The manufacturer shall confirm and provide the necessary resources which mentioned as fifth subparagraph of Article 14 to maintain the effective implementation of the quality management system and comply with the laws and regulations and the demands of customers.

Members of the team engaged in work affecting product quality shall be properly educated, trained, or have certain skills or experience to ensure their job competencies.

The manufacturer, regarding the establishment of personnel’ capabilities, the provision of necessary training and the correct awareness of their responsibilities, shall establish in writing the procedures for the following matters:
1. Identification of the competence of personnel engaged in work affecting product quality.
2. The provision of necessary training or other measures to maintain personnel capabilities.
3. Evaluation of the effectiveness of the training or measures in the preceding sub-paragraphs.
4. The insurance of the awareness of the relevance and importance of their operation and the attainment of the quality objectives.
5. Record keeping in the forms of audio recording, photographs, video recording, certificates and citations of the education, training, skills and experience of the personnel.

In order to meet product requirements, the manufacturer shall specify in writing the conditions of the infrastructure to avoid product confusion and disorderly handling.
The foregoing facilities shall include the following matters:
1. Buildings, working spaces and related facilities.
2. Hardware and software process equipment.
3. Support services such as transportation, communication or information systems.
If the maintenance on the aforementioned facilities affects the product quality, the manufacturer shall determine the content and frequency of the implementation of the maintenance activities; the implementation shall be recorded and kept on file.
These provisions apply to the control, monitoring, and measurement of work environment mutatis mutandis.

In order to ensure the consistency of product manufacturing, the manufacturer shall specify in writing the requirements on working environment and impose monitoring and control on those which may adversely affect the product quality.
The foregoing requirements shall include the following:
1. The health, cleanliness and clothing conditions of the personnel when their contact with the product or the operating environment can cause adverse effects on the safety or performance of medical devices;
2. The insurance of the necessary capabilities of temporary personnel working under special environmental conditions or of their monitoring by those who possess the capabilities.

In order to prevent pollution caused by other products, working environment or personnel, the manufacturer shall plan and establish in writing control measures for contaminated or susceptible products.
The manufacturer shall establish in writing contamination control measures of microbes or particulates on sterile medical devices; the necessary sanitation shall also be maintained in the process of assembly or packaging.