A testing institution may submit the application form, together with the following documents and information to the executive institution to apply for accreditation:
1. Photocopy of the establishment allowance certificate of the testing institution;
2. Organization, personnel and management data:
(1) Organizational structure, division of authority and responsibility, and mutual relationship;
(2) Table of positions and general statement of personnel qualification;
(3) Photocopy of the qualification and education background certificates of the personnel;
(4) Provisions on the management of documents and information of the testing institution.
3. Testing quality manual;
4. List of instruments and equipment;
5. The research data on the method validation of at least nine drugs or metabolites of those listed in Article 18, Paragraph 1 of the Regulations Governing Drug Abuse Urine Testing Operations.
6. Other documents and research data required by the executive institution.
Where the application documents and information fail to satisfy the requirements but can be supplemented and corrected, the executive institution shall notify the applicant to make supplement or correction within a given time limit; in case supplement or correction is not made in the specified time limit, the application shall be rejected.
Where the application documents and information satisfy the requirements, the executive institution shall present the same to the inspectors of the preceding Article for preliminary document review.

The applicant testing institution, within six months after passing the preliminary document review of Paragraph 3 of the preceding Article, shall complete three times of performance test and the inspection conducted by the executive institution on the drugs or metabolites of Paragraph 1 Subparagraph 5 of the preceding Article.
Performance test shall include negative urine specimen, positive urine specimen mixed with the drug to be tested of a known concentration, and positive urine specimen with a concentration near to the cutoff value of the drug to be tested or its metabolite.
The accuracy of performance test shall reach 90% or above, and false positive result may not occur. For 80% or more of the results, the difference between the measured value of the drug to be tested and the value nominated by the executive institution shall be within 20% or two standard deviations, and in no case the difference may be 50% or more.
Where the performance test fails to satisfy the requirements in the preceding Paragraph, three times of performance test shall be conducted after the defects are corrected.
Inspection shall be conducted in accordance with the relevant regulations of the drug abuse urine testing institutions. Where an applicant testing institution fails to pass the inspection, another inspection shall be performed additionally after the defects are corrected.

For a testing institution that has passed the performance test and inspection of the preceding Article, and the review conducted by the Review Committee, Ministry shall issue an accreditation certificate and have its name and accreditation number announced on the website of the executive institution (hereafter referred to as the website).
The testing institution shall hang up the accreditation certificate at an obvious place in the institution.

In case of alteration of name, address, principal, responsible person, certifying scientist, initial test method, confirmatory test method or testing instrument, the testing institution shall, within thirty days after alteration, submit the related data to the executive institution for approval, and the executive institution shall carry out inspection if necessary.
When the alteration of address in the preceding paragraph is related to the relocation of testing instruments, the report of the relocating testing instruments, schedule, address and a geographical location map shall be submitted to the executive institution for approval. The executive institution shall announce the relocating schedule on the website.
After the alteration is complete in the preceding paragraph, the test can be proceeded after the receiving the approval from the executive institution.

After being accredited, the testing institution shall accept , and shall not evade, hinder, or decline the performance test conducted by the executive institution once every three months.
The accuracy of performance test results shall reach 90% or above, and false positive result may not occur. For 80% or more of the results, the difference between the two consecutively measured values of the drug to be tested and the mean value of the testing institution participated in the test shall be within 20% or two standard deviations, and it is not allowable that the difference reaches 50% or more for two consecutive times.
The values measured by the testing institutions that are 20% or two standard deviations above the mean value shall not be included in the calculation of the mean value.

The performance test of testing institutions conducted by the executive institution every three months shall include at least ten urine specimens.

The urine specimens sent by the test consignor (hereafter referred to as the consignor) to the testing institution shall include blind performance test specimens accounting for not less than 5% of the total amount.
The blind performance test specimens of the preceding Paragraph shall include 80% of negative specimens and 20% of positive specimens. The positive urine specimens shall be used mainly for detecting the drugs to be tested, and the test results shall be reported based on qualitative research.

Where the test consignor finds any error in the result of blind performance test, it shall notify the testing institution and the executive institution. The testing institution shall, within ten days commencing from receipt of the notice, explain the reasons in writing to the executive institution.

The executive institution shall require the testing institution to correct within a given time limit the defects found in inspection, performance test, and blind performance test.
The corrections of the preceding Paragraph shall include statement of the defects and measures of remediation and prevention; where the defects are errors of testing skills or methods, the whole batch of performance test or blind performance test specimens whereof error occurs, shall be retested by the testing institution.
The statement, measures, and quality control information of retest shall be submitted by the testing institution to the executive institution within the time limit of the preceding Paragraph.

After being accredited, where necessary, the executive institution may, at any time, dispatch personnel to conduct inspection, and the testing institution may not evade, hinder, or declines such inspection.

Where a testing institution doesn't conform to the provisions of Articles 15, or is unqualified in inspection, it shall, within five days following receipt of the notice, make explanation and file an improvement report to the executive institution.

Upon receipt of specimen, the testing institution shall conduct tests in accordance with the items designated by the consignor as soon as possible, and produce a test report within fourteen days.
The results of initial test or confirmatory test shall first be confirmed by the cerifying scientist, and the test report shall be approved and signed by the responsible person.
A test report shall at least include the serial number of the accreditation certificate, the numbers of urine specimens, the cutoff values of drugs, and the drugs detected or not detected, and shall remark the employed test method, the limit of quantification, and other related data.

The testing institution shall retain the information relevant to the evaluation of the test methods and the test results.

The testing institution may not commission another testing institution to test the urine specimens, unless with the consent of the test consignor and the executive institution.

The testing institutions shall submit a monthly report of all the urine test cases, before the tenth day of the next month, in designated format to the executive institution for reference.

The executive institution may commission any relevant agency (institution) to conduct performance test and inspection activities.