An independent provider shall have an established management system and the related operating procedures established in coordination with its accreditation procedures and produce an information manual; the information manual shall contain at least the following information:
1. organization chart;
2. document control;
3. records;
4. nonconformities and corrective actions;
5. preventive actions;
6. internal audit;
7. management review;
8. complaints.
The independent provider shall periodically review the aforementioned manual to ensure its appropriateness, and update or make amendments from time to time to suit actual operating conditions.
The independent provider shall implement the matters in Subparagraphs 6 and 7 of Paragraph 1 at least once a year.

An independent provider shall ensure that the personnel implementing the accreditation procedures possess the necessary pharmaceutical testing related knowledge and proficiency; moreover, the independent provider shall keep a record of the initial and regular assessments conducted on said personnel.
The personnel stated in the preceding paragraph, shall attend at least 12 hours of continued education and training course conducted by an institution (body) or civilian institution or group recognized by the central competent health authority every year. Education or training curriculum shall include audit techniques, testing knowledge and skills, and related laws.

Any information acquired by an independent provider in the course of the accreditation process or any accreditation related information provided by the testing institution shall be retained on file for at least 15 years; whereas records of accreditation work related documents and information shall be permanently retained on file.
Upon the conclusion of the independent provider’s outsourcing service, the aforementioned documents and information retained on file shall be turned over to the central competent health authority.

An independent provider shall be obliged to maintain the confidentiality of all information acquired in the course of implementing accreditation work, and shall refrain from disclosing said information.

An independent provider implementing an on-site assessment pursuant to Paragraph 1 of Article 6 shall submit the prepared assessment schedule to the central competent health authority a week before the assessment date; on the other hand, the central competent health authority may appoint a representative to attend the assessment. The independent provider shall not evade, obstruct, or refuse such attendance.

An independent provider shall inform the central competent health authority of the accreditation results of every case processed; moreover, related documents and information shall be attached.

The central competent health authority may notify the independent provider of its requirement to submit operation-related documents and information and may conduct irregular audit procedures on the venue of operations of the independent provider.
The independent provider shall not evade, obstruct, or refuse the foregoing notice, requirement or audit.

All documents and information provided to the central competent health authority by the independent provider pursuant to the provisions of the Regulations shall be true and accurate.

An independent provider and its personnel entrusted with the processing of accreditation work shall observe the “conflict of interest” regulations as dictated in the Administrative Procedure Law.
An independent provider processing the work in the preceding paragraph shall not be engaged in behaviors in violation of the criminal law. Upon any suspicion of violation, the central competent health authority shall bring the case to the related law enforcement organizations.

The central competent health authority shall sign a work consignment contract with the independent provider. Contract shall clearly define matters and other details, related rights and obligations, breach of contract penalty and reasons, dispute processing, and factors for the revocation or temporary suspension of the consigned work and other information covered in the contract.

In any of the following circumstances of the independent provider, the central competent health authority may suspend or revoke the outsourcing eligibility of the independent provider. An independent provider shall not be qualified to accept any outsourcing appointment within one year if the outsourcing eligibility is revoked due to severe circumstances:
1. Violation of the provisions of Article 24.
2. Violation of the provisions of Article 25, by failing to notify the central competent health authority within the time limit, or by evading, obstructing, or refusing the attendance in assessment by the central competent health authority.
3. Violation of Paragraph 2 of Article 27.
4. Violation of the provisions of Article 28.
5. Violation of the provisions of Paragraph 1 of Article 29 on the “conflict of interest” regulations.
6. Any violation of the criminal law as provided in Paragraph 2 of Article 29.