Chapter 2 Permission
Article 3
For testing and analysis organizations that apply for the testing and analysis permits shall apply to the central competent authority.
The testing and analysis organization shall obtain a permit being issued by the central competent authority to carry out the testing and analysis as stipulated and authorized according to Article 1 of this regulation except being approved by the central competent authority.
Article 4
Those that apply for testing and analysis organization permits shall meet one of the following conditions:
Ⅰ. Be a non-public enterprise with paid-in capital of NT$ 5 million or more, or a juridical association with total registered assets of NT$ 5 million or more.
Ⅱ. Be a public enterprise or a government agency or organization other than an environmental protection competent authority.
Ⅲ. Be an academic institution at the public college level or higher.
Ⅳ. A social association or occupational association that has been approved and registered in accordance with the Civil Associations Act.
Article 5
Those that apply for testing and analysis organization permits shall possess their own laboratories; each laboratory shall possess dedicated instruments and equipment and six or more dedicated testing and analysis personnel, including one laboratory manager and quality assurance/quality control personnel. However, for those that apply as a government agency or organization other than an environmental protection competent authority, dedicated testing and analysis personnel shall be personnel related to the operations with which they are charged, and two or more testing and analysis personnel, one of which shall be the laboratory manager, shall be employed.
Those that obtain the testing and analysis organization permits pursuant to the proviso in the foregoing paragraph may only perform environmental testing and analysis operations for industry categories related to the operations with which they are charged.
Article 6
The qualifications of the laboratory manager in the foregoing Article shall be in compliance with the following conditions:
Ⅰ. Be a graduate of a chemistry or environment-related department of a school at the public or registered private college-level or higher or an overseas school at the college-level or higher that is recognized by the Ministry of Education. However, for those that apply as a government agency or organization other than an environmental protection competent authority, laboratory managers that are graduates of a department related to the operations with which they are charged of a school at the college-level or higher may also hold the position.
Ⅱ. Possess testing and analysis experience of five years or more related to the testing and analysis category for which they are applying for permission, and provide verification documents. However, those with a relevant bachelor’s degree may deduct two years of testing and analysis experience; those with a relevant master’s degree may deduct three years of testing and analysis experience; those with a relevant doctoral degree may deduct four years of testing and analysis experience.
The managers of laboratories engaging solely in testing of noise, vibration, physical hazards, or other test category items controlled by the central competent authority shall be graduates of physics or engineering departments of a school at the college-level or higher.
Article 7
The qualifications of the quality assurance/quality control personnel in Article 5 shall be in compliance with the following conditions:
Ⅰ. Be a graduate of a chemistry or environment-related department of a school at the public or registered private college-level or higher or an overseas school at the college-level or higher that is recognized by the Ministry of Education. However, for those that apply as a government agency or organization that is a non-environmental protection competent authority, quality assurance/quality control personnel that are graduates of a department related to the operations with which they are charged of a school at the college-level or higher may also hold the position.
Ⅱ. Possess testing and analysis experience of three years or more related to the testing and analysis category for which they are applying for permission, and provide verification documents. However, those with a relevant master’s degree may deduct one year of testing and analysis experience; those with a relevant doctoral degree may deduct two years of testing and analysis experience.
The quality assurance/quality control personnel of laboratories engaging solely in testing of noise, vibration, physical hazards, or other test category items controlled by the central competent authority shall be graduates of physics or engineering department of a school at the college-level or higher.
Article 8
The qualifications of testing and analysis personnel other than laboratory managers and quality assurance/quality control personnel shall be in compliance with the following conditions.
Ⅰ. Be a graduate of a science, engineering, medical, agricultural or environmental department of a school at the public or registered private college-level or higher or an overseas school at the college-level or higher that is recognized by the Ministry of Education.
Ⅱ. Be a graduate of a department that is not mentioned in the foregoing subparagraph of a school at the public or registered private college-level or higher or an overseas school at the college-level or higher that is recognized by the Ministry of Education., and have relevant testing and analysis experience for more than two years with supporting documents.
Ⅲ. Be a graduate of a chemical analysis, chemical engineering, agricultural chemistry, food science or environmental department of a school at the public or registered private high school or vocational school, and have relevant testing and analysis experience for more than two years with supporting documents.
Ⅳ. Be a graduate of a department that is not mentioned in the foregoing subparagraph of a school at the public or registered private high school or vocational school, and have relevant testing and analysis experience for more than three years with supporting documents.
Subparagraph 2 to Subparagraph 4 of the foregoing paragraph have relevant testing and analysis experience, can complete the following training courses organized by the central competent authority or its accreditation body instead of two years of relevant testing and analysis experience:
Ⅰ. Thirty hours of environment safety and basic principles of testing and analysis.
Ⅱ. Six hours of field training.
Article 9
The on-site statutory responsible quality assurance/quality control personnel, sampling personnel and statutory responsible safety and sanitation personnel of testing and analysis organizations that engage in the sampling of unknown industrial waste items shall undergo forty hours or more of safety and response awareness training and three days or more of field training.
The on-site statutory responsible quality assurance/quality control personnel, sampling personnel, and statutory responsible safety and sanitation personnel of analysis organizations that engage in the sampling of industrial waste items other than those in the foregoing paragraph shall undergo sixteen hours or more of safety and response awareness training and eight hours or more of field training.
Those that undergo the training in the first paragraph may engage in the sampling of industrial waste items in the foregoing paragraph.
Article 10
Those that apply for testing and analysis organization permits shall submit the following documents:
Ⅰ. An application form.
Ⅱ. Organization identification documents of the agency or organization.
Ⅲ. A photocopy of the personal identification document of the statutory responsible person.
Ⅳ. A diagram of the geographical locations of laboratories.
Ⅴ. Placement and layout diagrams of the testing and analysis facilities.
Ⅵ. Photocopies of verification documents demonstrating the positions, academic experiences and necessary training of testing and analysis personnel.
Ⅶ. Documents describing the items been applied, names of the methods been used and their standard operation procedures.
Ⅷ. Fifteen or more sets of real testing and analysis data and related quality control diagrams related to the testing and analysis items for which the permit application has been submitted.
Ⅸ. The management manual of laboratories prepared in accordance with the Basic Norm of Quality System of Environmental Analysis Organization Laboratory proclaimed by the central competent authority. Its content shall have at least included: impartiality, confidentiality, organization, personnel, facilities and environmental conditions, equipment, metrological traceability, externally provided products and services, review of requests, tenders and contracts, selection, verification and validation of methods, sampling, handling of test items, technical records, ensuring the validity of results, reporting of results, complaints, nonconforming work, control of data and information management, management system documentation, control of management system documents, control of records, actions to address risks and opportunities, improvement, corrective actions, internal audits, management reviews.
Ⅹ. Other documents designated by the central competent authority.
Those testing and analysis organizations for which application documents in the foregoing paragraph do not comply with regulations or for which contents are incomplete shall be notified by the central competent authority to make corrections within a limited time period; those that have failed to make corrections by the deadline shall have their applications rejected and their application documents shall not be returned.
Article 11
The testing and analysis organizations that establish one or more laboratory shall apply for permits for each laboratory.
The testing and analysis organizations that apply for extensions, the resumption of business, the relocation of a laboratory, or the addition of a laboratory, testing and analysis category or testing and analysis item shall submit the documents in Subparagraph 1 and Subparagraphs 4 through 10 of the foregoing article.
For the application for extensions in the foregoing paragraph, the testing and analysis organization shall also submit verification documents of testing and analysis personnel for training performed pursuant to Article 22.
Testing organizations which apply for relocation of laboratory shall apply to central competent authority for relocation of laboratory 15 days in advance and submit the plan of relocation for references. Testing organizations shall complete the relocation in accordance with the plan of relocation and submit documents mentioned in Paragraph 2 within 30 days after the completion of relocation.
Article 12
Testing and analysis categories for permits shall be as follows.
Ⅰ. Air testing and analysis category.
Ⅱ. Water quality and water volume testing and analysis category.
Ⅲ. Drinking water testing and analysis category.
Ⅳ. Waste testing and analysis category.
Ⅴ. Soil testing and analysis category.
Ⅵ. Environmental agents testing and analysis category.
Ⅶ. Toxic and Concerned chemical substances testing and analysis category.
Ⅷ. Noise testing and analysis category.
Ⅸ. Groundwater testing and analysis category.
Ⅹ. Bottom sediment category.
XI. Other testing and analysis categories officially announced by the central competent authority.
The limits for the items of the testing and analysis categories in each subparagraph in the foregoing paragraph shall be based on the control items of the regulations of environmental laws, the items of testing and analysis methods already officially announced by the central competent authority or other items officially announced by the central competent authority.
Article 13
The central competent authority shall perform the following matters for the review of testing and analysis organization permit applications, extensions, the resumption of business, the relocation of a laboratory, the addition of a laboratory, and the addition of an analysis category or analysis item; permits may be issued only after a review demonstrates compliance. However, reviews for the addition of an testing and analysis item may forego a systems evaluation.
Ⅰ. Review and approval of written documents: conduct review and approval of all application documents submitted by the testing and analysis organization.
Ⅱ. Performance evaluation: conduct blind sample testing, on-site comparison testing or practical application/technical proficiency examinations for all testing and analysis items for which the testing and analysis organization has applied.
Ⅲ. Systems evaluation: conduct on-site checks and evaluations of the quality control systems of each laboratory for which the testing and analysis organization has applied.
Ⅳ. Other approval and evaluation matters designated by the central competent authority.
If a testing and analysis organization applies for an extension in accordance with the provision of Article 16, and has no unqualified testing and analysis categories such as sanctions violations, blind sample testing, or on-site comparison testing within the validity period of the permit to the date of application, the testing and analysis items of the category will be exempted from performance evaluation.
Article 14
The central competent authority may establish an evaluation technique committee (herein referred to as “evaluation committee”) in order to conduct reviews, evaluations and consultations for the testing and analysis organization permits.
The evaluation committee in the foregoing paragraph shall establish positions for twenty-one to twenty-five committee members; terms shall be two years and committee members may be reappointed after the end of their terms.
Article 15
Permits shall record the following items:
Ⅰ. The name of the organization.
Ⅱ. The name and address of the laboratory.
Ⅲ. The name of the laboratory manager.
Ⅳ.Testing and analysis categories, items and methods.
Ⅴ. Validity period.
Ⅵ. Other items designated by the central competent authority.
Article 16
The maximum validity period of permits shall not exceed five years. Extension applications shall be filed by the testing and analysis organization five to six months prior the permit expiration. Categories or items that obtained the permit during the application extension period, the application should be made 60 days before the original permit expires. Period of each extension shall not exceed five years. But if during the permit valid period of time, it was found that the permit application documents, employment of testing and analysis organization personnel, testing results or data process procedures, testing report or other reporting materials with false statements and being punished by the central competent authority at least twice, for the extension of permit application for those testing items not being revoked or cancelled, the valid period to be approved shall be 3 years.
For the testing and analysis organizations apply for extension of permit but with application documents being reviewed as not comply with regulations or the contents were incomplete, the central competent authority shall notify the applicant to make corrections within a deadline. If failed to make corrections by the deadline, the application shall be rejected.
For the testing and analysis organizations apply for extension in accordance with Paragraph 1 within the regulated period of time and being determined as unable to make decision on approval or rejection due to review time needed for the central competent authority before expiration of the permit, the testing and analysis organizations may continue to perform their testing items in accordance with their original permit content during the time period from the permit expiration date to the completion date of review.
For the testing and analysis organizations failed to apply for extension in accordance with the foregoing Paragraph 1 within the regulated period of time or failed to pass the application for extension and re-applied within the validity of the permit, shall stop to perform their testing items since expiration date of the permit till the central competent authority has made the approval or rejection decision for the application.
If the testing and analysis organizations failed to apply for extension before the expiration date of the permit, their permits shall be invalid since the expiration date of the permits. A new permit application shall be submitted if they want to continue to perform their testing and analysis operation of the said items.