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Administrative Measures For Laboratory And Inspection Body Accreditation

Original Language Title: 实验室和检查机构资质认定管理办法

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(February 21, 2006 the State General Administration of quality supervision, inspection and quarantine promulgated as of April 1, 2006, 86th) Chapter I General provisions article to standardize quality management of laboratories and inspection bodies to improve laboratory and inspection body accreditation the scientific nature and effectiveness of the activities, in accordance with the People's Republic of China metrology Act, the People's Republic of China standardization law, the People's Republic of China product quality law, the People's Republic of China certification and Accreditation regulations and other relevant laws,
    Provisions of administrative regulations, these measures are formulated.
    The second qualification of laboratories and inspection bodies referred to in this way, is directed to social issue is proof of the data and results of laboratories and inspection bodies should have the basic conditions and capacity.
    Found in these measures, refers to the National Commission for certification and accreditation administration and the provinces, autonomous regions, and municipalities of quality and technical supervision Department of laboratory and basic requirements for inspection bodies and capacity in line with laws, administrative regulations, and the evaluation and recognition of the activities of the technical specifications or standards.
    Article in the People's Republic of China territory, issued with proof of data and results to the community of laboratories and inspection bodies and the implementation of its accreditation activities shall abide by these measures.
    Fourth national certification and accreditation Administration Committee (hereinafter referred to as CNCA) unified management, supervision and overall coordination of laboratory and inspection body accreditation.
    All provinces, autonomous regions and municipalities of quality and technical supervision departments and departments under the entry-exit inspection and quarantine institutions (hereinafter referred to as local quality inspection departments) in accordance with their respective duties in the area of laboratory and inspection body accreditation and supervision and inspection work.
    Article fifth laboratory and inspection body accreditation, should be guided by objective and impartial, scientifically accurate, standardized and contribute to detection of resource sharing and to avoid unnecessary duplication of review, evaluation, identification of principles.
    Chapter II accreditation article sixth qualification in the form of measurement accreditation and review approval.
    Measurement certification refers to the CNCA and local quality inspection departments in accordance with the relevant provisions of laws and administrative regulations, for product quality inspection organizations provide society with notarization data verification, performance of the test equipment, work environment and personnel skills and guarantee the value of a unified and accurate measures and data impartial and reliable assessment of the quality system.
    Review accreditation refers to the CNCA and local quality inspection departments in accordance with the relevant provisions of laws and administrative regulations, to assume that the product is conform to the standards of inspection tasks and other standard detection of conducting supervision and inspection tasks of inspection bodies as well as the review of the quality system. Seventh article engaged in following activities of institutions should through qualification finds: (a) for administrative organ made of administrative decided provides has proved role of data and results of; (ii) for judicial organ made of ruling provides has proved role of data and results of; (three) for arbitration institutions made of arbitration decided provides has proved role of data and results of; (four) for social public activities provides has proved role of data and results of; (five) for economic or trade relationship people provides has proved role of data and results of
    (Vi) other statutory qualifications is needed.
    Eighth State encourages laboratories, inspection bodies recognized by the CNCA authorized institution determined, to ensure their testing, calibration and inspection capacity in line with relevant international norms and General requirements, promote international mutual recognition of testing, calibration and inspection results. Section Nineth metrology accreditation and application review recognized the same project, evaluation, evaluation, evaluation should be combined to implement.
    In conformity with the relevant requirements, you can obtain the appropriate qualification.
    A CNCA determine authorized institutions accredited laboratories and inspection bodies, at the time of application for accreditation, qualification procedures should be simplified and the corresponding, to avoid unnecessary duplication of assessment.
    Article tenth laboratory and inspection body, shall, within the scope of accreditation certificate and mark correctly.
    11th related laws and administrative regulations on laboratory and other technical conditions and inspection bodies have special requirements, you can use qualification on the basis of the results of assessment, evaluation or assessment.
    12th a citizen, legal person or other organization, you need to verify the authenticity and validity of laboratory and inspection body accreditation, the CNCA and local quality inspection departments to submit written applications, the CNCA and local quality inspection departments should be for verification of confirmation.
    Laboratories and inspection bodies chapter III of the basic conditions and the 13th article of laboratories and inspection bodies shall be established by law to ensure objectivity, impartiality and independence, testing, calibration and inspection activities, and bear the corresponding legal responsibility.
    Article 14th laboratories and inspection bodies should have engaged in testing, calibration and inspection activities suitable for professional and technical personnel and managers.
    Special products for testing, calibration laboratories and inspection bodies and inspection activities, the professional technical and management personnel should also be in conformity with the relevant laws and administrative rules and requirements.
    15th laboratories and inspection bodies shall have a fixed place of work, their work environment should ensure that test, calibration and inspection data and results are true and accurate.
    16th laboratories and inspection bodies shall have the right to test, calibration and inspection activities required and independent leveling use of fixed and portable test, calibration and inspection facilities.
    17th laboratories and inspection bodies should be established to ensure its impartiality, independence and take the test, calibration and inspection activities adapted to the scope of the quality system, in accordance with the recognized basic norms or standards-setting the quality system documents and its effective implementation.
    Chapter fourth qualification program 18th National Laboratory and inspection body accreditation, the CNCA is responsible for implementation of local-level laboratory and inspection body accreditation, by local quality inspection departments responsible for implementation.
    Article 19th CNCA according to relevant national standards and technical specifications, development of metrology accreditation and review the recognized basic norms, assessment criteria, certification and marking, and promulgation and implementation.
    20th article measurement certification and review recognized program: (a) application of laboratory and check institutions (following referred to applicants), should according to need to national recognize JISC or place quality sector (following referred to accepted people) proposed written application, and submitted meet this approach third chapter provides of related proved material; (ii) accepted people should on applicants submitted of application material for preliminary review, and since received application material of day up 5th within made accepted or not accepted of written decided; (C) the assignee shall, from the date of acceptance of the application, as needed for the applicant to undergo a technical review and advise the applicant in writing, technology assessment within a period of time do not calculate the approval; (iv) acceptance shall, from the date of conclusion of the technical review in the 20th, make a decision on whether to approve under technical appraisal.
    Approved, certificate of qualification issued to the applicant and permit its use of accreditation logo; were rejected, it shall notify the applicant in writing and state the reasons; (v) the CNCA and local quality inspection departments should periodically post achieved qualification of laboratory and inspection body directory, certification and measurement project, authorized inspection of products.
    Article 21st qualification certificates are valid for 3 years.
    Applicants should be 6 months before the expiry date of the certificate of qualification for review, acceptance of the application, fails to make an application, cancellation of qualification certificates by the certification unit, and stop its use flags.
    22nd has obtained a qualification certificate of laboratory and inspection body, need new check inspection item, shall, in accordance with the procedure as provided herein, apply for accreditation expansion.
    Article 23rd accreditation staff shall comply with the relevant technical specifications or standards requirements and examinations by the CNCA or local quality inspection departments. Article 24th of CNCA and local quality inspection departments should establish accreditation experts, review panel as needed.
    Evaluation Expert Group accreditation activities should be independent, and responsible for the assessment conclusions.
    25th local quality inspection departments shall from the date of certificate of qualification issued to the applicant in the 15th, to the CNCA will approve decision record.
    Fifth chapter of laboratories and inspection bodies code of conduct article 26th laboratories and inspection agencies and their personnel should be independent of the test, calibration and inspection data and results of the stakeholders involved, not under the influence of any factor that could interfere with their technical judgment and ensure the testing, calibration and inspection results from laboratory and inspection body other than the influence of organizations or persons.
    27th article laboratory and check institutions of personnel shall not with engaged in of detection, and calibration and check project and issued of data and results exists interests relationship; shall not participation any undermines detection, and calibration and check judge of independence and integrity degrees of activities; shall not participation and detection, and calibration and check project or similar of competitive project has relationship of products of design, and development, and production, and supply, and installation, and using or maintenance activities.
    28th article laboratory and check institutions engaged in with holding shareholders production, and business of similar products or has competitive of products of detection, and calibration and check activities Shi, should established guarantee its detection, and calibration and check activities of independence and just sex of quality system and file, clear this institutions of duties, and responsibility and work program, and with holding shareholders engaged in of design, and development, and production, and supply, and installation, and using or maintenance, activities completely separate. Article 29th of laboratories and inspection bodies shall be established and effectively implemented and testing, calibration and inspection managers, technicians and key support staff job responsibilities, qualification assessment, training system, ensure that no reward, impact testing, calibration and checking the quality of work.

    Article 30th laboratory and inspection body shall, in accordance with the relevant requirements of the technical specification or standard, on the use of testing, calibration and inspection of facilities and equipment, as well as environmental requirements, such as expressly provided and properly identified.
    Used in laboratories and inspection agencies to test, calibration prior to affecting the accuracy of measurement and test equipment, shall, in accordance with technical specifications or standards related to verification and calibration.
    31st laboratories and inspection bodies shall ensure that its relevant measurement and calibration results traceability to the national standards for base, in order to ensure the accuracy of the results.
    Laboratory and inspection body shall establish and implement procedures for evaluating measurement uncertainty, and in accordance with the relevant technical specifications or standards required to assess and report on the uncertainty of measurement, calibration results.
    Article 32nd laboratory and inspection body shall, in accordance with the relevant technical specification or standard for the extraction, processing, transport and storage of samples, preparation and evaluation of uncertainty in measurement, survey data analysis, and other test, calibration and inspection activities.
    Article 33rd laboratory and inspection body shall, in accordance with the relevant technical specifications or standards and established procedures, testing, calibration and inspection data and issued in a timely manner the results and ensure accurate, objective, real data and results.
    34th laboratory and inspection body in accordance with the relevant technical specifications or standards of proficiency testing, to ensure ongoing compliance testing, calibration and inspection capacity.
    Article 35th of laboratories and inspection agencies and their personnel should be on the test, calibration and inspection activities are aware of State secrets, business secrets and technology confidential, and establish the appropriate security measures.
    Article 36th laboratories and inspection bodies should establish and improve the mechanism for handling appeals and complaints, handle objections to its testing, calibration and inspection results.
    37th article laboratories and inspection bodies for business-packet inspection, calibration or inspection work, should be working to comply with regulations and qualification laboratory or inspection body.
    Sixth chapter article 38th CNCA law of supervision and inspection to review activities of local quality inspection departments and organizations conducting supervision and inspection.
    Local quality inspection departments shall be submitted to the CNCA in January each year on the annual report on the work, accept the CNCA's inquiries and investigations, and take responsibility for the authenticity of the report.
    39th CNCA shall be organized to laboratories and inspection bodies monitor the qualification check; does not meet the requirements, and be dealt with in accordance with the relevant provisions.
    40th article of any units and individuals for laboratory and inspection body accreditation violations, to report to CNCA or local quality inspection departments, CNCA and local quality inspection departments should promptly investigate and deal with, and the informer confidential.
    41st article has following case one of of, national recognize JISC or place quality sector, can according to interest relationship people of requests or according to terms, revoked its made of laboratory and check institutions made qualification finds of decided: (a) qualification finds approval staff abuse, and negligence made laboratory and check institutions made qualification finds decided of; (ii) beyond statutory terms made laboratory and check institutions made qualification finds decided of;
    (C) the violation determination procedures for laboratory and inspection agency accreditation decisions, and (iv) do not have legal basic conditions and capabilities of laboratories and inspection bodies to achieve accreditation decision; (e) qualification in other circumstances may be withdrawn in accordance with law.
    42nd the applicant when applying for accreditation, withholding relevant information or provide false materials and accreditation supervision and management departments should not be considered whether or not to approve and give warning applicants may not apply again for qualification in just one year.
    Article 43rd laboratory and inspection body by fraud, bribery or other improper means to obtain the approval decision, the CNCA and local quality inspection departments should revoke its accreditation decision, and to the public.
    Laboratory and inspection body within 3 years from the date on which the revocation of accreditation shall not be applied for accreditation again.
    Laboratory and inspection body issues a false conclusion or conclusions serious misrepresentation of the issue, if the circumstances are serious, shall withdraw their qualifications, and to the public.
    44th local quality inspection departments shall, from the date of revocation decision in the 15th, its revocation decision written report to CNCA for archival purposes.
    The CNCA, through its Web site or otherwise publicize revocation of accreditation of laboratory and inspection body directory.
    Article 45th laboratory and inspection body accreditation of personnel who abuse their powers, neglect their duties or engages, shall be given administrative sanctions constitutes a crime, criminal responsibility shall be investigated according to law.
    Article 46th for laboratories and inspection agencies of other offences, shall be punished according to relevant laws and administrative regulations. Seventh chapter schedule 47th article following terms of meaning: (a) laboratory, is refers to engaged in science experiment, and test detection and calibration activities of technology institutions; (ii) check institutions, is refers to engaged in and certification about of products design, and products, and service, and process or production processing places of verification, and determine its meet provides requirements of technology institutions; (three) laboratory and check institutions of basic conditions, is refers to laboratory and check institutions should meet of legal status, and independence and just sex, and security, and environment, and human resources, and facilities, and
    Equipment, procedures and methods, quality systems, and financial requirements; (d) the capacity of laboratories and inspection agencies, is a laboratory and inspection body, in its basic conditions to ensure that they are issued with proof of data and results of the relevant experience and level of accuracy, reliability and stability.
    48th qualification fees shall be in accordance with the relevant provisions of the State.
    49th article of the approach by the State administration of quality supervision, inspection and quarantine is responsible for the interpretation. 50th these measures come into force on April 1, 2006.
                                Published on July 10, 1987 State Metrological Bureau of measurement accreditation management of product quality inspection organizations repealed simultaneously.