Rule number one In order to strengthen the supervision and management of occupational health technical service institutions and standardize the behavior of occupational health technical services, these measures are formulated in accordance with the Law of People's Republic of China (PRC) on the Prevention and Control of Occupational Diseases.
Rule number two These Measures shall apply to applying for the qualification of occupational health technical service institutions in People's Republic of China (PRC), engaging in occupational health detection and evaluation technical services, and implementing the qualification identification and supervision and management of occupational health technical service institutions by health authorities.
Rule three. The term "occupational health technical service institutions" as mentioned in these Measures refers to institutions that provide technical services such as detection of occupational disease hazard factors, evaluation of occupational disease hazard status, evaluation of occupational disease protection equipment and facilities and protective articles for employers.
Article 4? The state implements a qualification accreditation system for occupational health technical service institutions. Occupational health technical service institutions shall obtain the qualification of occupational health technical service institutions in accordance with these measures; Those who have not obtained the qualification of occupational health technical service institutions shall not engage in occupational health testing and evaluation technical services.
Article 5? The qualification grades of occupational health technical service institutions are divided into Grade A and Grade B. ..
Grade A qualification is recognized by the National Health and Wellness Committee and issued with certificates.
Grade B qualification is recognized and issued by the health authorities of provinces, autonomous regions and municipalities directly under the Central Government.
The National Health and Wellness Commission and the health authorities of all provinces, autonomous regions and municipalities directly under the Central Government are collectively referred to as qualification accreditation bodies.
Article 6? Occupational health technical service institutions with Grade A qualifications may engage in occupational health technical service activities nationwide in accordance with the recognized business scope.
Occupational health technical service institutions with Grade B qualification can engage in occupational health technical service activities in their provinces, autonomous regions and municipalities directly under the Central Government in accordance with the approved business scope.
The occupational health technical services of the following employers must be undertaken by the occupational health technical service institutions that have obtained Grade A qualifications:
(1) Employer of nuclear facilities;
(2) Production and operation of installations (facilities) across provinces, autonomous regions and municipalities directly under the Central Government.
Article 7? The National Health and Wellness Committee is responsible for guiding the supervision and management of the national occupational health technical service institutions.
Local health administrative departments at or above the county level shall be responsible for the supervision and management of occupational health technical service institutions within their respective administrative areas.
Article 8? The state encourages the occupational health technical service industry to strengthen self-discipline, standardize its practice and maintain the order of the industry.
Chapter two? Qualification recognition
Article 9? An applicant applying for the qualification of an occupational health technical service institution shall meet the following conditions:
(1) Being able to bear civil liability independently;
(2) Having a fixed workplace, and the areas of laboratories, archives and other places are suitable for the qualifications and business scope of the application;
(3) Having laboratories that meet the requirements, and having instruments and equipment that are suitable for the qualification and business scope;
(4) Having a sound internal management system and quality assurance system;
(five) professional and technical personnel who meet the requirements of academic qualifications, professional and technical titles. Not less than 30 professional and technical personnel applying for Grade A qualification; The number of professional and technical personnel applying for Grade B qualification shall not be less than fifteen;
(six) there are full-time technical directors and quality control directors. Apply for Grade A qualification, and the full-time technical director has a senior title and more than five years of occupational health-related work experience; To apply for Grade B qualification, the full-time technical person-in-charge has a senior professional title and more than three years of occupational health-related work experience, or an intermediate professional title and more than eight years of occupational health-related work experience. The person in charge of quality control has a senior title and more than three years of relevant work experience, or an intermediate title and more than five years of relevant work experience;
(seven) have the ability to apply for qualification and business scope detection and evaluation. To apply for Grade A qualification, the principal person in charge of the institution and the person in charge of key positions shall have more than five years of working experience in occupational health technical services;
(eight) as of the date of application, there is no record of serious violation of law and dishonesty within five years;
(9) Websites that are in normal operation and available for public inquiry;
(10) Other conditions stipulated by laws and administrative regulations.
Article 10? The applicant shall organize professional and technical personnel to receive professional training, so as to ensure that the professional and technical personnel are familiar with the laws, regulations and standards for the prevention and control of occupational diseases, and have the professional ability suitable for the occupational health technical services they are engaged in.
For the training of professional and technical personnel, the applicant may implement it by himself or entrust a qualified training institution to implement it. Professional and technical personnel training plan and training records (including text and video materials) should be filed for future reference.
Article 11? The applicant shall submit the following materials:
(1) An application signed by the legal representative or principal responsible person;
(2) A letter of commitment signed by the legal representative or principal responsible person to know the legal responsibilities, obligations, rights and risks of undertaking occupational health technical services;
(3) Business license or other legal person qualification certificates;
(4) Property right certificate or lease contract of the workplace;
(five) the list of professional and technical personnel, full-time technical person in charge and quality control person in charge, and their technical titles and labor relations certificates;
(6) A list of instruments and equipment, a schematic diagram of the layout and area of the workplace;
(seven) other materials that can prove that it has the corresponding business ability within the scope of applying for occupational health technical services.
The applicant is responsible for the authenticity of the application materials.
Article 12? To apply for the qualification of occupational health technical service institutions, the following procedures shall be followed:
(a) the applicant in accordance with the provisions of article fifth of these measures to apply to the corresponding qualification accreditation bodies, and submit the materials stipulated in the first paragraph of article eleventh of these measures;
(two) the qualification accreditation authority shall make a decision on whether to accept or not within five working days from the date of receiving the application materials. If the materials are complete and conform to the prescribed form, it shall be accepted and a written acceptance certificate shall be issued; If the materials are incomplete or do not conform to the prescribed form, the applicant shall be informed of all the contents that need to be corrected on the spot or within five working days; If it decides not to accept the application, it shall explain the reasons in writing to the applicant;
(3) The qualification accreditation organ shall, within 20 working days from the date of accepting the qualification application, organize a technical review of the applicant according to the Technical Review Standard for Qualification Accreditation of Occupational Health Technical Service Institutions, and make a decision on qualification accreditation according to the conclusion of the technical review. If the decision is approved, the qualification certificate shall be issued to the applicant within ten working days from the date of making the decision; If it decides not to approve, it shall explain the reasons in writing to the applicant. If the decision of approval cannot be made within twenty working days, it may be extended for ten working days with the approval of the person in charge of the qualification accreditation authority, and the applicant shall be informed of the reasons for extending the time limit.
Article 13 The National Health and Wellness Commission shall formulate the style and content of the relevant documents for the qualification identification of occupational health technical service institutions, the technical evaluation standards for the qualification identification of occupational health technical service institutions and the style of qualification certificates, and make them public.
Fourteenth qualification institutions shall establish a technical evaluation expert database (hereinafter referred to as the expert database) and its management system.
Technical review experts should be familiar with the laws, regulations and standards of occupational disease prevention and control, have senior technical titles in related majors, have more than five consecutive years of occupational health work experience, and have good professional ethics.
Technical evaluation experts shall carry out their work in accordance with the technical evaluation criteria, issue evaluation opinions and be responsible for the evaluation opinions.
Technical review experts shall not engage in technical review activities that have an interest in them.
Article 15 The State Health and Wellness Commission shall formulate and publish the examination outline for professional and technical personnel of occupational health technical service institutions, and establish a question bank.
Sixteenth qualification institutions shall randomly select 3 to 7 (odd) experts from the expert database to form an expert group to conduct technical review of the applicant.
Technical review includes technical review of application materials and on-site technical evaluation. The technical review conclusions of the application materials are divided into "passed" and "failed". If the conclusion of technical review is "passed", the on-site technical review will be continued; If the conclusion of technical review is "failed", on-site technical review will not be conducted.
On-site technical assessment shall include the following contents:
(a) to check the relevant equipment, facilities, instruments and meters on site;
(two) according to the assessment outline and question bank, the professional knowledge and practical operation ability of the full-time technical person in charge, the person in charge of quality control and relevant professional and technical personnel are assessed;
(three) sampling original work records, video materials, reports, summaries, files and other materials; ?
(4) Necessary blind sample detection.
On-site technical evaluation time generally does not exceed ten working days. The conclusions of on-site technical evaluation are divided into "passed" and "failed".
Article 17? The qualification certificate of occupational health technical service institutions is valid for five years. If the validity period of the qualification certificate expires and needs to be extended, the occupational health technical service institution shall apply to the original qualification certification authority three months before the expiration of the validity period. Those who pass the examination are allowed to continue; Unqualified, the extension shall not be approved, and the reasons shall be explained in writing to the applicant.
Article 18? Where an occupational health technical service institution has obtained the qualification for more than one year and needs to expand its business scope, it shall apply to the original qualification certification authority. The qualification accreditation organ shall make accreditation in accordance with the provisions of these Measures.
Article 19 Where an occupational health technical service institution changes its name, legal representative or principal responsible person, registered address and laboratory address, it shall apply to the original qualification accreditation authority for the change procedures.
Where an occupational health technical service institution is divided or merged, it shall apply for the change of qualification identification or reapply for the qualification identification of the occupational health technical service institution.
Article 20? If the qualification certificate of the occupational health technical service institution is lost, it shall, within 30 days from the date of the loss of the certificate, apply in writing to the original qualification certification authority for a replacement.
Article 21? Occupational health technical service institutions shall not alter, resell, lease or lend the qualification certificate of occupational health technical service institutions, or illegally transfer the qualification certificate of occupational health technical service institutions in other forms.
Article 22? The qualification accreditation institution shall promptly announce the qualified occupational health technical service institutions to the public and accept social supervision.
Chapter three? technical service
Article 23? Occupational health technical service institutions shall establish and improve the occupational health technical service responsibility system. The main person in charge is fully responsible for the occupational health technical service work of this institution. The full-time technical person in charge and the person in charge of quality control shall strengthen the whole process management of occupational health technical services in accordance with the provisions of laws, regulations and standards. Report reviewers, authorized signatories, technical service project leaders and participants shall participate in technical services according to their respective responsibilities, sign technical reports and original records, and assume corresponding responsibilities. Occupational health technical service institutions shall not arrange professional and technical personnel who do not meet the requirements of technical review and assessment to participate in occupational health technical services.
Occupational health technical service institutions shall organize professional and technical personnel to receive not less than eight hours of continuing education and training every year.
Article 24? Occupational health technical service institutions shall abide by laws and regulations, Monitoring and Sampling Standard for Hazardous Substances in Workplace Air (GBZ 159), Basic Standard for Protection against Ionizing Radiation and Safety of Radiation Sources (GB 1887 1), Hygienic Standard for Design of Industrial Enterprises (GBZ 1) and GBZ2.2) and other standards and specifications, carry out occupational health technical service activities such as on-site investigation, identification of occupational disease hazard factors, on-site sampling, on-site detection, sample management, laboratory analysis, data processing and application, hazard degree evaluation, protective measures and their effect evaluation, technical report compilation, truthfully record the original information of technical service, ensure the traceability of relevant data information, scientifically, objectively and truly reflect technical service matters, and undertake the occupational health technical report issued.
Article 25? Occupational health technical service institutions shall independently carry out occupational health technical service activities according to law. If it is impossible to carry out self-inspection due to the limitation of testing items or special requirements on the storage time of samples, it may entrust an occupational health technical service institution with corresponding testing capabilities to carry out sample testing. On-site sample collection, analysis and application of test results shall not be entrusted to other institutions.
Article 26? Occupational health technical service institutions shall make public their working systems and procedures to facilitate the clients and take measures to ensure the service quality.
Article 27? Occupational health technical service institutions shall carry out technical services within the approved scope, accept the supervision and management of the competent health department where the technical services are located, and timely submit relevant information such as the content, time and participants of occupational health technical services in accordance with regulations.
Provisions on the administration of information submission of occupational health technical services shall be uniformly formulated by the State Health and Wellness Commission and announced to the public.
Article 28? When carrying out technical services, occupational health technical service institutions shall clarify the content and scope of technical services and the responsibilities of both parties with the employer in written form.
If the content, scope and requirements of technical services proposed by the employer violate the provisions of laws, regulations and standards, the occupational health technical service institution shall refuse.
Article 29? Occupational health technical service institutions and their staff members shall not commit any of the following acts in engaging in occupational health technical service activities:
(a) engaged in technical service activities beyond the scope of qualification;
(two) issued a false or inaccurate occupational health technical report;
(3) Subcontracting occupational health technical service projects;
(4) changing or simplifying the procedures and related contents of occupational health technical services without authorization;
(five) other illegal acts as prescribed by laws and regulations.
Article 30? Occupational health technical service institutions shall not use their non-professional technical personnel to engage in occupational health technical service activities.
Professional and technical personnel of occupational health technical service institutions shall not have the following acts:
(1) Signing on behalf of the technical report on occupational health or relevant original records;
(two) did not participate in the corresponding occupational health technical service matters, and signed the technical report or relevant original records;
(three) other acts in violation of laws, regulations and standards.
Article 31? Occupational health technical service institutions shall establish occupational health technical service files and keep them properly for a long time. The archives of occupational health technical service include the process control records of occupational health technical service, on-site investigation records, relevant original records, video materials, technical reports and relevant certification materials.
Occupational health technical service institutions shall provide necessary personal protective equipment for professional and technical personnel.
The occupational health technical service institution shall, within 20 working days from the date of issuing the occupational health technical report, disclose the relevant information of the technical report on the website of the unit (except for information involving state secrets, commercial secrets, technical secrets and personal privacy, and information prohibited by laws and regulations), and the disclosure time shall not be less than five years. The public information shall include the following contents:
(1) Name, address and contact person of the employer;
(2) List of technical service project team members;
(3) The name list and time of professional and technical personnel for on-site investigation, on-site sampling and on-site inspection, and the accompanying personnel of the Employer;
(4) Images that prove on-site investigation, on-site sampling and on-site detection.
Chapter four? management by supervision
Article 32? The qualification accreditation organ shall, within the validity period of the qualification accreditation, conduct at least one evaluation and inspection of the occupational health technical service institutions recognized by it, focusing on the maintenance and conformity of the qualification conditions.
Evaluation and inspection can be carried out by means of capability verification and on-site verification.
Article 33? The local health authorities at or above the county level shall, in accordance with the relevant provisions of "double randomness and one openness", strengthen the post-event supervision of occupational health technical service institutions within their respective administrative areas.
Article 34? The local health administrative departments at or above the county level shall supervise and inspect the occupational health technical service institutions, mainly including the following contents:
(a) whether the content and scope of technical services and the responsibilities of both parties have a clear written agreement with the employer;
(2) Whether to carry out occupational health technical service activities such as on-site investigation, identification of occupational hazard factors, on-site sampling, on-site detection, sample management, laboratory analysis, data processing and application, evaluation of hazard degree, evaluation of protective measures and their effects, and preparation of technical reports in accordance with the requirements of standards and specifications;
(three) whether the internal audit of technical services and the original information records are standardized;
(4) Whether the occupational health technical service files are complete;
(five) whether there is any illegal situation such as fraud in the process of technical service;
(six) whether to submit the relevant information of occupational health technical service to the competent health department where the technical service is located in accordance with the regulations;
(seven) whether the relevant information of the occupational health technical report is disclosed on the Internet in accordance with the regulations;
(eight) other contents that should be supervised and inspected according to law.
The local health authorities at or above the county level shall strengthen the extended inspection of the occupational health technical services provided by the relevant occupational health technical service institutions when supervising and inspecting the occupational disease prevention and control work of the employing units.
Article 35? The competent health department at or above the county level shall establish the information management system of occupational health technical service institutions, establish the credit files of occupational health technical service institutions and their employees, record illegal and untrustworthy behaviors and make them public according to law, and implement classified supervision according to the credit status of occupational health technical service institutions.
Article 36? In any of the following circumstances, the qualification accreditation authority shall cancel its qualification:
(a) the validity period of qualification accreditation has not been extended;
(2) Termination according to law;
(three) the qualification is revoked or withdrawn according to law, or the qualification certificate is revoked according to law;
(four) other circumstances in which the qualification shall be cancelled as stipulated by laws and regulations.
Article 37? The competent department of health and its staff shall not commit any of the following acts:
(a) require the employer to accept the occupational health technical services provided by the designated occupational health technical service institutions;
(two) the administrative license is set in disguise outside the provisions of laws and regulations;
(three) to restrict the occupational health technical service institutions outside the administrative area to carry out occupational health technical services in this area;
(four) to interfere with the normal activities of occupational health technical service institutions;
(five) to collect fees from occupational health technical service institutions or in disguised form;
(six) to apportion property and sell products to occupational health technical service institutions;
(seven) the expense reimbursement of occupational health technical service institutions;
(eight) to recognize the qualifications of unqualified applicants.
Article 38? Any unit or individual has the right to report to the health administrative department at or above the county level or other relevant departments if it finds that the occupational health technical service institutions and their employees, the health administrative department and its staff, and the technical evaluation experts violate the laws, regulations and the provisions of these measures on the prevention and control of occupational diseases.
The competent department of health and wellness shall keep confidential the informants and conduct verification and handling according to law.
Chapter five? Legal liability
Article 39? Staff of health departments at or above the county level who fail to perform their duties as prescribed in the present Measures, engage in malpractices for selfish ends, abuse their powers, practise fraud and neglect their duties shall be given corresponding sanctions according to law.
If a technical evaluation expert engages in malpractices for personal gain, practices fraud or neglects his duty in the technical evaluation of occupational health technical service institutions, his qualification as a technical evaluation expert shall be revoked and he shall not re-enter the expert database for life.
Article 40? If the applicant conceals relevant information or provides false materials to apply for the qualification certification of occupational health technical service institutions, the qualification certification authority shall not accept or disapprove it and give a warning; The applicant shall not apply for the qualification of occupational health technical service institutions again within one year from the date when the qualification accreditation authority decides not to accept or disapprove.
Where an occupational health technical service institution obtains the qualification certification of an occupational health technical service institution by cheating, bribery or other improper means, the qualification certification authority shall revoke its qualification certification and give it a warning; Within three years from the date when the qualification certification authority revokes the qualification certification, the applicant may not apply for the qualification of occupational health technical service institution again.
Article 41? Those who have not obtained the qualification of occupational health technical services and are approved to engage in occupational health testing and evaluation technical services shall be ordered by the local health administrative department at or above the county level to immediately stop the illegal acts and confiscate the illegal income; If the illegal income is more than 5,000 yuan, a fine of more than two times and less than ten times the illegal income shall be imposed; If there is no illegal income or the illegal income is less than 5,000 yuan, a fine of 5,000 yuan to 50,000 yuan shall be imposed; If the circumstances are serious, the directly responsible person in charge and other directly responsible personnel shall be given demotion, dismissal or dismissal according to law.
Article 42? Where an occupational health technical service institution commits one of the following acts, the local health department at or above the county level shall order it to immediately stop the illegal act, give it a warning and confiscate its illegal income; If the illegal income is more than 5,000 yuan, a fine of more than two times and less than five times the illegal income shall be imposed; If there is no illegal income or the illegal income is less than 5,000 yuan, a fine of 5,000 yuan to 20,000 yuan shall be imposed; If the circumstances are serious, the original qualification accreditation authority shall cancel its qualification accreditation; The directly responsible person in charge and other responsible personnel shall be punished by demotion, dismissal or dismissal according to law; If the case constitutes a crime, criminal responsibility shall be investigated according to law:
(a) engaged in occupational health technical services beyond the scope of qualification;
(2) Failing to perform statutory duties in accordance with the provisions of the Law on the Prevention and Control of Occupational Diseases;
(3) Issuing false documents.
Article 43? Where an occupational health technical service institution commits one of the following acts, the local health department at or above the county level shall order it to make corrections, give it a warning and impose a fine of 1 10,000 yuan but not more than 30,000 yuan; If the case constitutes a crime, criminal responsibility shall be investigated according to law:
(1) Altering, reselling, leasing or lending the qualification certificate of the occupational health technical service institution, or illegally transferring the qualification certificate of the occupational health technical service institution in other forms;
(2) Failing to submit relevant information on occupational health technical services to the competent health department where the technical service institution is located;
(3) Failing to disclose the relevant information of occupational health technical report on the Internet as required;
(four) other acts in violation of the provisions of these measures.
Article 44? In any of the following circumstances, the local health authorities at or above the county level shall order it to make corrections, give a warning and may impose a fine of not more than 30,000 yuan:
(a) failing to provide occupational health technical services in accordance with the standards, or changing or simplifying the service procedures and related contents without authorization;
(2) Failing to carry out entrusted testing as required;
(3) Subcontracting occupational health technical service projects;
(four) the content, scope and responsibilities of technical services are not clearly defined with the employer in writing;
(five) the use of non-professional technical personnel to engage in occupational health technical service activities;
(six) to arrange professional and technical personnel who do not meet the requirements of technical review and assessment to participate in occupational health technical services.
Article 45? Professional and technical personnel of occupational health technical service institutions are under any of the following circumstances, and the local health authorities at or above the county level shall order them to make corrections, give them a warning and impose a fine of 1 10,000 yuan:
(1) Signing on behalf of the technical report on occupational health or relevant original records;
(two) did not participate in the corresponding occupational health technical service matters, and signed the technical report or relevant original records;
(three) other acts in violation of the provisions of these measures.
Article 46? The occupational health technical service institutions that have obtained the qualification certification no longer meet the prescribed qualification conditions, and the original qualification certification authority shall order them to make corrections, informed criticism; If the circumstances are serious, its qualification shall be revoked according to law.
Article 47? The administrative punishment prescribed in these Measures shall be decided by the local health administrative department at or above the county level where the technical service institution is located, except for the implementation by the original qualification accreditation authority.
Chapter six? supplementary terms
Article 48? The meanings of the following terms in these Measures:
Professional and technical personnel refer to personnel engaged in occupational health technical services in occupational health technical service institutions or units that intend to apply for the qualification of occupational health technical service institutions.
Nuclear facilities refer to nuclear power plants (nuclear power plants, nuclear thermal power plants, nuclear steam supply and heating plants, etc.). ) and other reactors (research reactors, experimental reactors, critical devices, etc. ); Nuclear fuel production, processing, storage and reprocessing facilities; Radioactive waste treatment and disposal facilities. ?
Article 49? The management of technical service institutions such as personal dose monitoring, radiation protection equipment and radioactive products detection, and radiation hazard assessment of medical institutions shall be stipulated separately.
Article 50? Before the implementation of these Measures, the qualification of occupational health technical service institutions has been obtained, and the qualification will continue to be valid. If the qualification expires before 202113, the validity period will be extended to 2021April 30th.
After the expiration of Grade A and Grade B qualifications, if it is necessary to continue to engage in occupational health technical services, it shall apply for an extension of qualification accreditation in accordance with the provisions of these Measures; After the expiration of Grade C qualification, if it is necessary to continue to engage in occupational health technical services, a Grade B qualification certificate shall be renewed in accordance with the regulations.
Article 51? These Measures shall come into force as of February 20th, 1 year. On April 27th, 20 12, the Interim Measures for the Supervision and Administration of Occupational Health Technical Service Institutions issued by the State Administration of Work Safety and revised on May 29th, 2012 shall be abolished at the same time.