consumers, the certification body shall bear joint and several liability with the manufacturer and seller.
Chapter VII Supplementary Provisions
Article 75 These Regulations shall not apply to good manufacturing practice for pharmaceutical products inspection and the good supply practice for pharmaceutical products inspection, quality certification for laboratory animals, certification of products for military use, and accreditation for laboratories as well as their staff members that engage in calibration or testing for military industrial products.
Where a certification body approved in accordance with these Regulations engages in management system certification for mines or manufacturers or operators of hazardous chemicals or fireworks, such certification shall be organized by the work safety regulatory department of the State Council by taking into consideration special requirements of work safety; a certification body that is to engage in comprehensive assessment of the work safety of mines, manufacturers or operators of hazardous chemicals or fireworks shall not be accredited only after it is recommended by the work safety regulatory department of the State Council.
Article 76 Structural fee charts for certification and accreditation shall be in conformity with the provisions of relevant laws and administrative regulations of the State on pricing.
Article 77 Measures for administration of certification training bodies and certification consultancy bodies shall be developed by the certification and accreditation regulatory department of the State Council.
Article 78 These Regulations shall be effective as of November 1, 2003. The Regulations of the People’s Republic of
Article 30 Products listed into the Catalogue must be subject to certification by the certification bodies designated by the certification and accreditation regulatory department of the State Council.
The certification marks of products listed into the Catalogue shall be solely governed by the provisions of the certification and accreditation regulatory department of the State Council.
Article 31 Where products listed into the Catalogue come under the catalogue of import-export commodities subject to inspection, the inspection procedures therefor shall be simplified in the import-export commodity inspection.
Article 32 The certification bodies, certification-related inspection bodies and laboratories designated by the certification and accreditation regulatory department of the State Council (hereinafter referred to as the designated certification bodies, inspection bodies and laboratories) to undertake certification of products listed into the Catalogue shall be those that have engaged in the relevant business for a certain length of time without records of malpractice and obtained accreditation in accordance with the provisions of these Regulations, and be competent to engage in relevant certification activities. When designating certification bodies to undertake certification of products listed into the Catalogue, the certification and accreditation regulatory department of the State Council shall ensure that at least two certification bodies that meet the requirements of these Regulations are designated for each field of products listed into the Catalogue.
Before designating the certification bodies, inspection bodies and laboratories referred to in the preceding paragraph, the certification and accreditation regulatory department of the State Council shall publish relevant information and set up a panel composed of experts well-recognized in relevant fields to review the qualifications of the certification bodies, inspection bodies and laboratories that meet the requirements specified in the preceding paragraph and, based on such review and upon consultation with other relevant departments of the State Council, make a decision within the published time limit by following the principles of rational use of resources, fair competition, convenience and effectiveness.
Article 33 The certification and accreditation regulatory department of the State Council shall publish the directory of designated certification bodies, inspection bodies and laboratories as well as their respective designated business scopes.
Without designation, any body shall not engage in certification, certification-related inspection or testing activities of products listed into the Catalogue.
Article 34 Manufacturers, sellers, or importers of products listed into the Catalogue may apply to a designated certification body for the certification on their own initiative.
Article 35 Designated certification bodies, inspection bodies or laboratories shall provide convenient and timely certification, inspection or testing services to applicants within the designated business scopes, and shall not delay, discriminate against applicants, impede or inhibit access by applicants, or seek undue interests.
Designated certification bodies shall not subcontract the designated certification business to other bodies.
Article 36 International mutual recognition activities conducted by designated certification bodies, inspection bodies and laboratories shall be within the framework of the international mutual recognition arrangements concluded by the certification and accreditation regulatory department of the State Council or other departments of the State Council upon authorization.
Chapter IV Accreditation
Article 37 The accreditation body authorized by the certification and accreditation regulatory department of the State Council (hereinafter referred to as the accreditation body) conducts accreditation activities independently.
No unit other than the accreditation body authorized by the certification and accreditation regulatory department of the State Council may engage in accreditation activities directly or in a disguised form; if any other unit does so, its accreditation results shall be invalid.
Article 38 Any certification body, inspection body or laboratory may seek accreditation by the accreditation body to demonstrate that its certification, inspection or testing capability meets the accreditation requirements continuously and steadily.
Article 39 Any individual engaged in certification activities such as audit or assessment shall not engage in related certification activities only after he registers with the accreditation body.
Article 40 The accreditation body shall have a quality system commensurate with its business scope and establish internal audit system to ensure effective implementation of the quality system.
Article 41 The accreditation body may choose or employ individuals to conduct assessment activities in accreditation in light of the needs of accreditation. Such individuals shall be well-recognized experts in relevant fields, be familiar with relevant laws, administrative regulations and accreditation rules and procedures, and have good morality, professional knowledge and competence that are needed for accreditation.
Article 42 Where the accreditation body subcontracts any specific assessment task related to accreditation, the accreditation body shall take responsibility for the assessment decision.
Article 43 The accreditation body shall make publicly available information such as accreditation requirements, accreditation procedures and the structural fee chart.
When accepting an application, the accreditation body shall not set on the applicant any conditions or restrictions irrelevant to accreditation activities.
Article 44 The accreditation body shall, in accordance with national standards and provisions of the certification and accreditation regulatory department of the State Council, complete the assessment of a certification body, an inspection body or a laboratory and make a decision whether or not to grant accreditation within the published time limit, make a complete record of the process of accreditation and keep such record on file. The accreditation body shall ensure the objectiveness, impartiality, integrity and effectiveness of accreditation and take responsibility for accreditation decisions.
The accreditation body shall issue accreditation certificates to accredited certification bodies, inspection bodies and laboratories and publish the directory of such accredited certification bodies, inspection bodies and laboratories.
Article 45 The accreditation body shall, in accordance with national standards and provisions of the certification and accreditation regulatory department of the State Council, evaluate individuals engaged in certification activities such as audit or assessment and register those who are qualified upon examination.
Article 46 The accreditation certificate shall specify the accreditation scope, accreditation criteria, accreditation field, and period of validity.
The format of the accreditation certificate and the pattern of the accreditation mark are subject to the approval of the certification and accreditation regulatory department of the State Council.
Article 47 The accredited body shall use its accreditation certificate and accreditation mark within the accredited scope. If the accredited body improperly uses its accreditation certificate or accreditation mark, the accreditation body shall suspend or even withdraw its accreditation certificate and make such suspension or withdrawal public.
Article 48 The accreditation body shall exercise effective follow-up surveillance over accredited bodies and individuals and conduct regular re-assessment over accredited bodies to verify whether they maintain conformity with the accreditation requirements. If an accredited body or a registered individual is found no longer meeting the accreditation requirements, the accreditation body shall withdraw the accreditation certificate and make such withdrawal public.
The accredited body shall inform the accreditation body in a timely manner of changes in its staff, principal responsible persons, facilities, self-developed specific certification rules and procedures and other changes affecting the conformity with the accreditation requirements.
Article 49 The accreditation body shall not accept any financial support that might affect the objectiveness and impartiality of accreditation activities.
Article
Chapter VI Supervision and Administration
Article 51 The certification and accreditation regulatory department of the State Council may, when exercising supervision of certification bodies, certification-related inspection bodies and laboratories for their conformity with the provisions of these Regulations, takes the form of organizing survey among counterparts, soliciting comments from applicants or certificate holders, conducting sampling examination over certification activities and certification results, or requiring certification bodies, certification-related inspection bodies and laboratories to report on their business activities. Upon finding any violation of these Regulations, the certification and accreditation regulatory department of the State Council shall conduct investigation and make disposition promptly, and inform other relevant departments of the State Council in a timely manner if the case is related to the functions and duties of such departments.
Article 52 The certification and accreditation regulatory department of the State Council shall conduct target supervision over the designated certification bodies, inspection bodies and laboratories by conducting regular or irregular inspection over their certification, inspection and testing activities. A designated certification body, inspection body or laboratory shall regularly submit reports to the certification and accreditation regulatory department of the State Council and take responsibility for the authenticity of the reports. The reports shall include information about the certification, inspection or testing activities of products listed into the Catalogue.
Article 53 The accreditation body shall regularly submit reports to the certification and accreditation regulatory department of the State Council and take responsibility for the authenticity of the reports. The reports shall include information about its implementation of the accreditation system, accreditation activities and performance of its staff.
The certification and accreditation regulatory department of the State Council shall evaluate the reports from the accreditation body and exercise supervision over the accreditation body by taking forms such as reviewing files and documents on accreditation activities or enquiring relevant individuals.
Article 54 The certification and accreditation regulatory department of the State Council may, in light of the needs of supervision and administration of certification and accreditation activities, enquire the principal responsible persons of the accreditation body, certification bodies, inspection bodies or laboratories, carry out investigation and give cautionary advice, and the individuals concerned shall provide active cooperation.
Article 55 The quality and technical supervision departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government and the entry-exit inspection and quarantine agencies established locally by the quality supervision, inspection and quarantine department of the State Council shall exercise supervision and administration of certification activities in accordance with the provisions of these Regulations and within the scope authorized by the certification and accreditation regulatory department of the State Council.
The quality and technical supervision departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government and the entry-exit inspection and quarantine agencies established locally by the quality supervision, inspection and quarantine department of the State Council that are authorized by the certification and accreditation regulatory department of the State Council are collectively referred to as local certification regulatory departments.
Article 56 Any unit or individual has the right to inform the certification and accreditation regulatory department of the State Council or the local certification regulatory departments of any illegal activities in certification and accreditation. The certification and accreditation regulatory department of the State Council and the local certification regulatory departments shall conduct investigation and make disposition in a timely manner, and keep the informant confidential.
Chapter VI Legal Liability
Article 57 Anyone that engages in certification activities without approval or authorization shall be banned and imposed a fine of not less than 100,000 yuan but not more than 500,000 yuan, and the illegal income, if any, shall be confiscated.
Article 58 Where a foreign certification body establishes a representative office within the territory of the People’s Republic of
Where a foreign certification body’s representative office, the establishment of which is approved, engages in certification activities within the territory of the People’s Republic of China, the said representative office shall be ordered to make corrections and be imposed a fine of not less than 100,000 yuan but not more than 500,000 yuan; the illegal income, if any, shall be confiscated; if the circumstances are serious, the approval document shall be revoked and such revocation shall be made public.
Article 59 Where a certification body accepts financial support that might affect the objectiveness and impartiality of certification activities, engages in activities such as product development, or marketing that might affect the objectiveness and impartiality of certification activities, or has interests relationship with its applicants in assets or management, it shall be ordered to suspend its business for rectification; if the circumstances are serious, the approval document shall be revoked and such revocation shall be made public; the illegal income, if any, shall be confiscated; if such act constitutes a crime, criminal liability shall be investigated according to law.
Article 60 Where a certification body comes under any of the following circumstances, it shall be ordered to make corrections and be imposed a fine of not less than 50,000 yuan but not more than 200,000 yuan; the illegal income, if any, shall be confiscated; if the circumstances are serious, it shall be ordered to suspend its business for rectification, or even the approval document shall be revoked and such revocation shall be made public.
(1) conducting certification activities beyond the approved scope;
(2) adding, reducing, or omitting procedures required by the principled certification rules and specific certification rules and procedures；
(3) failing to exercise effective follow-up surveillance of the certified products, services or management systems or failing to suspend or withdraw the certificate and make such suspension or withdrawal public in a timely manner upon finding any failure of certified products, services or management systems in maintaining conformity with the certification requirements;
(4) employing individuals who do not register with the accreditation body to conduct certification activities.
Where a certification-related inspection body or a laboratory adds, reduces or omits procedures required by the principled certification rules and specific certification rules and procedures, punishment shall be imposed thereupon in accordance with the preceding paragraph.
Article 61 Where a certification body comes under any of the following circumstances, it shall be ordered to make corrections within a specified time limit; if it fails to do so, it shall be imposed a fine of not less than 20,000 yuan but not more than 100,000 yuan:
(1) refusing to provide certification services within its business scope on the excuse that the applicant has not sought certification consultation or attended certification training, or setting conditions or restrictions irrelevant to the certification activities on the applicant;
(2) having its own designed pattern, descriptive text or name of the certification mark being the same as or similar to the certification mark promoted by the State, obstructing the administration of public order, or doing harm to social morality and customs;
(3) failing to make publicly available information such as principled certification rules and specific certification rules and procedures, and the structural fee chart.
(4) failing to make a complete record of the process of certification and keep such record on file;
(5) failing to issue the certificate to the certified applicant in a timely manner.
Where a certification-related inspection body or a laboratory fails to make a complete record of the process of certification and keep such record on file, punishment shall be imposed thereupon in accordance with the preceding paragraph.
Article 62 Where a certification body issues a false certification conclusion or a certification conclusion that is highly inconsistent with the facts, its approval document shall be revoked and such revocation shall be made public; the persons in charge bearing direct responsibility and the certification personnel directly responsible therefor shall be disqualified; if such act constitutes a crime, criminal liability shall be investigated according to law; if any damage is thus caused, the certification body shall be liable for the compensation.
Where a designated certification body commits one of the illegal acts prescribed in the preceding paragraph, the designation shall be revoked concurrently.
Article 63 Where certification personnel, when engaging in certification activities, do not practice in one certification body or practice in more than one certification body at the same time, they shall be ordered to make corrections and their practice shall be suspended for not less than six months but not more than two years; if they fail to make corrections, they shall be disqualified.
Article 64 Where a certification body or a certification-related inspection body or laboratory, without designation or authorization, engages in certification or certification-related inspection or testing activities of products listed into the Catalogue, it shall be ordered to make corrections and be imposed a fine of not less than 100,000 yuan but not more than 500,000 yuan; the illegal income, if any, shall be confiscated.
Where a certification body, without designation or authorization, engages in certification of products listed into the Catalogue, its approval document shall be revoked and such revocation shall be made public.
Article 65 Where a designated certification body, inspection body or laboratory engages in certification or certification-related inspection or testing activities of products listed into the Catalogue beyond its designated business scope, it shall be ordered to make corrections and be imposed a fine of not less than 100,000 yuan but not more than 500,000 yuan; the illegal income, if any, shall be confiscated; if the circumstances are serious, the designation shall be revoked or even the approval document shall be revoked and such revocation shall be made public.
Where a designated certification body subcontracts the designated certification business, punishment shall be imposed thereupon in accordance with the preceding paragraph.
Article 66 Where a certification body, inspection body or laboratory obtains accreditation from a foreign accreditation body but fails to make a report to the certification and accreditation regulatory department of the State Council for the record, it shall be given a warning and such warning shall be made public.
Article 67 Where a product listed into the Catalogue, without certification, is released from the manufacturer, marketed, imported or used for any commercial purposes, corrections shall be ordered to be made and a fine of not less than 50,000 yuan but not more than 200,000 yuan shall be imposed; the illegal income, if any, shall be confiscated.
Article 68 Where the accreditation body comes under any of the following circumstances, it shall be ordered to make corrections; if the circumstances are serious, the principal responsible person and persons responsible shall be dismissed from their posts or discharged from employment:
(1) granting accreditation to the body or individual that does not meet the accreditation requirements;
(2) failing to withdraw an accreditation certificate and make the withdrawal public when finding that the accredited body or individual does not meet the accreditation requirements;
(3) accepting financial support that might affect the objectiveness and impartiality of accreditation activities.
The principal responsible person and persons responsible dismissed from their posts or discharged from employment shall not engage in accreditation activities within five years from the date of such dismissal or discharge.
Article 69 Where the accreditation body comes under any of the following circumstances, it shall be ordered to make corrections and its principal responsible person and persons responsible shall be given a warning:
(1) setting on an applicant conditions or restrictions irrelevant to accreditation activities when accepting an application;
(2) failing to complete accreditation activities within the published time limit, or failing to make publicly available information such as accreditation requirements, accreditation procedures and the structural fee chart;
(3) failing to suspend or withdraw the accreditation certificate and make such suspension or withdrawal public in a timely manner, when finding that an accredited body improperly uses the accreditation certificate or the accreditation mark.;
(4) failing to make a complete record of the process of accreditation and keep such record on file.
Article 70 Where the certification and accreditation regulatory department of the State Council or local certification regulatory departments or their staff members abuse their power, commit illegalities for personal interests or by fraudulent means, or neglect their duties by committing any of the following acts, the persons in charge bearing direct responsibility and other persons directly responsible therefor shall be given an administrative sanction of demotion or dismissal from post according to law; if such act constitutes a crime, criminal liability shall be investigated according to law:
(1) Failing to conduct approval and designation in accordance with the requirements or procedures of these Regulations;
(2) Failing to revoke approval document or designation when finding that a certification body no longer meets the requirements for approval and designation in these Regulations;
(3) failing to revoke designation when finding that a designated inspection body or laboratory no longer meets relevant requirements prescribed in these Regulations;
(4) failing to conduct investigation and make disposition when finding that a certification body, certification-related inspection body or laboratory issues false certification conclusion or certification-related inspection or testing conclusion or such conclusion is highly inconsistent with the facts;
(5) failing to conduct investigation and make disposition when finding other illegal acts in certification and accreditation prescribed in these Regulations.
Article 71 Any person who forges, falsely uses, buys or sells certification marks or certificates shall be investigated and dealt with in accordance with the provisions of the Law of the People’s Republic of
Article 72 The administrative penalty prescribed in these Regulations shall be imposed by the certification and accreditation regulatory department of the State Council or its authorized local certification regulatory departments within their respective scope of functions and duties. If laws or other administrative regulations provided otherwise, the provisions of such laws or administrative regulations shall apply.
Article 73 Where any of the certification personnel is disqualified, the accreditation body shall not accept his registration application within five years from the date of the disqualification.
Article 74 Where a certification body fails to conduct effective follow-up surveillance over its certified products, or fails to suspend or withdraw the certificate and require the cease of use of the certification mark in a timely manner when finding that the certified products fail to maintain conformity with the certification requirements, and thus causes damages to consumers, the certification body shall bear joint and several liability with the manufacturer and seller.
Chapter VII Supplementary Provisions
Article 75 These Regulations shall not apply to good manufacturing practice for pharmaceutical products inspection and the good supply practice for pharmaceutical products inspection, quality certification for laboratory animals, certification of products for military use, and accreditation for laboratories as well as their staff members that engage in calibration or testing for military industrial products.
Where a certification body approved in accordance with these Regulations engages in management system certification for mines or manufacturers or operators of hazardous chemicals or fireworks, such certification shall be organized by the work safety regulatory department of the State Council by taking into consideration special requirements of work safety; a certification body that is to engage in comprehensive assessment of the work safety of mines, manufacturers or operators of hazardous chemicals or fireworks shall not be accredited only after it is recommended by the work safety regulatory department of the State Council.
Article 76 Structural fee charts for certification and accreditation shall be in conformity with the provisions of relevant laws and administrative regulations of the State on pricing.
Article 77 Measures for administration of certification training bodies and certification consultancy bodies shall be developed by the certification and accreditation regulatory department of the State Council.
Article 78 These Regulations shall be effective as of November 1, 2003. The Regulations of the People’s Republic of
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