Laws of Vietnam

Pursuant to Decree No. 73/CP of November 1, 1995 of the Government stipulating the functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to Decree No. 86/CP of December 8, 1995 of the Government stipulating the assignment of responsibilities for the State management over the goods quality;

At the proposal of the Director of the Department for Science, Technology and Product Quality,

DECIDES:

Article 1.- To promulgate 10 TCN 382-99 Standard: "General Requirements of the Agricultural Laboratory".

Article 2.- This Decision takes effect 15 days after its signing.

Article 3.- The Director of the Office, the Director of the Department for Science, Technology and Product Quality, leading officials of organizations and individuals concerned shall have to implement this Decision.

For the Minister of Agriculture and Rural Development

Vice Minister

10 TCN 382 - 99

(Issued together with Decision No. 44/1999/QD-BNN-KHCN of February 27, 1999)

1. Introduction:

- This standard is built on the basis of TCVN 5958 - 95.

- This standard prescribes general requirements to be met by the laboratory in all its activities. It also applies to the evaluation and recognition of the agricultural laboratories.

2. Managerial organization:

2.1. The laboratory must have the legal person status, be organized and operate under the requirements of this standard.

2.2. The laboratory must:

- Be staffed with capable managerial cadres and technicians acquiring necessary professional qualifications for the fulfillment of the assigned tasks.

- Have the appropriate organizational structure so that all of its members shall not have any pressure to bear upon, which affect the professional quality.

- Prescribe the responsibility and power for every member as well as the inter-relations between employees and leaders of the laboratory.

- Supervise through professionally qualified persons the procedures and methods of analyzing and evaluating results.

- Be staffed with cadres in charge of technical matters, who take full responsibility for the entire technical operation, including the management and maintenance of operation of equipment.

- Be staffed with cadres in charge of the quality matters, who take responsibility for the quality system and the application thereof.

3. Staff members:

3.1. The laboratory must be fully staffed with employees who have professional qualifications and technical experiences necessary for the performance of assigned functions and tasks (according to the State’s regulations on titles and posts)

3.2. The laboratory’s staff members must be regularly fostered and trained so as to raise their professional levels.

3.3. The laboratory must compile records on the staff members’ qualifications, skills and experiences so as to elaborate plans for their professional fostering and training.

4. The quality system, inspection and examination:

4.1. The laboratory must establish and maintain the quality system suitable to the type, scope and volume of experiments assigned to it.

4.2. The quality manual: The laboratory shall have to open the quality manual as prescribed in Clause 4.3 TCVN 5958 - 1995.

4.3. The laboratory shall have to organize the inspection of its activities within certain periods of time so as to ensure that its activities comply with the requirements of the quality system. The inspection must be carried out by well-trained and qualified cadres and be independent from the activities of the inspected laboratory. Upon detection of any doubts about the accuracy and effects of the experiment results through the inspection, the laboratory shall have to immediately notify it in writing to customers whose work may be affected thereby.

4.4. The approved and applied quality system which has satisfied the requirements of this standard must be reconsidered at least once a year by the leadership of the laboratory so as to ensure its continued conformity and efficiency and to make other necessary changes and improvements.

4.5. Any problems detected in the investigation or examination as well as the solutions thereto must be recorded in writing. The persons in charge of product quality must ensure that these work shall be completed within a time limit agreed upon.

4.6. Alongside the periodical examination, the laboratory shall have to ensure the quality of results provided for customers through the regular examination including:

a) The internal quality control system, using statistical techniques when conditions permit.

b) Checking the expertise or inter-lab comparative experiments.

c) The regular use of recognized standard substances and samples or the use of second-grade standard substances to control the quality at laboratory.

d) Experimenting on the repeated use of the same testing method or different testing methods.

e) Re-testing reserved samples.

f) Considering the correlation between results and different properties of the objects.

5. Facilities and environment:

5.1. The experimentation facilities and environment must not affect the quality of testing methods and the equipment require high precision.

5.2. The laboratory must be equipped with necessary equipment to control the environmental conditions which affect the testing results.

5.3. The laboratory should work out appropriate measures to ensure the industrial hygiene therein.

5.4. Equipment:

5.4.1. The laboratory must be fully equipped with essential equipment of different types to perform the testing with precision (with separate list for each professional field).

5.4.2. All the equipment must be fully and regularly maintained so as to ensure that no errors shall be made during the experiment.

5.4.3. All the lab equipment, including standard substances and specimen, must have follow-up records as prescribed in Clause 8.4 TCVN 5958 - 1995.

5.4.4. All measuring and testing equipment which affect the precision or efficiency of experiments must be adjusted or checked before they are put to use, and be readjusted and rechecked periodically once every 6 months or a year.

6. Testing methods:

6.1. The laboratory must apply standard testing methods already announced in the Vietnamese standards, international standards, branch standard (including the sample taking, sample preparation, sample preservation…).

6.2. When testing methods have not yet been standardized, the testing methods announced by well-known technical organizations, or written into official documents and commonly applied in research institutions at home and abroad may apply.

In case of necessity, the laboratory shall have to come to written agreement with customers on the use of the testing methods not yet standardized.

7. Management of testing samples:

7.1. The laboratory must be equipped with appropriate facilities to avoid wrongly taking or damaging testing samples during the process of experiment preparation, warehousing; personnel engaged in sample reception and storage must strictly abide by the instructions relating to testing samples. The testing samples must be stored under safe environment conditions, and, if necessary, be controlled and fully recorded.

7.2. The laboratory shall have to strictly follow the procedures for sample taking, storing and liquidation as prescribed.

8. Archives:

8.1. The laboratory shall have to maintain an archival system suitable to its concrete conditions and adhere to all current regulations.

8.2. Archival records must be codified so as to ensure their confidentiality and to find them easily when necessary.

9. Certificates and reports:

9.1. All experiment results must be clearly, accurately and objectively reported in conformity with the instructions on the experiment methods. Usually, the results should be recorded in experiment reports or certificates of experiment results, which should contain all necessary information on the testing samples.

9.2. The experiment results card must contain at least the following information:

a) Title: For example "Phieu ket qua thu nghiem" (Experiment result card), "Chung chi chat luong" (quality certificate),…

b) Name and address of the laboratory

c) Code number of the experiment result card (serial number)

d) Name and address of customer(s)

e) Codification of testing samples

f) The date of receiving samples, the date of testing and the date of taking the samples

g) The used testing method or description of used method in box of division with official standards

h) Experiment results and comments

i) Signature and position of the person in charge of the contents of the certificate or the result card and the signing date.

j) Announcing (at the end of page) the validity of the experiment result card which must not be photocopied or duplicated without the written consent of the laboratory.

9.3. If the experiment result card contains the experiment results of other laboratories, the latter must be clearly stated.

9.4. The experiment result card must be uniform in its arrangement for each experiment field, ensuring its scientism, accuracy and clarity. The form must be designed carefully and specifically for each testing performed. The titles must be highly standardized.

9.5. The amendment or supplement to the issued experiment result card is made only in the form of a supplementary document.

9.6. The laboratory shall have to notify the experiment results to customers in a convenient and quick manner.

10. Receiving and processing information:

10.1. The laboratory must elaborate the regulations on settlement of petitions from customers and relevant agencies on its operations.

10.2. The laboratory must adopt measures to settle in time comments on its operation and responsibility in accordance with the regulations mentioned in this standard.

10.3. The laboratory shall have to keep all the records on comments and the solutions thereto.

For the Minister of Agriculture and Rural Development

Vice Minister