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MEASURES FOR THE ADMINISTRATION OF COMPULSORY PRODUCTS CERTIFICATION BODIES, INSPECTION INSTITUTIONS AND LABORATORIES |
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(Order of the State Administration of Quality Supervision, Inspection and Quarantine (No.65), June 23, 2004: The Measures for the Administration of Compulsory Products Certification Bodies, Inspection Institutions and Laboratories, which were deliberated and adopted at the executive meeting of the State Administration of Quality Supervision, Inspection and Quarantine on April 30, 2004, are hereby promulgated, and shall come into force as of August 1, 2004)
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SUBJECT : COMPULSORY PRODUCTS CERTIFICATION BODIES, INSPECTION INSTITUTIONS AND LABORATORIES |
ISSUING DEPARTMENT : THE STATE ADMINISTRATION OF QUALITY SUPERVISION, INSPECTION AND QUARANTINE OF THE PEOPLE'S REPUBLIC OF CHINA |
ISSUE DATE : 06/23/2004 |
IMPLEMENT DATE : 08/01/2004 |
LENGTH : 2,799 words |
TEXT : |
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TABLE OF CONTENTS CHAPTER I GENERAL PROVISIONS CHAPTER II DESIGNATION CONDITIONS CHAPTER III DESIGNATION PROCEDURES CHAPTER IV BEHAVIOR CRITERIONS CHAPTER V SUPERVISION AND INSPECTION CHAPTER VI PENALTIES CHAPTER VII SUPPLEMENTARY PROVISIONS
CHAPTER I GENERAL PROVISIONS
Article 1. The present Measures are formulated in accordance with the Certification and Accreditation Regulation of the People's Republic of China (hereinafter referred to the Regulation) for the purpose of regulating the administration on compulsory product certification bodies, inspection institutions and laboratories, making use of social resources properly and ensuring the effective implementation of the compulsory product certification system.
Article 2. The "Compulsory Product Certification Bodies, Inspection Institutions and Laboratories" mentioned in the present Provisions shall refer to the certification bodies undertaking the activities of the compulsory product certification, and the inspection institutions and testing laboratories undertaking the activities of inspection and testing related to the compulsory product certification.
Article 3. The present Measures shall be applicable to the designation of and supervision over the compulsory product certification bodies, inspection institutions and laboratories within the territory of the People's Republic of China.
Article 4. The state implements designation system on the compulsory product certification bodies, inspection institutions and laboratories.
Article 5. The State Certification and Accreditation Regulatory Commission (hereinafter referred to the SCARC) shall be responsible for the work of establishment, implementation of and supervision over the compulsory product certification bodies, inspection institutions and laboratories.
Article 6. The compulsory product certification bodies, inspection institutions and laboratories shall meet and have the conditions and abilities prescribed in the Regulation and other laws and administrative regulations, and may not undertake compulsory product certification activities and inspection and testing activities in relation to the compulsory product certification until they are designated by the SCARC.
Article 7. The principle of proper use of resources and actual needs, fair competition, openness and justness, and convenience and effectiveness shall be followed for the designated work of the compulsory product certification bodies, inspection institutions and laboratories.
Article 8. In case the compulsory product certification bodies, inspection institutions and laboratories or any two of them are the same one legal person, their qualifications of undertaking compulsory product certification and inspection and testing activities in relation to the certification shall be designated separately.
CHAPTER II DESIGNATION CONDITIONS
Article 9. The following conditions shall be met for a certification body that applies for undertaking activities of compulsory product certification:
(1) Being established according to the provisions of the Regulation, and having experiences of certification in the corresponding fields for over two years or having issued more than 20 certification certificates of the relevant products;
(2) Being accredited by the accreditation bodies determined by the state;
(3) Having no illicit records within 6 months before the application;
(4) The nature of legal person, constitution of property right and organization structure of the body can ensure the objectiveness and fairness of its compulsory certification activities;
(5) Having technology and management ability which will enable it to undertake compulsory product certification activities justly, independently and effectively; and
(6) Having resources of testing and inspection, which meet the requirements for undertaking compulsory product certification activities and may be dispatched and used independently; and having certification personnel meeting the requirements of the Regulation and stable financial resources fitting in with the work task of compulsory product certification.
Article 10. An inspection institution that applies for undertaking activities of compulsory product certification and inspection shall meet the following conditions:
(1) Having basic conditions and abilities prescribed by laws and administrative regulations, which have been accredited according to law;
(2) Having inspection experiences of the corresponding fields, and having undertaken inspection work for over two years or having issued more than 20 inspection reports on the relevant products;
(3) Having been accredited by the accreditation body determined by the state;
(4) Having no illicit records within 6 months before application;
(5) The nature of legal person, constitution of property right and organization structure of the body can ensure its implementation of inspection activities fairly and independently;
(6) Having facilities, personnel and other resources needed for undertaking activities of compulsory products certification and inspection;
(7) The personnel undertaking the activities of compulsory product certification and inspection shall have the necessary professional knowledge, and have obtained the registration qualification of certification and inspection personnel;
(8) The professional ability of the full-time inspectors engaged shall meet the requirements for the designated business; and
(9) The proportion of part-time inspectors engaged shall not exceed two thirds of the total number of the full-time inspectors.
Article 11. A laboratory applying for undertaking activities of compulsory products certification and testing (hereinafter referred to the laboratory) shall meet the following requirements:
(1) Having the basic conditions and abilities prescribed by laws and administrative regulations, which have been accredited according to law;
(2) Having testing experiences of the relevant fields, and having undertaken testing work for more than two years or having issued more than 20 testing reports of the relevant fields;
(3) Having been accredited by the accreditation bodies determined by the state;
(4) Having no illicit records within 6 months before application;
(5) The nature of legal person, constitution of property right and organization structure of the body can ensure its implementation of testing activities justly and independently;
(6) Having all the equipment and facilities needed for undertaking the activities of respective product certification and testing; or it may use such equipment and facilities independently upon the authorization of the property right entities of the relevant equipment and facilities; and
(7) The inspectors have received education and training are necessary for their undertaking of the corresponding product certification and testing, and have mastered the relevant standards, technical specifications and requirements of the rules for the implementation of compulsory product certification, and have the necessary product testing ability.
CHAPTER III DESIGNATION PROCEDURES
Article 12. The SCARC shall propose the designation plan according to the concrete requirements and implementation request of the compulsory product certification system. The designation plan shall cover the business fields and quantity, scope of products of the designated institution, the requirements for the designated institutions applied for, the designation procedures and the relevant provisions on the time limit, and constitution of the expert examination committee (hereinafter referred to the expert committee), etc..
In case the designated business fields involve the relevant departments of the State Council, the SCARC shall solicit opinions form the relevant departments of the State Council concerning the relevant designation plans.
Article 13. The SCARC shall issue the designation plan and other relevant information through a written public notice and its website.
Article 14. Any certification body, inspection institution or laboratory applying for undertaking activities of compulsory product certification (hereinafter referred to the application institution) shall file an application in writing to the SCARC according to the requirements of the designation plan and other relevant information, and submit the relevant supporting documents.
Article 15. The SCARC shall, within 10 working days from accepting the application of the application institution, make examination on the written documents submitted by the application institution in accordance with the provisions of Articles 9, 10 and 11 of the present Measures, and put forward opinions of preliminary examination, and reflect the opinions about the preliminary examination to the application institution. If the application meets the requirements of the preliminary examination, it shall be submitted to the expert committee for review.
Article 16. The relevant departments of the State Council, trade organizations, enterprises, accreditation bodies, certification bodies and other technical institutions may recommend candidates for the expert committee to the SCARC. The SCARC shall determine the members of the expert committee on the basis of objects of examination and fields of examination, and form the corresponding expert committee respectively.
Article 17. The expert committee shall be a temporary organization, which consists of 7-13 persons, and is responsible for the work of examination on the application institutions.
The expert committee shall dissolve automatically after the examination work is finished.
Article 18. The members of the expert committee shall meet the following requirements:
(1) Having good professional knowledge and professional ethics;
(2) Having senior professional technical title or the equivalent technical qualification; and
(3) Being familiar with the relevant situations of the industry, the supervision system of relevant products, and allocation and distribution of resources of technical institution, etc.
Article 19. The expert committee shall make examination on the application institutions by ways of discussion at meetings, hearing, and picking up documents to read, and may suggest the SCARC to make on-site investigation on the application institutions upon the need.
In case any member of the expert committee has any relations of interests with the application institution concerned (including the entity he works in is an application institution, etc.), the relevant member of the expert committee shall withdraw.
Article 20. Where the expert committee makes examination on an application institution, it shall take into full consideration the effective linkup of factors such as the characteristics of the development of industries of the related fields, distribution of production enterprises, certification systems with other ways of supervision, so as to ensure the effective implementation of the certification system, proper utilization of resources, and convenience to the agent of certification.
A scientific, proper and accurate examination conclusion shall be made in combination with such conditions of technical ability and relevant reputation and credit standing of the application institution on the basis of the analysis of cost and efficiency.
The expert committee shall make examination conclusions by way of ballot, and the examination conclusions shall be passed by two thirds of the voting.
The time for the examination work of the expert committee shall not exceed 30 days.
Article 21. The SCARC shall make the designation decision within 10 working days on the basis of the examination conclusion made by the expert committee in light of the principle prescribed in Article 7 of the present Measures. Where there is necessity to extend the period for special circumstances, it may be extended to 15 working days.
In case the designated business fields involve the relevant departments of the State Council, the SCARC shall make the designation decision after soliciting the opinions from the relevant departments of the State Council.
Article 22. The SCARC shall, within 10 working days after making the designation decision, publicize the check-list of the designated compulsory product certification bodies, inspection institutions and laboratories and the specific designated business scopes.
Article 23. In case the application institution has any objections to the designation decision, it shall file an appeal or complaint to the SCARC within 15 working days from the date the designated check-list is publicized.
The SCARC shall be responsible for handling the appeals and complaints.
CHAPTER IV BEHAVIOR CRITERIONS
Article 24. The compulsory product certification bodies, inspection institutions and laboratories that are designated by the SCARC (hereinafter referred to the designated certification bodies, inspection institutions and laboratories) shall provide services to the agent of certification within the designated scope in accordance with the basic standards for certification and the requirements of certification rules, and shall not transfer or transfer in disguised form the designated certification, inspection and testing business.
Article 25. The designated certification bodies, inspection institutions and laboratories shall formulate management systems and procedures to clearly differentiate between the activities of compulsory product certification, inspection and testing, and of voluntary product certification, inspection by entrustment and testing by entrustment, and shall not develop or undertake the voluntary product certification business and entrusted inspection and testing business by making use of their designated qualifications.
Article 26. The designated certification bodies shall strictly differentiate between the compulsory product certification business and the voluntary product certification business in the publicity.
Article 27. A designated certification body shall sign written agreement with the designated inspection institution and laboratory, clarifying the rights and obligations and legal liabilities of each of them, and ensure that the inspection and testing activities of the inspection institution and laboratory it uses may correspond with the requirements of the national standards for compulsory product certification and the certification rules, and ensure that the inspection institution and laboratory (including those in the same legal person) it uses may enjoy the equal rights and perform the equal obligations.
Article 28. In case the designated certification body, inspection institution and laboratory or any two of them are the same legal person, the designated institution shall formulate relevant management systems and ensure their sustainable and effective operation, and ensure that the activities of certification, inspection and testing may be carried out independently, as well as ensure that the certification personnel, inspectors, and testing personnel may carry out activities independently.
Article 29. The designated certification bodies, inspection institutions and laboratories shall undertake compulsory product certification activities within the designated business scope, and ensure to provide certification, inspection and testing services in time and effectively to the certification agent, and may not discriminate or create difficulties for the certification agent or seek for unjust interests.
Article 30. The designated certification bodies, inspection institutions and laboratories shall carry out international mutual recognition activities within the framework of the international mutual recognition agreement concluded by the SCARC or the relevant authorized departments of the State Council.
Article 31. The designated institutions shall provide information on compulsory product certification, inspection and testing in time according to the provisions and requirements of the SCARC, and cooperate with the SCARC and local certification regulatory departments in their carrying out of the work of supervision over and inspection on compulsory product certification.
CHAPTER V SUPERVISION AND INSPECTION
Article 32. The SCARC shall make periodical supervision and inspection on the designated certification bodies, inspection institutions and laboratories once a year.
Article 33. The designated certification bodies, inspection institutions and laboratories shall submit the work report of the previous year on their undertaking of compulsory product certification activities to the SCARC before February 15 every year and accept the inquiry of the SCARC on the relevant matters concerned. The annual work report shall include the internal auditing and examination on management.
Article 34. The SCARC shall make non-periodical investigation into the quality of the work of certification, inspection and testing of the designated certification bodies, inspection institutions and laboratories, and solicit opinions and suggestions of the relevant certificate agents and holders of certification certificate.
Article 35. The SCARC shall organize the peer review on such conditions of the designated certification bodies, inspection institutions and laboratories as the technical ability, service quality, work efficiency, professional ethics of the staff members and the implementation of the basic certification regulations and certification rules, and publicize the result of the review.
Article 36. The SCARC shall make special spot-check on the certification, inspection and testing activities and the certification results of the designated certification bodies, inspection institutions and laboratories, and publicize the result of the spot-check.
Article 37. Any entity or individual may report the acts of the designated certification bodies, inspection institutions and laboratories and the acts in the designation work that are in violation of laws and regulations to the SCARC or local certification regulatory departments.
CHAPTER VI PENALTIES
Article 38. In case any designated certification body, inspection institution or laboratory has any of the following circumstances, it shall be ordered to correct and fined RMB 20 thousand Yuan up to 30 thousand Yuan:
(1) Lacking the necessary management systems and procedures for differentiating between the compulsory product certification, factory inspection and testing activities and the voluntary product certification, entrusted inspection and entrusted testing activities;
(2) Promoting and popularizing voluntary product certification business by making use of the compulsory product certification business;
(3) Failing to provide certification, inspection and testing services to the certification agents in time and effectively, or purposely postponing or discriminating or creating difficulties for the certification agents, and seeking for unjust interests;
(4) Failing to cooperate in the activities of law enforcement supervision and inspection or refusing to provide the relevant information; or
(5) Failing to submit the annual work report required or to provide information of compulsory product certification, factory inspection and testing.
Article 39. In case any designated certification body, inspection institution or laboratory has any circumstance of being suspended or revoked of certification or has no longer had other designated conditions, the SCARC shall revoke the designation to it.
Article 40. In case any designated certification body, inspection institution or laboratory is revoked of designation due to issuing of false certificate and other illegal acts, it may not apply for designation within 3 years from the date of being revoked of designation.
The certification bodies shall no longer accept the registration application of any inspector who undertakes inspection activities within five years from the date when he is revoked of his qualification of practice.
Article 41. The relevant provisions of the Regulation shall be followed in punishing other illegal acts in violation of the provisions of the Regulation.
CHAPTER VII SUPPLEMENTARY PROVISIONS
Article 42. The power to interpret the present Measures shall remain with the SAQSIQ.
Article 43. The present Measures shall come into force as of August 1, 2004.
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