Regulations Governing Recognition of Designated Testing Laboratory for Commodity Inspection Article 4
The testing laboratory applying for recognition shall fulfill the following conditions:1. Complying with the following criteria:(1) Common criteria: CNS 17025 or ISO/IEC 17025; and(2) Particular criteria: Any other particular criteria of technical and quality management requirements other than the preceding common ones for a particular testing category.2. Possessing necessary testing equipment, facility, personnel, and management system; possessing ample information and a full understanding of inspection standards as well as applicable laws and regulations for the commodity to be tested; the testing and related activities facility shall not violate Regional Plan Act, Urban Planning Law, Spatial Planning Act, Building Act or other relevant laws and regulations;3. The personnel responsible for ensuring technical effectiveness and quality management shall possess the following qualifications:(1) The personnel responsible for ensuring technical effectiveness shall possess a college or university degree or higher in related field, testing-related professional training, and an on-hand experience of related product testing for three years or higher; or possess testing-related professional training, and an on-hand experience of related product testing for five years or higher;(2) The personnel responsible for quality management shall possess a college or university degree or higher, quality management-related professional training, and an on-hand experience of quality management in related product testing for three years or higher; or possess quality management-related professional training, and an on-hand experience of quality management in related product testing for five years or higher.4. The report signatory shall be designated, possess the qualifications in item one of preceding subparagraph and possess the following conditions:(1) The report signatory shall not act as both the personnel responsible for ensuring technical effectiveness and quality management.(2) The report signatory shall not serve in the designated testing laboratories of other institutions, schools or juristic persons.(3) The report signatory shall not be replaced according to article 17-1 within three years.5. The personnel responsible for testing shall not serve in the designated testing laboratories of other institutions, schools or juristic persons.Depending upon different geographic areas, testing categories, testing items or commodity categories, the BSMI may designate and announce that the testing laboratory applying for recognition shall be granted an accreditation that also demonstrates compliance with the requirements set out in the preceding paragraph by a domestic accreditation body who is the signatory of the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC MRA) (hereinafter referred to as "the domestic accreditation body").Depending upon testing categories, the particular criteria in subparagraph 1 and the necessitated testing equipment in subparagraph 2 of the first Paragraph of this Article shall be prescribed by the BSMI.The testing laboratory applying for recognition before the amendments of these Regulations take effect upon the date, 10 February 2022, shall fulfill the amended conditions if a recognition certificate for designated testing laboratory has not be issued after the date.
中文原文 商品檢驗指定試驗室認可管理辦法第4條
申請認可之試驗室，應具備下列條件：
一、符合下列規範：
（一）共通規範：CNS17025或ISO／IEC17025。
（二）特定規範：對個別檢測領域之技術要求及品質管理要求有別於共通規範之特別規定。
二、具備必要之檢測設備、場地、人員及管理系統，對該檢測領域商品檢驗標準及相關法規，應有充足之資訊並能充分瞭解；其供檢測或相關活動使用之場地，不得違反區域計畫法、都市計畫法、國土計畫法、建築法或其他相關法規之規定。
三、置確保技術有效性及品質管理之人員，並符合下列資格：
（一）確保技術有效性之人員：大專以上相關科系畢業，曾受檢測相關專業訓練，並從事相關產品檢測實務工作三年以上；或曾受檢測相關專業訓練，並從事相關產品檢測實務工作五年以上。
（二）品質管理之人員：大專以上畢業，曾受品質管理相關專業訓練，並從事相關檢測領域品質管理實務工作三年以上；或曾受品質管理相關專業訓練，並從事相關檢測領域品質管理實務工作五年以上。
四、指定具前款第一目資格之報告簽署人，並符合下列條件：
（一）未同時擔任確保技術有效性及品質管理之人員。
（二）非其他機構、學校或法人所屬指定試驗室之報告簽署人。
（三）三年內未受第十七條之一規定之撤換。
五、測試人員非其他機構、學校或法人所屬指定試驗室之測試人員。
標準檢驗局得依地區、檢測領域、檢測項目或商品種類，指定公告申請認可之試驗室應先取得簽署國際實驗室認證聯盟（ILAC）相互承認協議（MRA）之我國認證機構（以下簡稱我國認證機構）證明符合前項規定之認證。
第一項第一款特定規範及第一項第二款必要之檢測設備，由標準檢驗局依檢測領域分別定之。
試驗室於本辦法中華民國一百十一年二月十日修正施行前向標準檢驗局申請認可，於修正施行後尚未取得指定試驗室認可證書者，其應具備之條件依修正施行後之規定辦理。
一、符合下列規範：
（一）共通規範：CNS17025或ISO／IEC17025。
（二）特定規範：對個別檢測領域之技術要求及品質管理要求有別於共通規範之特別規定。
二、具備必要之檢測設備、場地、人員及管理系統，對該檢測領域商品檢驗標準及相關法規，應有充足之資訊並能充分瞭解；其供檢測或相關活動使用之場地，不得違反區域計畫法、都市計畫法、國土計畫法、建築法或其他相關法規之規定。
三、置確保技術有效性及品質管理之人員，並符合下列資格：
（一）確保技術有效性之人員：大專以上相關科系畢業，曾受檢測相關專業訓練，並從事相關產品檢測實務工作三年以上；或曾受檢測相關專業訓練，並從事相關產品檢測實務工作五年以上。
（二）品質管理之人員：大專以上畢業，曾受品質管理相關專業訓練，並從事相關檢測領域品質管理實務工作三年以上；或曾受品質管理相關專業訓練，並從事相關檢測領域品質管理實務工作五年以上。
四、指定具前款第一目資格之報告簽署人，並符合下列條件：
（一）未同時擔任確保技術有效性及品質管理之人員。
（二）非其他機構、學校或法人所屬指定試驗室之報告簽署人。
（三）三年內未受第十七條之一規定之撤換。
五、測試人員非其他機構、學校或法人所屬指定試驗室之測試人員。
標準檢驗局得依地區、檢測領域、檢測項目或商品種類，指定公告申請認可之試驗室應先取得簽署國際實驗室認證聯盟（ILAC）相互承認協議（MRA）之我國認證機構（以下簡稱我國認證機構）證明符合前項規定之認證。
第一項第一款特定規範及第一項第二款必要之檢測設備，由標準檢驗局依檢測領域分別定之。
試驗室於本辦法中華民國一百十一年二月十日修正施行前向標準檢驗局申請認可，於修正施行後尚未取得指定試驗室認可證書者，其應具備之條件依修正施行後之規定辦理。