History

No. Date Law Name
1. 2014.11.06 Directions Governing Type Verification of Machinery, Equipment and Tools
2. 2016.05.31 Directions Governing Type Verification of Machinery, Equipment and Tools
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1.These Directions are established in accordance with Subparagraph 1, Paragraph 1 of Article 4 of the Regulations Governing the Registration of Safety Information for Machinery, Equipment and Tools to implement the requirements for type verification.
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2.Government agencies, academic institutes and non-profit legal entities may apply for becoming type verification (hereinafter referred to as verification) bodies.
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3.A verification body shall possess the following qualifications:
(1)To have the competence to perform verification activities, a fixed place for business, a sound organization structure and good financial infrastructure,
(2)To have testing facilities, appliances and personal protective equipment required for performing verification (Appendix 1),
(3)To have verification management manuals in place to address the following items:
a.organization and responsibilities,
b.designation, discharge of duties, disposition, training, review of qualifications, team-up and division of labor for verification supervisors and verifiers,
c.operation procedures for verification and operation methods for verification standards,
d.quality measures and criteria for verification activities,
e.control of verification documents and records,
f.time for performing verification activities,
g.place for performing verification activities,
h.verification fee schedules and methods for collecting verification fees,
i.issuance, changes to the content, re-issuance, replacement and return of type verification certificates, and
j.maintenance of verification-related documents and accounting reports.
(4)To have professional testing laboratories related to verification activities and accredited against ISO/IEC 17025 in relevant fields,
(5)To have product certification units related to verification activities and accredited against ISO/IEC 17065 in relevant fields,
(6)To have one qualified verification supervisor and at least two verification members,
(7)To have archive rooms or places for maintaining archives properly, and
(8)To be impartial and professional when performing verification activities.
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4.There shall be laboratory supervisors, technical supervisors, quality supervisors and verifiers in the testing laboratories of the verification body.
For the positions mentioned in the preceding subparagraph, a person may carry more than one title, where necessary. However, there shall be 2 full-time employees at least.
The qualifications for technical supervisors of the testing laboratory mentioned in subparagraph 1 shall be the same for verifiers. The qualifications for quality supervisors shall be graduates from universities or colleges, acceptance of quality-related professional training and having on-hand experience of related quality management in related testing areas for 3 years or more.
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5.A verification body may apply for recognition by submitting an application form (Appendix 2) and the following documents to the central competent authority. The same procedure shall apply to applications for changes to the verification scope. Government agencies that apply for recognition do not need to provide the following documents.
(1) documents that can demonstrate that the body is legally established or registered,
(2) organization charters that describe the purpose, missions and activities of the organization, and
(3) written documents that contain the followings:
a.lists of testing facilities and the necessary personal protective equipment,
b.list of verification supervisors and verifiers, as well as documents related to the qualifications, academic certificates, experience, etc., and
c.Description and summary of businesses that the organization runs other than verification activities.
(4) type verification management manual,
(5) accreditation certificates against ISO/IEC 17025 and ISO/IEC 17065 in related sectors, and
(6) other documents designated by the central competent authority.
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6.A verification body shall perform the activities in accordance with the verification management manual.
The verification management manual mentioned in the preceding subparagraph is meant to assist in conducting verification activities and shall be updated to meet the needs of practical situations.
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7.A verification supervisor shall possess the following qualifications:
(1)master degrees from mechanical or electrical engineering programs of graduate schools or higher, and participation in verification-related research, design, production, safety inspection and safety testing of machinery, equipment and tools, or having on-hand verification experience, for 3 years or more with demonstration documents,
(2)graduated from mechanical or electrical engineering departments of universities or colleges or higher, and participation in verification-related research, design, production, safety inspection and safety testing of machinery, equipment and tools, or having on-hand verification experience, for 5 years or more with demonstration documents,
(3)graduated from mechanical or electrical engineering departments of vocational high schools, and participation in verification-related research, design, production, safety inspection and safety testing of machinery, equipment and tools, or having on-hand verification experience, for 7 years or more with demonstration documents, or
(4)other equivalent qualifications recognized by the central competent authority.
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8.A verifier shall possess the following qualifications:
(1)master degrees from mechanical or electrical engineering programs of graduate schools or higher, and participation in verification-related research, design, production, safety inspection and safety testing of machinery, equipment and tools, or having on-hand verification experience, for 1 years or more with demonstration documents,
(2)graduated from mechanical or electrical engineering departments of universities or colleges or higher, and participation in verification-related research, design, production, safety inspection and safety testing of machinery, equipment and tools, or having on-hand verification experience, for 2 years or more with demonstration documents,
(3)graduated from mechanical or electrical engineering departments of vocational high schools, and participation in verification-related research, design, production, safety inspection and safety testing of machinery, equipment and tools, or on-hand verification experience for 3 years or higher with demonstration documents, or
(4)other equivalent qualifications recognized by the central competent authority.
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9.A verification body shall provide new technical supervisors and verifiers with pre-job training courses recognized by the central competent authority for at least 12 hours, and on-the-job training for 6 hours each year thereafter.
A verification body shall assign personnel that has received training mentioned in the preceding subparagraph to perform verification activities.
For those that do not take the training courses mentioned in subparagraph 1, the verification body shall request that the training be taken within a certain time limit before such personnel can perform verification activities.
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10.The central competent authority shall review the documents submitted by the applicant verification body in accordance with Item 5 and conduct on-site assessment. The verification body that has passed the review and assessment will be announced to the public for its recognition status. The same shall apply to applications for changes to the verification scope.
The term of validity for the recognition mentioned in the preceding subparagraph shall be in a period of 3 years. The verification body shall request for extension of the validity period by submitting an extension application (Appendix 2) to the central competent authority 3 months prior to the expiry date of the validity period. The term of validity for each extension shall be 3 years the longest.
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11.The following documents shall be submitted to the verification body when making applications for type verification:
(1)registration documents: factory registration, company registration, business registration or other equivalent documents that demonstrate official approval for establishment, except where registration is not required by laws or relevant information has been registered with no changes,
(2)basic information about machinery, equipment and tools.
(3)description of the product type, including product catalog, product name, illustration of the appearance of the product, product classification code (HS code or CCC code), specification of the main processing unit and control unit, etc.,
(4)explanations for type classifications, except for type verification of stand alone unit,
(5)lists of the main types and series of types,
(6)construction graphics, including illustrations of the functions of the product safety devices and the installed locations,
(7)drawings of the electric, hydraulic or pneumatic circuit, if applicable,
(8)instructions of performance,
(9)instructions of the installation, operation, maintenance and repair of the product, as well as recommended practices for responding to hazards,
(10)lists of product safety devices and safety accessories, including the names, specifications, safety performance and compliance status, test reports of critical components and related strength calculations of the devices, and
(11)instructions of manufacturing processes.
The verification body may request the applicant mentioned in the preceding subparagraph to provide related test reports, documents or articles if it is deemed necessary.
The verification body may request the applicant to provide electronic files for related documents mentioned in the preceding two subparagraphs for purpose of storage and management.
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12.Upon acceptance of the applications, the verification body shall conduct verification, perform necessary testing and assess the consistency of the quality of production technologies.
The verification body shall conduct verification activities in their names. Nevertheless, verification-related testing and assessment of consistency of the quality of production technologies may be subcontracted to testing laboratories or professional organizations approved by the central competent authority based on its professional and technological needs.
Where a verification body intends to have the testing mentioned in the preceding subparagraph be done in the manner of witnessed testing or on-site testing due to special circumstances, it shall prepare evaluation and analysis reports for approval by the central competent authority.
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13.For imported machinery, equipment and tools, the verification body may accept, in whole or in part, test reports, inspection certificates or related certification documents provided by the applicant, and waive the whole or part of the verification or testing mentioned in the preceding item, if such certification documents are issued under bilateral or multilateral mutual recognition agreements or conventions signed by the Republic of China with other countries, regional organizations or international organizations. Nevertheless, the verification body may apply to the central competent authority for approval on the acceptance of test reports via the arrangement of mutual recognition between testing laboratories under the circumstances that agreements or conventions do not exist, or there are difficulties in accepting such certificates due to special reasons.
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14.The verification body shall issue type verification certificates to the applicant (Appendix 3) for record if the machinery, equipment or tools pass verification.
The verification body, upon issuance of type verification certificates, shall notify the applicant to affix verification compliance labels in a prominent place to the body of products that are of the same types or series of types with those tested. Where the body of the product is too small to bear the label or affixing of label is impossible due to other special reasons, applications may be made to the central competent authority for affixing the label in other manners.
The verification body shall notify the applicant in written of reasons of noncompliance if the products do not pass verification.
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15.The term of validity of the type verification certificates mentioned in subparagraph 1 of the preceding item shall be in a period of 3 years. Applications can be made to the verification body for extension of the validity period by submitting the original certificate and related graphics, drawings and documents 3 months prior to the expiry date of the validity period. The term of validity for each extension shall be 3 years. A new application for verification shall be made under any of the following circumstances:
(1)The design of the construction of the type has been changed and does not comply with the original verified type, or
(2)The regulations on which the verification is based have been revised.
The verification body shall collect the original certificate and issue a new certificate upon granting the application for extension of validity period mentioned in the preceding subparagraph.
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16.Where the type verification certificate is lost, damaged, blemished or the content needs to be changed, an application for re-issuance, replacement or modification of the certificate can be made to the original verification body within the term of validity by submitting the following documents:
(1)where the certificate is lost or damaged: statement of reasons,
(2)where the certificate is blemished to the extent that further use of the certificate is not possible: the original certificate, and
(3)where the content of the certificate needs to be modified: documents that demonstrate changes to the name, address and other related information.
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17.The verification body shall file and maintain the integrity of documents, the original copy, attachments, graphics and booklets, etc., resulted from conducting verification activities. Such documents shall be classified based on their characteristics and importance and be kept forever or for not less than 15 years. Nevertheless, according to the Implementation Regulations Governing the Storage and Management of Electronic Archives, the storage period of paper documents can be shortened to 3 years if they are already stored in electronic format.
Documents related to type verification activities as mentioned in the preceding subparagraph shall be properly maintained and kept confidential to protect the rights and interests of the applicant.
The verification body, before destroying document mentioned in subparagraph 1, shall produce electronic copies of documents that are stored for a certain time period and the time period expires.
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18.The verification body shall prepare booklets to record the following information and transmit electronically to the information website designated by the central competent authority the implementation results of the previous month, together with the type verification status report (Appendix 5), before the fifth day of the next month:
(1)the name, title, address and telephone number of the applicant that applies for verification or extension of the term of validity,
(2)the types and performance of machinery, equipment and tools that are type verified or the term of validity is extended,
(3)the date of verification and extended term of validity,
(4)the serial number of the type verification certificate,
(5)the name of verifiers performing verification,
(6)the name of verification supervisor that made the decision of pass or failure,
(7)the reason of failure where the application for verification or extension of term of validity is determined to be not in compliance with the requirements, and
(8)other matters related to the implementation of verification activities.
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19.The verification body shall transmit document related to verification activities electronically to the database established or information website designated by the central competent authority in accordance with the requirements of the central competent authority.
The documents mentioned in the preceding subparagraph and required to be transmitted shall follow the scope and format specified by the central competent authority.
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20.The verification body shall report to the central competent authority within 15 days upon changes to the verification personnel and submit a list of personnel changed and qualification documents for the new personnel.
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21.The verification body that intends to terminate or suspend verification activities shall apply to the central competent authority 3 months in advance.
For the situation mentioned in the preceding subparagraph, the verification body shall forward verification cases not completed to other bodies designated by the central competent authority.
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22.In order to monitor the conduction of verification activities by the verification body, the central competent authority may perform on-site surveillance or check, and where necessary request the provision of verification records, booklets and talk to related personnel.
The verification body shall present relevant records, reports, documents or explanations concerning the surveillance or check mentioned in the preceding subparagraph, and shall take corrective actions within a certain time limit as notified in written by the central competent authority.
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23.In order to maintain the independence and impartiality of verification bodies, the verification supervisors, verifiers, related administrative and technical personnel employed shall avoid the following behaviors:
(1)disclosure of confidential information related to production technology, equipment and finance, etc., that is obtained or known resulted from performing duties. So is after resignation, and
(2)engagement in financial relationship directly or indirectly with the applicant that applies for verification.