Quyết định 116/2008/QD-BNN

DECISION

PROMULGATING THE REGULATION ON AUDIT AND DESIGNATION OF QUALITY LABORATORIES FOR AGRICULTURAL, FORESTRY, FISHERY PRODUCTS

MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT

Pursuant to the Law on Standards and Technical Regulation No.68/2006/QH11 passed by the XI National Assembly on 29/06/2006 and entered into force on January 01, 2007;
Pursuant to the Law on Products and Goods Quality No.05/2007/QH12 passed by XII National Assembly on 21/11/2007 and entered into force from July 01, 2008;
Pursuant to the Ordinance on Food Hygiene and Safety; and Decree No.163/2004/ND-CP of September 07, 2004 of the Government detailing the implementation of some Articles of the Ordinance on Food Hygiene and Safety;
Pursuant to Decree No.01/2008/ND-CP of January 03, 2008 of Government defining the functions, tasks, powers and organizational structure of The Ministry Of Agriculture and Rural Development;
At the Proposal of the Director of National Agro-Forestry-Fisheries Quality Assurance Department,

DECIDES:

Article 1. Issuing together with this Decision is “the Regulation on audit and designation of quality laboratories for agricultural, forestry, fishery products”.

Article 2. This Decision takes effect 15 days after its publication on Official Gazette

Article 3. Head of Ministry's Office, Director of the National Agro-Forestry-Fisheries Quality Assurance Department, Heads of the agencies under the Ministry, the Directors of Agriculture and Rural Development Departments of the provinces and cities under central authority shall implement this decision./.

REGULATION

ON AUDIT AND DESIGNATION OF QUALITY LABORATORIES FOR AGRICULTURAL, FORESTRY, FISHERY PRODUCTS
(promulgated by the Decision No. 116/2008/QD-BNN dated 03 December 2008 by the Minister of Agriculture and Rural Development)

Chapter I

GENERAL PROVISIONS

Article 1. Scope and objects of application

1. This regulation prescribes the mode, procedure of laboratory audit and designation for criteria / groups of criteria related to food quality of agricultural, forestry and fishery products of animal origin (hereafter referred to as quality criteria) to serve official control on food quality and safety of the Ministry of Agriculture and Rural Development.

2. This Regulation applies to laboratories operated by relevant competent authorities, laboratory services, foreign individuals / organizations located in Vietnam and agro-forestry-fishery processors (hereafter referred to as laboratories), which perform analysis of quality criteria of agriculturak, forestry and fishery products.

3. List of quality criteria subject to audit and designation in compliance with this Regulation shall be promulgated by the Ministry of Agriculture and Rural Development in specific periods.

Article 2. Definition

For the purpose of this Regulation, the following definitions shall apply:

1. Proficiency testing means performance of testings in the homogenized samples by many laboratories under specific conditions to assess competence of testing performance by the laboratory.

2. Inter-laboratory comparisons mean assess quality of testing results performed by 02 or many laboratories by comparing testing results in the homogenized samples with mean value of measurement results of participating laboratories.

3. Laboratory audit means examination and assessment of conformity of quality management system and testing capability for each quality criteria in comparison with specific requirements or standards.

Article 3. Legal bases for audit

1. ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories or equivalent standards.

2. Regulation on requirements for the competence of quality laboratories for agricultural, forestry and fishery products promulgated by the Ministry of Agriculture and Rural Development.

3. Requirements of competent authorities relating to quality of agricultural, forestry and fishery products, requirements of competent authorities of importing countries relating to testing competence: laboratory quality assurance system, analyzing methods, limit of detection (LOD), limit of quantification (LOQ), minimum required performance limit (MRPL).

Article 4. Modes of audit

1. Initial audit shall be applied to:

a. Laboratories which apply at the first time for audit and designation in accordance with this Regulation.

b. Laboratories which had been designated but the designation decisions have been terminated in compliance with Clause 2, Article 18 of this Regulation.

2. Renewal shall be applied to:

a. Laboratories undergoing initial audit but incompetent to be designated.

b. Laboratories which have been audited and designated but designation decisions are no longer in force.

c. Laboratories which have been audited and designated but designation decisions are suspended in compliance with Clause 1, Article 18.

d. Laboratories which have been designated but moved to another place or changed structure, premise lay-out, equipments, analyzing methods which can affect testing conditions and results.

3. Extension audit shall be applied to laboratories which have been designated and additionally apply for audit of new parameters or extension of designation scope of designated parameters.

4. Surveillance audits shall be applied to designated laboratories. Surveillance audits are conducted according to the Plan built up by auditing body and sent to laboratories. Frequency of regular audits is once a year.

5. Unexpected audits shall be conducted on occurrence or suspicion of violations which may affect accuracy of testing results and without prior notice.

Article 5. Audit and designation body

1. Within the scope of this Regulation, laboratory auditing body is the National Agro-Forestry-Fisheries Quality Assurance Department.

2. Within the scope of this Regulation, laboratory designating body is the Ministry of Agriculture and Rural Development.

Article 6. Modes of designation

1. Based on audit report and request by the auditing body, designating body issues laboratory designation decisions enclosed with list of designated analysis.

2. Each designated laboratory has its own identification number in the first designation. Identification system is stipulated by the designating body and applied nation-wide.

Chapter II

AUDIT

Article 7. Application dossier

1. Initial audit

a. Application (Appendix 1. Form BNN-01);

b. Laboratory competency report (Appendix 2. From BNN-02);

c. Certificate of Accreditation to ISO/IEC 17025:2005 or equivalent document;

d. Proficiency testing reports relating to parameters applied for audit and designation (if available);

e. Other documents relating to legal status and business license.

2. Renewal audit

a. Application (Appendix 1. Form BNN-01);

b. Reports on corrective actions against non-conformities found by audit team in the audits stipulated in 2.a and 2.c of Article 4. Period of corrective actions is 60 days since previous audit.

3. Extension audit

Application dossiers include those as stipulated in 1.a, 1.c and 1.d of Clause 1 of this Article.

Article 8. Acknowledgement of application

1. Application dossiers as stipulated in Article 7 shall be submitted to the National Agro-Forestry-Fisheries Quality Assurance Department or its Branches in Hai Phong, Da Nang, Nha Trang, Hochiminh City, Can Tho and Ca Mau.

2. Within five (05) working days since receipt of application dossiers, auditing body shall assess the document’s adequacy and accuracy. Any significant omissions or deviations from the prescribed requirements intimated by the auditing body will have to be corrected by the applicant.

Article 9. Setting up audit team

1. Within ten (10) working days since receipt of completed application, Head of the auditing body shall issue the decision setting up the audit team, specifying modes of audit as stipulated in Articile 4.1, 4.2 and 4.3 and inform laboratory of audit plan.

2. Decision setting up the audit team shall specify audit scope, audit content, members of audit team and responsibilities of each member. Members of the audit team shall include professionals from the National Agro-Forestry-Fisheries Quality Assurance Department and another competent authorities and organizations (if necessary).

3. Members of the audit team include:

a. Team leader:

- Having professional knowledge and experience on auditing laboratory quality management system and analyzing management relating to quality criteria of agricultural, forestry and fishery products.

- Being trained on auditing skills.

b. Auditors:

- Having professional knowledge and experience on analyzing for quality criteria applied by the laboratory.

- Being trained on auditing skills.

Article 10. Audit content

1. Compliance and conformity of the laboratory quality management system with the regulation in force on requirements for the competence of quality laboratories for agricultural, forestry and fishery products. In case that the laboratory has been accredited to ISO/IEC 17025 or equivalent standards granted by accreditation bodies, audit content will be considered to decrease in the accredited fields and analyzing methods with the laboratoty’s request accompanied by verified duplicates of accreditation certificates.

2. Compliance of analyzing methods for quality criteria applied for designation with provisional regulation on requirements for laboratory competence for agricultural, forestry and fishery products and requirements of importing countries.

Article 11. Audit methods

1. During the audit, audit team shall apply the following methods:

a. Interviewing Head and staff of the laboratory.

b. Document check.

c. In-site inspection to premise layout, environment and facilities’ conditions, test performance and other test facilities.

d. Assessment of test performing competence, compliance of analyzing methods, test facilities, materials by observation during the test performance and examination of analyzing reports.

2. Audit checklist and audit instruction are elaborated by the auditing body.

Article 12. Audit report

1. Non-conformities observed during the audit shall be mentioned in the audit report (Appendix 3. Form BNN-03).

2. Audit report shall be announced at closing meeting. Audit report must include audit content and be signed be by laboratory representative and leader of audit team.

3. In the case that laboratory representative does not accept the audit report, any complaints shall be written at the end of the report with signature and seal. Audit report is still authentic without signature of laboratory representative.

Article 13. Submit audit report

Within three (03) working days since the audit, leader of audit team must submit to the auditing body the audit report as stipulated in Article 12.1, 12.2.

Article 14. Processing audit report

Within ten (10) working days since receipt of audit report, auditing body conducts verification of audit report and takes appropriate measures:

1. To laboratories which have not been designated or expiry of designation, initial, renewal and extension audit will be applied.

a. When audit results are satisfactory according to the provisional regulation on laboratory requirements of agricultural, forestry and fishery products, audit body submit application for designation to designating body in compliance with provisions of Article 16.

b. When criteria applied for designation do not meet the requirements according to the regulation in force, auditing body inform laboratory about audit results.

2. To designated laboratories, surveillance and unexpected audits will be applied.

a. When criteria applied for designation fully meet the requirements according to the regulation in force, auditing body submit application for designation maintenance.

b. When non-conformities are found, auditing body will execute Article 18.

Article 15. Verification

1. Verification shall be conducted in one of the following cases:

a. Auditing body and/or designating body have doubts about the audit result.

b. Laboratories complain to the auditing body about the audit result.

2. Auditing body issues Decision setting up verification team and conducts verification in compliance with the procedures in Articles 9, 10, 11, 12 and 13 of this Regulation in relation to the cases mentioned at points a and b of this Article.

3. Verification result will be the final legal base for laboratory designation.

Chapter III

DESIGNATION

Article 16. Designation of laboratory

1. Application document includes:

a. Application dossiers mentioned in Article 7 and audit report mentioned in Article 12 of this Regulation.

b. Verification report of audit report for laboratory designation as described in Article 14 of this Regulation.

2. Within five (5) days since receipt of completed application document, designating body shall issue Designation Decision and grant an identification number to the designated laboratory in compliance with the Article 6.2.

3. If necessary, designating body shall request auditing body to conduct verification according to Article 15 of this Regulation.

Article 17. Validity of designation

1. Validation of designation is three (3) years.

2. 3 months the validity of designation comes to an end, laboratory must apply for renewal audit.

Article 18. Suspension or withdrawal of designation

1. Based on non-conformities found in surveillance audit or unexpected audit or verification report, considering the requests of auditing body, designating body decides total or partial suspension of designation scope till non-conformities are corrected by the laboratory.

2. Withdrawal of designation applies to the following cases:

a. Laboratory’s violations relating to laboratory’s identification number or non-conformities beyond laboratory’s competence of corrective actions or overdue non-conformities.

b. Laboratory’s bankruptcy or no longer operation in designation scope.

c. During designation suspension, non-conformities are not corrected.

3. Based on audit report and considering the request of auditing body, designating body decides withdrawal of designation.

4. Designating body shall inform relevant competent authorities, agencies and food business operators about the designation suspension or withdrawal.

Chapter IV

AUDIT FEE

Article 19. Audit fee

1. Auditing body is allowed to collect fees for the following cases:

a. Initial audit;

b. Renewal audit;

c. Extension audit;

d. Surveillance audit;

đ. Verification audit as requested by laboratories (prescribed in the Article 15.1.b).

2. Audit fees shall be managed and used in compliance with regulations in force by the Ministry of Finance or contract if relevant regulations are not available.

Chapter V

RIGHTS AND RESPONSIBILITIES

Article 20. Designation body

1. To consistently manage laboratory audit and designation for quality of agricultural, forestry and fishery products nation-wide.

2. To require auditing body to conduct verification of audit results.

3. To issue laboratory designation decisions, suspension or withdrawal.

4. To deliver documents of laboratory designation to auditing body to keep as archives.

5. To periodically promulgate list of designated laboratories.

6. To promulgate list of audited and designated criteria for a specific periode.

Article 21. Audit body

1. To perform audit to laboratories applying for designation in co-ordination with other Departments of the Ministry of Agriculture and Rural Development.

2. To elaborate, publish audit checklist and guide the implementation of this Regulation.

3. To manage and supervise designated laboratories in audit mode and at frequency (surveillance and unexpected audits) in compliance with this Regulation.

4. To organize and guide application for participating in proficiency test or inter-laboratory comparison programs for designated laboratories.

5. To receive and deal with complaints by laboratories in accordance with the Article 25.2 of this Regulation.

6. To keep secret all information and data related to secrets of audited laboratories. To keep systematically all documents of audit and designation. To present, report adequately and accurately audit results on request by the Ministry of Agriculture and Rural Development.

7. To consistently manage, organize technical trainings for auditors. To guide and assist laboratories to fulfil the regulations in force.

8. To report to the Ministry of Agriculture and Rural Development on laboratory competences and activities and propose recommendations for improvement.

9. To require the affiliates and designated laboratories to i) report to the National Agro-Forestry-Fisheries Quality Assurance Department on laboratory competence and ii) create good conditions for inspection and surveillance of compliance with this Regulation and relevant legal documents.

10. To request for participation of specialized Department into audit team depending on respective specialized field if necessary.

11. To conduct inspection and impose sanction to relevant organizations and individuals violating this Regulation in compliance with Article 25 of this Regulation.

Article 22. Members of audit team

1. To assess compliance of laboratory to the standards and regulations in force.

2. To assure objectiveness of the audit.

3. To report to Leader of the auditing body for measures against cases beyond audit team’s jurisdiction.

4. To keep secret all information of audited laboratory.

5. To be authorized to interview, take notes, request for documents, data, performance and proofs relating to the audit.

Article 23. Applicants for audit and designation

1. To assure reliability and accuracy of testing results regarding to designated criteria.

2. To be designated to perform analysis of criteria within designation scope.

3. To print identification number granted by designating body in analysis reports regarding designated criteria.

4. To perform analysis of designated criteria for purpose of quality certification for agricultural, forestry and fishery products in compliance with relevant regulations in force, which does not apply to laboratories stipulated in Paragraph 5 of this Article.

5. Laboratories of food business operators are allowed to use testing results for own check, and responsible for analysis of quality criteria from raw materials to final products. Own check testing results will be considered for relaxed inspections according to relevant regulations in force.

6. To complain to auditing body about audit results.

7. To be given instructions for participation in proficiency tests.

8. To be subject to laboratory inspections and surveillance by internal and external inspection delegations by request of competent authorities of quality assurance for agricultural, forestry and fishery products.

9. To create good conditions for audit team during the audit.

10. To report to auditing body about changes relating to designation content (Appendix 5. Form BNN-05) within 10 days since the changes occur.

11. Designated laboratories must make semi-annual and annual reports to auditing body about their testing activities within designation scope.

12. To pay audit and designation fee.

Chapter VI

REWARDS, HANDLING OF VIOLATIONS AND DENUNCIATIONS

Article 24. Rewards

1. Organizations and individuals who have made a great contribution to the implementation of this Regulation shall be rewarded as regulated by Law on Emulation and Rewards.

2. Rewards policy for the mentioned organizations and individuals is done as regulated by the legislation.

Article 25. Sanction

1. Any organization or individual violating this Regulation shall be subject to administrative sanctions in compliance with the Decree of the government regarding handling of administrative violations in agriculture, forestry and fishery sector and other relevant legislation.

2. When any obstruction, opposition to auditing and designating bodies; violations of the Regulation cause serious damage, crimimal proceedings could be imposed as provided by law.

Article 26. Complaints and settlement of complaints

1. Organizations and individuals may complain about and denounce acts violating the provisions of this Regulation according to the provisions of the Law on complaints and denunciations.

2. Auditing and designating bodies shall settle complaints and denunciations relating to audit and designation of quality laboratory for agricultural, forestry, fishery products in the competence, procedures and time limits.

Chapter VII

EXECUTIVE PROVISIONS

Article 27. Amendment

1. All difficulties in implementation of this Regulation should be submitted to auditing body and the Ministry of Agriculture and Rural Development for settlement.

2. The amendment of this Regulation shall be decided by the Minister of Agriculture and Rural Development.

APPENDIX 1

FORM BNN-01

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------------------

Place…………, date … … …

APPLICATION FOR AUDIT AND DESIGNATION

OF QUALITY LABORATORY FOR AGRICULTURAL, FORESTRY AND FISHERY PRODUCTS

ATTN: The National Agro-Forestry-Fishery Quality Assurance Department

1. Name of laboratory supervisor:

Address:

Telephone:

Fax:

2. Name of laboratory:

Address:

Telephone:

Fax:

3. Expected mode of audit:

Initial audit                 Renewal audit                        Expension audit

4. Analyzing method applied for audit and designation:

a. Scope of audit and designation:

b. List of criteria applied for designation:

c. List of analysts performing analysis of criteria applied for designation:

5. We commit to comply with the Regulation on audit and designation of quality laboratory for agricultural, forestry and fishery products by the Ministry of Agriculture and Rural Development.

6. The laboratory will be available for audit on (date) .......

APPENDIX 2

FORM BNN-02

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
--------------------------

Place…………, date … … …

REPORT ON LABORATORY CAPABILITY

1. Name of laboratory supervisor:

Address:

Telephone:

Fax:

2. Name of laboratory:

Address:

Telephone:

Fax:

3. Name and title of laboratory manager:

4. List of analysts:

5. Equipments

5.1. Main equipments

5.2. Other equipment

6. Laboratory space and environment.

6.1. Laboratory layout and surface (m2) of each laboratory

6.2. Working environment

- Laboratory layout, cross-contamination possibility;

- Temperature, humidity recording;

- Ventilation system (for release of heat and toxic gas);

- Other conditions (anti-vibration, prevention of dust, anti-noise, light, radioactivity…)

We commit to comply with the Regulation on audit and designation of quality laboratory for agricultural, forestry and fishery products by the Ministry of Agriculture and Rural Development.

6.3. Conditions of labour safety

7. List of performed analysis

APPENDIX 3

FORM BNN-03

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
------------------------

LABORATORY AUDIT REPORT

1. Laboratory correspondance:

2. Observed non-conformities:

Laboratory’s feedback

The report is made in 2 copies being equally authentic: 01 for each.

APPENDIX 4

FORM BNN-04

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
-----------------------------

Place……, date……

RECOMMENDATION BY AUDIT TEAM

ATTN: (Auditing body).....................................................................................

Based on laboratory audit report made on (date) ……….. .

1. Laboratory correspondance:

2. Recommendations

2.1. General

2.2. Auditing body is invited to examine audit report and submit to designating body for designation of the following analyzing methods:

APPENDIX 5

FORM BNN-05

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
----------------------------

Place…………, date … … …

REPORT ON LABORATORY’S CHANGES

1. Name of laboratory supervisor:

Address:

Telephone:

2. Name of laboratory:

Address:

Telephone:

Fax:

3. Name and title of laboratory manager:

4. Changes: