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Chapter Law Content

Chapter 3 Recognition and Management of Certification Bodies
Article 23
Government agencies, academic institutes or non-profit legal persons possessing the following qualifications may apply to the central competent authority for becoming recognized certification bodies:
1.To have the competence to perform certification activities and be impartial, have a fixed place for business, have a sound organization structure and have good financial infrastructure,
2.To have established product certification systems in compliance with ISO/IEC 17065 or other equivalent standards, and to be accredited by the accreditation body in Taiwan recognized by the central competent authority in relevant fields,
3.To have professional testing laboratories related to type certification and be accredited against ISO/IEC 17025 in relevant fields,
4.To have one full-time professional certification personnel for each product category it intends to provide certification service, and
5.Other qualifications stipulated by the central competent authority.
Article 24
The certification personnel shall possess one of the following qualifications:
1.master degrees from mechanical or electrical engineering programs of graduate schools or higher of public or private universities in Taiwan or in other countries recognized by the Ministry of Education, and participation in certification-related research, design, production, safety inspection, safety testing, or having on-hand type verification experience, for 2 years or more with demonstration documents,
2.graduated from mechanical or electrical engineering departments of public or private universities or colleges in Taiwan or in other countries recognized by the Ministry of Education, and participation in certification-related research, design, production, safety inspection, safety testing, or having on-hand type verification experience, for 5 years or more with demonstration documents,
3.graduated from mechanical or electrical engineering departments of vocational high schools in Taiwan or in other countries recognized by the Ministry of Education, and participation in certification-related research, design, production, safety inspection, safety testing, or having on-hand type verification experience, for 7 years or more with demonstration documents, or
4.other qualifications recognized by the central competent authority.
Article 25
The certification personnel shall be familiar with technical regulations and technical specifications related to type certification and shall be registered after having taken training courses given by the central competent authority or professional groups recognized by the central competent authority before they can conduct type certification activities.
Article 26
The registered certification personnel mentioned in the preceding Article shall not conduct inspection involved in the process of type certification.
Article 27
The organization meeting the qualification requirements specified in Article 23 (hereinafter referred to as the applicant) shall complete an application form and submit the following documents when they apply for becoming a recognized certification body:
1.Documents stating the scope of product certification,
2.Copies of demonstration documents of qualifications in compliance with Article 23 and related supporting documents,
3.List of certification personnel and the product certification activities they are in charge of,
4.Explanations about the organizational chart and functions,
5.Layout of the offices and working areas as well as a simple graphic of geographical locations,
6.Quality manuals, structure and list of quality documents, and
7.Other documents that are deemed necessary by the central competent authority.
The central competent authority may notify the applicant to supply documents within a certain time limit if the application documents do not comply with the requirements. The application shall be denied if the documents are not supplied within the specified time limit.
Article 28
The central competent authority may establish an assessment team comprised of academic scholars and experts to conduct on-site assessment if the application documents provided by the applicant comply with the requirements mentioned in the preceding Article.
The on-site assessment mentioned in the preceding paragraph shall cover the following items and an assessment report shall be provided:
1.Compliance of the product certification systems with ISO/IEC 17065 or other equivalent standards,
2.Ability to implement technical regulations, operation procedures, safety standards, national standards or international standards, required by type certification activities for the products,
3.Ability to manage risks specified in national standards, international standards or other relevant standards, in order to implement type certification activities for the products,
4.Availability of internal documents required for the employment, training, recognition, surveillance, assessment and management of certification personnel and the ability to implement the documents,
5.Availability of internal documents for the recognition of qualifications, surveillance, assessment, maintenance and management of internal and external conformity assessment bodies, in order to promote type certification activities for the products, and the ability to implement the documents,
6.Ability to prepare monitoring plans for certified products and to implement the plans, and
7.Other information required by the central competent authority.
The central competent authority shall notify the applicant of nonconformities found during the on-site assessment and request that corrective actions be taken within a certain time limit. The application shall be denied if corrective actions are not taken within the specified time limit.
Article 29
The central competent authority shall issue an approval document and publish the recognition status of the applicant to perform type certification activities of products, if the on-site assessment mentioned in the preceding Article yields approval of the application.
The certification body shall conduct type certification activities in its name. Nevertheless, conformity assessment activities related to type certification may be subcontracted to conformity assessment bodies approved by the central competent authority based on its professional and technological needs.
Where the certification body intends to have the conformity assessment activities mentioned in the preceding paragraph be done in the manner of witnessed testing or on-site testing, it shall prepare related evaluation and analysis reports and obtain approval from the central competent authority.
Article 30
The term of validity of the recognition granted to certification bodies shall be in a period of 3 years. Applications for extension of the validity period may be made by the certification body 60 days prior to the expiry date.
Where the central competent authority approves the application for extension mentioned in the preceding paragraph, the requirements stipulated in Paragraph 1, Article 29 regarding the publication of recognition status shall apply mutandis mutatis.
Article 31
The certification body performing type certification and related conformity assessment activities shall not deny or discriminate applications without justified reasons.
Article 32
The certification body shall transmit electronic files of related documents concerning type certification, implementation status and results to Information Reporting Website designated by the central competent authority for record.
Article 33
The certification body shall apply to the central competent authority for approval if it intends to extend certification scope or items by submitting an application form and related documents. A new approval of recognition shall be issued.
Where the accreditation scope of the certification body is reduced by the accreditation body in Taiwan, the certification body shall stop performing conformity assessment activities in relevant type certification fields affected by the reduction of accreditation scope. An application for changes to the type certification scope shall be made to the central competent authority for issuing a new approval of recognition.
Article 34
The certification body shall apply to the central competent authority by submitting related documents for changes to the content of approval documents within 3 months after it relocates to a new address or modifies its basic information. Type certification activities shall not be conducted before approval of the changes is granted.
Article 35
The certification body shall report to the central competent authority for record within 15 days when there are changes to the certification personnel as a result of resignation, recruitment or employment.
Article 36
The central competent authority may order the certification body to stop conducting type certification activities when there are vacancies of certification personnel leading to non-conformities to subparagraph 5 of Article 23.
The certification body shall apply to the central competent authority for resuming the conduction of type certification by submitting the basic information of the certification personnel after the vacancies mentioned in the preceding paragraph are filled.
Article 37
The certification body shall not accept applications for type certification 30 days prior to the expiry date if it does not obtain approval from the central competent authority for extending the term of validity.
Article 38
The central competent authority shall perform regular checks and irregular monitoring to certification bodies each year and the certification body shall not evade, impede or refuse the checks or monitoring without justified reasons.
Article 39
Under any of the following circumstances, the central competent authority may order the certification body to stop performing type certification activities and request that correction actions be taken within a certain time limit:
1.where its accreditation status is suspended by the accreditation body in Taiwan,
2.where the approval is granted by the central competent authority for conformity assessment bodies it subcontracted,
3.where the documents are not provided without justified reasons within the specified time limit,
4.where it refuses to be checked by the central competent authority without justified reasons, or
5.where it does not assist in processing appeals, complaints or disputes that it has the obligation to provide assistance.
Conduction of type certification shall be resumed only after the situations mentioned in the preceding paragraph are improved and confirmed by the central competent authority to be in compliance with related requirements.
Article 40
Under any of the following circumstances, the central competent authority shall withdraw or rescind the approval granted to the certification body:
1.where the certification body applies for terminating the approval,
2.where the accreditation of the certification body is withdrawn or rescinded by the accreditation body in Taiwan,
3.where the approval of subcontracted conformity assessment bodies was withdrawn or rescinded by the central competent authority,
4.where the certification body loses the ability to perform type certification activities or is unable to maintain impartiality to perform type certification activities effectively,
5.where the principles of avoidance of conflict of interest or observance of confidentiality are violated,
6.where the certification body performs type certification or conformity assessment activities beyond the scope it is authorized or in a manner of tardiness,
7.where the provisions of Article 31 are violated,
8.where the application for approval or for changes is not made in accordance with Article 33 or conduction of type certification is resumed before the approval is obtained,
9.where the provisions of Article 38 are violated,
10.where corrective actions are not taken within the specified time limit in accordance with Article 39 and conduction of type verification activities is resumed before the central competent authority confirms compliance of the corrective actions,
11.where fraudulence is found for the issuance of certificate of type certification,
12.where the fees are not paid and still not paid within the notified time limit,
13.where the certification body accepts gratuities such as monetary or material gifts, meals or other entertainment, or of instances of entreaties or lobbying from interested parties, or take advantage of their powers, procedures or opportunities to seek illegitimate gain for itself or third parties and the violations are significant, or
14.where the violations against other laws and regulations are significant.
Article 41
For circumstances mentioned in Article 37 and the preceding Article, the certification body shall forward cases not completed to other certification bodies designated by the central competent authority.
The certification body of which the approval of recognition is withdrawn or rescinded shall not apply for becoming a recognized certification body within 3 years from the date the approval is terminated, except where recognition is terminated as a result of application made by the certification body in accordance with subparagraph 1 of the preceding Article.
Article 42
The certification body shall deliver the complete files of all conformity assessment cases related to type certification to organizations designated by the central competent authority within 7 days before the expiry date of recognition.