Laws Information

法規資訊
Title: Regulations Governing Recognition of Designated Testing Laboratory for Commodity Inspection
Am Date: 2008-01-11
Legislative History: Articles 2, 4, 11 and 18 amended and promulgated by Ministerial Order on 11 January 2008.

Transaction

Amendment

Article 2
The terms used by these Regulations are defined as follows:
1. Testing laboratory: It shall mean the laboratory that performs tests.
2. The designated testing laboratory for Commodity Inspection (hereinafter referred to as the “designated testing laboratory ”): It shall mean the testing laboratory that has been recognized by the Bureau of Standards, Metrology and Inspection of the Ministry of Economic Affairs (hereinafter referred to as the “BSMI”) in accordance with these Regulations and therefore may perform the required tests of commodities subject to legal inspection.

Article 4
The testing laboratory applying for recognition shall fulfill the following conditions:
1. Complying with the following criteria:
(1) Common criteria: CNS 17025 or ISO/IEC 17025; and
(2) Particular criteria: Any other particular criteria of technical and quality management requirements other than the preceding common ones for a particular testing category.
2. Possessing necessary testing equipment, facility, personnel, and management system; possessing ample information and a full understanding of inspection standards as well as applicable laws and regulations for the commodity to be tested;
3. The technical and quality management supervisors shall possess the following qualifications:
(1) The technical supervisor shall possess a college or university degree or higher in related field, testing-related professional training, and an on-hand experience of related product testing for three years or higher;
(2) The quality management supervisor shall possess a college or university degree or higher, quality management-related professional training, and an on-hand experience of quality management in related product testing for three years or higher.
4. The report signatory shall be designated. The report signatory shall not act as both technical and quality management supervisors.
Depending upon different geographic areas, testing categories, testing items or commodity categories, the BSMI may designate and announce that the testing laboratory applying for recognition shall be granted an accreditation that also demonstrates compliance with the requirements set out in the preceding paragraph by the Taiwan Accreditation Foundation (hereinafter referred to as “the TAF”).
Depending upon testing categories, the particular criteria in subparagraph 1 and the necessitated testing equipment in subparagraph 2 of the first Paragraph of this Article shall be prescribed by the BSMI.

Article 11
If surveillance finds that the designated testing laboratory has major defects, the corrective action shall be completed within a 30-day period.
Upon the expiration of the preceding period, the BSMI shall perform a second surveillance.
If surveillance finds minor defects but the designated testing laboratory still can operate effectively, the designated testing laboratory shall submit a corrective action plan to the BSMI within a given time limit.

Article 18
If a designated testing laboratory has any of the following circumstances, the BSMI may temporarily suspend the right of the designated testing laboratory to issue the test report in whole or a part of relevant testing categories in the name of a designated testing laboratory within a certain period of time. The BSMI shall resume the right after the designated testing laboratory has completed the corrective action and be examined and approved by the BSMI:
1. Where major defects have been found by two consecutive surveillance in accordance with Article 10;
2. Where the result of the second surveillance set forth in Paragraph 2 of Article 11 is not satisfied, or the corrective action plan is not submitted within the prescribed timeframe as required under Paragraph 3 of the same Article or the submitted corrective action plan cannot effectively correct the defects;
3. Where the designated testing laboratory has been found to be not in conformity with the requirements in two consecutive proficiency testing program;
4. Where the designated testing laboratory has failed to submit documents within the given time limit after receiving a notice to submit by a given time limit unless good cause is shown;
5. Having violated the provision of Article 16 by evading, impeding or rejecting the review, examination or verification;
6. Having failed to participate in the proficiency testing program designated by the BSMI;
7. Having failed to take appropriate actions and cooperate with the BSMI in handling surveillance, appeals, complaints and disputes and have further not cooperated with the BSMI after receiving a notice to cooperate.
8. Where the accreditation of the designated testing laboratory has been temporarily suspended by the TAF and the recognition of which is granted in accordance with Article 17;
9. Having rejected the application for product testing within the scope recognized by the BSMI, unless good cause is shown; or
10. Other circumstances that are deemed by the BSMI as having unfavorable impact on the good practice for commodity inspection or quality of testing operation.