What certificates need to be provided to the tested party for third-party testing? The official reply came

Recently, some netizens consulted about "inspection and testing" in the public message system on the website of the State Administration of market supervision, and the certification supervision and Administration Department of the State Administration of market supervision gave a reply.

1. What certificates need to be provided to the tested party for third-party testing

Q:

1. What are the certificates that the third-party testing institutions and personnel entrusted by the market supervision bureau need to provide for door-to-door testing? 2. If the tested party wants to prove the authenticity, legitimacy and professionalism of the third-party testing institutions and personnel, can it require the testing Party's institutions and personnel to provide business licenses, qualification recognition of the company's testing and professional certificates of the testing personnel? 3. Is it necessary to have the presence of law enforcement officers of the market supervision bureau before testing institutions and personnel can carry out testing?

Answer:

Hello, message received. With regard to the personnel of inspection and testing institutions, Article 7 of the measures for the supervision and administration of inspection and testing institutions stipulates that personnel engaged in inspection and testing activities shall not work in more than two inspection and testing institutions at the same time. The authorized signatory of inspection and testing shall meet the requirements of relevant technical capabilities. Where there are other provisions in laws and administrative regulations on the practice qualification or prohibition of inspection and testing personnel or authorized signatories, such provisions shall prevail. With regard to the qualification of inspection and testing institutions, Article 2 of the measures for the administration of qualification identification of inspection and testing institutions stipulates that the inspection and testing institutions referred to in these Measures refer to those established according to law, using technical conditions and professional skills such as instruments, equipment and environmental facilities in accordance with relevant standards or technical specifications, A professional technical organization that inspects products or specific objects specified by laws and regulations.

Reply Department: Department of accreditation, inspection and testing supervision and management

Time: May 14, 2021

2. Is it necessary to apply Article 11 of the measures for the administration of testing and inspection institutions to the third-party medical inspection report and affix the official seal or special seal for testing on the report?

Q:

Hello!

Article 11 of the measures for the administration of testing and inspection institutions, which will take effect in June 2021, stipulates that the testing and inspection institution shall affix the official seal or special seal for testing and inspection on its testing and inspection report, which shall be signed and issued by the authorized signatory within its technical capacity. There is no requirement in the management specification for independent medical laboratory (for Trial Implementation) that the medical test report must be stamped with the official seal or special seal of the testing unit. The specific requirements are as follows: (XI) the contents of the medical test report or diagnostic report shall comply with the basic specification for medical record writing, which shall at least include: 1 Examination number, specimen type, clinical diagnosis, test method, instrument model and mutual recognition items. 　　2. Patient's name, gender, age, name and address of independent or interlocking medical laboratory, and consultation telephone number. 　　3. For samples submitted by other institutions for examination, the name of the institution submitting for examination, inpatient medical record or outpatient medical record number shall be indicated. 　　4. Inspection item, inspection result and UOM, reference interval (if applicable), critical value (if applicable), abnormal result prompt. 　　5. Name of inspector, name of reviewer, time of sample collection, receiving time and reporting time. 　　6. Other contents and remarks to be reported. If necessary, important information related to clinical diagnosis shall be reported. Now, do you need to affix the official seal or special seal of the testing institution on the testing report issued by the third-party medical testing and testing institution? Are the laws, regulations, rules and normative documents directly applicable to medical institutions and third-party medical laboratories? There is no mandatory requirement to affix the official seal or special seal for testing on the inspection report? Thank you for your answer, thank you.

Answer:

Hello, message received. Article 2 of the measures for the supervision and administration of inspection and testing institutions stipulates that "inspection and testing institutions within the territory of the people's Republic of China are engaged in issuing inspection and testing data, results and reports with certification to the society (hereinafter referred to as inspection and testing reports) These Measures shall apply to the activities and their supervision and administration. Where there are other provisions in laws and administrative regulations on the supervision and administration of inspection and testing institutions, such provisions shall prevail. " In principle, the third-party medical inspection and testing institutions belong to special laws and regulations.

Reply Department: Department of accreditation, inspection and testing supervision and management

Time: May 13, 2021

3. Use of inspection and testing qualification

Q:

According to Article 6 of the measures for the supervision and administration of inspection and testing institutions (Order No. 39 of the General Administration), inspection and testing institutions and their personnel engaged in inspection and testing activities shall abide by the provisions of laws, administrative regulations and departmental rules, follow the principles of objectivity, independence, fairness, honesty and credibility, abide by professional ethics and bear social responsibilities. The inspection and testing institution and its personnel shall be independent of the interested parties involved in the inspection and testing report issued by it, free from any factors that may interfere with its technical judgment, and ensure that the inspection and testing report issued by it is true, objective, accurate and complete. Our company is a 100% holding independent legal person company subordinate to the parent company. Can we undertake the testing business of the parent company and belong to stakeholders? Can CMA test report be issued?

Answer:

According to the relevant provisions of the measures for the administration of qualification recognition of inspection and testing institutions, inspection and testing institutions that have obtained qualification recognition according to law can issue data and results with certification to the society as an independent third party.

Reply Department: Department of accreditation, inspection and testing supervision and management

Time: May 13, 2021

4. Want the government authority to explain

Q:

I am a hotel owner. According to the requirements of the competent department, I want to detect the indoor microclimate. I entrusted a company to the shop for on-site inspection, but the competent department did not recognize the inspection report because the company was a CMA qualification recognized by other provinces. Let me recheck. I asked for a refund, but the testing company showed me the qualification certificate, which really said that it was valid in the people's Republic of China. I went to consult a lawyer again. The lawyer said "it can be done without prohibition by law" and said that the report issued by the company is OK. I can't figure it out. I can only ask the highest competent department of the state for an explanation. Thank you!

Answer:

According to the measures for the administration of qualification accreditation of inspection and testing institutions, inspection and testing institutions that have passed the qualification accreditation may issue data and results with certification to the society within the territory of the people's Republic of China.

Reply Department: Department of accreditation, inspection and testing supervision and management

Time: May 12, 2021

5. On site qualification review and social security issues

Q:

During the on-site review of the qualification of inspection and testing institutions, the review criteria do not require the provision of social security, but the inspection and testing institutions do not pay social security or the authorized signatory works part-time. Can you ask the inspection and testing institutions to submit social security.

Answer:

The technical review of qualification shall be carried out in strict accordance with the criteria for qualification review of inspection and testing institutions, and the assessment contents and relevant obligations shall not be added.