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Laws & Regulations Database of The Republic of China (Taiwan)

Print Time:2024/11/24 00:04
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Chapter Law Content

Chapter 3 Management
Article 16
Testing organizations shall observe the following regulations when performing testing:
Ⅰ. A laboratory's testing personnel shall use the laboratory's dedicated instruments and equipment.
Ⅱ. A standard operating procedures manual shall be prepared in accordance with analysis methods and quality control items officially announced by the central competent authority, and shall be placed in the laboratory for reference; testing shall be performed in accordance with the manual.
Ⅲ. Prepare a laboratory management manual based on the basic quality system standards officially announced by the central competent authority, and conduct lab operations based on this manual.
Ⅳ. Other items designated by the central competent authority.
Article 17
Testing reports presented by testing organizations shall be signed by the managers of each laboratory at issue. However, in consideration of a professional field or operational requirements, testing reports may be signed by a testing report signatory that has been evaluated and authorized by the central competent authority.
The regulations for laboratory managers shall apply to the qualifications for the testing report signatory in the foregoing paragraph.
The time period for the authorization by the central competent authority of the signing of reports by the testing report signatory shall be the same as the validity period for permits. Testing organization may apply for the authorization of the testing report signatory at the same time as applying for the extension of a permit.
Article 18
Testing organizations shall carry out the related testing evaluation with the vehicles and testing organization designated by the central competent authority. The testing also must be completed and test results be sent out by mail within the designated deadline.
Differences between testing results of testing organizations and designated testing organizations in the foregoing paragraph must not exceed the allowable range set by the central competent authority two times in a row.
Expenses required for the carrying out of the first paragraph shall be the responsibility of the testing organization applying for the item.
Article 19
Any change of the testing personnel of a testing organization laboratory shall be registered within thirty days after the change. For those circumstances in which there is a personnel change for a laboratory manager or quality assurance/quality control personnel, vacated positions shall be filled within thirty days. As the remaining number of testing personnel fail to be in compliance with the regulations for the number of analysis personnel in Article 5 due to personnel change, all vacated positions shall be filled within ninety days after the change.
For those circumstances in which there are changes to the items recorded on a permit, the testing organization shall register the changes through the central competent authority within thirty days after the change.
Article 20
The central competent authority may dispatch personnel carrying with proving documents entering the testing organization or testing site to proceed inspection works and order to provide relevant information. The testing organization shall not evade, retard or refuse the inspection works.
The central competent authority shall abide the confidential responsibility for all information involve individual privacy, corporate secrets or military secrets of the one under inspection acquired during the proceeding of inspection following the regulation cited in foregoing paragraph or in the process of applications, reviews, issuance, replacement, revocation, or cancellation of testing organization permits.
Article 21
A testing organization, when suspending business on its own initiative, shall submit its permit to the central competent authority for cancellation.
For those testing organizations that terminate business, are dissolved, or lose the ability to conduct operations, the central competent authority may directly cancel their permits.
Those analysis organizations in the two foregoing paragraphs for which permits are cancelled by the central competent authority shall be exempt from the restrictions of Article 10, Article 15, Paragraph 3 of Article 17, Article 18, and Article 19.
Article 22
If one of the following situations occur at testing organizations, they shall be punished pursuant to Article 70 of the Air Pollution Control Act and Paragraph 2 of Article 32 of the Noise Control Act:
Ⅰ. Those violate Paragraph 3 of Article 10, Paragraph 1, 2 or 4 of Article 16, Paragraph 1 of Article 17, Paragraph1 of Article 18, Paragraph 2 of Article 19 or Paragraph 1 of Article 20.
Ⅱ. Those violate Paragraph 3 of Article 16 that fail to follow the regulations cited in the laboratory management manual regarding personnel, equipment, review of requests, tenders and contracts, selection, verification and validation of methods, sampling, handling of testing vehicles, technical records, reporting of results, control of management system documents, control of records.
Ⅲ. Those violate Paragraph 1 of Article 19 but belonging to those circumstances in which personnel that are not laboratory manager or quality assurance personnel and fail to register personnel change within regulated time limit in accordance with Paragraph 1 of Article 19 and has violate three times totally in a year.
Ⅳ. Those permit application documents, the employment of testing personnel, testing or data processing procedures, testing reports, or other reporting documents that are determined to be fake or fraud.
Those testing organizations shall be determined as critical violations for any the following circumstances when proceeding motor vehicle air pollutant and noise emission testing and may order them to stop their testing business according to the regulation in previous paragraph beside the fine punishments. Also their permits may be abolished or order to cease their testing business:
Ⅰ. Those permit application documents, the employment of testing personnel, testing or data processing procedures, testing reports, or other reporting documents that are determined to be fake or fraud.
Ⅱ. Those violate Paragraph 2 or 3 of Article 16 and have been punished three times by central competent authority for the same testing item in one year.
Ⅲ. Those that yield a related testing evaluation result with a difference between testing organizations and the designated testing organization exceed the allowable range in two consecutive testing. After a notification of correction in limited deadline and still not able to complete the correction.
Article 23
Those testing organizations for which the central competent authority has revoked or cancelled the permit or suspended testing categories or items may not perform the said testing business.
Those testing organizations that have their testing permits been revoked or cancelled by the central competent authority shall not allowed to submit to the central competent authority application for permit of same testing items within one year since the date of revocation or cancellation.
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