As per the terms under Sec. 820.20 management responsibility, each manufacturer must maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements. Manufacturer shall establish the right responsibility and interrelation of all personnel managing, performing, and assessing work that affects quality, and provide authority necessary to perform these tasks. Each manufacturer shall provide appropriate amount of resources, including assignment of trained personnel to manage performance, and assessment activities, to meet the requirements of this part. Read further to learn about the personnel, purchasing and traceability requirements for medical device training under FDA.
Section Sec. 820.25 Personnel
Each manufacturer shall have sufficient personnel with the necessary education, skill, and experience to assure that all the activities required by this part are correctly performed. Each manufacturer shall establish procedures for identifying training needs to ensure that all personnel are trained to perform the responsibilities assigned. Training shall be documented. As part of their training, personnel must be made aware of device defects which may occur from the improper performance of their specific jobs. What do you think this means? Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.
Sec. 820.50 Purchasing controls
Each manufacturer must maintain certain procedures to make sure that all products which are purchased or received and services obey specified requirements. Every manufacturer must maintain requirements, such as quality requirements that need to be met by contractors, suppliers and consultants. Manufacturer shall evaluate and select potential contractors, suppliers, and consultants on the basis of their ability to meet specified requirements. The evaluation requires to be documented.