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Republic of China Certification and Accreditation

                                                      Date:2003-09-03

PRC State Council Order No. 390

"Republic of China Certification and Accreditation" has been August 20, 2003 the 18th executive meeting of the State Council, is hereby promulgated, November 1, 2003 shall come into force.

Premier Wen Jiabao 2003-09-03

Republic of China Certification and Accreditation

Chapter I General Provisions

The first order to standardize the certification and accreditation activities, improve the product, service quality and management level, to promote economic and social development, the enactment of this Ordinance.

Article The term certification is defined by the certification body to prove the products, services, management systems comply with the relevant technical specifications, technical specifications related to the mandatory requirements or standards for conformity assessment activities.

The term recognition is by a recognized body of certification bodies, inspection bodies, laboratories, and in the review, audit certification activities, staff capacity and qualification, recognition of conformity assessment activities.

Article in the PRC engaged in certification and accreditation activities shall comply with the regulations.

The state shall exercise unified supervision and management system certification and accreditation.

Certification and accreditation work to implement the state Certification and Accreditation Administration of the State Council departments under a unified management, supervision and overall coordination with all parties working together to implement the mechanism.

Article certification and accreditation regulatory department of the State Council shall on the certification training institutions, certification advisory bodies activities to strengthen supervision and management.

Article certification and accreditation activities should follow the objective, independent, open, fair, and good faith.

Article 7 The State encourages equality and mutual benefits to carry out the international mutual recognition of certification and accreditation activities. International mutual recognition of certification and accreditation activities must not harm national security and public interests.

Article 8 certification and accreditation activities of institutions and their staff are aware of its state secrets and commercial secrets obligation to keep confidential.

 

Chapter II certification

 

Article 9 Where a certification body, shall be subject to certification and accreditation regulatory department of the State Council for approval and obtain legal personality in accordance with the law, before engaging in activities approved within the scope of certification.

Without approval, no unit or individual shall not engage in certification activities.

Article establishment of certification bodies must meet the following conditions:

(A) have a fixed place and necessary facilities;

(B) comply with the requirements of management system certification and accreditation;

(C) the registered capital of not less than RMB 300 million;

(D) the corresponding field of more than 10 full-time certified staff.

Engaged in product certification activities of certification bodies, should also have engaged in relevant product certification activities with the fit testing, inspection and other technical skills.

Article 11 The establishment of certification bodies in addition to foreign investment shall comply with the provisions of Article X of this Ordinance, the conditions should also meet the following conditions:

(A) foreign investors in their country or region to obtain authorized institution;

(B) the foreign investor with more than 3 years of business experience in the certification activities.

The establishment of foreign investment applications for certification, approval and registration, in accordance with relevant foreign investment laws, administrative regulations and relevant state regulations.

Article XII of the establishment of institutions for certification and approval procedures:

(A) establish the applicant certification body shall be filed with the State Certification and Accreditation Administration department a written application and submit meet the requirements specified in Article 10 of these Regulations supporting documents;

(B) certification and accreditation regulatory department of the State Council from accepting certification body set up within 90 days from the date of application should be made whether to approve the decision. State Council departments involved in duties, shall solicit the views of relevant departments of the State Council. Decision to approve, the approval documents issued to the applicant, the decision not to approve, it shall notify the applicant and the reasons;

(3) The applicant with the certification and accreditation regulatory department of the State Council issued the document of approval, according to registration.

Certification and accreditation regulatory department of the State Council shall publish the list of certification bodies established by law.

Article XIII of foreign certification bodies established in the PRC representative, subject to ratification, industrial and commercial administrative department shall, after registration, before engaging with the affiliation of business-related promotional activities, but shall not engage in certification activities.

Foreign certification body set up representative offices in the PRC, the application, approval and registration of foreign investment in accordance with the relevant laws, administrative regulations and relevant state regulations.

Article XIV certification body shall not exist between the executive and interests.

Certification body shall not accept any certification activity may affect the funding objective and fair; certification shall not engage in any activity likely to affect the objectivity of product development, marketing and other activities.

Certification bodies and certification of the client there is no asset management interests.

Article XV certified personnel engaged in certification activities, a certification body should be in practice, not more than two certification bodies in the same practice.

Article XVI issued to the community has proved the role of data and results of the inspection bodies, laboratories, should have the relevant laws and administrative regulations of the basic conditions and capabilities, and have been determined by law only after engaging in appropriate activities, the results found by the State Council certification and accreditation regulatory department announced.

 

Chapter Certification

 

The State shall according to the economic and social development, the implementation of products, services, management system certification.

Article 18 The certification body shall be certified in accordance with basic standards, certification rules in certification activities. Basic norms of certification, certification rules for certification and accreditation by the State regulatory authority; duties involving relevant State Council departments, certification and accreditation regulatory department of the State Council shall, jointly with relevant departments of the State Council.

Are new areas of certification, the department has not yet developed the preceding paragraph, the rules of certification, certification bodies can develop their own certification rules, and report to the State Certification and Accreditation Administration department.

Article 19 Any legal person, organization or individual can legally established voluntary accreditation of certification bodies products, services, management system certification.

Diershitiao certification body shall consult with the client did not participate in certification or certification training grounds, refuse to provide the certification body within the scope of certification services, nor shall propose to the client and certification activities related requirements or restrictions.

Twenty-one certification body should be the basic norms of public certification, certification rules, fees and other information.

Article 22 certification bodies and the relevant inspection and certification bodies, laboratories engaged in the certification and inspection and certification, testing activities should be completed certification of basic standards, certification rules of procedures to ensure certification, inspection, testing complete, objective , the real, not increase, decrease, missing procedures.

Certification bodies and inspection bodies and certification of the laboratory should be on the certification, inspection and testing process to make a complete record, archive retained.

Article 23 certified personnel certification bodies and their certification should be timely conclusion, and to ensure that the objective of certification results and true. Conclusion certification signed by the certified staff, signed by the certification agency.

Certified personnel certification bodies and their certification results.

Concluded that Article 24 certified products, services, management systems meet the certification requirements, the certification body shall promptly issue a certificate to the client.

Article 25 to obtain the certificate, should be used within the scope of certification certificate and certification mark, shall not use products, services, certification, certification marks and related words, symbols to mislead the public that its management system has been certified, and shall not use management system certification, certification marks and related words, symbols to mislead the public that its products and services have been certified.

Article 26 certification bodies can develop their own certification mark, and report to the State Certification and Accreditation Administration department.

Certification bodies developed their own certification mark of the style, words and names, not violate laws, administrative regulations, not with the national implementation of the certification mark identical or similar to, without prejudice to social management, and not detrimental to social morality.

Article 27 The accreditation body should be certified for its products, services, management system, effective follow-up survey, certification of products, services, management system can not continue to meet certification requirements, the certification body shall suspend or even revoke the certification of its use, and to the public.

Article 28 In order to protect national security, prevent fraud, protect human health or safety, animal and plant life or health protection, environmental protection, national regulations related products must be certified, shall be subject to certification and labeling the certification mark, before leaving the factory , sale, import or use in other business activities.

Article 29 The State of the products must be certified, unified product catalog, technical specifications of the mandatory uniform requirements, standards and conformity assessment procedures, uniform signs, standardized charges.

Unified product catalog (hereinafter referred to as directories) Certification and Accreditation Administration of the State Council department in conjunction with relevant departments of the State Council, adjusted by the certification and accreditation regulatory department of the State Council issued and implemented in conjunction with stakeholders to come together.

Article 30 listed in the catalog must be approved by the State Certification and Accreditation Administration certification body designated by the department for certification.

Included in the catalog product certification mark, certification and accreditation by the State Council administrative department uniform regulations.

Article 31 listed in the catalog, covering the import and export commodity inspection directory, import and export commodity inspection should be simplified inspection procedures.

Article 32 Certification and Accreditation Administration of the State Council departments included in the directory specified in the product certification activities, certification bodies and inspection bodies and certification of the laboratory (hereinafter referred to as the designated certification bodies, inspection bodies, laboratories), should be the long-term in the relevant business, no bad record, and has been made in accordance with the provisions of this Ordinance, approval, have engaged in activity related to certification bodies. Certification and Accreditation Administration of the State Council departments included in the directory specified in the product certification activities of certification bodies, should ensure that each product included in the directory field specify at least two conditions in line with the institutional regulations.

Certification and accreditation regulatory department of the State Council designated the preceding paragraph of the certification bodies, inspection bodies, laboratories, information should be published in advance, and organizations in related areas of recognized experts in the expert review committee to meet the requirements of the preceding paragraph, the certification bodies, inspection institutions, laboratories accreditation; accredited and to solicit the views of relevant departments of the State Council, in accordance with rational use of resources, fair competition and facilitate the effective principle, make a decision within the time announced.

Article 33 The certification and accreditation regulatory department of the State Council shall publish the designated certification bodies, inspection bodies and laboratories and specified business scope.

Not specified, the agency shall not engage in any product included in the directory and certification on certification and inspection and testing activities.

Article 34 included in the catalog of products producers or sellers, importers, can be commissioned its own designated certification body for certification.

Article 35 The designated certification bodies, inspection bodies, laboratories should be designated within the scope of business for the client to provide convenient and timely certification, inspection, testing services, without delay, without discrimination, making things difficult for the client, shall not seek unfair advantage .

Designated certification body may transfer to other institutions designated certification business.

Article 36 The designated certification bodies, inspection agencies, international mutual recognition activities, laboratories, under the State Council or the certification and accreditation regulatory department of the State Council authorized the signing of the international mutual recognition agreements of external framework.

 

Chapter Approved

 

Article 37 Certification and Accreditation Administration of the State Council department of authorized institutions (hereinafter referred to as AI), independently recognized activities.

In addition to the State Certification and Accreditation Administration department of the authorized institutions, the other units shall not directly or disguised accreditation activities. Other units directly or disguised in accreditation activities, the approval was invalid.

Article 38 certification bodies, inspection bodies, laboratories accredited by accreditation bodies to ensure that its certification, inspection, testing capabilities continuous and stable in accordance with acceptable conditions.

Article 39 in the review, audit and other certification activities shall be registered by the authorized institution, before engaging in the corresponding certification activities.

Article 40 The accreditation body shall have to adapt to their scope of accreditation of quality system, and establish an internal audit system to ensure the effective implementation of quality system.

Article 41 authorized institutions in accordance with recognized needs assessment activities can be recognized in the selection of personnel. Personnel engaged in the activities of accredited assessors should be recognized experts in related fields, familiar with relevant laws, administrative regulations and approved rules and procedures, with the assessment of the required qualities, expertise and operational capacity.

Article 42 authorized institutions entrust others to complete the review and approval of specific business-related, by a recognized body responsible for assessment review.

Article 43 authorized institutions should be publicly recognized conditions, approval procedures, fees and other information.

Authorized agency to receive accreditation, not to the applicant with the accreditation activities related requirements or restrictions.

Article 44 The accreditation body shall announce the time in accordance with national standards and certification and accreditation regulatory department of the State Council's requirement to complete the certification bodies, inspection bodies, laboratory assessment, to make the decision whether to grant approval, and approval process make a complete record, archive retained. AIs should ensure fair and objective recognition of the complete and effective, and approved conclusions.

AI should be to accredited certification bodies, inspection bodies and laboratories issued with a certificate and publish the accredited certification bodies, inspection bodies and laboratories.

Article 45 authorized institutions shall be in accordance with national standards and certification and accreditation regulatory department of the State Council's regulations, to engage in evaluation, audit and other certification activities for assessment, evaluation qualified to be registered.

Article 46 The certificate shall include the scope of accreditation, accreditation standards, accreditation field and expiration date.

Certificate format and style subject to approval mark certification and accreditation regulatory department of the State Council for approval.

Article 47 of the accredited bodies shall be used within the scope of a recognized certificate and recognition signs. Accredited institution recognized by the improper use of a certificate and logo, the accreditation body shall suspend or even revoke a certificate of its use, and to the public.

Article 48 The accreditation body shall obtain the approval of institutions and personnel in the implementation of effective follow-up supervision, regularly re-accredited bodies to review to verify continued compliance with accreditation requirements. Accredited institutions and personnel no longer meets the conditions of approval, accreditation body shall revoke a certificate and to the public.

Accredited institutions of practitioners and key people, facilities, develop their own certification rules and conditions of the relevant circumstances recognized by a change, it shall promptly inform the authorized institutions.

Article 49 authorized institution shall not accept any of the approved activities may affect the objective and fair funding.

Within Article 50 certification bodies, inspection bodies and laboratories outside the authorized institution to obtain approval shall submit to the State Certification and Accreditation Administration department.

 

Chapter Supervision and Administration

 

Article 51 Certification and Accreditation Administration of the State Council departments to organize peer review, to be certified business comments on the results of certification activities and certification checks, and certification requirements for certification bodies and inspection bodies, the business activities of the laboratory report approach to its compliance with the regulations to monitor the situation. Found guilty of acts of this Ordinance, shall be promptly investigated, involving duties of the State Council departments, shall promptly inform the relevant departments.

Article 52 The certification and accreditation regulatory department of the State Council should focus on the designated certification bodies, inspection bodies and laboratories to monitor its certification, inspection, testing activities, regular or irregular inspection. Designated certification bodies, inspection bodies, laboratories should report regularly to the State Certification and Accreditation Administration department reports, and is responsible for the authenticity of the report; report included in the directory should be engaged in product certification, inspection and testing activities to explain.

Article 53 authorized institutions should regularly provide the certification and accreditation regulatory department of the State Council report, and is responsible for the authenticity of the report; report should be recognized by the system implementation of the AI ​​situation in approved activities, the work of employees to explain .

Certification and accreditation regulatory department of the State Council shall report to the authorized institutions to evaluate and take access to archives accreditation activities to the relevant personnel to understand the situation, etc., on the supervision of authorized institutions.

Article 54 The State Department certification and accreditation regulatory department according to Certification and Accreditation Administration of the needs of authorized institutions on matters related inquiries, certification bodies, inspection bodies and laboratories of the main person in charge of the investigation to understand the situation, to give warning, the officer should be actively cooperation.

Article 55 provinces, autonomous regions and municipalities quality and technical supervision departments and the State Quality Supervision, Inspection and Quarantine departments in local entry-exit inspection and quarantine agencies in the certification and accreditation regulatory department of the State Council, within its mandate, in accordance with the provisions of this Ordinance certification activities, supervision and management.

Certification and accreditation regulatory department of the State Council authorized the provinces, autonomous regions and municipalities quality and technical supervision departments and the State Quality Supervision, Inspection and Quarantine departments in local entry-exit inspection and quarantine agencies, collectively referred to local certification regulatory departments.

Article 56 Any unit or individual for certification and accreditation violations, the right to Certification and Accreditation Administration of the State Council departments and local certification regulatory agencies. Certification and Accreditation Administration of the State Council departments and local certification regulatory departments shall promptly investigate and deal with, and keep the secret.

 

Chapter VI Legal Liability

 

Article 57 engaged in certification activities without approval, and shall be banned, 100,000 yuan to 500,000 yuan shall be imposed, the illegal income shall be confiscated.

Article 58 without the approval of foreign certification bodies established in the PRC on behalf of institutions, be banned, 50,000 yuan and 200,000 yuan fine.

Approved the establishment of representative offices of foreign certification bodies engaged in certification activities in the PRC, and ordered to make corrections, 100,000 yuan to 500,000 yuan shall be imposed, there is illegal income, confiscate the illegal income; serious cases, revocation of approval documents , and to the public.

Article 59 The certification body to receive certification activities may impact the objectivity and fairness of funding, or to engage in certification activities may affect the objectivity of product development, marketing and other activities, or with the authentication client assets or the interests of management relations, and ordered to suspend business for rectification; serious cases, revocation of the approval document, and to the public; the illegal income, confiscate the illegal income; constitute a crime, be held criminally responsible.

Article 60 The certification of the following circumstances shall be ordered to correct, 50,000 yuan and 200,000 yuan fine, the illegal income, confiscate the illegal income; the circumstances are serious, shall be ordered to suspend business for rectification, revoke its approval documents, and to be announced:

(A) engaged in certification activities beyond the approved scope of;

(B) increase, decrease, missing the basic certification standards, certification rules of procedure;

(C) not certified their products, services, management system, effective follow-up survey, or that its certified products, services, management system can not continue to meet certification requirements, not in time to suspend or revoke the certification of its use and to the public's ;

(D) employ an unauthorized institution registered to engage in certification activities.

The inspection and certification bodies, laboratories increase, decrease, missing the basic certification standards, certification rules of procedure, in accordance with the preceding paragraph shall be punished.

Article 61 certification of the following circumstances, shall order rectification; if it fails, 20,000 yuan to 100,000 yuan shall be imposed:

(A) the client did not participate in certification training, consulting or certification as a reason for refusing to provide the certification body within the scope of certification services, or proposed to the client and certification activities related requirements or restrictions of;

(B) draw up their own certification mark of the style, words and names, and national implementation of the certification mark identical or similar to, or impede the social management, or undermine social morality;

(C) not basic norms of public certification, certification rules, fees and other information;

(4) failing to make a complete record of the certification process, archive retained;

(5) Failure to timely issue its authentication certificate of the client.

The inspection and certification bodies, laboratories and certification is not relevant to the inspection and testing process to make a complete record, archive retained, in accordance with the preceding paragraph shall be punished.

Article 62 The certification issued by the conclusion false certification, or certification issued by the conclusions of serious misrepresentation, revocation of the approval document, and to the public; the directly responsible person in charge and persons directly responsible for certification, revocation of the solicitor; form crime shall be investigated for criminal responsibility; damage, the certification body shall bear the corresponding liability.

Certification bodies designated under the preceding paragraph, violations, and revocation of designation.

Article 63 certified personnel engaged in certification activities, not to practice or certification body simultaneously in two or more certification bodies to practice, make corrections, give to stop practicing for more than six months to two years of punishment, is still not correct, revoke the qualification .

Article 64 certification bodies and inspection bodies and certification of the laboratory without engaging in specified products listed in the directory and certification on certification and inspection, testing activities, and ordered to make corrections, 100,000 yuan to 500,000 yuan fine, the illegal income shall be confiscated.

Certification included in the directory without specifying engaging in the activities of product certification, revocation of the approval document, and to the public.

Article 65 of the designated certification bodies, inspection bodies and laboratories engaged in the business scope beyond the specified products listed in the catalog as well as certification and certification-related inspection, testing activities, and ordered to make corrections, 100,000 yuan to 500,000 yuan fine, the illegal gains shall be confiscated; serious cases, revocation of designation until the revocation of the approval document, and to the public.

Transfer of designated certification body designated certification business, in accordance with the preceding paragraph shall be punished.

Article 66 certification bodies, inspection bodies and laboratories outside the authorized institutions to obtain recognition, not to the State Certification and Accreditation Administration departments for the record, given a warning, and to the public.

Article 67 listed in the catalog without the certification, without the factory, sold, imported or used in other business activities, and ordered to make corrections, 50,000 yuan and 200,000 yuan fine, the illegal income shall be confiscated income.

Article 68 authorized institutions of the following circumstances shall be ordered to correct; the circumstances are serious, responsible and liable for removal or dismissal of staff:

(A) do not meet the conditions of institutions and personnel authorized to be recognized;

(B) find an accredited institution and who do not meet the recognition criteria, not timely revoke a certificate and be released;

(C) the acceptance of accreditation activities may affect the objective and fair funding.

Dismissal or the dismissal of the authorized institutions and persons responsible primarily responsible, since the dismissal or five years from the date of dismissal shall not engage in accreditation activities.

Article 69 authorized institutions of the following circumstances shall be ordered to rectify; responsible and liable for the person to give a warning:

(1) Accepting an application for recognition to the applicant with the accreditation activities related requirements or restrictions of;

(B) is not completed within the published time recognized activities, or conditions not publicly endorsed, authorized procedures, fees and other information;

(C) find an accredited institution recognized by the improper use of a certificate and logo, not in time to suspend or revoke the certificate of its use and to the public's;

(D) did not make a complete record of the accreditation process, archive retained.

Article 70 Certification and Accreditation Administration of the State Council departments and local certification regulatory departments and their staff, abuse of power, corruption, dereliction of duty, the following acts, the directly responsible person in charge and other directly responsible personnel shall be given administrative sanction of demotion or dismissal; constitutes a crime, criminal responsibility shall be:

(A) not in accordance with the provisions of this Ordinance, the conditions and procedures, implementation of the approved and designated;

(B) the certification body that no longer meets the approval of the regulations or specified conditions, not to revoke the approval documents or specified;

(C) that the designated inspection agency, the laboratory no longer meets the conditions specified in this Ordinance, no withdrawal of the designation;

(D) that the certification bodies and inspection bodies and certification, laboratory certification and issued false and certification-related inspection, testing, and conclusions or certification issued by the relevant inspection and certification, testing conclusions seriously inaccurate, not investigated;

(E) that the certification and accreditation regulations and other illegal acts, not investigation.

Article 71 forgery, fraudulent use, the sale of certification marks or certificates, in accordance with the "Product Quality Law" and other provisions of the law punished.

Article 72 The provisions of this Ordinance, the administrative penalty by the State Department certification and accreditation regulatory department or its authorized local certification regulatory departments to implement their duties. Legal and other administrative regulations, in accordance with laws, regulations and other administrative regulations.

Article 73 certified personnel qualification since been revoked five years from the date of an authorized institution shall not accept his application for registration.

Article 74 of the certification body of its certified products are not effective follow-up survey, or that its certified products meet the certification requirements can not be sustained, not in time to suspend or revoke the certificate and asking them to stop using the certification mark of the damage caused to consumers , and producers, sellers jointly and severally liable.

Chapter VII Supplementary Provisions

Article 75 pharmaceutical manufacturing, quality management standards certification enterprises, animal quality standards certification, certification of military products, as well as for military products, calibration and testing laboratories and staff recognition, are not applicable regulations.

In accordance with the regulations approved certification bodies in the mines, dangerous chemicals, fireworks production and business unit management system certification from the State Production Safety Supervision and Management with special safety requirements of the organization; in the mines, dangerous chemicals, fireworks production and management comprehensive evaluation of unit safety certification organization, the State Production Safety Supervision and Management recommended, in order to obtain authorized institution.

Article 76 certification and accreditation fees, the price should be in line with relevant state laws and administrative regulations.

Article 77 certification training institutions, certification of management consulting organization by the State Council certification and accreditation regulatory department.

Article 78 of the Ordinance from November 1, 2003 shall come into force. May 7, 1991 the State Council issued the "Product Quality Certification Management Regulations" shall be repealed simultaneously.

 

  

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