Testing institutions applying for accreditation shall have their exclusive test laboratory that meets the following requirements:
1. Equipped with the essential test equipment, space, and quality management system, capable of performing tests independently.
2. Complete with a laboratory head, a report signatory, a technical manager, a quality control manager, and the pertinent test personnel possessing the following qualifications:
(1) Education: graduates from the undergraduate or graduate program of a local college or university, or a foreign college or university and the academic records of which are recognized in accordance with the Regulations Governing the Assessment and Recognition of Foreign Academic Records by Institutions of Higher Education, with a major in medicine, chemistry, biology, food science, or other related disciplines;
(2) Work Experience:
1. for the laboratory head, the report signatory, the technical manager, and the quality control manager, having completed quality management related professional training and at least 3 years of testing related work experience;
2. for test personnel, having completed testing work related training.
The work experience requirements in Item (2)-1 in Sub-paragraph 2 of the preceding paragraph may be offset by the education qualifications in Item (1) in the same sub-paragraph; the master's degree counts for one year, and the doctoral degree counts for two years. Only one degree can be used for offset in case the person holds several degrees on the same level, and only the highest degree can be used in a case.

Testing institutions applying for accreditation shall submit an application form, together with the following supporting documents and information to the central competent health authority:
1. the certificates manifesting the compliance with the requirements stipulated in the preceding article;
2. documents certifying the testing capability;
3. documents prepared in accordance with the Basic Guidelines Governing the Quality System of Testing Institutions and Laboratories as provided by the central competent health authority:
(1) Quality Manual;
(2) Standard operating procedures for methods of testing, including the measures for quality control of testing results;
(3) Assessment report of uncertainty of measurements in case of an application filed for quantitative test item;
(4) A method validation assessment report if the test item under accreditation application is not a testing method provided in the Chinese Pharmacopoeia or Taiwan Herbal Pharmacopeia;
(5) The template of test report of the accredited test items and the signature format of the report signatory in Chinese.
4. Laboratory location map and the configuration diagram of the test facilities.

Where the documents and information stipulated in the foregoing article do not comply with regulations or is found incomplete, the central competent health authority shall issue a supplementation request and deadline to the applicant; where requirement is not fulfilled within the prescribed deadline, application shall be denied.

The central competent health authority shall conduct a document review and on-site assessment on the applications of testing institutions.
Where the on-site assessment finds a deficiency, the testing institutions shall submit a corrective plan to the central competent health authority for re-assessment after the end of on-site assessment within 60 days.

Where the application passes the assessment stated in Article 4, the central competent health authority shall issue the accreditation certificate and make official announcement in acknowledgment thereof.

The accreditation certificate shall contain the following information:
1. The title of the testing institution.
2. The title and address of the laboratory, and the full name of the laboratory head.
3. Test items as accredited, test method, test scope, and the report signatory.
4. Year, month, day, and serial number of the accreditation certificate.
5. Validity period of the accreditation certificate.
The testing institution shall display the accreditation certificate in a highly visible place of the premises.

The accreditation certificate has a validity period of three years. An application for extension, when necessary, shall be filed between six and eight months preceding the date of expiration. The maximum period of an extension is three years.
The provisions of Articles 4 to 6 shall apply mutatis mutandis to the document, information and procedures required for accreditation period extension application. The documents and information specified in all sections thereof, except for those listed in Paragraph 2 of Article 4, need not be included in the application provided that there is no change in the content since the previous application for accreditation or extension.
If the application for extension filed during the period as specified in Paragraph 1 does not receive a decision of approval or dismissal from the central competent health authority within the original accreditation validity period, the validity of the original accreditation is extended to the date of the decision.