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Title: Regulations Governing Commissioned for Food Sanitation Testing CH
Amended Date: 2013-11-22
Category: Ministry of Health and Welfare(衛生福利部)
Article 1
These Regulations are established in accordance with the third paragraph of Article 37 of the Act Governing Food Sanitation (hereinafter referred to as the Act).
Article 2
The testing institutions, academic groups or research institutes (hereinafter collectively referred to as the Commissioned Entities) commissioned by the competent authorities to conduct the testing for food sanitation (hereinafter referred to as the Testing) shall bear the following qualifications:
1. Compliance with the system (ISO/IEC 17025:2005, etc.) certified by international standard organizations;
2. Ability to conduct the commissioned tests, as well as the necessary corresponding premises and facilities; and
3. Established test control procedures and quality assurance measures.
Article 3
Commissioned entities shall station the following personnel with proper qualifications:
1. Director of testing division who has a bachelor ’ s or master ’ s degree in food, medicine or chemistry related fields from a public or registered private university, independent college or a foreign university or independent college accredited by the Ministry of Education and has received appropriate professional testing training and is equipped with at least three years of relevant practical work experience.
2. Examiner who has a bachelor ’ s or master ’ s degree in food, medicine or chemistry related fields from a public or registered private university, independent college or a foreign university or independent college accredited by the Ministry of Education and has received relevant training.
Article 4
The competent authorities may commission the testing by either appointing qualified entities directly or selecting proper ones through open screening procedures.
Article 5
The competent authorities shall enter into a contract with the Commissioned Entities in accordance with the Regulations, which shall specify commissioned test items, relevant rights and obligations, methods of conflict settlement, etc.
Article 6
In order to be eligible or commission under Article 4, both the entities appointed or the applicants taking part in the screening procedures shall prepare and submit the following documents to the competent authorities:
1. Performance plan of commissioned testing;
2. Certificates and documents regarding the qualifications of the entity and its personnel;
3. Introduction to the entity;
4. Layout of the testing premises;
5. Testing items to be granted and a description of relevant testing equipment and its quantity, specifications and functions;
6. Description of test control procedures and quality assurance measures;
7. Certificates of compliance with the system certified by international standard organizations; and
8. Documents pertinent to the accounting and auditing systems of the entity.
Article 7
The Commissioned Entity shall inform the competent authorities of any and all changes regarding the directors or examiners of the testing division or relevant testing facilities or equipment. If the above changes are serious enough to affect the entity ’ s ability to test the commissioned items, the competent authorities shall ask said entity to improve within a specific period of time.
Failure to make satisfactory improvements will result in the dissolution of the contract for the commissioned work.
Article 8
When delivering food samples to the Commissioned Entity for Testing, the Competent authorities shall fill out the commission test sheet (hereinafter referred to as the test sheet) and affix seal to the food samples.
Once the Commissioned Entity receives the test sheet and food samples delivered by the competent authorities, the Commissioned Entity shall issue a receipt and then be responsible for safekeeping the samples.
Article 9
After the Commissioned Entity completes the testing, it shall issue a test report; the competent authorities may order the Commissioned Entity to send the test report electronically to them first, if necessary.
The above test report shall include the following items:
1. Name, address, telephone number and fax number of the Commissioned Entity;
2. Name and address of the competent authority, and test sheet number;
3. Description of physical characteristics of the food samples, identification mark, receipt date and test performance date;
4. Name of test equipment and testing method used and test results; and
5. Date of report, and signature and seal affixed by the person in charge of the Commissioned Entity.
Article 10
The Commissioned Entity and the relevant personnel shall keep the commissioned test work confidential and shall not disclose any relevant test results.
The competent authorities shall not disclose the name of the Commissioned Entity, except when otherwise provided by laws and statutes.
Article 11
The competent authorities may inspect the test equipment, personnel, technological ability, test records, effectiveness period, quality control, financial income, expenses, etc. of the Commissioned Entity, and shall request said entity to amend any fault found during the inspection within a given period of time.
The Commissioned Entity shall cooperate with the above inspection and shall not evade, impede or refuse it.
Article 12
These Regulations shall be implemented from the date of promulgation.