Regulations for Administration on Human Organ Bank Article 5
The quality director of an organ bank must be a physician, or a medical technician or a person with a degree in biology related field with at least one year of practical experience in organ bank, blood bank or related field. The responsibilities of the quality director are as follows:1. Establish and maintain the quality management system of the organ bank.2. Set up medical and technical standard operating procedures for organ preservation.3. Investigate adverse events related to organ transplant.4. Handle other matters related to the quality assurance of organ bank.A quality director may not act concurrently as a medical director or a quality director of another organ bank.
中文原文 人體器官保存庫管理辦法第5條
保存庫之品質主管應為具保存庫、血庫或相關領域實務經驗一年以上之醫師、醫事檢驗師或具生物相關系所學位者，其職責如下：
一、建立及維持保存庫品質管理系統。
二、訂定器官保存有關之醫學與技術標準作業程序。
三、調查器官移植有關之不良反應事件。
四、辦理其他與保存庫品質保證有關事項。
品質主管不得由醫學主管兼任，亦不得兼任其他保存庫之品質主管。
一、建立及維持保存庫品質管理系統。
二、訂定器官保存有關之醫學與技術標準作業程序。
三、調查器官移植有關之不良反應事件。
四、辦理其他與保存庫品質保證有關事項。
品質主管不得由醫學主管兼任，亦不得兼任其他保存庫之品質主管。