Part 3 Good Manufacturing Practices for Medical Devices
Chapter 2 Standard Mode
Section 3 Resource Management
Manufacturers shall determine and provide the following resources needed to:
(1) Implement and promote the quality management system and to maintain its effectiveness;
(2) Meet regulatory and customer requirements.
Manufacturers shall ensure their personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills and experience.
Manufacturers shall establish documented procedures to implement the following:
(1) Determining the necessary competence for personnel performing work affecting product quality;
(2) Providing training or taking other actions to satisfy the above needs;
(3) Evaluating the effectiveness of the actions taken;
(4) Ensuring that the personnel are aware of the relevance and importance of their activities and how to achieve the quality objectives; and
(5) Maintaining records of personnel education, training, skills and experience.
Manufacturers shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements.
Infrastructure shall include the following:
(1) Buildings, workspace and associated utilities;
(2) Process equipment (both hardware and software); and
(3) Supporting services (such as transport or communication).
Manufacturers shall establish documented requirements for maintenance activities, including their frequency, when such activities or lack thereof can affect product quality.
The above records of maintenance shall be maintained.
Manufacturers shall determine and manage the work environment needed to achieve conformity to product requirements, including adopting the following measures:
(1) Manufacturers shall establish documented requirements for health, cleanliness and clothing of personnel if contact between such personnel and the product or work environment could adversely affect the quality of the product.
(2) If work environment conditions can have an adverse effect on product quality, manufacturers shall establish documented requirements for the work environment conditions and documented procedures or work instructions to monitor and control these work environment conditions.
(3) Manufacturers shall ensure that all personnel who are required to work temporarily under special environmental conditions within the work environment are appropriately trained or supervised by a trained person.
(4) If appropriate, manufacturers shall establish documented special arrangements for the control of contaminated or potentially contaminated product in order to prevent contamination of other product, the work environment or personnel.