Circular No. 09/2009/TT-BKHCN guiding the requirements, procedures, and formalities for designating conformity assessment organizations

 CIRCULAR

GUIDELINES ON REQUIREMENTS, PROCEDURES, AND PROCEDURES FOR DESIGNATING ORGANIZATIONS TO CONDUCT COMPLIANCE ASSESSMENTS

On the basis of The Law on Product and Commodity Quality dated November 21, 2007;
Decree No. Decree No. 28/2008/NĐ-CP dated March 14, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology,
Decree No. Decree No. 132/2008/ND-CP dated December 31, 2008 of the Government detailing implementation of certain provisions of Law on Product Quality;
The Ministry of Science and Technology guides uniformly on requirements, procedures, and formalities for designating organizations to assess conformity as follows:

This technical regulation sets out technical requirements, testing methods, sampling procedures; management requirements; responsibilities of organizations and individuals producing, trading, and importing cigarettes.

Thông tư này quy định chi tiết khoản 4 Điều 38 Luật Thủy sản số 18/2017/QH14 đã được sửa đổi, bổ sung tại điểm c khoản 21 Điều 14 Luật số 146/2025/QH15.

1.2. This Circular does not apply to metrological verification activities of measuring instruments listed in the mandatory verification list under the Law on Measurement.

1.3. In cases where international treaties, agreements, or mutual recognition arrangements between Vietnam and other countries or territories concerning the recognition of compliance assessment results of designated organizations have different provisions from this Circular, the provisions of such international treaties, agreements, or arrangements shall be applied.

1.3. In cases where international treaties, agreements, or mutual recognition arrangements between Vietnam and relevant countries or territories concerning the recognition of assessment results from designated conformity assessment organizations have provisions different from this Circular, such provisions shall be applied.

Thông tư này áp dụng đối với tổ chức, cá nhân có liên quan đến hoạt động kinh doanh đối tượng thủy sản nuôi chủ lực trên lãnh thổ Việt Nam.

This Circular applies to:

2.1. State agencies with authority as specified in Clause 1, Section III of this Circular, related to testing, inspection, examination, certification activities to determine conformity with corresponding technical regulations;

2.3. Organizations and individuals producing, trading products, goods, processes, environments that require testing, inspection, verification, certification for compliance with corresponding technical regulations.

2.3. Organizations and individuals engaged in production and business that have products, goods, processes, or environments requiring testing, inspection, examination, certification to conform to corresponding technical regulations.

In this Circular, terms related to verification, recognition of compliance assessment results, and designated compliance assessment organizations are applied according to the provisions of Article 3 of the Product Quality Law.

In this Circular, terms relating to examination, recognition of assessment results, and designated conformity assessment organizations are applied according to the provisions of Article 3 of the Law on Product and Goods Quality.

4.1. The designation of compliance assessment organizations by state agencies with competent authority is based on the assessment of the organization's capacity to conduct compliance assessment activities in accordance with the requirements of corresponding technical regulations and other relevant legal requirements.

4.1. The designation of conformity assessment organizations by state agencies with authority is based on the assessment of their capability to perform conformity assessment activities in accordance with the requirements of corresponding technical regulations and other relevant requirements under the law.

4.2. The assessment results of conformity assessment organizations in the designated field will be utilized by state agencies with authority during the process of inspecting and supervising product and goods quality.

1. Requirements for designated compliance assessment organizations

1.1. For certification organizations

Certification organizations must meet the following requirements:

1.1.1. Have registered their scope of certification activities at the Ministry of Science and Technology according to Circular No. 08/2009/TT-BKHCN dated April 8, 2009, issued by the Minister of Science and Technology, guiding on requirements, procedures, and procedures for registering the scope of compliance assessment activities;

1.1.1. Have registered the field of certification activity at the Ministry of Science and Technology in accordance with Circular No. 08/2009/TT-BKHCN dated April 8, 2009, guiding the requirements, procedures, and formalities for registering fields of conformity assessment activities issued by the Minister of Science and Technology.

1.1.2. Have at least three full-time staff members (civil servants or employees with contracts of at least twelve months or indefinite-term contracts) who are experts in assessment, having a university degree or higher and expertise relevant to the corresponding certification of products, goods, processes, or environments, and at least three years of work experience.

1.2. For testing organizations, inspection organizations, and verification organizations

1.2.1. General requirements:

Testing organizations, inspection organizations, and verification organizations must meet the specific requirements as follows:

1.2.1.1. Have registered their scope of testing, inspection, and verification activities at the relevant sectoral management ministry or agency according to Circular No. 08/2009/TT-BKHCN dated April 8, 2009, issued by the Minister of Science and Technology, guiding on requirements, procedures, and procedures for registering the scope of compliance assessment activities;

1.2.1.1. Have registered the field of testing, inspection, examination activity at the sector management agency in accordance with Circular No. 08/2009/TT-BKHCN dated April 8, 2009, guiding the requirements, procedures, and formalities for registering fields of conformity assessment activities issued by the Minister of Science and Technology.

1.2.1.2. In each specialized field, have at least two technical staff members with qualifications suitable for testing, inspection, examination activities of corresponding products or goods and at least three years of work experience.

1.2.2. Other requirements:

Compliance assessment organizations, in addition to meeting general requirements,

Conformity assessment organizations, in addition to meeting general requirements, must also meet specific industry requirements stipulated by sector management ministries, provincial people's committees, and municipal people's committees directly under the central government.

1.3. Conformity assessment organizations holding certificates of recognition issued by legitimate accreditation bodies in Vietnam or foreign accreditation bodies that are members of international and regional mutual recognition agreements will be given priority consideration and designation.

2.1. When a conformity assessment organization wishes to participate in testing, inspection, examination, certification activities serving state management in a specific field, it must prepare an application and submit it to the relevant agency as follows:

2.1.1. The competent authority shall be responsible for managing conformity assessment activities within the specialized fields of ministries and agencies in charge of industries and sectors in accordance with Clause 1 of Section III of this Circular.

2.1.2. The lead agency responsible for managing conformity assessment activities of provincial people's committees and municipal people's committees directly under the central government, as stipulated in Clause 1, Section III of this Circular.

2.2. The registration dossier shall include:

2.2.1. A conformity assessment designation registration form in accordance with Appendix I of this Circular;

2.2.2. A copy of the Certificate of Registration for Testing, Inspection, Calibration, and Certification Activities;

2.2.3. A list of testers, inspectors, examiners, and assessment experts meeting the requirements specified in Clause 1.2.1.2 of this Section, in the format prescribed in Appendix II of this Circular;

2.2.4. A list of technical documents, standards, and testing, inspection, examination, certification procedures corresponding to the products, goods, processes, or environments registered for designation, in the format prescribed in Appendix III of this Circular;

2.2.5. Samples of Test Result Certificates, Inspection Certificates, Calibration Certificates, and Certificates;

2.2.6. Documents proving compliance with other requirements stipulated in Point 1.2.2 of Clause 1 of this Section (if applicable);

2.2.7. Accreditation certificates for testing, inspection, calibration, and certification capabilities issued by accreditation organizations as stipulated in Point 1.3 of Clause 1 of this Section (if applicable);

2.2.8. Results of testing, inspection, calibration, and certification activities conducted in the registered field during the most recent year (if applicable).

2.3. Within thirty working days from the date of receipt of complete and valid applications, the lead agency will review the applications, conduct practical capability assessments at the premises if necessary, and issue a decision on the designation of conformity assessment organizations in the format prescribed in Appendix IV of this Circular. The validity period of the designation decision shall not exceed three years.

In case of refusal to designate, the competent authority must notify the reasons for refusal in writing to the conformity assessment organization.

2.4. Three months before the designation decision expires, if there is a need, the conformity assessment organization must reapply for designation in accordance with Point 2.2, Clause 2 of this Section.

2.5. If a designated conformity assessment organization needs to change or supplement its scope or field of designation, it must follow the procedures for changing or supplementing registration (new registration) as stipulated in Point 2.2, Clause 2 of this Section.

III. RESPONSIBILITIES OF THE MANAGEMENT AUTHORITY AND DESIGNATED CONFORMITY ASSESSMENT ORGANIZATIONS

1. Responsibilities of the management authority

1.1. Responsibilities of ministries managing sectors and provincial people's committees and municipal people's committees directly under the central government within their assigned management areas include:

1.1.1. Directing and managing conformity assessment activities in accordance with this Circular;

1.1.2. Designate lead agencies responsible for managing the designation of conformity assessment organizations; notify the list of designated lead agencies to relevant organizations, individuals, and the Ministry of Science and Technology (General Department of Standardization, Metrology, and Quality Control) for coordination.

1.2. The Ministry of Science and Technology designates the following organizations as competent authorities:

1.2.1. The General Department of Standardization, Metrology, and Quality Control is the lead agency responsible for receiving and processing applications for designation and issuing decisions on the designation of conformity assessment organizations for products, goods, processes, or environments regulated by technical regulations issued by the Ministry of Science and Technology (excluding products related to nuclear radiation safety).

1.2.2. The Radiation and Nuclear Safety Agency shall be the central agency responsible for receiving, processing registration files, and issuing designation decisions for products related to nuclear radiation safety as specified in national technical standards issued by the Ministry of Science and Technology.

1.3. Responsibilities of the designated competent authority

1.3.1. Receive, process registration files for designation and issue designation decisions for conformity assessment organizations in the fields of products, goods, processes, and environments as specified in corresponding technical standards issued by the relevant ministries, sectors, provincial People's Committees, and municipal People's Committees under the Central Government.

1.3.2. Announce on mass media the list of designated conformity assessment organizations so that organizations and individuals can be informed, while simultaneously reporting to the Ministry of Science and Technology (General Department of Standardization, Metrology, and Quality Control) for coordinated management.

1.3.3. Manage and inspect the activities of designated conformity assessment organizations. Apply warning measures, suspend the effectiveness of the designation decision, or revoke the designation decision when a conformity assessment organization violates the provisions of this Circular or Article 20 of the Product and Goods Quality Law. Announce on mass media the name of the designated conformity assessment organization that has been suspended or had its designation decision revoked, while simultaneously reporting to the Ministry of Science and Technology (General Department of Standardization, Metrology, and Quality Control) for coordinated management.

1.3.4. Summarize the situation of designated conformity assessment activities and report quarterly or at any time upon request to the relevant ministries, sectors, provincial People's Committees, and municipal People's Committees under the Central Government, and the Ministry of Science and Technology (General Department of Standardization, Metrology, and Quality Control).

2.1. Perform rights and obligations as stipulated in Articles 19 and 20 of the Product and Goods Quality Law. In case of violation of the provisions of this Circular or Article 20 of the Product and Goods Quality Law, depending on the nature and severity of the violation, they will be warned, have their designation decision temporarily suspended, or have their designation decision revoked.

As for designated testing organizations, within the validity period of the designation decision, they must participate in a proficiency testing program and a once-only inter-laboratory comparison program.

2.2. Report periodically every six months or at any time upon request, the results of conformity assessment activities that have been designated according to the form prescribed in Appendix V of this Circular to the central agency that designated the conformity assessment organization for consolidation.

2.3. Notify the agency issuing the designation decision of any changes affecting the testing, inspection, certification, and conformity assessment capabilities registered within fifteen days from the date of change.

IV. IMPLEMENTATION

1. The Ministry of Science and Technology assigns the General Department of Standardization, Metrology, and Quality Control to organize the implementation of this Circular. Periodically, the General Department of Standardization, Metrology, and Quality Control reports to the Ministry of Science and Technology on the designation work and the operational status of designated conformity assessment organizations.

2. Relevant ministries, sectors, and provincial People's Committees, and municipal People's Committees under the Central Government are responsible for guiding the specific implementation of this Circular in their respective areas of management.

3. For inspection organizations established by relevant ministries and sectors to conduct quality inspections of products and goods within their assigned scope, management shall be carried out in accordance with the regulations of the relevant ministries and sectors.

4. Competent state management agencies shall carry out inspection and supervision activities in conformity assessment operations as stipulated in this Circular and current relevant regulations. If there is a violation, depending on the nature and severity of the violation, it will be handled according to the law.

5. This Circular shall take effect forty-five days from the date of issuance and shall replace the provisions regarding the registration of conformity assessment activities in Articles 12 and 13 of the Regulation on Conformity Assessment and Declaration of Conformity issued together with Decision No. 24/2007/QĐ-BKHCN dated September 28, 2007, of the Minister of Science and Technology.

6. For inspection organizations designated before this Circular takes effect, they may continue to operate until the expiration of the validity period specified in the designation decision.

7. During the implementation process, if there are any difficulties, agencies and organizations should promptly reflect them to the Ministry of Science and Technology (National Standardization Agency) for consideration and resolution./.

 

ANNEX I

MODEL APPLICATION FOR DESIGNATION OF CONFORMITY ASSESSMENT ACTIVITIES
(Issued together with Circular No.: 09/2009/TT-BKHCN dated April 8, 2009 of the Minister of Science and Technology)

SOCIALIST REPUBLIC OF VIET NAM
Independence – Freedom – Happiness
-------------------

..., day ..., month ..., year ....

 

APPLICATION FOR DESIGNATION OF CONFORMITY ASSESSMENT ACTIVITIES

Respectfully submitted to: ...(name of the central agency designated by the competent state authority)

1. Name of Organization:...

2. Contact Address: …

Telephone: ... Fax: ... E-mail: ...

3. Establishment Decision (if applicable)/Business Registration Certificate/Investment Permit number ... Issuing Authority: ... issued on ... at ...

4. Attached Documents:

- ...............

- ...............

5. After studying the conditions for conformity assessment activities as stipulated in Decree No. 132/2008/NĐ-CP dated December 31, 2008, of the Government detailing the implementation of certain articles of the Product and Goods Quality Law; Circular No. 09/2009/TT-BKHCN dated April 8, 2009, of the Minister of Science and Technology guiding requirements, procedures, and formalities for designating conformity assessment organizations; and guidance documents of ...(name of the sectoral or field-specific ministry) on testing/inspection/certification conditions and capability conditions as specified in technical standards, we find that we meet all the conditions to be designated to perform testing/inspection/certification activities in the fields of products, goods, processes, and environments (specify the names of products, goods, processes, environments, and corresponding technical standards).

We request (name of the central agency designated by the competent state authority) to consider and designate (name of the organization) to conduct testing/inspection/certification activities in the corresponding fields and objects.

We commit to fully comply with national regulations in the designated conformity assessment field and take responsibility for the declarations made above./.

 

 

ANNEX II

MODEL LIST OF STAFF AND EXPERTS OF THE CONFORMITY ASSESSMENT ORGANIZATION APPLYING FOR DESIGNATION
(Issued together with Circular No.: 09/2009/TT-BKHCN dated April 8, 2009 of the Minister of Science and Technology)

 

NAME OF THE ORGANIZATION:…

LIST OF STAFF/EXPERTS OF THE CONFORMITY ASSESSMENT ORGANIZATION REGISTERING DESIGNATION FOR TESTING/INSPECTION/CERTIFICATION

 

 

Note: Register the field of activity being applied for designation

 

ANNEX III

MODEL LIST OF DOCUMENTS SUPPORTING CONFORMITY ASSESSMENT
(Issued together with Circular No.: 09/2009/TT-BKHCN dated April 8, 2009 of the Minister of Science and Technology)

NAME OF THE ORGANIZATION:…

LIST OF DOCUMENTS

SUPPORTING TESTING/INSPECTION/EXAMINATION/CERTIFICATION

 

 

Note: Register the field of activity being applied for designation

 

ANNEX IV

MODEL DECISION ON DESIGNATION OF CONFORMITY ASSESSMENT ORGANIZATION
(Issued together with Circular No.: 09/2009/TT-BKHCN dated April 8, 2009 of the Minister of Science and Technology)

 

Pursuant to …;

Regarding the designation of conformity assessment organizations

... (Position of the person signing the decision) ...
... (Name of the central agency designated by the competent state authority)

Pursuant to the Law on Product Quality and Commodities dated November 21, 2007;

Based on Decree/Decision No. ... specifying the functions, tasks, powers, and organizational structure of ...(Name of the competent agency designated by the competent state authority)

Pursuant to Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing the implementation of certain provisions of the Law on Product Quality and Goods;

Pursuant to Circular No. 09/2009/TT-BKHCN dated April 8, 2009 of the Minister of Science and Technology guiding requirements, procedures, and formalities for designating conformity assessment organizations;

Based on Circular/Decision No. ... dated ... month ... year 2009 of ...(name of the sectoral or field-specific ministry) providing detailed conditions for testing/inspection/examination/certification activities and capacity conditions specified in technical standards (if any);

At the proposal of ...(name of the unit under the central agency tasked with reviewing registration designation files),

DECISION:

Article 1. Designate ...(name of the conformity assessment organization) belonging to ...(name of the parent organization, if any), address ... to conduct testing/inspection/certification ...(name of the designated product, goods, process, environment field) in accordance with technical standards ...name of the technical standard, number).

Article 2. The effective term of this Decision is three years, from the date of signature.

Article 3. This shall record the responsibility of the conformity assessment body designated. (Example: Organization .... shall be responsible for conducting conformity assessment activities to serve state management when required and must comply with the regulations and guidance of the competent state agency).

The organizations mentioned in Article 1 and relevant agencies and organizations are responsible for implementing this Decision./.

 

 

ANNEX V

MODEL REPORT ON THE STATUS OF CONFORMITY ASSESSMENT ACTIVITIES
(Issued together with Circular No.: 09/2009/TT-BKHCN dated April 8, 2009 of the Minister of Science and Technology)

………, day …….month…..year 200…..

REPORT

STATUS OF CONFORMITY ASSESSMENT ACTIVITIES

(From day…/…./200… to day ……/…./200….)

 

 

1. Name of the conformity assessment body:…

3. Telephone: …;   Fax: …; Email: …

3. Telephone: …Fax: …Email:…

4. Status of activities

…………..(name of the conformity assessment organization) report on the operation of the designated conformity assessment activities from day …/…./200… to day ……/…./200…. as follows:

a) Testing/surveying/calibration/certification activities during the reporting period:

- Field of specialization

- Quantity and content of work that has been assessed for conformity

- ….

b) Units with testing/surveying/calibration/certification certificates revoked or expired (if any) during the reporting period

5. Recommendations and proposals (if any)

………(name of the conformity assessment organization) report to (name of the competent agency designated by the competent state authority) and the General Department of Standards and Quality are hereby notified./.