Regulations Governing Laboratory Testing for Communicable Diseases and Management of Laboratory Testing Institutions Article 2
Terms used in this set of Regulation are defined as follows:1. a laboratory testing institution can be a local health authority agency, a medical care organization, or an academic or research institute, which engages itself in collecting and testing/diagnosing communicable disease specimens, and has been either designated, commissioned, or authorized by the central competent authority for doing so;2. a laboratory accreditation body is an organization capable of carrying out suitable inspection and assessment in order to certify the testing competency and quality of a laboratory to the international standards; and3. a laboratory proficiency test for laboratory competency refers to a process of comparing its own testing results to those of other laboratories to evaluate the testing or correcting capability of the target laboratory.
中文原文 傳染病檢驗及檢驗機構管理辦法第2條
本辦法用詞,定義如下:
一、檢驗機構:指由中央主管機關指定、委託或認可,從事傳染病檢體檢驗之衛生機關、醫事機構、學術或研究機構。
二、實驗室認證機構:指對實驗室之檢驗能力及品質,依國際標準進行符合性評鑑及認證之機構。
三、實驗室能力試驗:指藉由實驗室間之比對以評估實驗室測試或校正能力之試驗。
一、檢驗機構:指由中央主管機關指定、委託或認可,從事傳染病檢體檢驗之衛生機關、醫事機構、學術或研究機構。
二、實驗室認證機構:指對實驗室之檢驗能力及品質,依國際標準進行符合性評鑑及認證之機構。
三、實驗室能力試驗:指藉由實驗室間之比對以評估實驗室測試或校正能力之試驗。