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

Print Time:2024/11/22 09:19
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Chapter Law Content

Chapter 3 Management
Article 17
The testing and analysis organization shall comply with the following regulations to perform the environmental testing and analysis operations.
Ⅰ. A laboratory’s testing and analysis personnel shall use the laboratory’s dedicated instruments and equipment.
Ⅱ. A standard operating procedures manual shall be prepared in accordance with testing and analysis methods and quality control items officially announced by the central competent authority, and shall be placed in the laboratory for reference; testing and analysis 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. Quality control data for each year shall be reported prior to January 31.
Ⅴ. A three-month test statistics form shall be submitted to the central competent authority on the 15th day of the January, April, July, and October of each year; the reported items shall consist of test category, number of test item, number of test samples, and payment amount.
Ⅵ. Testing data shall be transmitted via the Internet in accordance with the items, format, and content required by the central competent authority.
Ⅶ. Other items designated by the central competent authority.
For those items reported for the sampling personnel of effluent shall also report the exact date and time entering the site, the starting and finished date and time of sampling, pictures for eyewitness personnel of the plant and so on.
Article 18
The testing and analysis reports presented by the testing and analysis organizations shall be signed by the managers of each laboratory at issue. However, in consideration of a professional field or operational requirements, testing and analysis reports may be signed by an testing and analysis 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 and analysis 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 and analysis report signatory shall be the same as the validity period for permits. A testing and analysis organization may apply for the authorization of the testing and analysis report signatory at the same time as applying for the extension of a permit.
Article 19
A change in testing and analysis personnel at a testing and analysis 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, the vacated positions shall be filled within thirty days. When a personnel change causes the remaining number of testing and analysis personnel to fail to be in compliance with the regulations for the number of analysis personnel as stipulated in Article 5, the vacated positions shall be filled within ninety days after the change.
The change in the representative of a testing and analysis organization shall be registered within 90 days after the change.
For those circumstances in which there were changes to the items recorded on a permit, the testing and analysis organization shall register the changes to the central competent authority within thirty days after the change.
Article 20
The central competent authority may send personnel bearing verifying documents to a testing and analysis organization or sampling site to perform an audit, and may order the organization to provide relevant information, in which case the testing and analysis organization may not evade, obstruct, or refuse to this request.
The central competent authority shall maintain the confidentiality of all information involving test recipients' personal privacy, business secrets, and military secrets obtained from an audit conducted pursuant to the foregoing paragraph, or from a testing and analysis organization permit application, review, renewal (replacement), revocation, or cancellation.
Article 21
The testing and analysis organizations and testing and analysis personnel shall conduct sampling technique evaluations and blind sample testing in accordance with the designation of the central competent authority, and shall submit blind sample testing results to the central competent authority by the designated deadline.
The foregoing blind test can also be carried out by the designated testing and analysis organization or its testing and analysis personnel to participate in domestic or international blind test. The testing and analysis organization shall pay relevant expenses by itself. Those that cannot participate in the blind test due to not paying the expenses shall be deemed as refuse to participate.
Article 22
The central competent authority may order a testing and analysis organization to dispatch appropriate or designated testing and analysis personnel to receive on-the-job training; the testing and analysis organization shall not refuse.
Article 23
A testing and analysis organization, when suspending business on its own initiative, shall submit its permit to the central competent authority for cancellation.
For the testing and analysis organizations that have terminated their business, were dissolved, or lost their ability to conduct operations, the central competent authority shall directly cancel their permits.
Article 24
When any one of the following situations occurred, the testing and analysis organization shall be subject to the penalty provisions as stipulated in Article 70 of the Air Pollution Control Act, Article 16 of the Indoor Air Quality Management Law, Article 32, Paragraph 2 of the Noise Pollution Control Act, Article 49 of the Water Pollution Control Act, Article 42, Paragraph 1, Subparagraph 2 and Paragraph 2 of the Soil and Groundwater Pollution Remediation Act, Article 58 of the Waste Disposal Act, Article 58, Subparagraph 7 of the Toxic and Concerned Chemical Substances Control Act, Article 48, Subparagraph 5 of the Environmental Chemical and Biological Agents Control Act, or Article 24-1 of the Drinking Water Management Statutes:
Ⅰ. Any violation of the provisions of Article 3, Paragraph 2; Article 11, Paragraph 4; Paragraph 1, Paragraph 2, Paragraph 4, Paragraph 5, or Paragraph 7 of Article 17; Article 18, Paragraph 1; Article 19, Paragraph 3; Article 20, Paragraphs 1; or Article 22.
Ⅱ. Any violation of Paragraph 1, Subparagraph 3 of Article 17 that failed to follow the requirements being cited in the laboratory management manual regarding the personnel, equipment, review of requests, tenders and contracts, selection, verification and validation of methods, sampling, handling of test items, technical records, reporting of results, control of management system documents, control of records.
Ⅲ. Any violation of Paragraph 1, Subparagraph 6 of Article 17 and failed to comply with each environmental protection regulation and being accumulated to three times.
Ⅳ. Any violation of Article 17, Paragraph 1 and for the circumstance belong to the personnel of laboratory managers or testing and analysis personnel for quality assurance that failed to register for the name changes within regulated deadline in accordance with Paragraph 1 of Article 19 and the violations have reached three times within one year.
Ⅴ. Any violation of Article 21 that failed to turn in results of blind test or refuse to participate in the central competent authority designated sampling technique evaluation or blind testing.
Ⅵ.When participated in the sampling technique evaluation or blind testing that being held by the central competent authority and failed twice consecutively.
Ⅶ. Any testing and analysis organizations that failed to apply for permit extension within regulated deadline or failed to pass the application for extension and re-applied within the validity of the permit, and continue to carry out the said items of analysis operation after the expiration date of the permit; or continue to carry out the said item of analysis operation since the date that the penalty decision has been officially delivered for those analysis categories or items with permits that being revoked, cancelled or ordered to be stopped.
Ⅷ. Any false statements related to permit application documents, employment of testing personnel, testing results or data processing procedures, testing reports, or other reporting documents.
If the testing and analysis organizations conducted critical violations on any of the following circumstances when performing the environmental testing and analysis matters, their testing operations shall be ordered to be stopped in accordance with the foregoing provisions besides the fine. Also their permits shall be revoked or being ordered to cease their testing operations:
I. Any false statements related to the permit application documents, employment of testing personnel, testing or data processing procedures, testing reports, or other reporting documents.
II. Any violations of Subparagraph 2 or 3 of Paragraph 1 of Article 17 and being punished by the competent authority for the same testing and analysis item three times within one year.
Ⅲ. For the testing and analysis organizations that failed the sampling technique evaluation or blind testing twice consecutively and unable to be improved within the notified deadline.
IV. Carry out the testing and analysis operations as stipulated in and authorized by Article 1 of this regulation without the approval or obtained a permit that being issued by the central competent authority.
Article 24-1
If the test report issued by the testing and analysis organization has involved in violation of the regulations as stipulated in Paragraph 1, Subparagraph 2 of Article 17, the laboratory manager or signatory that signed the said report shall being evaluated and approved by the central competent authority to resume the authorization to sign on the report of testing and analysis items relevant to the foregoing problematic report.
If the test report issued by the testing and analysis organization has involved in significant violation of Paragraph 2 of Article 24 and the central competent authority has revoked its permit and to prohibit its permit application for the same testing and analysis items within a certain period of time; the laboratory manager or signatory shall apply to the central competent authority for evaluation after the designated period of time and being approved to resume the authorization to sign on the test report with the same testing and analysis items as the foregoing problematic report.
Article 25
For the testing and analysis organizations with their permits being revoked or cancelled, or with suspended testing and analysis categories or items by the central competent authority, since the delivered date of penalty decision, shall not to perform the testing and analysis operations at issue again.
For the testing and analysis organizations with their testing analysis permits being revoked or cancelled by the central competent authority shall not allowed to submit application to the central competent authority for the permit of the same testing and analysis items within two year since the date of revocation or cancellation.
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