Regulations Governing Recognition of Designated Testing Laboratory for Commodity Inspection Article 7

If the assessment result of the testing laboratory shows major defects, the application for recognition shall be denied. If minor defects are shown but the testing laboratory still can operate effectively, the BSMI shall inform the testing laboratory to submit a corrective action plan for further review within a given time limit. If no submission is being made by the required time frame or the submitted corrective action plan cannot effectively correct the defects, the application for recognition shall be denied.The preceding major and minor defects shall be judged by the following principles:1. Major defects: It shall mean defects occurred as a result of the fact that a management system and the technical competency of testing have not been established or have been established but the implementation does not follow the operation procedures, thereby causing gross defect and a failure in the testing operation or significantly reducing the effects;2. Minor defects: It shall mean defects occurred as a result of the fact that although a management system and the technical competency of testing have been established and the implementation follows the operation procedures, the deficiency has been found not to such an extent as to cause a failure in the testing operation or said defects occur accidentally.
中文原文 商品檢驗指定試驗室認可管理辦法第7條
試驗室評鑑結果有主要缺點者,不予認可;有次要缺點而仍可有效運作者,標準檢驗局得通知試驗室於限期內提出改善計畫報請審核;屆期未提出或提出之改善計畫未能有效改善缺點者,不予認可。
前項主要缺點及次要缺點判定原則如下:
一、主要缺點:未建立管理制度及檢測技術能力或已建立而未依作業規定執行,有重大缺失,易導致檢測作業失敗或顯著降低效果之缺點。
二、次要缺點:已建立管理制度及檢測技術能力,並依所建立之作業規定執行,但無導致使檢測作業失敗或屬偶發之缺點者。

English translation for reference only; the Chinese text prevails. Not legal advice.