The top management shall ensure the establishment, implementation and effective maintenance of the quality management system, and shall provide evidence of participation in the following matters:
1. Internal communication of customer needs and the importance of compliance with laws and regulations.
2. Establishment of quality policies.
3. Establishment of quality objectives.
4. Management review of the quality management system.
5. The supply of resources required by the quality management system.

The top management shall confirm the contents which mentioned as first subparagraph of foregoing procedures that shall be complied with to satisfy the demands, and shall ensure their implementation.

The top management shall ensure the quality policies which mentioned as second subparagraph of Article 14 is consistent with the establishment purposes of the manufacturer, and its content includes the following matters:
1. Compliance with the requirements of the quality management system and the commitment to maintain the effectiveness of the system;
2. The framework for establishing and reviewing quality objectives.
The suitability of the quality policy shall be reviewed and communicated within the manufacturer's organization to ensure the understanding by members of each group.

The top management shall ensure that all levels of offices complete the establishment of the quality objectives which mentioned as third subparagraph of Article 14.
The foregoing quality objectives shall be set on the basis of the quality policies, and the content includes measurable items that shall be completed in order to comply with regulations and product requirements.

The top management shall confirm the following:
1. The planning of the quality management system conforms to the quality objectives and the requirements of Articles 4 to 8;
2. The change of the quality management system shall keep the integrity of the system.

The top management shall specify in writing the duties and functions of the staffs of its internal offices and have all the staffs of these offices informed of the same.
The top management shall bestow on the foregoing staffs whose jobs involve the management, execution, and monitoring of quality the necessary power and the independence to exercise the power, and shall be made the relationship among their duties.

The quality management system shall have one person as the management representative, who shall be assigned by the top management. The duties and functions of the aforementioned representative shall be stated in writing covering the following matters:
1. Confirmation of the establishment of the quality management system process in writing;
2. Submission to the top management the report on the confirmation of the effectiveness of the quality management system and the necessary improvement measures;
3.Strengthening of the understanding among all the staffs of the manufacturer of relevant laws and regulations and customer demands.

The top management shall establish appropriate communication channels within the organization to ensure that matters related to the effectiveness of quality management system are reflected.

The manufacturer shall establish, in writing, the management level review procedure of the quality management system, and its content shall include the evaluation of the changes or advancement of the quality management system including quality policy and objectives.
The top management level shall periodically review the quality management system in accordance with the provisions of the preceding paragraph to ensure its suitability, adequacy and effectiveness; its review shall be recorded and kept on file.

The review as mentioned in the preceding Article shall include the following matters:
1. Feedback;
2. The handling customer complaints;
3. Reports to the competent central competent authority;
4. Results of internal or external audits;
5. Monitoring and measurement of the process and the results;
6. Monitoring and measurement of the products and the results;
7. Corrective measures;
8. Preventive measures;
9. Follow-up treatment of the conclusions of the previous review;
10. Changes that may affect the quality management system;
11. Recommendations for improvement;
12. Measures to cope with the amendments to the law and regulations.

The record mentioned in Article 22 shall include the following matters:
1. Matters reviewed and their content;
2. Necessary improvement measures to maintain the suitability, appropriateness and effectiveness of the quality management system and its processes;
3. Product improvement measures based on customer demands;
4. Measures to cope with the amendments of laws and regulations;
5. Resource requirements for implementing the first three sub-paragraphs above.