✦ Tóm lược thông minh
Circular No. 55/2012/TT-BNNPTNT guides procedures for designating organizations to certify conformity and announcing conformity within the management scope of the Ministry of Agriculture and Rural Development, applicable to relevant agencies, organizations, and individuals. It provides detailed regulations on requirements for certification organizations, evaluation methods, registration files, announcement procedures, responsibilities of management agencies, and penalties for violations.
Đối tượng áp dụng
Agencies, organizations, and individuals related to activities of certifying conformity and announcing conformity for products, goods, services, processes, and environments within the management scope of the Ministry of Agriculture and Rural Development.
Các điểm cốt lõi
- Certification organizations must meet requirements regarding establishment, operational capacity, evaluation experts, technical documents, and testing laboratories (if available).
- Conformity assessment methods include eight different methods.
- The evaluation and designation authority includes the Fisheries General Department, Forestry General Department, Water Resources General Department, Quality Management Bureau of Agriculture and Forestry Products and Aquatic Products, etc.;
- The application file for designating a conformity certification organization includes various documents such as capability reports, expert lists, and technical documents.
- The designation decision is valid for three years, after which it must be re-evaluated. The decision will be suspended or revoked if the organization violates conditions.
- Conformity announcement is carried out through conformity assessment and registering the announcement at the Department of Agriculture and Rural Development.
🌐 Tác động xã hội từ văn bản này
- Establishes a legal basis for managing the quality of products, goods, and services in the agricultural and rural development sector.
- Reduces food safety risks through strict regulations on conformity certification.
- Dependence on certification organizations may impose financial burdens on businesses.
- Resources are needed to train and maintain the capabilities of evaluation experts.
❓ Câu hỏi thường gặp
Which organization is responsible for designating conformity certification organizations?
Evaluation and designation authorities such as the Fisheries General Department, Forestry General Department, Quality Management Bureau of Agriculture and Forestry Products and Aquatic Products, etc., are responsible for designating certification organizations.
What requirements must certification organizations meet?
Certification organizations must have functions in the certification field, operational systems and capacities meeting national or international standards, at least five evaluation experts, and related technical documents.
How many conformity assessment methods are there?
There are eight conformity assessment methods specified in this Circular.
For how long is the designation decision effective?
The designation decision is valid for three years, after which it must be re-evaluated.
When will a certification organization's designation decision be suspended or revoked?
A certification organization's designation decision will be suspended or revoked if it violates conditions, refuses supervision activities, or fails to comply with inspection and supervision requirements.
Toàn văn
CIRCULAR
Guidelines for Procedures to Designate Certification Bodies for Conformity Assessment and Declaration of Conformity
within the Scope of Management of the Ministry of Agriculture and Rural Development
______________________
Pursuant to 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;
Pursuant to the Law on Product Quality and Commodities adopted by the National Assembly on November 21, 2007 and Decree No. 132/2008/ND-CP dated December 31, 2008 of the Government detailing and guiding the implementation of certain provisions of the Law on Product Quality and Commodities;
Pursuant to the Law on Technical Standards and Regulations adopted by the National Assembly on June 29, 2006 and Decree No. 127/2007/ND-CP dated August 1, 2007 of the Government detailing and guiding the implementation of certain provisions of the Law on Technical Standards and Regulations;
Pursuant to the Food Safety Law No. 55/2010/QH12 adopted by the National Assembly on June 17, 2010;
Considering the proposal of the Director of the Department of Science, Technology and Environment;
The Minister of Agriculture and Rural Development issues this Circular to regulate procedures for designating certification bodies for conformity assessment and declaration of conformity for products, commodities, services, processes, and environments under the management scope of the Ministry of Agriculture and Rural Development.
PART I
GENERAL PROVISIONS
Article 1. Scope of Regulation
This Circular regulates procedures for designating certification bodies for conformity assessment and declaration of conformity for products, commodities, services, processes, and environments under the management scope of the Ministry of Agriculture and Rural Development.
Article 2. Applicability
This Circular applies to agencies, organizations, and individuals related to activities of conformity assessment certification and declaration of conformity for products, commodities, services, processes, and environments under the management scope of the Ministry of Agriculture and Rural Development.
Article 3. Nature of Conformity Assessment Certification and Declaration of Conformity
Conformity assessment certification and declaration of conformity are mandatory activities for organizations and individuals producing, trading in products, commodities, services, processes, and environments as prescribed in corresponding national technical regulations.
Article 4. Conformity Mark
3. The Conformity Mark may be enlarged or reduced but must maintain the correct ratio and be recognizable to the naked eye.
2. The conformity mark shall be displayed directly on the product, commodity, or on its packaging or label attached to the product, commodity at a visible and readable position, and simultaneously printed in accompanying technical documentation.
3. The conformity mark may be enlarged or reduced but must ensure the correct ratio and be recognizable to the naked eye.
4. The conformity mark must be displayed in the same color and be easily distinguishable.
Article 5. Methods of Conformity Assessment
1. Conformity assessment shall be carried out according to one of the following methods:
a) Method 1: Testing typical samples;
b) Method 2: Testing typical samples combined with production process evaluation and market surveillance through testing samples taken from the market;
c) Method 3: Testing typical samples combined with production process evaluation and market surveillance through testing samples taken from the production site combined with production process evaluation;
d) Method 4: Testing typical samples combined with production process evaluation and market surveillance through testing samples taken from the production site and the market combined with production process evaluation;
đ) Method 5: Testing typical samples combined with production process evaluation and market surveillance through testing samples taken from the production site or the market combined with production process evaluation;
e) Method 6: Combined evaluation and system management supervision;
g) Method 7: Testing and evaluating batches of products, commodities;
h) Method 8: Testing or inspecting entire products, commodities.
2. The contents, procedures, and principles for using these methods of conformity assessment are specified in Appendix 2 issued together with this Circular.
3. The method of conformity assessment applicable to specific types of products, commodities, services, processes, and environments is prescribed in corresponding technical standards.
Chapter II
EVALUATION, DESIGNATION OF CONFORMITY ASSESSMENT CERTIFICATION BODIES
Article 6. Requirements for certification organizations
Certification organizations designated must meet the following requirements:
1. The certification organization must be established in accordance with the provisions of the law and have the function of operating in the field of certification.
2. The management system and operational capacity of the certification organization must comply with the requirements stipulated in the National Standard TCVN 7457:2004 or the international standard ISO/IEC Guide 65:1996 and related guidelines of the International Accreditation Forum (IAF) for product certification activities; National Standard TCVN ISO/IEC 17021:2008 or international standard ISO/IEC 17021:2006 and related guidelines of the International Accreditation Forum (IAF) for management system certification activities.
3. The certification organization must have at least five full-time staff members (civil servants or employees under contracts of at least twelve months or indefinite-term contracts); at least three experts with three years of experience working in relevant fields registered for certification and meeting the following requirements:
a) Hold a bachelor's degree or higher in one of the relevant fields corresponding to the certification area;
b) Have evaluation capabilities that comply with the provisions in the National Standard TCVN ISO 19011:2003 or the international standard ISO 19011:2002 - Guidelines for quality management systems and/or environmental management systems assessment;
c) Be trained in management system certification evaluation, including HACCP, ISO 22000:2005 or equivalent.
4. The certification organization must have all technical documents, relevant technical standards, and procedures for conducting conformity certification activities.
5. In cases where testing activities are utilized, the certification organization must have a laboratory designated by the Ministry of Agriculture and Rural Development or must have a subcontracting agreement with laboratories designated by the Ministry of Agriculture and Rural Development.
Article 7. Forms of Evaluation of Certification Organizations
1. Initial designation evaluation:
Applies to the following situations:
a) A certification organization applying for initial registration and evaluation according to this Circular;
b) A certification organization that has been designated but had its designation decision revoked pursuant to Clause 2, Article 20 of this Circular.
2. Re-designation evaluation:
Applies to the following situations:
a) A certification organization that has undergone initial evaluation but does not yet meet the conditions for designation;
b) A certification organization that has been designated but whose designation decision has expired;
c) A certification organization that has been designated but has changed its quality management system or evaluation expert personnel not meeting the requirements stipulated in Clauses 2 and 3, Article 6 of this Circular;
d) A certification organization whose designation decision has been suspended pursuant to Point a, Clause 1, Article 19.
3. Expanded designation evaluation: applies to a certification organization that has been designated but subsequently registers for additional scope of certification evaluation and designation.
4. Surveillance evaluation:
a) Applied to a certification organization that has been designated to monitor the maintenance of the designated contents of the certification organization;
b) The frequency of surveillance evaluations is once per year.
5. Ad hoc evaluation:
Applies to the following situations:
a) When a certification organization shows signs of violation related to the designated scope of certification or when complaints are made by organizations or individuals;
b) When the conformity certification results of the certification organization are inconsistent with the inspection results of competent state authorities.
Article 8. Evaluation and Designation Authorities
1. The Fisheries General Department shall be the authority for evaluating and designating Certification Organizations regarding aquaculture certification; aquatic seed; feed, raw materials for feed production, additives, biological preparations, water quality for aquaculture; aquaculture environment, breeding areas, feed production and trading establishments, biological preparation establishments for aquaculture; fishing vessels, fish ports, fishing vessel repair facilities.
2. The Forestry General Department shall be the authority for evaluating and designating Certification Organizations regarding forestry planting seeds, processes, services, and forestry environments.
3. The Water Resources General Department shall be the authority for evaluating and designating Certification Organizations regarding the exploitation and protection of irrigation systems, clean water supply systems, dikes, flood prevention, dam safety management, and water conservation usage.
4. The Quality Management Bureau of Agricultural, Forest, and Aquatic Products shall be the authority for evaluating and designating Certification Organizations regarding agricultural, forest, and aquatic products; non-food agricultural and forest products imported for processing; domestically produced products before export or domestic consumption; conditions ensuring product quality and food hygiene safety for aquatic products.
5. The Processing and Marketing Bureau of Agricultural, Forest Products, and Salt Industry shall be the authority for evaluating and designating Certification Organizations regarding processes, services, and environments in salt production and product manufacturing; machinery and equipment in agriculture, additives, and chemicals used in forest product processing.
6. The Crop Production Bureau shall be the authority for evaluating and designating Certification Organizations regarding agricultural crop seeds, fertilizers, raw materials for fertilizer production, biological preparations for crop production; environments in crop production; conditions ensuring product quality and food hygiene safety for crop products.
7. The Plant Protection Bureau shall be the authority for evaluating and designating Certification Organizations regarding plant quarantine, plant protection chemicals and raw materials; production, processing, bottling, and packaging of plant protection chemicals, storage chemicals for agricultural and forest products.
8. The Livestock Production Bureau shall be the authority for evaluating and designating Certification Organizations regarding livestock farming seeds, livestock feed and raw materials, biological preparations for livestock farming; livestock feed production and trading; livestock farming facilities; environments in livestock farming production; conditions ensuring product quality and food hygiene safety for livestock products.
9. The Animal Health Bureau shall be the authority for evaluating and designating Certification Organizations regarding animal diseases, animal quarantine, veterinary drugs and raw materials, veterinary hygiene conditions, veterinary drug production and trading.
10. The Construction Project Management Bureau shall be the authority for evaluating and designating Certification Organizations regarding irrigation projects during investment preparation and construction phases.
11. The Science, Technology, and Environment Department shall be the authority for evaluating and designating Certification Organizations for activities within the scope managed by two or more evaluation and designation authorities as specified from Clause 1 to Clause 10 of this Article.
Article 9. Identification Number of Designated Certification Organizations
1. The Ministry of Agriculture and Rural Development shall uniformly issue and manage the identification number of designated Certification Organizations;
The Ministry of Agriculture and Rural Development (Science, Technology, and Environment Department) shall review and issue the identification number for Certification Organizations that have been evaluated and designated within five working days upon receipt of the report from the Evaluation and Designation Authority.
2. The identification number of designated Certification Organizations shall be issued at the time of initial evaluation and designation and stated in the Decision on Designation. This number shall not change in cases of re-designation or expansion of the scope of designation.
3. The provisions concerning the issuance of identification numbers to Certification Organizations are stipulated in Appendix 3 attached to this Circular.
Article 10. Fees for assessing Conformity Assessment Certification Organizations
1. The Evaluation Authority and Designation Authority shall collect fees in the following cases:
a) Initial assessment;
b) Reassessment;
c) Expanded assessment;
d) Surveillance assessment.
2. The collection of fees for assessing Conformity Assessment Certification Organizations shall be carried out in accordance with the current regulations of the Ministry of Finance.
Article 11. Registration Documents for Designating Conformity Assessment Certification Organizations
1. Initial Assessment
a) Application form (in accordance with Form 4 attached to this Circular).
b) Report on the organization's certification capability (in accordance with Form 5 attached to this Circular).
c) Certified copy of the Decision on Establishment or Business Registration Certificate or Investment License.
d) Certified copy of the Business Registration Certificate for the certification activity field issued by the Ministry of Science and Technology, or the Regulations on functions and tasks for public service units.
đ) List of assessors meeting the requirements stipulated in Clause 3, Article 6 of this Circular, in accordance with the model prescribed in Form 6 attached to this Circular, accompanied by certified copies of corresponding training certificates.
e) Catalogue of technical documents and other documents proving the organization's certification activity capability (in accordance with Form 7 attached to this Circular); description of the conformity assessment certification process conducted by the certification organization.
g) Sample Test Result Forms, Certificates.
2. Reassessment
a) Registration documents specified in Points a, b, e, Clause 1 of this Article;
b) In the case stipulated in Point a, Clause 2, Article 7 of this Circular, it is necessary to supplement a report on the results of implementing corrective actions for non-conformities of the Certification Organization;
c) In the case stipulated in Points b, c, Clause 2, Article 7 of this Circular, it is necessary to supplement registration documents specified in Point đ, Clause 1 of this Article.
3. Expanded Assessment
Registration documents specified in Points a, b, e, Clause 1 of this Article.
Article 12. Acceptance of Registration Documents
1. A Conformity Assessment Certification Organization that wishes to be designated, redesignated, or expanded designation shall submit one set of registration documents in accordance with Article 11 of this Circular to the Evaluation Authority and Designation Authority via postal service or direct submission (in the case of direct submission, the documents specified in Point c, d, Clause 1 of Article 11 of this Circular are photocopies and must be accompanied by original documents for verification).
2. Within three working days from the date of receipt of the registration documents, the Evaluation Authority and Designation Authority mentioned in Article 8 of this Circular shall examine the completeness of the documents and issue a written guidance to the Certification Organization to supplement missing or incorrectly provided contents.
Article 13. Formation of the Assessment Team
1. Within five working days from the date of receiving complete and valid registration documents from the Certification Organization, the Evaluation Authority and Designation Authority shall establish the Assessment Team. The Evaluation Authority and Designation Authority shall be responsible for sending the Decision on Establishing the Assessment Team to the Certification Organization fifteen days before conducting the assessment.
2. Composition of the Assessment Team:
a) For Certification Organizations registering activities in fields under the management of one Evaluation and Designation Authority as stipulated in Article 8 of this Circular, the team members consist of 3 to 5 representatives of the Evaluation and Designation Authority, experts, and at least one member of the team has a certificate in evaluation expertise;
b) For Certification Organizations registering activities in fields under the management of two or more Evaluation and Designation Authorities as stipulated in Article 10 of this Circular, the team members consist of 5 to 7 representatives of the Department of Science, Technology, and Environment; representatives of related specialized management authorities, experts, and at least one member of the team has a certificate in evaluation expertise.
3. The Decision on Establishing the Assessment Team includes the following main contents:
a) Names and positions of the team leader and team members;
b) Responsibilities of the Assessment Team members (as prescribed in Form 8 attached to this Circular);
c) Expected assessment date;
d) Scope, content, and form of assessment; responsibilities of the Certification Organization; personnel and document preparation requirements for working with the Assessment Team.
Article 14. Content and methods of evaluation
1. Content of Assessment
a) Compliance and suitability of the quality management system and certification conformity procedures and methods;
b) Human resources and physical facilities, equipment.
2. Methods of evaluation
a) Review of documents and interviews;
b) On-site evaluation (physical facilities, equipment);
c) Direct observation of the implementation of conformity certification by the Certification Body at the facility (if necessary).
Article 15. Procedure for conducting evaluation at the Certification Body
1. The evaluation team announces the Decision establishing the team, clearly stating the purpose and content of the evaluation.
2. The evaluation team conducts on-site evaluation:
a) Evaluation of conformity of the quality management system, certification conformity procedures, and human resources, physical facilities, and equipment of the Certification Body through document review, interviews, and on-site evaluation. In cases where the Certification Body has a certificate recognizing compliance with standard TCVN 7457:2004 issued by the accreditation organization, the scope recognized may be considered for a reduction in the conformity evaluation content (management requirements) of the quality management system. The evaluation team may also conduct direct observation of the implementation of conformity certification by the Certification Body at the facility if necessary (except in cases where the Certification Body has not been designated);
b) Guidance on determining the level of error during the evaluation process as specified in Appendix 9 attached to this Circular.
3. The evaluation team prepares the evaluation record and holds a final meeting. The evaluation record must meet the following requirements:
a) Prepared immediately after the completion of the evaluation at the headquarters of the Certification Body;
b) Fully and accurately reflects the evaluation results;
c) Clearly records non-conformities and deadlines for correction;
d) States the overall conclusion regarding the degree of compliance of the Certification Body;
e) Includes the opinion of the authorized representative of the Certification Body on the evaluation results and commitment to correct non-conformities;
f) Signed by the Head of the evaluation team, signed by the authorized representative of the Certification Body, and stamped by the Certification Body (if applicable). If the representative of the Certification Body does not agree to sign the evaluation record, the evaluation team must note that "The representative of the evaluated Certification Body did not sign the record and specify the reason why the representative of the Certification Body did not sign." This record still has legal validity when it bears the signatures of all participants in the evaluation;
g) Prepared in two copies: one copy retained by the Evaluation Agency and Designation Authority, one copy retained by the Certification Body.
Article 16. Submission of evaluation result report
Within five working days from the date of completion of the evaluation period, the Head of the team must submit to the Evaluation Agency and Designation Authority the evaluation result report and all related documents.
Article 17. Handling of evaluation results
1. Within ten working days from the date of receipt of the evaluation results, the Evaluation Agency and Designation Authority shall issue a Decision designating the Certification Body for conformity certification, if the Certification Body meets all conditions for designation, re-designation, expansion of the scope of designation, or notify the Certification Body in writing of the results if the Certification Bodies do not meet the conditions for designation, specifying non-conformities and deadlines for correction.
2. Model of the Decision designating the Certification Body for conformity certification, Decision changing and supplementing the field and object of conformity certification as stipulated in Appendices 10 and 11 attached to this Circular.
Article 18. Supervisory assessment, sudden assessment:
1. The assessment agency shall designate the conduct of supervisory assessments and sudden assessments in cases specified in Clauses 4 and 5 of Article 7 of this Circular.
2. Supervisory assessments and sudden assessments shall be carried out through the establishment of an Assessment Team in accordance with Clauses 2 and 3 of Article 13.
3. For supervisory assessment, the assessment plan must be notified to the Certification Organization at least 10 (ten) working days before the scheduled assessment date. For sudden assessment, the assessment plan must be announced at the opening meeting of the Assessment Team at the Certification Organization.
4. Within 10 working days from the date of receipt of the Assessment Team's assessment results, the assessment agency shall notify the assessment results in writing to the Certification Organization, specifying the non-compliant contents and the deadline for rectification or issuing a Decision to suspend or revoke the designation decision if the Certification Organization violates the provisions of Clauses 1 and 2 of Article 20 of this Circular.
Article 19. Effectiveness of the Designation Decision
1. The validity period of the Designation Decision for the Certification Organization is three (3) years.
2. Three (3) months before the expiration of the validity period of the Designation Decision, the Certification Organization must prepare and submit registration files to the assessment agency for re-assessment.
Article 20. Suspension or Revocation of the Designation Decision
1. The designation decision for the Certification Organization shall be suspended in the following cases:
a) The results of the supervisory assessment or sudden assessment conducted by the assessment agency show that the Certification Organization does not meet the conditions for designation or has not rectified the non-compliant contents identified in the previous assessment round;
b) The Certification Organization refuses to undergo supervisory assessment by the assessment agency for eighteen (18) months or more;
c) The Certification Organization fails to comply with inspection and supervision requirements as stipulated in Point i, Clause 2, Article 21 of this Circular;
d) The Certification Organization fails to fully implement reporting procedures as stipulated in Point n, Clause 2, Article 21 of this Circular.
2. The designation decision for the Certification Organization shall be revoked in the following cases:
a) The Certification Organization violates the designated scope;
b) The Certification Organization has been suspended from the designation decision but is still found to be conducting certification activities;
c) The Certification Organization falsifies or alters the content of the designation decision;
d) The Certification Organization is dissolved or ceases operations in the designated field;
đ) The Certification Organization commits other violations as determined by the Minister of Agriculture and Rural Development;
e) The Certification Organization fails to comply with supervisory assessment, inspection, supervision, and reporting activities after being suspended from the Designation Decision for six (6) months.
3. In case the Designation Decision for the Certification Organization is revoked, the certification results within the period from the last assessment to the revocation date will lose their validity.
Article 21. Rights and Obligations of the Certification Organization
1. Rights of the Certification Organization:
a) Conduct testing, appraisal, inspection, and quality certification of products, goods, services, processes, and environments based on contracts signed with organizations and individuals requesting conformity assessment in the registered fields and designated by competent state agencies;
b) Be entitled to charge fees agreed upon with production and business organizations requiring conformity certification or as prescribed by competent state agencies;
c) Issue conformity certification certificates valid for no more than three (3) years for products, goods, services, processes, and environments certified as conforming to relevant technical standards;
d) To grant and guide the use of the conformity mark to organizations or individuals whose products or goods have been certified for conformity;
đ) Issue new, renew, or expand conformity certifications;
e) Narrow the scope, temporarily suspend, or revoke conformity certification certificates and the right to use conformity marks when organizations or individuals whose products, goods, services, processes, and environments have been certified violate regulations on conformity certification;
g) Refuse to provide information related to testing, appraisal, inspection, and conformity certification results to third parties unless required by competent state agencies;
h) To be recognized by the competent state authority regarding the conformity assessment results according to the law.
2. Obligations of the Certification Organization:
a) To meet the requirements stipulated in Article 6 of this Circular;
b) Carry out conformity certification activities in the designated fields according to prescribed procedures and formalities. They may not refuse to provide services without justifiable reasons;
c) Ensure the procedures and formalities of conformity assessment as prescribed by law;
d) Based on the conformity assessment methods specified in relevant technical standards, establish specific conformity certification procedures and notify relevant authorities, organizations, and individuals;
đ) To keep confidential information, data, and conformity assessment results of the assessed organization, except when required by the competent state authority;
e) To ensure transparency, independence, objectivity, accuracy, and non-discrimination in the origin of goods and organizations or individuals in conformity certification activities;
g) Monitor entities that have been certified for conformity to ensure continued compliance with relevant technical standards;
h) Timely report to the competent management authority and widely announce on mass media about issuing new, renewing, expanding, narrowing the scope, or temporarily suspending, revoking conformity certification certificates and the right to use conformity marks;
i) To accept inspections and audits by the competent state authority regarding conformity certification activities;
k) Bear legal responsibility for the results and activities of conformity certification;
l) Compensate for damages arising from providing incorrect results to organizations and individuals requesting conformity certification in accordance with civil law regulations. Organizations and individuals whose products, goods, services, processes, and environments have been certified must prove the incorrect results and the fault of the conformity certification organization;
m) Notify the Management Authority of any changes affecting the registered conformity certification capacity within fifteen (15) days from the date of change;
n) Report periodically every six (6) months or at any time upon request, the results of conformity certification activities according to the model prescribed in Appendix 12 of this Circular to the Management Authority that has designated the conformity certification organization;
o) Pay evaluation fees as prescribed in Article 10 of this Circular.
Chapter III
DECLARATION OF COMPLIANCE WITH TECHNICAL REGULATIONS
Article 22. Procedures and formalities for declaring conformity
The announcement of compliance shall be carried out as follows:
1. Step 1: Assessment of conformity of the subject to be declared with technical standards.
a) The assessment of conformity may be conducted by a conformity assessment body designated for this purpose or by organizations and individuals declaring conformity themselves;
b) In cases where self-assessment of conformity is carried out, organizations and individuals must conduct testing at laboratories designated by the Ministry of Agriculture and Rural Development;
c) The results of the conformity assessment serve as the basis for organizations and individuals to declare conformity and comply with relevant regulations.
2. Step 2: Registering the declaration of conformity with the Department of Agriculture and Rural Development where the organization or individual has registered their production and business activities.
Article 23. Documents for registering declarations of conformity
1. Documents for declaring conformity based on the results of conformity assessment by a conformity assessment body:
a) A declaration of conformity according to the form prescribed in Appendix 13 of this Circular;
b) A certified copy of the certificate of conformity issued by the designated conformity assessment body certifying that the product, goods, service, process, and environment meet the corresponding technical standards;
c) A general description of the product, goods, service, process, and environment (characteristics, features, functions, purposes).
2. Documents for declaring conformity based on the results of self-assessment by organizations and individuals engaged in production and business activities:
a) A declaration of conformity according to the form prescribed in Appendix 13 of this Circular;
b) A general description of the product, goods, service, process, and environment (characteristics, features, functions, purposes);
c) Testing and calibration results (if applicable) conducted at designated laboratories;
d) Production processes and quality control plans established and implemented according to the form prescribed in Appendix 14 of this Circular or a certified copy of the ISO 9001:2008 standard certification if the organization or individual declaring conformity has a quality management system certified as compliant with the ISO 9001:2008 standard;
đ) Periodic monitoring plan;
e) A conformity assessment report including the following contents: the subject certified for conformity; (number, name) of technical documentation used as the basis for conformity certification; name and address of the organization conducting the conformity assessment; methods of conformity assessment used; description of the conformity assessment process (sampling, evaluation, duration of assessment) and necessary explanations (for example: reasons for selecting sampling/evaluation methods); assessment results (including deviations and acceptance levels); additional information.
Article 24. Registration of declarations of conformity
1. Organizations and individuals declaring conformity submit directly or through postal services one set of documents as stipulated in Article 23 of this Circular to the Department of Agriculture and Rural Development in the locality where they have registered their production and business activities for registration.
2. Within seven working days from the date of receipt of the declaration of conformity documents, if the documents are complete as required, the Department of Agriculture and Rural Development will notify in writing the organization or individual declaring conformity about the acceptance of the declaration according to the form prescribed in Appendix 15 attached to this Circular;
If the documents do not meet the requirements, within five working days, the Department of Agriculture and Rural Development will notify in writing the organization or individual declaring conformity about the non-compliant points and contents for improvement and resubmission for registration.
Article 25. Responsibilities of organizations and individuals publishing conformity declarations
1. Shall be responsible for the conformity of products and goods that have been published as conforming; maintain quality control, testing, and regular monitoring at the enterprise.
2. Use the conformity mark for products and goods that have been published as conforming according to the provisions of Article 4 of this Circular before putting them into circulation on the market.
3. When discovering non-conformity of products, goods, services, processes, and environments that have been published as conforming with corresponding technical standards during production, circulation, operation, and use, they must:
a) Timely notify relevant management agencies about the non-conformity;
b) Take corrective measures. If necessary, temporarily suspend production and business activities and proceed to withdraw non-conforming products and goods currently circulating on the market.
c) Notify relevant management agencies about the results of correcting the non-conformity before resuming production and business operations.
4. Retain the announcement of compliance documents as a basis for inspection and supervision by state management agencies.
5. Reannounce when there is any change in the content of the previously registered announcement of compliance.
Chapter IV
IMPLEMENTATION
Article 26. Responsibilities of management agencies
1. The Department of Science, Technology, and Environment shall be responsible for assisting the Minister of Agriculture and Rural Development in uniformly managing and guiding conformity certification and declaration activities according to the provisions of this Circular;
Assign code numbers to certification organizations that have been evaluated and designated.
2. The agency evaluating and designating certification organizations according to the provisions of Article 8 of this Circular shall be responsible for:
a) Compiling a list of areas and objects required to undergo conformity certification and declaration according to national technical standards within their management responsibility and announcing it through mass media and on their website;
b) Receiving registration files, evaluating, and designating certification organizations for areas under the management of the Ministry of Agriculture and Rural Development; establishing and publicly announcing on their website and appropriate communication channels the list of designated certification organizations for organizations and individuals to choose from;
c) Compiling a list of products, goods, services, processes, and environments that have been declared as conforming and certified as conforming under their management responsibility to report to the Ministry of Agriculture and Rural Development (Department of Science, Technology, and Environment) and announce on their website;
Directing and managing conformity certification and declaration activities in assigned areas; annually reporting to the Ministry of Agriculture and Rural Development on the situation of conformity certification and declaration activities.
3. Provincial Departments of Agriculture and Rural Development shall be responsible for:
a) Cooperating with specialized management General Directorates and Bureaus under the Ministry of Agriculture and Rural Development in urging and guiding the implementation of conformity certification and declaration activities according to the provisions of this Circular.
b) Receiving registration files, issuing announcements on receiving conformity declarations, maintaining records and managing declaration files according to the provisions of this Circular;
c) Annually, or at any time when requested, compiling and reporting to the Ministry of Agriculture and Rural Development on the situation of conformity declaration activities.
Article 27. Inspection, Audit, and Handling Violations
1. State management agencies with authority shall carry out inspection, audit, and handle violations of laws in conformity certification and declaration activities according to the provisions of the law on administrative penalties in the field of standards, measurement, and product quality, and other current relevant regulations.
2. Organizations and individuals violating the provisions on conformity certification and declaration, depending on the nature and degree of violation, will be handled according to current laws.
Chapter V
IMPLEMENTING PROVISIONS
Article 28. Effective Date
1. This Circular takes effect from December 15, 2012.
2. This Circular replaces Circular No. 83/2009/TT-BNNPTNT dated December 25, 2009, issued by the Minister of Agriculture and Rural Development guiding activities of conformity certification and declaration under the management of the Ministry of Agriculture and Rural Development; replaces the provisions on designation of certification organizations in Circular No. 32/2010/TT-BNNPTNT dated June 17, 2010, issued by the Minister of Agriculture and Rural Development on the designation and management of sampling personnel, testing personnel, testing laboratories, and quality certification organizations for crop seeds and fertilizers; and the provisions on designation of certification organizations in Article 5 of Circular No. 17/2011/TT-BNNPTNT dated April 6, 2011, issued by the Minister of Agriculture and Rural Development.
3. Certification organizations that have been designated by the Ministry of Agriculture and Rural Development according to Circulars No. 83/2009/TT-BNNPTNT dated December 25, 2009; No. 32/2010/TT-BNNPTNT dated June 17, 2010; and No. 17/2011/TT-BNNPTNT dated April 6, 2011, issued by the Minister of Agriculture and Rural Development before the effective date of this Circular shall retain their validity as recorded in the designation decision.
4. During the implementation of this Circular, if there are any difficulties, individuals and organizations are advised to reflect these issues to the Ministry of Agriculture and Rural Development for research and amendment./.
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Văn bản này có sẵn ở các ngôn ngữ sau:
Tiếng Việt
Thông tư số 55/2012/TT-BNNPTNT Hướng dẫn thủ tục chỉ định tổ chức chứng nhận hợp quy và công bố hợp quy thuộc phạm vi quản lý của Bộ Nông nghiệp và Phát triển nông thôn
한국어
시행규칙 제 55/2012/TT-BNNPTNT 농림수산부 관리 범위 내에서 합격 인증 기관 지정 절차와 합격 공표 절차에 관한 지침
中文
通知第55/2012/TT-BNNPTNT号关于农业和农村发展部管理范围内合格评定机构指定和合格评定公告程序的指导意见