Circular No. 16/2011/TT-BNNPTNT on the evaluation, designation, and management of agricultural and rural development laboratories

CIRCULAR

Rules on evaluation, designation, and management of agricultural and rural development laboratories

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Based on Decree No. 01/2008/ND-CP dated January 3, 2008, of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development; Decree No. 75/2009/ND-CP dated September 10, 2009, of the Government amending Article 3 of Decree No. 01/2008/ND-CP dated January 3, 2008;

Based on the Law on Technical Standards and Regulations No. 68/2006/QH11 adopted by the National Assembly, Session XI, on June 29, 2006, and effective from January 1, 2007;

Based on Decree No. 127/2007/ND-CP dated August 1, 2007, of the Government detailing the implementation of certain provisions of the Law on Technical Standards and Regulations;

Based on the Law on Product Quality No. 05/2007/QH12 adopted by the National Assembly, Session XII, on November 21, 2007, and effective from July 1, 2008;

Based on Decree No. 132/2008/ND-CP dated December 31, 2008, of the Government detailing the implementation of certain provisions of the Law on Product Quality;

Based on the Food Safety Ordinance No. 12/2003/PL-UBTVQH adopted by the Standing Committee of the National Assembly on July 26, 2003;

Based on Decree No. 163/2004/ND-CP dated September 7, 2004, of the Government detailing the implementation of certain provisions of the Food Safety Ordinance;

The Ministry of Agriculture and Rural Development guides the requirements and procedures for evaluating, designating, and managing agricultural and rural development laboratories as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. Scope of application: This Circular stipulates the procedures for evaluating, designating, and managing laboratories in fields under the management responsibility of the Ministry of Agriculture and Rural Development.

2. Applicability: This Circular applies to laboratories, relevant administrative agencies involved in the activities of evaluating, designating agricultural and rural development laboratories.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Laboratory: A technical organization that performs the determination of product, commodity, material, equipment, structure, physical phenomenon, process, or specific service characteristics according to a defined procedure.

2. Inter-laboratory testing: The assessment of the quality of testing results between two or more laboratories by comparing test results on identical samples with the common value obtained from the set of results from participating proficient laboratories.

3. Laboratory evaluation: An activity to check and review the suitability of the quality management system and analytical capability for each quality parameter compared to specific regulations or standards.

4. Evaluation and designation agency: The state administrative agency authorized to carry out laboratory evaluation and designation.

Article 3. Evaluation and Designation Agencies

1. The Forestry General Department is the agency responsible for evaluating and designating laboratories for forestry crop seeds, wood, wood products, and non-wood forest products.

2. The Water Resources General Department is the agency responsible for evaluating and designating laboratories for water conservancy works, water supply and drainage, dikes and embankments.

3. The Fisheries General Department is the agency responsible for evaluating and designating laboratories for fishery seeds; feed, raw materials for feed production, additives, biological preparations, water quality for aquaculture.

4. The Crop Production Department is the agency responsible for evaluating and designating laboratories for crop seeds, soil, fertilizers, raw materials for fertilizer production, biological preparations for crop production.

5. The Livestock Production Department is the agency responsible for evaluating and designating laboratories for livestock breeding seeds; livestock feed and raw materials for feed production, preservatives used in livestock feed, biological preparations for livestock production.

6. The Plant Protection Department is the agency responsible for evaluating and designating laboratories for plant quarantine, plant protection chemicals, residues of plant protection chemicals in agricultural and forestry products.

7. The Animal Health Department is the agency responsible for evaluating and designating laboratories for animal diseases, veterinary drugs and raw materials for veterinary drugs.

8. The Quality Management Department for Agricultural and Forestry Products and Aquatic Products is the agency responsible for evaluating and designating laboratories for the quality of agricultural and forestry products, aquatic food and non-food products.

9. The Processing Department for Agricultural and Forestry Products and Salt Industry is the agency responsible for evaluating and designating laboratories for salt and salt products, agricultural machinery and equipment.

10. The Science, Technology, and Environment Department is the agency responsible for evaluating and presenting to the Ministry for issuance of decisions to designate multi-disciplinary laboratories (from two fields or more).

Article 4. General Principles

1. The evaluation and designation of laboratories by the competent authorities specified in Article 3 shall be based on the consideration of the laboratory's capacity to meet the requirements of corresponding technical regulations and other related requirements as prescribed by law.

2. Testing methods designated by the agencies specified in Article 3 will be used by competent state authorities in the process of inspecting and supervising the quality of products and commodities.

Article 5. Basis for evaluating testing laboratories

1. Standards regarding the requirements for the competence of testing laboratories TCVN ISO/IEC 17025:2007 or equivalent standards.

2. Standards regarding technical requirements and testing methods related to the evaluation.

Article 6. Forms of laboratory evaluation

1. Initial assessment, applicable in the following cases:

a) Testing laboratories applying for the first time to be evaluated and designated in accordance with this Circular;

b) Testing laboratories that have been designated but had their designation decisions revoked pursuant to Clause 2, Article 19 of this Circular.

2. Re-assessment, applicable in the following cases:

a) Testing laboratories that have undergone initial assessment but do not yet meet the conditions for designation;

b) Testing laboratories that have been designated but whose designation decisions have expired;

c) Testing laboratories that have been assessed and designated but had their designation decisions temporarily suspended pursuant to Clause 1, Article 19 of this Circular.

3. Expanded assessment, applicable to testing laboratories that have been designated and have submitted applications to add new tests or fields.

Article 7. Method of designation

Based on the assessment report and the verification record of the assessment results:

1. Authorities specified from Clause 1 to Clause 9, Article 3 issue decisions to designate testing laboratories and report the results to the Ministry (Department of Science, Technology and Environment).

2. The authority specified in Clause 10, Article 3 submits to the Ministry for issuance of decisions to designate multi-disciplinary testing laboratories.

Article 8: Laboratory Identification Number

1. The Ministry of Agriculture and Rural Development uniformly issues and manages the identification number of designated testing laboratories.

2. The identification number of designated testing laboratories is stipulated in the designation decision of the designating authority.

3. The identification number is displayed on the stamp prescribed in Appendix 5 of this Circular.

Article 9. Fees for laboratory evaluation

1. The evaluation agency may collect fees in the following cases:

a) Initial assessment;

b) Reassessment;

c) Expanded assessment;

2. The collection and use of evaluation fees shall be carried out in accordance with current laws.

Chapter II

EVALUATION AND DESIGNATION OF TESTING LABORATORIES

Article 10. Registration Documents

1. Initial Assessment

a) Application form (in accordance with the model prescribed in Appendix 1. Form BNN-01 issued together with this Circular);

b) Report on the capacity of the testing laboratory (in accordance with the model prescribed in Appendix 2. Form BNN-02 issued together with this Circular);

c) A copy of the certificate or relevant documents concerning the recognition of the quality management system of the testing laboratory in compliance with TCVN ISO/IEC 17025:2007 or equivalent (if available). In case of submission through postal service, a certified copy must be provided;

d) Inter-laboratory test results for the registered tests to be designated;

e) A copy of the Certificate of Registration for the field/activity of testing.

2. Reassessment

a) Application form (in accordance with the model prescribed in Appendix 1. Form BNN-01 issued together with this Circular);

b) Report on corrective action results (if any).

c) Report on testing activities since designation.

3. Expanded Assessment

The application forms specified in Point a and d, Clause 1 of this Article.

Article 11. Acceptance of registration applications and confirmation of registration

1. Registration applications for designation of testing laboratories as prescribed in Article 10 must be sent to the evaluation and designation authorities specified in Article 3 of this Circular via postal service or delivered directly.

2. Within five (05) working days from the date of receipt of the application, the evaluation and designation authorities shall examine the completeness and validity of the application and request the applicant to provide additional documents or information if necessary.

Article 12. Establishment of the Evaluation Team

1. Within ten (10) working days from the date of receiving complete and valid registration files for laboratory designation, the Evaluation and Designation Authority specified in Article 3 shall issue a decision to establish the evaluation team and notify the laboratory of the evaluation plan.

2. The decision to establish the evaluation team must clearly specify the scope and content of the evaluation, the list of members and their assigned responsibilities. The evaluation team consists of five to seven members with specialized knowledge and experience in the designated field and representatives of relevant management agencies.

Article 13. Content of Evaluation

1. Compliance and suitability of the laboratory's quality management system with current regulations.

2. Suitability of analytical capacity for registered quality indicators compared to laboratory capability requirements and related regulatory authorities' requirements.

3. In cases where the laboratory has certification recognized as meeting the TCVN ISO/IEC 17025: 2007 standard or equivalent standards issued by accreditation organizations, the content of the evaluation regarding compliance (management requirements) of the quality management system for the certified fields and tests may be reduced.

Article 14. Methods of Evaluation

The evaluation team applies all four methods below:

1. Direct interviewing of the laboratory manager and staff regarding relevant information;

2. Reviewing stored records and related documents of the laboratory;

3. Observing the actual layout, environmental conditions, equipment status, other facilities of the laboratory, and the operations of laboratory staff;

4. Evaluating inter-laboratory test results and corrective action reports (if any).

Article 15. Evaluation Results

1. Non-conformities discovered during the evaluation process must be recorded in the evaluation report (in accordance with the form prescribed in Appendix 3, Form BNN-03 issued together with this Circular).

2. The evaluation report must be announced at the final meeting. The evaluation report must contain all contents and be signed to confirm by the laboratory representative and the head of the evaluation team.

3. In case the laboratory representative disagrees with the evaluation results, the laboratory representative has the right to record their objections and complaints at the end of the report before signing and affixing the confirmation stamp. The evaluation report still retains legal validity even if the laboratory representative does not sign the report.

Article 16. Submission of evaluation result report

Within five (05) working days from the end of the evaluation period, the Head of the Team must submit to the Evaluation and Designation Authority the evaluation result report (according to the form in Appendix 4, Form BNN-04 issued together with this Circular) and all related documents of the evaluation period.

Article 17. Handling of Evaluation Results

Within ten (10) working days from the date of receipt of all related documents on the evaluation results, the Evaluation and Designation Authority will review the evaluation results and take measures according to each specific case as follows:

1. In cases where the laboratory requesting designation meets the provisions set out in Article 5, within five (05) working days, the Evaluation and Designation Authority specified from Clause 1 to Clause 9 of Article 3 will report the evaluation results to the Ministry (Science, Technology and Environment Department) to request issuance of a laboratory code. Upon receipt of the request document, within five (05) working days, the Science, Technology and Environment Department will issue the laboratory code in writing. After receiving the laboratory code, the Evaluation and Designation Authority specified from Clause 1 to Clause 9 of Article 3 will issue a designation decision and notify the result to the Ministry (Science, Technology and Environment Department); the Evaluation and Designation Authority specified in Clause 10 of Article 3 will submit to the Ministry for issuance of the designation decision.

2. In cases where the laboratory requesting designation does not meet the provisions set out in Article 5, the Evaluation and Designation Authority will notify the laboratory in writing of non-conformities and the time for rectification. After receiving the rectification report from the laboratory, the Evaluation and Designation Authority will review the rectification reports, and if necessary, send representatives to inspect the rectification actions. If the non-conformities have been rectified, within five (05) working days, the evaluation result report will be submitted to the Ministry (Science, Technology and Environment Department) to request issuance of a laboratory code. Upon receipt of the request document, within five (05) working days, the Science, Technology and Environment Department will issue the laboratory code in writing. After receiving the laboratory code, the Evaluation and Designation Authority specified from Clause 1 to Clause 9 of Article 3 will issue a designation decision and notify the result to the Ministry (Science, Technology and Environment Department); the Evaluation and Designation Authority specified in Clause 10 of Article 3 will submit to the Ministry for issuance of the designation decision.

3. In cases where non-conformities remain unrectified, the Evaluation and Designation Authority will suspend the evaluation until the laboratory completes the rectification and submits a designation request.

Article 18. Duration of Effectiveness of the Designation Decision

1. The duration of effectiveness of the designation decision for testing laboratories is three (03) years.

2. Three (03) months before the expiration of the duration of effectiveness of the designation decision, the testing laboratory shall prepare and submit the re-designation registration dossier to the Evaluation and Designation Authority specified in Article 3 to be re-designated (if necessary).

Article 19. Suspension or Revocation of the Effectiveness of the Designation Decision for Testing Laboratories

1. Suspension of the Effectiveness of the Designation Decision:

Based on non-conformities discovered through regular or ad hoc evaluations as recorded in the evaluation report, upon the proposal of the Head of the Evaluation Team, within fifteen (15) days, the Evaluation and Designation Authority shall issue a temporary decision to suspend part or all of the designated scope of the testing laboratory.

2. Revocation of the Effectiveness of the Designation Decision applies to the following cases:

a) If the testing laboratory violates any provisions stipulated in Article 13 of this Circular or if non-conformities are discovered but it lacks the ability to rectify them or more than six (06) months have passed since the discovery of the non-conformities without rectification;

b) If the testing laboratory is dissolved or ceases operations within its designated scope;

c) Based on non-conformities discovered through regular or ad hoc evaluations as recorded in the evaluation report and upon the proposal of the Head of the Evaluation Team, or based on the report from the recognized testing laboratory regarding its dissolution or cessation of operations within its designated scope, within fifteen (15) days, the Evaluation and Designation Authority shall issue a decision to revoke the previous designation decision.

3. The Evaluation and Designation Authority must immediately notify relevant agencies, units, and enterprises about the suspended or revoked designation decision of the testing laboratory after issuing the suspension or revocation decision.

Chapter III

MANAGEMENT OF TESTING LABORATORY ACTIVITIES

Article 20. The Science, Technology and Environment Department is the lead unit managing the evaluation and designation work for agricultural and rural development sector testing laboratories nationwide.

Article 21. The Evaluation and Designation Authority specified in Article 3 is responsible for conducting regular inspections once a year and ad hoc inspections when required.

Chapter IV

RESPONSIBILITIES AND LIMITATIONS OF THE INVOLVED PARTIES

Article 22. Evaluation and Designation Authority

1. Issuing designation decisions, suspending or revoking the effectiveness of designation decisions for testing laboratories issued by itself.

2. Annually, the Science, Technology and Environment Department publishes a list of testing laboratories along with the tests they have been designated to perform on the website of the sector.

3. Receiving and resolving complaints from testing laboratories according to current laws.

Article 23. Members of the Evaluation Team

1. Evaluating and reviewing the compliance of testing laboratories with the provisions set out in Article 5.

2. Ensuring objectivity in the evaluation process.

3. Reporting to the head of the evaluation and designation authority to handle cases exceeding their authority as prescribed.

4. Protecting information related to the confidentiality of the evaluated testing laboratory, complying with all current legal regulations.

5. Being permitted to interview, request to review books, documents, and dossiers related to the testing laboratory, collect and record necessary information, require the performance of specialized tasks, and provide evidence to support the evaluation activities.

Article 24. Designated laboratories

1. Ensure the reliability and accuracy of test results for designated tests.

2. Participate in testing the designated tests.

3. Notify the method of conducting the test on the test result report.

4. Have the right to appeal the evaluation results to the evaluation and designation authority.

5. Be guided in registering to participate in proficiency testing programs and inter-laboratory testing.

6. Be subject to inspection and supervision regarding testing activities by domestic and foreign inspection teams upon request of the State Management Authority.

7. Create favorable conditions for the Evaluation Team during the evaluation process at the laboratory.

8. Regularly before December 31 each year or at any time, the laboratory must report to the authorities specified in Article 3 on the testing activity situation within the designated scope according to the requirements of the State Management Authorities.

9. Pay the evaluation and designation fee as prescribed.

Chapter V

IMPLEMENTING PROVISIONS

Article 25. Effective Date

1. This Circular takes effect forty-five (45) days from the date of issuance.

2. This Circular abolishes the Regulation on Recognition and Management of Agricultural Testing Laboratories issued together with Decision No. 139/1999-QĐ-KHCN dated October 11, 1999; the Regulation on Evaluation and Designation of Quality Inspection Laboratories for Forestry, Aquaculture and Agriculture Products issued together with Decision No. 116/2008/QĐ-BNN dated December 3, 2008; Articles 4 and 7; Clause 1 of Article 11; Clause 1 of Article 12; Clauses 1 and 2 of Article 13; Article 16; and abolishes the term "Quality Inspection Laboratory" in Clause 1 of Article 19, Clause 1 of Article 14, and Clauses 1 and 2 of Article 15 of Circular No. 32/2010/TT-BNNPTNT on designation and management of sampling personnel, quality inspectors, testing laboratories, organizations certifying crop seed and fertilizer quality; the Regulation on Evaluation and Designation of Animal Feed Testing Laboratories issued by Decision No. 187/QĐ-CN-TACN dated October 31, 2008 of the Director of the Livestock Production Department; Circular No. 08/2011/TT-BNNPTNT dated February 14, 2011 on procedures and formalities for evaluating and recognizing aquatic disease diagnosis and testing laboratories.

3. During the implementation of this Circular, if there are difficulties or obstacles, organizations and individuals shall report to the Ministry of Agriculture and Rural Development for consideration, revision, and supplementation./.