1 鐵路使用之產品檢測驗證機構認可及監督管理辦
法草案  
Draft Regulations Governing the Recognition, Supervi-
sion and Management to the Testing and Certification 
Bodies of Products for Railway Applications  
中文法規  Regulations  
第一條 本辦法依鐵路法 (以下簡稱本
法)第十九條之一第三項及規費法第
十條第一項規定訂定之。  Article 1  
These Reg ulations are enacted pursuant 
to Paragraph 3, Article 19 -1 of the 
Railway Act, (hereinafter referred to as 
the Act) and Paragraph 1, Article 10 of 
the Charges and Fees Act.  
第二條 本辦法用詞，定義如下：  
一、指定產品：指交通部依本法第
十九條之一第二項規定公告指
定之鐵路使用之材料、零組
件、設備、軟體、系統或其他
構成鐵路之部分。  
二、檢測 機構：指取得交通部認
可，辦理指定產品之檢測業務
者。 
三、驗證機構：指取得交通部認
可，辦理指定產品之驗證業務
者。 
四、認證機構：指依國際標準組織
之標準建立認證制度，並據以
實施認證業務，且已簽署國際
或區域認證組織相關認證領域
相互承認協議之機構。  Article 2  
Definitions:  
(1) Designated products: materials, 
components, apparatus, software, 
systems for railway applications, or any 
other parts that form railways, which 
designated by the MOTC in accordance 
with Paragraph 2, Article 19 -1 of the 
Act. 
(2) Testing body:  a body recognized by 
the MOTC to perform testing operation 
on designated products.  
(3) Certification body: a body 
recogni zed by the MOTC to perform 
certification activities for  designated 
products.  
(4) Accreditation body: a body who 
have established accreditation system 
in accordance with the standards of the 
International Standards Organization, 
and implement accreditation activities 
accordingly, and have signed mutual 
recognition agreements by international 
or regional accreditation organizations.  
第三條 檢測機構之資格條件如下：  
一、我國之行政機關（構） 、專科以
上學校或公益法人。但情況特
殊，經交通部公告者，不在此
限。 
二、取得我國認證機構之認證，符
合國際標準 ISO/IEC 17025 或國
家標準CNS 17025 測試實驗室認Article 3  
The required qualifications for the 
testing bodies are as follows:  
(1) Domestic administrative authorities 
or institutions, schools of college or 
above, or non -profit juristic persons, 
except i n the case of extraordinary 
circumstances and publicly announced 
by the MOTC;  
(2) Being accredited as a testing 2 中文法規  Regulations  
證規範，認證範圍包含指定 產品
之檢測程序。  
三、具備必要之人員、設施、檢測
設備與計量追溯性、管理系統，
足以辦理指定產品之檢測業務。  laboratory to CNS 17025 or ISO/IEC 
17025 by domestic accreditation 
bodies, where the testing procedures of 
designated products are included in t he 
scope of accreditation; and  
(3) Possessing necessary personnel, 
facility, test equipment and 
metrological traceability, and 
management system, which are 
sufficient to handle the testing 
operation of the designated products.  
   具備前項資格條件者，得檢附
下列資料向交通部申請認可為檢測
機構： 
一、申請表。  
二、符合前項第一款及第二款資格
條件之證明文件。  
三、辦理指定產品檢測業務之人員
職務說明及履歷資料。如實驗室
主管、品質負責人、報告簽署
人、檢測人員或其他依申請者組
織型態及管理系統所配置適任人
員。 
四、地理位置簡圖、機構布置圖及
檢測設備配置圖。  
五、檢測設備規格及計量追溯性之
佐證文件。  
六、標準作業程序書或依其管理系
統建立之同等文件。  Those who meet the afore mentioned  
qualifications may submit the 
following documents to the MOTC for 
recogni tion as a testing body:  
(1) Application Form;  
(2) Documentary proof that the 
applying body meets the qualifications 
required in subparagraph 1 and 2 of the 
preceding paragraph ; 
(3) Function description and resumes 
of the personnel handling  the testing 
operation on designated products, such 
as those of the chief of laboratory, the 
chief of quality assurance, report 
signatories, and testing personnel, or 
other competent personnel  allocated 
according to the organization type and 
the management system of the applying 
body;  
(4) Location guide map and layout plan 
of the body, and allocation drawings of 
test equipment;  
(5) The specifications of test equipment 
and documentary proof of m etrological 
traceability accordingly; and  
(6) Standard operation procedures 
(SOP) of testing, or equivalent 
documentation according to the 
management system of the body.  3 中文法規  Regulations  
第四條 驗證機構之資格條件如下：  
一、我國之行政機關（構） 、專科以
上學校或公益法人。但情況特
殊，經交通部公告者，不在此
限。 
二、取得我國認證機構之認證，符
合國際標準 ISO/IEC 17065 或國
家標準CNS 17065 相關領域之產
品驗證機構認證規範，認證範圍
包含指定產品之驗證基準。  
三、具備辦理指定產品驗證業務之
適任性、公正性之管理與維護機
制及固定辦公處所，組織架構健
全且財務穩定。  
四、設有與指定產品驗證業務相關
之檢測實驗室或可取得適當之外
部資源，應符合 ISO/IEC 17025
或CNS 17025 相關領域 之測試實
驗室認證規範。  Article 4  
The required qualifications for the 
certification bodies are as follows:  
(1) Domestic administrative authorities 
or institutions, schools of college or 
above, or non -profit juristic persons, 
except in the case of extraordinary 
circums tances and publicly announced 
by the MOTC.  
(2) Being accredited as a product 
certification body to CNS 17065 or 
ISO/IEC 17065 by domestic 
accreditation bodies, where the 
certification criteria for the designated 
products are included in the scope of 
accred itation;  
(3) Possessing competence to perform 
certification activities of designated 
products, management and maintaining 
mechanism for impartial, and fixed 
place for business, with a sound 
organization structure and good 
financial infrastructure; and  
(4) Having established testing 
laboratories related to the testing 
operation on the designated products, 
or obtaining appropriate external 
resources, which all shall comply with 
accreditation specifications for testing 
laboratory to CNS 17025 or ISO/IEC 
17025.  4 中文法規  Regulations  
   具備前項資格條件者，得檢附
下列資料向交通部申請認可為驗證
機構： 
一、申請表。  
二、符合前項第一款及第二款資格
條件之證明文件。  
三、驗證過程中負責評估、審查、
作成驗證決定之人員職務說明及
履歷資料。  
四、品質手冊、品質文件系統架構
及一覽表或依其管理系統建立之
同等文件。  
五、公正性之管理與維護機制說
明。 
六、地理位置簡圖及機構布置圖。  
七、組織架構及業務功能之說明。  
八、具備穩定財務之說明及證明文
件。 
九、辦理評估所需資源一覽表，含
自設檢測實驗室及可取得之外部
資源，以及確保可信賴性之說
明。 Those wh o meet the aforementioned  
qualifications may submit the 
following documents to the MOTC for 
recogni tion as a certification body:  
(1) Application form;  
(2) Documentary proof that the 
applying body meet the qualifications 
required in sub paragraph 1 and 2 of the 
preceding paragraph;  
(3) Function description and resumes 
of the personnel, who are responsible 
for evaluation, review and certification 
decision in the process;  
(4) Quality manual, system structure 
and overview list for quality 
documents, or equivalent 
documentation according to its 
management system;  
(5) Description of management and 
maintaining mechanism for impartial;  
(6) Location guide map and layout plan 
of the body;  
(7) Description of the organization and 
functions;  
(8) Descr iption of stable finances and 
supporting documentation; and  
(9) List of resources required for the 
evaluation, including self -established 
testing laboratories and available 
external resources, as well as 
description of ensuring confidence.  
第五條 第三條第二項及前條第二項
情形，申請文件不完備者，經交通
部通知限期補正，屆期未補正或補
正不完備者，不予受理。  Article 5  
In the case of Article 3, Paragraph 2 
and Paragraph 2 of the preceding 
article, where the application 
documents are deemed incomplete, if 
the application are not fully 
supplemented after t he applicant 
receiving notice from the MOTC to 
undertake corrective action within a 
prescribed period of time, their 
applications shall be dismissed.  
   前項通知，交通部應逐項列出
須補正之事項或文件，一次通知申
請者於收到通知之次日起三十日內
補正。 For the aforementioned notice , the 
MOTC shall list matters or documents 
to be supplemented by items, notifying 
the applicant to make a supplement 
within THIRTY  (30) days after 
receiving the notice.  5 中文法規  Regulations  
第六條 交通部受理第三條第二項及
第四條第二項申請後辦理書面審
查，必要時得派員赴現場勘查，經
審查通過者，由交通部核發認可文
件。 Article 6  
Where an applicati on as described in 
Paragraph 2, Article 3 and Paragraph 2, 
Article 4 is received by the MOTC, the 
MOTC shall conduct document review, 
with onsite survey when necessary, and 
a document of recognition will be 
issued by the MOTC  after the 
application passes r eview.  
   依前項審查未符規定，經交通
部通知限期改善並申請複審，屆期
未申請複審或經複審仍未符規定
者，不予認可。  If an application does not fulfill 
requirements of the regulations herein 
according to the aforementioned 
review , the MOTC shall notify the 
applicant to undertake corrective action 
within a p rescribed period of time and 
apply for a second review; in case of 
failure to apply for a second review by 
the given deadline or failure of the 
second review, the recognition shall not 
be granted.  
   前項通知，交通部應逐項列出
未符規定事項，一次通知申請者於
通知送達之次日起六十日內改善完
成並向交通部申請複審。  For the aforementioned notice , the 
MOTC shall list matters or documents 
to be corrected by items, notifying the 
applicant to complete the improvement 
and apply for a second review within 
SIXTY  (60) days after receiving the 
notice.  
   經複審仍未符規定者，申請者
於不予認可通知送達之次日起九十
日後，始得重新提出申請。  It the application does not meet the 
requirements after the second review, 
the applicant may re -apply after 
NINETY  (90) days from the following 
day to the date of receiving  the notice 
for recognition not granted.  
第七條 檢測機構或驗證機構之認可
有效期間為自取得認可之日起三
年；有效期間屆滿之日前九十日
內，得向交通部申請展延，每次展
延期間為三年。  Article 7  
The recognition of a testing body or a 
certification body has a validity period 
of three years, beginning on the day of 
recognition granted. Within NINETY  
(90) days prior to expirati on, the 
recognized body may apply for 
renewal, each renewal period shall be 
THREE  (3) years.  
   展延之申請、審查及核發展延
認可文件，準用第三條至前條規
定。 The provisions from Article 3 to the 
preceding article shall  apply mutatis 
mutandis to the application for renewal, 
review, and do cument issued for 
recognition renewal.  6 中文法規  Regulations  
第八條 檢測機構或驗證機構擬增列
認可範圍時，準用第三條至第四條
之規定，應檢具申請書及相關資料
向交通部申請認可並重新核發認可
文件。 Article 8  
Where the testing body or the 
certification body applying for 
expansion of the scope  of recognition , 
the provisions of Article 3 to 4 shall 
apply mutatis mutandis, and the body  
shall apply to the MOTC for 
recognition and re -issuing the 
document of recognition.  
   檢測機構或驗證機構經認證機
構減列認證範圍時，應即停止辦理
受影響業務，並於認證範圍減列生
效之次日起三十日內檢具申請書向
交通部申請變更範圍及重新核發認
可文件。  Where the scope of accreditation of the 
testing body o r the certification body 
has been reduced by the accreditation 
body, the testing body or certification 
body shall immediately stop 
performing the activities relating to the 
affected area, and apply to the MOTC 
within THIRTY  (30) days from the 
following  day to the effective date of 
reduction  of the scope of accreditation . 
   因增列或減列認可範圍，交通
部重新核發之認可文件，其有效期
限與原認可文件相同。  For expansion or reduction of the scope 
of recognition, the validity period of 
documents re -issued by the MOTC 
shall be identical with that of  the 
original documents . 
第九條 檢測機構依第三條第二項第
二款、第四款至第六款或驗證機構
依第四條第二項第二款、第四款至
第九款所定資料有異動情形時，應
於異動發生之次日起三十日內檢附
相關資料向交通部申請異動記載；
未經審查核准前，不得辦理指定產
品之檢測或驗證業務。  Article 9  
In case of alternation of the document  
contents prescribed  in Subparagraph 2, 
4 to 6 of Paragraph 2, Article 3 for the 
testing body, or in Subparagraph 2, 4 to 
9 of Paragraph 2, Article 4 for the 
certification body respectively, the 
body shall, within THIRTY  (30) days 
from the following day to the date of 
alternation , apply to  the MOTC by 
submitting related documents  for 
change of registration . The t esting 
operation or certifica tion activities on 
the designated products shall not be 
conducted before review and approval 
of the changes is granted.  
第十條 檢測機構依第三條第二項第
三款或驗證機構依第四條第二項第
三款所定人員有出缺、增補或任免
之異動者，應於異動發生之次日起
三十日內，檢附異動人員資料報請
交通部備查。  Article 10  
Where there are changes in the 
personnel  prescribed in Subparagraph 3 
of Paragraph 2, Article 3 for the testing 
body, or in Subparagraph 3 of 
Paragraph 2, Article  4 for the 
certification body respectively, as a 
result of resignation, recruitment or 
employment , the body shall, within 7 中文法規  Regulations  
THIRTY  (30) days from the following 
day to the date of changes , report  to the 
MOTC  with information of the 
personnel  for reference . 
第十一條  檢測機構或驗證機構之檢
測報告、審查紀錄、驗證文件及相
關技術文件應詳實記載，並至少保
存十年。但其他法令規定較長保存
期限者，從其規定。  Article 11  
The test  reports, review records, 
certification documents  and relevant 
technical documents  shall be r ecorded 
correctly and in detail, and shall be 
preserved  for TEN  (10) years at least . 
Nonetheless, if the period of 
preservation is otherwise prescribed in 
other laws and regulations, the longer 
shall apply . 
第十二條  交通部應對檢測機構或驗
證機構辦理每年業務定期查核及不
定期督導；檢測機構或驗證機構無
正當理由者，不得規避、妨礙或拒
絕。 Article 12  
The MOTC  shall conduct  periodic  
checks  on the annual operatio n of the 
testing bodies and the certification 
bodies, and non-periodic supervis ion as 
well. T he bodies  shall not evade, 
impede or refuse the checks or 
supervis ion without justified reason s. 
   依前項查核或督導發現有缺失
之情形者，應依交通部通知限期改
善。 If there is non -conformity foun d by the 
aforementioned checks or  supervision , 
the bodies  shall make improvement by 
the deadline  noticed  by the MOTC  
第十三條  交通部為辦理鐵路監督事
項、行車事故或異常事件調查，得
向檢測機構或驗證機構調閱認可範
圍相關業務文件或資料；檢測機構
或驗證機構無正當理由者，不得規
避、妨礙或拒絕。  Article 13  
The MOTC may,  in order for the 
supervisio n on railways, and 
investigation into accidents and 
abnormal events , access documents and 
information  of the operation and 
activities  related to  the scope  of 
recognition  of the testing bodies and 
the certification bodies.  The bodies  
shall not evade, impede  or refuse  
without justified reason s. 8 中文法規  Regulations  
第十四條  檢測機構或驗證機構有下
列情事之一者，交通部得令其暫停
辦理全部或部分認可範圍之業務，
並限期改善：  
一、檢測機構或驗證機構之人員出
缺未補實，致不符合第三條第一
項第三款或第四條第一項第三款
所定資格條件。  
二、經認證機構暫停其認證資格。  
三、驗證機構對其驗證之產品疏於
追查。 
四、經交通部通知限期提供資料，
無正當理由屆期未提供。  
五、於交通部辦理定期查核、不定
期督導時，無正當理由未配合辦
理，或有缺失之情形未依限期改
善。 
六、有申訴 、陳情或爭議案件時，
無正當理由未配合辦理。  Article 14  
Under any of the following 
circumstances, the MOTC  may order 
the testing body or the certification 
body to stop performing all or part of 
the operation or activities of the scope  
of recognition , and request that 
correction actions be taken within a 
certain time limit:  
(1) Where the testing body or the 
certification body does not fill in a 
vacant position of the personnel and 
violates the requirements set out in 
Subparagraph 3, Paragraph 1 of Article 
3 or Subparagraph 3, Para graph 1 of 
Article 4 respectively;  
(2) Where the accreditation by the 
accreditation body has been suspended;  
(3) The certification body fails to 
surveillance  the certified products ; 
(4) N ot provid ing the necessary 
information requested by the MOTC  
within t he requested period without 
justified reason s; 
(5) Refusing  to be periodically checked  
or supervised  by the MOTC  without 
justified reasons, or  in the event of 
defects that cannot be rectified in a 
timely manner ; or 
(6) N ot assist ing in processing appeals, 
complaints or disputes without justified 
reason.  
   前項情形經改善，並經交通部
確認符合者，始予恢復辦理業務。  The operation or activities  shall be 
resumed only after the aforementioned  
situations are improved and confirmed 
by the MOTC  to be in compliance with 
related requirements.  
第十五條  檢測機構或驗證機構有下
列情事之一者，交通部得撤銷或廢
止其認可：  
一、主動申請終止認可。  
二、經認證機構撤銷或廢止其認證
資格。 
三、喪失辦理業務能力或有礙公正
有效辦理業務。  
四、執行認可範圍之業務違反利益Article 15  
Under any of the following 
circumstances, the MOTC  may 
withdraw or abolish the recognition  
granted to the testing body or the 
certification body:  
(1) Where the body appli es for 
terminating the recognition;  
(2) Where the accreditation is 
withdrawn or revoked  by the 
accreditation body ; 
(3) Where the body loses the ability to 9 中文法規  Regulations  
迴避或保密義務原則。  
五、逾越認可範圍或怠於辦理業
務。 
六、無正當理由而為差別待遇。  
七、未依第八條規定申請增列或減
列認可範圍，或未經認可前擅自
辦理檢測或驗證業務。  
八、未依前條規定於限期內完成改
善並經交通部認定符合者，而逕
自恢復業務。  
九、簽署報告或核發證明文件有虛
偽不實之情事。  
十、接受認可範圍 之業務利害關係
者餽贈財物、飲宴應酬或請託關
說，或假借職務上之權力、方
法、機會圖本人或第三人不正之
利益，情節重大。  
十一、其他違反法令規定，情節重
大。 perform operation or  activities , or is 
unable to maintain impartiality to 
perform the operation or ac tivities 
effectively;  
(4) Where the principles of avoidance 
of conflict of interest or observance of 
confidentiality are violated  during the 
operation or activities of the scope of 
recognition;  
(5) Where the body performs operation 
or activities beyond the  scope of 
recognition or in a manner of tardiness,  
(6) Discriminat ion without justified 
reasons ; 
(7) Where the application for expansion 
or reduction of the scope of recognition  
is not made in accordance with Article 
8, or conduct ing the operation or 
activiti es before the recognition  is 
granted;  
(8) Where corrective actions are not 
taken within the specified time limit in 
accordance with the preceding a rticle  
and resuming conduction of the 
operation  or activities before 
confirm ation by the MOTC of 
compliance ; 
(9) Where fraudulence is found for the 
report signatory  or issuance of 
certificate ; 
(10) Where the body accepts gratuities 
such as monetary or material gifts, 
meals or other entertainment, or of 
instances of entreaties or lobbying from 
interested parties  in the operation or 
activities of the scope of recognition , or 
take advantage of their powers, 
procedures or opportunities to seek 
illegitimate gain for itself or third 
parties and the violations are 
significant;  or 
(11) W here the violations against other 
laws and regulations are significant.  
   經交通部撤銷或廢止其認可
者，應於撤銷或廢止之次日起三十
日內，將受理案件之完整文件及檔
案移交至交通部指定機構，無正當
理由者，不得規避、妨礙或拒絕。  The one whose recognition  has been 
withdrawn  or abolished by the M OTC  
shall, within THIRTY  (30) days from 
the following  day to the date of 
withdrawal  or abolish ment , transfer the 
complete documents and files of the 10 中文法規  Regulations  
cases to the agency designated by the 
MOTC . The one shall not evade, 
impede or refuse without justified 
reasons . 
   檢測機構或驗證機構之認可經
撤銷或廢止者，自撤銷或廢止之次
日起三年內不得重新申請認可。但
依第一項第一款主動申請終止認
可，其情形特殊並經交 通部同意
者，不在此限。  The one whose  recognition is  
withdrawn or abolished  shall not , 
within THREE(3) years from the 
following day to the date of withdraw al 
or abolishment,  apply for recogni tion, 
except  where recognition is terminated 
as a result of application made by the 
body in accordance with Subparagraph 
1 of Paragraph 1 hereof, and the case of 
extraordinary circumstances  is 
approved  by the MOTC . 
第十六條  檢測機構或驗證機構之認
可範圍及有效期間，交通部應公告
並公開於資訊網路；異動時，亦
同。 Article 16  
The scope of recognition and validity 
period of the testing body  or the 
certification body  shall be publicly 
announced by the MOTC  and publish 
on the World Wide Web. The same 
process  shall  apply in the event of any 
change s. 
第十七條  檢測機構或驗證機構經撤
銷或廢止認可時，交通部得協調其
他檢測機構或驗證機構，配合接收
保管原認可範圍之業務相關文件及
檔案。 Article 17  
Where the recognition  of a testing body 
or a certification body has been 
withdrawn  or abolished , the MOTC 
may coordinate with  other testing 
bodies  or certification bodies to receive 
and preserve r elevant documents and 
files of  the operation and activities of 
the original scop e of recognition.  
第十八條  申請認可為檢測機構或驗
證機構者，應繳納審查費每件新臺
幣一萬二千元；向交通部申請認
可、展延或增列認可範圍時繳納。
展延及增列認可範圍依性質得併案
申請者，以一件計收之。  Article 18  
To apply for recognition as a testing 
body or a certification body  shall pay 
the review fee of NT$ 12,000; review 
fee shall be paid at the time  when apply 
to the MOTC for recognition, r enewal  
of recognition  or expansion  of the 
scope  of recognition. Where the 
renewal  of recognition  or expansion  of 
the scope  of recognition  can be filed 
together according to their nature,  the 
applications may be treated as one 
application case . 11 中文法規  Regulations  
   為應申請者需要，有赴國外辦
理審查、勘查、查核或督導之必要
時，除前項費用外，交通部派員出
國之差旅費另依國外出差旅費報支
要點所定各項費用基準計收。  At the request  of the applicant, for any 
review, survey , checks and supervision  
conducted abroad , in addition to  the 
aforementioned fee, expen ses for the 
MOTC to send personnel abroad shall 
be collected in accordance with the 
Directions for the Overseas Travel 
Allowance Disbursement . 
第十九條  第三條至第十條、第十二
條至第十四條、第十六條至前條所
定交通部之事項，交通部得委任所
屬機關執行之；其委任事項及法規
依據，應公告及刊登行政院公報。  Article 19  
The MOTC may delegate its 
subordinate authorities to perform 
matters of the MOTC prescribed in 
Article 3 to 10, Article 12 to 14, and 
from Article 16 to the proceeding 
article; The matter delegated and the 
legal basis for such delegation shall be 
publicly ann ounced and published in 
Executive Yuan Gazette.  
第二十條  本辦法自發布日施行。  Article 20  
These Regulations shall be effective 
upon the day of promulgation.