Administrative Measures for Accreditation of Laboratories and Inspection Organizations
Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Decree No. 86
Secretary Li Changjiang
February 21, 2006 Article 1
In order to standardize the management of qualification management of laboratories and inspection organizations and to improve the Scientific and effective, according to the "People's Republic of China *** and the State Metrology Law", "People's Republic of China *** and the State Standardization Law", "People's Republic of China *** and the State Product Quality Law", "People's Republic of China *** and the State Certification and Accreditation Regulations" and other relevant laws, administrative regulations, the formulation of these measures.
Second
The qualification of laboratories and inspection bodies referred to in these measures, is to the community to issue data and results with the role of proof of laboratories and inspection bodies should have the basic conditions and capabilities.
The measures referred to in the recognition, refers to the National Certification and Accreditation Administration and the provinces, autonomous regions and municipalities directly under the Central People's Government of the quality and technology supervision departments of laboratories and inspection bodies of the basic conditions and capabilities in line with the provisions of the laws, administrative regulations and related technical specifications or standards for the implementation of the evaluation and recognition of activities.
Article 3
In the People's Republic of China *** and the State, engaged in the issuance of data and results to the community with the role of proof of laboratories and inspection bodies and their implementation of the qualification activities should comply with these measures.
Article 4
The State Certification and Accreditation Administration (hereinafter referred to as the CNCA) shall unify the management, supervision and comprehensive coordination of the accreditation of laboratories and inspection bodies.
Provinces, autonomous regions, municipalities directly under the Central People's Government quality and technology supervision departments and entry-exit inspection and quarantine agencies (hereinafter collectively referred to as the local quality inspection departments) in accordance with their respective responsibilities within their respective jurisdictions responsible for the accreditation of laboratories and inspection bodies and supervision and inspection work.
Article 5
Laboratory and inspection agency accreditation, should follow the objective and fair, scientific and accurate, uniform and standardized, conducive to testing resources **** enjoy and avoid unnecessary duplication of assessment, evaluation, recognition of the principle. Article VI
The form of accreditation includes metrological certification and examination and recognition.
Measurement certification refers to the national commission and local quality inspection departments in accordance with relevant laws and administrative regulations, to provide the community with notarized data on the product quality inspection agency's metrological verification, testing equipment, working performance, working environment and the operating skills of the personnel and to ensure uniformity of the quantitative value of the accurate measures and testing data is fair and reliable quality system capabilities of the assessment.
Review of the accreditation refers to the national commission and local quality inspection departments based on relevant laws and administrative regulations, to undertake the task of testing whether the product complies with the standard and other standards to implement the task of supervision and inspection of the inspection agency's ability to test and quality system review.
Article VII
The following activities should be engaged in the agency through the accreditation:
(a) administrative agencies to make administrative decisions to provide evidence of the role of data and results;
(b) for the judiciary to make rulings to provide evidence of the role of data and results;
(c) for the arbitration body to make arbitration decisions to provide evidence of the role of data and results;
(c) the arbitration body to make arbitration (iii) Providing data and results with supporting functions for the arbitration decision made by the arbitration authority;
(iv) Providing data and results with supporting functions for social public welfare activities;
(v) Providing data and results with supporting functions for the economic or trade relations;
(vi) Other statutory needs to be recognized through the qualification.
Article 8
The State encourages laboratories and inspection organizations to obtain accreditation from accreditation bodies determined by the CNCA, so as to ensure that their testing, calibration and inspection capabilities comply with the relevant international basic standards and general requirements, and to promote international mutual recognition of the results of testing, calibration and inspection.
Article IX
Application for metrological certification and application for review and approval of the same project, its assessment, evaluation and evaluation shall be combined. Meet the requirements of the relevant provisions of the corresponding qualification can be obtained.
To obtain accreditation by the national commission to determine the accreditation body accredited laboratories and inspection bodies, when applying for accreditation, should simplify the corresponding accreditation procedures, to avoid unnecessary duplication of assessment.
Article 10
Laboratories and inspection bodies, should be within the scope of accreditation and the correct use of certificates and logos.
Article XI
Related laws and administrative regulations on laboratories and inspection agencies have special requirements for other technical conditions and capabilities, can be assessed, evaluated or appraised based on the use of the results of accreditation.
Article XII
Citizens, legal persons or other organizations, the need to verify the authenticity and validity of the qualification certification of laboratories and inspection bodies, may apply in writing to the CNCA and the local quality inspection departments, the CNCA and the local quality inspection departments shall confirm the application for verification. Article XIII
Laboratories and inspection organizations shall be established in accordance with law to ensure objectivity, impartiality and independence in testing, calibration and inspection activities, and bear the corresponding legal responsibilities.
Article XIV
Laboratories and inspection organizations shall have professional and technical personnel and management personnel appropriate for their testing, calibration and inspection activities.
Laboratories and inspection organizations engaged in testing, calibration and inspection activities of special products, their professional and technical personnel and management personnel shall also meet the requirements of relevant laws and administrative regulations.
Article 15
Laboratories and inspection organizations shall have a fixed workplace, and their working environment shall ensure that the testing, calibration and inspection data and results are true and accurate.
Article 16
Laboratories and inspection organizations should have the correct testing, calibration and inspection activities required and can be independently deployed to use fixed and mobile testing, calibration and inspection equipment and facilities.
Article XVII
Laboratories and inspection agencies shall establish a quality system to ensure their impartiality, independence and the scope of their testing, calibration and inspection activities appropriate, in accordance with the recognition of the basic norms or standards for the development of the corresponding quality system documents and effective implementation. Article 18
National laboratories and inspection bodies accreditation by the national commission responsible for the implementation; local laboratories and inspection bodies accreditation by the local quality inspection departments responsible for the implementation.
Article 19
The CNCA, based on relevant national standards and technical specifications, formulates the basic specifications for metrological accreditation and review and approval, evaluation guidelines, certificates and logos, and publishes them for implementation.
Article 20
Measurement certification and review of accreditation procedures:
(a) the application of laboratories and inspection bodies (hereinafter referred to as the applicant), should be based on the need to the CNCA or the local quality inspection departments (hereinafter referred to as the acceptor) to submit a written application, and submit the relevant materials in line with the provisions of Chapter III of the Measures;
(b) the acceptor The applicant shall submit a preliminary review of the application materials, and from the date of receipt of the application materials within five days to make a written decision on acceptance or inadmissibility;
(c) the acceptance of the application shall be accepted from the date of the applicant, according to the applicant needs to carry out a technical review, and notify the applicant in writing, the technical review time is not counted in the period of time for the approval;
(d) the acceptance of the The person shall, within 20 days from the date of completion of the technical review, based on the results of the technical review to make a decision on whether to approve. Decision to approve the applicant issued a certificate of accreditation, and permission to use the accreditation mark; not approved, the applicant shall be notified in writing, and explain the reasons;
(e) CNCA and local quality inspection departments should be regularly published to obtain accreditation of laboratories and inspection agencies directory, as well as measurement of certified items, authorized to test the product and so on.
Article 21
The certificate of accreditation is valid for three years.
The applicant should be in the qualification certificate expires six months before the application for review and acceptance, late application, by the issuing unit to cancel the qualification certificate, and stop its use of the logo.
Article 22
Already obtained a certificate of accreditation of laboratories and inspection agencies, the need for new inspection and testing projects, should be in accordance with the procedures set out in these measures, apply for accreditation expansion.
Article 23
The personnel engaged in accreditation assessment shall meet the requirements of the relevant technical specifications or standards, and by the national commission or the local quality inspection departments qualified.
Article 24
The CNCA and the local quality inspection departments shall establish a pool of experts for accreditation assessment, and form an expert group for accreditation according to the needs. Assessment of the expert group shall independently carry out accreditation assessment activities, and is responsible for the assessment conclusions.
Article 25
Local quality inspection departments shall issue a certificate of accreditation to the applicant within 15 days from the date of approval of its decision to the national commission for the record. Article 26
Laboratories and inspection agencies and their personnel shall be independent of all parties interested in the data and results of testing, calibration and inspection, and shall be free from any factors that may interfere with their technical judgment, and ensure that the results of testing, calibration and inspection are not influenced by organizations or persons outside the laboratories and inspection agencies.
Article 27
Personnel of laboratories and inspection agencies shall not have an interest in the testing, calibration and inspection projects they are engaged in and in the data and results they issue; they shall not engage in any activities that impair the independence and integrity of the judgments made in testing, calibration and inspection; and they shall not be involved in the design of products related to the testing, calibration and inspection projects or similar competitive projects, Development, production, supply, installation, use or maintenance activities.
Article 28
Laboratories and inspection agencies engaging in testing, calibration and inspection activities of similar products produced or operated by their controlling shareholders or competitive products shall establish a quality system and its documents to ensure the independence and impartiality of their testing, calibration and inspection activities, clarify the duties, responsibilities and working procedures of the agency and engage in designing, developing, producing, supplying, installing, using or maintaining activities related to the testing, calibration and inspection items or similar competitive items of the products of their controlling shareholders. design, development, production, supply, installation, use or maintenance activities are completely separated.
Article 29
Laboratories and inspection agencies shall establish and effectively implement a system of job duties, qualification assessment, and training of management personnel, technicians, and key support personnel related to testing, calibration, and inspection, to ensure that the quality of the testing, calibration, and inspection work is not compromised due to compensation or other reasons.
Article 30
Laboratories and inspection organizations shall, in accordance with the requirements of the relevant technical specifications or standards, make clear provisions for the testing, calibration and inspection facilities and equipment they use as well as the environmental requirements, etc., and correctly identify them.
Laboratories and inspection agencies in the use of testing, calibration of the accuracy of the measurement, inspection equipment before the impact, should be in accordance with relevant national technical specifications or standards for verification, calibration.
Article 31
Laboratories and inspection bodies shall ensure that their relevant measurements and calibration results can be traced back to the national base standards to ensure the accuracy of the results.
Laboratories and inspection bodies shall establish and implement procedures for assessing measurement uncertainty, and assess and report the uncertainty of measurement and calibration results in accordance with the requirements of the relevant technical specifications or standards.
Article 32
Laboratories and inspection agencies should be implemented in accordance with the relevant technical specifications or standards for sample extraction, disposal, transmission and storage, preparation, assessment of measurement uncertainty, analysis of test data and other testing, calibration and inspection activities.
Article 33
Laboratories and inspection agencies shall, in accordance with the relevant technical specifications or standards and the prescribed procedures, timely issuance of testing, calibration and inspection data and results, and to ensure that the data and results are accurate, objective and true.
Article 34
Laboratories and inspection agencies in accordance with the relevant technical specifications or standards to carry out proficiency testing to ensure that they continue to meet the testing, calibration and inspection capabilities.
Article 35
Laboratories and inspection agencies and their personnel shall be responsible for the confidentiality of state secrets, commercial secrets and technical secrets known to them in the testing, calibration and inspection activities, and the establishment of appropriate confidentiality measures.
Article 36
Laboratories and inspection bodies shall establish a sound complaint and grievance mechanism to deal with the relevant parties to their testing, calibration and inspection findings of the objections.
Article 37
When laboratories and inspection agencies need to subcontract testing, calibration or inspection work due to their work, they shall subcontract their work to laboratories or inspection agencies that are in compliance with the provisions of these Measures and have obtained qualifications. Article 38
The CNCA shall supervise and inspect the accreditation activities of local quality inspection departments and their organizations in accordance with law.
Local quality inspection departments shall submit to the CNCA in January of each year, the previous year's work report, to accept the State commission's inquiries and investigations, and is responsible for the authenticity of the report.
Article 39
The CNCA shall, in accordance with the law, organize supervisory sampling of the qualifications of laboratories and inspection agencies; those that do not meet the requirements shall be dealt with in accordance with the relevant provisions.
Article 40
Any unit or individual has the right to report to CNCA or the local quality inspection departments for violations of laws and regulations in the accreditation of laboratories and inspection bodies; CNCA and the local quality inspection departments shall investigate and deal with them in a timely manner and maintain the confidentiality of the informants.
Article 41
One of the following circumstances, the CNCA or the local quality inspection departments, according to the request of the interested party or on the basis of competence, to revoke its decision to obtain accreditation of laboratories and inspection bodies:
(a) accreditation of the examination and approval of the abuse of power and dereliction of duty by the staff to make the laboratory and inspection bodies to obtain accreditation of the decision;
(a) the accreditation of staff abuse of power, dereliction of duty to obtain accreditation of laboratories and inspection bodies Decision;
(ii) exceeding the statutory authority to make the decision of laboratories and inspection agencies to obtain accreditation;
(iii) violation of accreditation procedures to make the decision of laboratories and inspection agencies to obtain accreditation;
(iv) for laboratories and inspection agencies that do not have the basic conditions and capabilities of the law to make the decision to obtain accreditation;
(v) Other cases in which the qualification recognition can be revoked according to law.
Article 42
Applicants applying for accreditation, concealment of relevant information or provide false materials, the supervision and management of accreditation shall be inadmissible or unapproved, and be given a warning; the applicant shall not apply for accreditation again within one year.
Article 43
Laboratories and inspection bodies to cheat, bribery and other improper means to obtain approval of the decision, the CNCA and the local quality inspection departments shall revoke the qualification decision, and shall be published.
Laboratories and inspection bodies shall not apply for accreditation again within three years from the date of revocation of accreditation.
Laboratories and inspection agencies issued false conclusions or issued conclusions seriously inaccurate, the circumstances are serious, it shall revoke the qualification recognized that it has obtained, and shall be published.
Article 44
The local quality inspection department shall, within 15 days from the date of the revocation decision, report its revocation decision in writing to the CNCA for record.
The CNCA publishes the list of laboratories and inspection organizations that have withdrawn their accreditation to the society through its website or other means.
Article 45
Staff engaged in the accreditation of laboratories and inspection bodies abuse of power, dereliction of duty, favoritism and malpractice, shall be given administrative sanctions according to law; constitutes a crime, shall be investigated for criminal responsibility.
Article 46
Other illegal acts of laboratories and inspection agencies shall be punished in accordance with the provisions of relevant laws and administrative regulations. Article 47
The meaning of the following terms:
(1) laboratory, refers to the scientific experimentation, testing and calibration activities of technical institutions;
(2) inspection agency, refers to the verification of product design, products, services, processes, or production and processing sites engaged in the certification, and to determine that it meets the prescribed requirements of the technical institutions;
(c) the basic conditions of laboratories and inspection bodies, refers to the laboratory and inspection bodies should meet the legal status, independence and impartiality, safety, environment, human resources, facilities, equipment, procedures and methods, quality systems and financial requirements.
(d) Competence of laboratories and inspection bodies refers to the relevant experience and level of laboratories and inspection bodies in applying their basic conditions in order to ensure the accuracy, reliability, and stability of the data and results they issue with a certifying role.
Article 48
Qualification fees shall be handled in accordance with relevant state regulations.
Article 49
These measures shall be interpreted by the State Administration of Quality Supervision, Inspection and Quarantine.
Article 50
These measures shall come into force on April 1, 2006. July 10, 1987 the former State Bureau of Weights and Measures issued by the "Measurement Certification of Product Quality Inspection Bodies Management Measures" shall be repealed simultaneously.