Measures for the Administration of Accreditation of Laboratory and Inspection Institutions
The Administrative Measures for the Accreditation of Laboratory and Inspection Institutions have been deliberated and adopted at the Executive meeting of the General Administration of Quality Supervision, Inspection and Quarantine of the State on December 31, 2005, and are hereby promulgated and shall come into force as of April 1, 2006。On July 10, 1987, the "Measures for the Management of Measurement Certification of Product Quality Inspection Institutions" issued by the former State Bureau of Metrology was repealed simultaneously。
局 长
February 21, 2006
Measures for the Administration of accreditation of laboratories and inspection institutions
Chapter I General provisions
Article 1 Standardize the qualification management of laboratories and inspection institutions，To improve the scientific and effective accreditation activities of laboratories and inspection institutions，In accordance with the provisions of the Metrology Law of the People's Republic of China, the Standardization Law of the People's Republic of China, the Product Quality Law of the People's Republic of China, the Regulations of the People's Republic of China on Certification and Accreditation and other relevant laws and administrative regulations，Formulate these measures。
Article 2 The qualification of laboratories and inspection institutions as mentioned in these Measures refers to the basic conditions and capabilities that laboratories and inspection institutions that issue data and results with certification role should have。
The accreditation mentioned in these Measures refers to the evaluation and recognition activities of the Certification and Accreditation Administration of the State and the quality and technical supervision departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government on whether the basic conditions and capabilities of laboratories and inspection institutions comply with the provisions of laws, administrative regulations and the implementation of relevant technical norms or standards。
Article 3 Within the territory of the People's Republic of China, laboratories and inspection institutions engaged in the issuance of data and results with certification role to the community and the implementation of qualification verification activities shall comply with these Measures。
Article 4 The Certification and Accreditation Administration of the State (hereinafter referred to as the CNCA) shall uniformly administer, supervise and comprehensively coordinate the accreditation work of laboratories and inspection institutions。
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 institutions directly under them (hereinafter referred to as the local quality inspection departments) shall, in accordance with their respective functions and responsibilities, be responsible for the qualification recognition and supervision and inspection work of laboratories and inspection institutions within their jurisdiction。
Article 5 The qualification identification of laboratories and inspection institutions shall follow the principles of objectivity, fairness, scientific accuracy, unified norms, conducive to the sharing of testing resources and avoiding unnecessary repeated review, evaluation and identification。
Chapter II Qualification Recognition
Article 6 The forms of qualification recognition include metrological certification and examination and approval。
Metrological certification refers to the CNCA and local quality inspection departments in accordance with relevant laws and administrative regulations，To provide notarial data for the community of product quality inspection institutions of metrological verification, testing equipment performance, working environment and personnel operating skills and ensure the unity of the quantity value, accurate measures and testing data fair and reliable quality system ability to assess。
Examination and approval refers to the CNCA and the local quality inspection departments in accordance with the relevant laws and administrative regulations, to undertake the inspection task of whether the product meets the standards and undertake other standards implementation supervision and inspection tasks of the inspection institutions testing capabilities and quality system review。
Article 7 Institutions engaged in the following activities shall pass qualification recognition:
(1) providing evidencing data and results for administrative decisions made by administrative organs;
(2) providing data and results that can prove a decision made by a judicial organ;
(3) providing evidencing data and results for the arbitration decision made by the arbitration institution;
(4) providing data and results with proof for social public welfare activities;
(5) providing evidentiary data and results for economic or trade relations;
(6) Other statutory requirements for qualification recognition。
Article 8 The State encourages laboratories and inspection institutions to obtain accreditation from accreditation institutions determined by the CNCA, so as to ensure that their testing, calibration and inspection capabilities meet relevant international basic standards and general requirements, and promote international mutual recognition of testing, calibration and inspection results。
Article 9 Where the items applied for metrological certification are the same as those applied for review and approval, the review, evaluation and assessment shall be combined。In accordance with the relevant provisions and requirements, can obtain the corresponding qualification。
Laboratories and inspection institutions accredited by accreditation bodies determined by the CNCA shall simplify the corresponding accreditation procedures when applying for accreditation to avoid unnecessary repeated reviews。
Article 10 Laboratories and inspection institutions shall correctly use certificates and marks within the scope of qualification recognition。
Article 11 Where relevant laws and administrative regulations have special requirements on other technical conditions and capabilities of laboratories and inspection institutions, they may conduct evaluation, evaluation or examination on the basis of the results of qualification recognition。
Article 12 Citizens, legal persons or other organizations need to verify the authenticity and effectiveness of the accreditation of laboratories and inspection institutions, can submit a written application to the CNCA and the local quality inspection department, the CNCA and the local quality inspection department shall confirm the matters applied for verification。
Chapter III Basic conditions and capabilities of laboratories and inspection institutions
Article 13 Laboratories and inspection institutions shall be established in accordance with the law to ensure the objective, impartial and independent conduct of testing, calibration and inspection activities, and bear the corresponding legal responsibilities。
Article 14 Laboratories and inspection institutions shall have professional and technical personnel and managerial personnel suitable for their testing, calibration and inspection activities。
Laboratories and inspection institutions engaged in the testing, calibration and inspection of special products, and their professional and technical personnel and management personnel shall also meet the requirements of relevant laws and administrative regulations。
Article 15 Laboratories and inspection institutions shall have fixed workplaces, and their working environment shall ensure the authenticity and accuracy of testing, calibration and inspection data and results。
Article 16 Laboratories and inspection institutions shall have fixed and mobile testing, calibration and inspection equipment and facilities necessary for correct testing, calibration and inspection activities and can be independently deployed and used。
Article 17 Laboratories and inspection institutions shall establish quality systems that can guarantee their impartiality, independence and the scope of testing, calibration and inspection activities they undertake, and formulate corresponding quality system documents in accordance with the identified basic norms or standards and effectively implement them。
Chapter IV Qualification Accreditation procedures
Article 18 The accreditation of national laboratories and inspection institutions shall be implemented by the CNCA.The qualification of local laboratories and inspection institutions shall be implemented by local quality inspection departments。
Article 19 The CNCA shall, in accordance with relevant national standards and technical norms, formulate basic standards, evaluation criteria, certificates and marks for metrological certification and examination and accreditation, and publish them for implementation。
Article 20 Metrological certification and review and approval procedures:
(A) the application laboratory and inspection institution (hereinafter referred to as the applicant), shall, as necessary, to the CNCA or the local quality inspection department (hereinafter referred to as the acceptor) to submit a written application, and submit the relevant certification materials in accordance with the provisions of Chapter III of these Measures;
(2) The acceptor shall conduct a preliminary examination of the application materials submitted by the applicant, and make a written decision on acceptance or rejection within 5 days from the date of receipt of the application materials;
(3) The acceptor shall, from the date of acceptance of the application, conduct technical review of the applicant as necessary, and inform the applicant in writing that the technical review time shall not be counted within the time limit for approval;
(4) The acceptor shall, within 20 days from the date of completion of the technical review, make a decision on whether to approve or not based on the results of the technical review。If approval is decided, a certificate of accreditation shall be issued to the applicant, and the applicant shall be permitted to use the mark of accreditation;If approval is not granted, the applicant shall be notified in writing and the reasons shall be given;
(5) The CNCA and the local quality inspection department shall regularly publish the list of laboratories and inspection institutions that have obtained the qualification, as well as the metrological certification items and authorized products for inspection。
Article 21 The validity period of the qualification certificate shall be 3 years。
The applicant shall submit an application for review and acceptance six months before the expiration of the certificate of qualification. If the application is not submitted within the time limit, the issuing unit shall cancel the certificate of qualification and stop its use of the mark。
22nd has obtained the certificate of qualification laboratory and inspection institutions, need to add inspection inspection and testing items, should be in accordance with the procedures provided for in these measures, apply for qualification accreditation expansion。
Article 23 Personnel engaged in qualification accreditation and evaluation shall meet the requirements of relevant technical norms or standards, and pass the examination by the CNCA or the local quality inspection department。
Article 24 The CNCA and the local quality inspection departments shall establish an expert database of qualification accreditation and evaluation personnel, and form an evaluation expert group as needed。The evaluation group shall independently carry out the qualification evaluation activities and be responsible for the evaluation conclusions。
Article 25 The local quality inspection department shall, within 15 days from the date of issuing the qualification certificate to the applicant, file the approval decision with the CNCA。
Chapter V Code of Conduct for laboratories and inspection institutions
Article 26 Laboratories and inspection institutions and their personnel shall be independent of the stakeholders involved in testing, calibration and inspection data and results，Is not affected by any factors that may interfere with its technical judgment，And ensure that the results of testing, calibration and inspection are not affected by organizations or personnel other than laboratories and inspection institutions。
Article 27 Personnel of laboratories and inspection institutions shall not have an interest relationship with the testing, calibration and inspection items they engage in and the data and results they issue;Do not engage in any activity that may impair the independence and integrity of testing, calibration and inspection judgments;Not to participate in the design, development, production, supply, installation, use or maintenance of products related to testing, calibration and inspection projects or similar competitive projects。
Article 28 When laboratories and inspection institutions are engaged in testing, calibration and inspection of similar products or competitive products produced or managed by their controlling shareholders，A quality system and documentation shall be established to ensure the independence and impartiality of its testing, calibration and inspection activities，Clarify the responsibilities, responsibilities and working procedures of the organization，And its controlling shareholder engaged in the design, development, production, supply, installation, use or maintenance activities are completely separate。
Article 29 Laboratories and inspection institutions shall establish and effectively implement work duties, qualification assessment, training and other systems for managers, technicians and key support personnel related to testing, calibration and inspection to ensure that the quality of testing, calibration and inspection work is not affected by reasons such as remuneration。
Article 30 Laboratories and inspection institutions shall, in accordance with the requirements of relevant technical norms or standards, make clear provisions on the testing, calibration and inspection facilities and equipment and environmental requirements used by them, and correctly mark them。
Laboratories and inspection institutions shall carry out verification and calibration in accordance with relevant national technical specifications or standards before using measurement and inspection equipment that may affect the accuracy of detection and calibration。
Article 31 Laboratories and inspection institutions shall ensure that their relevant measurement and calibration results can be traced to the national base standards to ensure the accuracy of the results。
Laboratories and inspection institutions shall establish and implement procedures for evaluating measurement uncertainty, and evaluate and report the uncertainty of measurement and calibration results in accordance with relevant technical specifications or standards。
Article 32 Laboratories and inspection institutions shall, in accordance with relevant technical norms or standards, carry out sample extraction, disposal, transmission and storage, preparation, assessment of measurement uncertainty, analysis of inspection data and other testing, calibration and inspection activities。
Article 33 Laboratories and inspection institutions shall, in accordance with the requirements and procedures of relevant technical norms or standards, promptly issue testing, calibration and inspection data and results, and ensure that the data and results are accurate, objective and true。
Article 34 Laboratories and inspection institutions shall carry out capacity verification in accordance with relevant technical specifications or standards to ensure continuous compliance with testing, calibration and inspection capabilities。
Article 35 Laboratories and inspection institutions and their personnel shall have the obligation to keep confidential the state secrets, trade secrets and technical secrets that they come to know during testing, calibration and inspection activities, and establish corresponding confidentiality measures。
Article 36 Laboratories and inspection institutions shall establish a sound appeal and complaint mechanism to deal with objections raised by relevant parties to their testing, calibration and inspection conclusions。
Article 37 When laboratories and inspection institutions need to subcontract testing, calibration or inspection work due to work, they shall subcontract their work to laboratories or inspection institutions that comply with the provisions of these Measures and have obtained qualifications。
Chapter VI Supervision and inspection
Article 38 The CNCA shall, according to law, supervise and inspect the evaluation activities of local quality inspection departments and their organizations。
The local quality inspection department shall submit the work report of the previous year to the CNCA in January each year, accept the inquiry and investigation of the CNCA, and be responsible for the authenticity of the report。
Article 39 The CNCA shall, in accordance with law, organize supervision and random inspection of the qualifications of laboratories and inspection institutions;Those that do not meet the requirements shall be dealt with in accordance with relevant provisions。
Article 40 Any unit or individual shall have the right to report to the CNCA or the local quality inspection department the violations of the laboratory and inspection agency qualification, and the CNCA and the local quality inspection department shall promptly investigate and deal with the violations and keep confidential for the informants。
Article 41 Under any of the following circumstances, the CNCA or the local quality inspection department may, at the request of the interested party or according to its functions and powers, revoke the decision made by the laboratory and inspection institution to obtain qualification accreditation:
(1) The qualification examination and approval personnel abuse their power and neglect their duties to make the decision on the qualification of laboratories and inspection institutions;
(B) beyond the statutory authority to make laboratory and inspection institutions to obtain qualification decisions;
(C) in violation of the accreditation procedures to make laboratory and inspection institutions to obtain qualification accreditation decisions;
(4) making decisions on the qualification of laboratories and inspection institutions that do not have the basic conditions and capabilities prescribed by law;
(5) Other circumstances in which the qualification recognition can be revoked according to law。
Article 42 Where an applicant conceals relevant information or provides false materials when applying for accreditation, the supervisory and administrative department for accreditation shall not accept or approve the application and shall give a warning;The applicant shall not apply for qualification recognition again within one year。
Article 43 Where laboratories and inspection institutions obtain approval decisions by cheating, bribery and other improper means, the CNCA and the local quality inspection department shall revoke the qualification recognition decisions obtained by them and publish them。
Laboratories and inspection institutions shall not apply for accreditation again within 3 years from the date of revocation of accreditation。
If the laboratory or inspection institution issues false conclusions or seriously inaccurate conclusions, and the circumstances are serious, the qualification recognition obtained by the laboratory or inspection institution shall be revoked and announced。
Article 44 The local quality inspection department shall, within 15 days from the date of making the cancellation decision, report its cancellation decision in writing to the CNCA for the record。
The CNCA announces to the public through its website or other means the list of laboratories and inspection institutions whose accreditation has been revoked。
Article 45 Personnel engaged in the accreditation of laboratory and inspection institutions who abuse their power, neglect their duties, practice favoritism and commit malpractices shall be given administrative sanctions according to law;If the case constitutes a crime, criminal responsibility shall be investigated according to law。
Article 46 Other illegal acts of laboratories and inspection institutions shall be punished in accordance with relevant laws and administrative regulations。
Chapter VII Supplementary Provisions
Article 47 Meaning of the following terms:
(1) Laboratory means a technical institution engaged in scientific experiments, inspection, testing and calibration activities;
(2) Inspection institutions refer to technical institutions that are engaged in the verification of product designs, products, services, processes or production and processing sites related to certification and determine their compliance with the prescribed requirements;
(3) The basic conditions of laboratories and inspection institutions refer to the requirements that laboratories and inspection institutions should meet in terms of legal status, independence and impartiality, safety, environment, human resources, facilities, equipment, procedures and methods, quality systems and finance。
(4) The ability of laboratories and inspection institutions refers to the relevant experience and level of the use of basic conditions by laboratories and inspection institutions to ensure the accuracy, reliability and stability of the data and results issued by them with certification。
Article 48 Fees for accreditation shall be handled in accordance with the relevant provisions of the State。
Article 49 The State General Administration of Quality Supervision, Inspection and Quarantine shall be responsible for the interpretation of these measures。
Article 50 These Measures shall come into force as of April 1, 2006。On July 10, 1987, the "Measures for the Management of Measurement Certification of Product Quality Inspection Institutions" issued by the former State Bureau of Metrology was repealed simultaneously。
