Consolidated Document number 12/VBHN-BKHCN guiding the requirements, procedures, and formalities for designating conformity assessment organizations.

MINISTRY OF SCIENCE AND TECHNOLOGY TECHNOLOGY	SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom - Happiness ---------------
Number: 12/VBHN-BKHCN	Hanoi, February 27, 2015

CIRCULAR

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

Circular No. 09/2009/TT-BKHCN dated April 8, 2009, issued by the Minister of Science and Technology, guiding on requirements, procedures, and procedures for designating organizations to conduct compliance assessments, took effect from May 23, 2009, and was amended and supplemented by:

Circular No. 11/2011/TT-BKHCN dated June 30, 2011, issued by the Minister of Science and Technology, amending and supplementing certain provisions of Circular No. 09/2009/TT-BKHCN dated April 8, 2009, issued by the Minister of Science and Technology, guiding on requirements, procedures, and procedures for designating organizations to conduct compliance assessments, took effect from August 20, 2011.

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

Pursuant to 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;

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

The Ministry of Science and Technology guides uniformly on requirements, procedures, and procedures for designating organizations to conduct compliance assessments as follows 1.1. This Circular guides on requirements, procedures, and procedures for designating organizations to conduct compliance assessments to perform evaluations according to corresponding technical regulations serving state management needs.: [1]

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.

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

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:

2.2. Domestic and foreign organizations conducting testing, inspection, verification, certification activities in Vietnam;

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

3. Terminology and Definitions

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.

4. General Principles

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.

4.2. The results of compliance assessments conducted by designated organizations will be utilized by state agencies with competent authority during product quality inspections and audits.

II. REQUIREMENTS, PROCEDURES, AND PROCEDURES FOR DESIGNATING ORGANIZATIONS TO CONDUCT COMPLIANCE ASSESSMENTS

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;

1.1.2. Have at least three full-time staff members (civil servants or employees with contracts of at least twelve months or indefinite-term contracts) with a university degree or higher and relevant expertise in the corresponding product, goods, process, or environmental certification activities, and at least three years of work experience;

1.1.3. Possess all necessary technical documents, standards, and certification procedures consistent with corresponding technical regulations.

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;

1.2.1.2. In each specialized field, have at least two technical staff members with relevant expertise in testing, inspection, and verification of corresponding products and goods, and at least three years of work experience;

1.2.1.3. Possess all necessary technical documents, standards, and testing, inspection, and verification procedures consistent with corresponding technical regulations.

1.2.2. Other requirements:

Compliance assessment organizations, in addition to meeting general requirements,

must also meet special industry-specific requirements stipulated by sectoral management ministries or agencies, provincial people's committees, and centrally governed city people's committees. 1.3. Compliance 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 agreement organizations will be given priority consideration and designation.

2. Procedures for Designating Compliance Assessment Organizations

When compliance assessment organizations wish to participate in testing, inspection, verification, and certification activities to serve state management in specific fields, they must prepare one set of registration documents and submit it to the relevant agency as follows.

2.1.[2] In cases where the application is submitted directly to the lead agency specified in Clause 1, Section III of Circular No. 09/2009/TT-BKHCN, original copies of the documents specified in Points 2.2.2 and 2.2.7, Clause 2, Section II, which have not been certified, must be provided for comparison. In cases where the application is sent by mail, the certification organization must submit certified copies of the documents specified in Points 2.2.2 and 2.2.7, Clause 2, Section II.

In the case where the application is submitted directly to the agency specified in Clause 1, Section III of Circular No. 09/2009/TT-BKHCN, the documents specified in Points 2.2.2 and 2.2.7 of Clause 2, Section II that have not been authenticated must be presented with the original for verification. In the case where the application is sent by post, the certifying organization must submit certified copies of the documents specified in Points 2.2.2 and 2.2.7 of Clause 2, Section II.

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 competent authority shall be responsible for managing conformity assessment activities of provincial People's Committees under the central government in accordance with Clause 1 of 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.[3] A list of testers, inspectors, calibrators, experts meeting the requirements specified in Subclauses 1.1.2 and 1.2.1.2 of Section II of Circular No. 09/2009/TT-BKHCN dated April 8, 2009, issued by the Ministry of Science and Technology guiding the requirements, procedures, and formalities for designating conformity assessment organizations (hereinafter referred to as Circular No. 09/2009/TT-BKHCN), in accordance with the model prescribed in Appendix II of said Circular;

2.2.4. A list of technical documents, standards, and testing, inspection, calibration, and certification procedures corresponding to the products, goods, processes, and environments registered for designation in accordance with the model 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.[4] Within twenty working days from the date of receipt of a complete and valid application dossier, the competent authority shall examine the dossier, conduct an actual capability assessment at the facility (if necessary), and issue a decision on the designation of conformity assessment organizations in accordance with the model prescribed in Appendix IV of Circular No. 09/2009/TT-BKHCN. 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 designated conformity assessment organization must re-register according to the provisions of Point 2.2 of Clause 2 of this Section.

2.5. If the designated conformity assessment organization needs to change or supplement the scope or field of designation, it must follow the procedure for changing or supplementing the registration (new registration) as stipulated in Point 2.2 of 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 in charge of industries and sectors and provincial People's Committees within their assigned areas of management include:

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

1.1.2. Designating the competent authority responsible for managing the designation of conformity assessment organizations; notifying the list of designated competent authorities to relevant organizations, individuals, and the Ministry of Science and Technology (Standardization, Metrology, and Quality Control Administration) for coordination.

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

1.2.1. The Standardization, Metrology, and Quality Control Administration is the competent authority responsible for receiving, processing registration dossiers, and issuing decisions on the designation of conformity assessment organizations for products, goods, processes, and environments specified in technical regulations issued by the Ministry of Science and Technology (excluding products related to nuclear radiation safety).

1.2.2. The Radiation Safety and Nuclear Safety Administration is the competent authority responsible for receiving, processing registration dossiers, and issuing decisions on the designation of conformity assessment organizations for products related to nuclear radiation safety specified in national technical regulations issued by the Ministry of Science and Technology.

1.3. Responsibilities of the designated competent authority

1.3.1. Receiving, processing registration dossiers, and issuing decisions on the designation of conformity assessment organizations for products, goods, processes, and environments specified in technical regulations issued by the ministry in charge of the industry or sector, or by the provincial People's Committee.

1.3.2. Announcing in mass media the list of designated conformity assessment organizations so that organizations and individuals can be informed, while also notifying the Ministry of Science and Technology (Standardization, Metrology, and Quality Control Administration) for coordination in management.

1.3.3. Managing and inspecting the activities of designated conformity assessment organizations. Applying warning measures, suspending the effectiveness of the designation decision, or revoking the designation decision when a conformity assessment organization violates the provisions of this Circular or Article 20 of the Product Quality Law. Announcing in mass media the name of the designated conformity assessment organization whose designation decision has been suspended or revoked, and simultaneously notifying the Ministry of Science and Technology (Standardization, Metrology, and Quality Control Administration) for coordination in management.

1.3.4. Summarizing the situation of designated conformity assessment activities and reporting periodically every quarter or at any time upon request to the ministry in charge of the industry or sector, the provincial People's Committee, and the Ministry of Science and Technology (Standardization, Metrology, and Quality Control Administration).

2. Responsibilities of the designated conformity assessment organization

2.1. Implementing rights and obligations as prescribed in Articles 19 and 20 of the Product Quality Law. In case of violation of the provisions of this Circular or Article 20 of the Product Quality Law, depending on the nature and severity of the violation, they may be subject to warnings, suspension of the effectiveness of the designation decision, or revocation of the designation decision.

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.[5] Annually on a regular basis, or upon request, report the results of conformity assessment activities that have been designated according to the form prescribed in Appendix V of Circular No. 09/2009/TT-BKHCN to the competent authority that has designated the conformity assessment organization for consolidation.

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

IV. IMPLEMENTATION [6]

1. The Ministry of Science and Technology assigns the National Standardization Agency to implement this Circular. Annually, the National Standardization Agency reports to the Ministry of Science and Technology on the designation work and the operational status of designated conformity assessment organizations.

2. Ministries managing sectors and fields, People's Committees of provinces and centrally governed cities are responsible for guiding the implementation of this Circular in their respective areas of management.

3. For inspection organizations established by ministries managing sectors and fields to conduct product quality inspections within their assigned scope, management shall be carried out in accordance with the regulations of the corresponding sectoral or field-specific ministry.

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

5. This Circular takes effect forty-five days from the date of issuance and replaces the provisions on registration of conformity assessment activities in Articles 12 and 13 of the Regulations 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./.

Place of Receipt: - Minister (for reporting) - Office of the Government (for publication in the Official Gazette); - Official website of the Ministry of Science and Technology (for publication); - To be filed with: VT, TĐC, PC.

CERTIFIED CONSOLIDATED DOCUMENT DEPUTY MINISTER DEPUTY MINISTER Tran Viet Thanh

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 VIETNAM
Independence - Freedom - Happiness
----------------------

..., date..., month..., year...

APPLICATION FOR DESIGNATION OF CONFORMITY ASSESSMENT ACTIVITIES

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

1. Name of Organization:...

2. Contact Address: …

Telephone:...Fax: ...Email: ...

3. Decision on Establishment (if any)/Business Registration Certificate/Investment License No.:...Issuing Authority: ...issued on ...at ...

4. Attached Documents:

- .....

- .....

5. After reviewing the conditions for conformity assessment activities stipulated in Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing certain provisions of the Law on Product and Goods Quality; 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; guidance documents of ...( name of the sectoral or field-specific ministry) on testing/inspection/examination/certification conditions and capacity conditions specified in technical standards, we find that we meet all the conditions to be designated to perform testing/inspection/examination/certification activities in the fields of products, goods, processes, and environment (specify the names of products, goods, processes, environment, and corresponding technical standards).

Request (Name of the competent agency designated by the competent state authority) for consideration and designation (name of organization) to conduct testing/inspection/examination/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./.

Representative of the Organization... (Name, Signature, Stamp)

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 ORGANIZATION:...

LIST OF STAFF AND EXPERTS

OF THE CONFORMITY ASSESSMENT ORGANIZATION APPLYING FOR DESIGNATION FOR TESTING/INSPECTION/EXAMINATION/CERTIFICATION

Serial number	Full Name	Professional training certificate	Testing/Inspection/Examination training certificate	Work experience	Type of labor contract signed	Remarks
1
2
3
4
5
6
7
8
9
10
....
....

..., date..., month..., year... Representative of the Organization... (Name, Signature, Stamp)

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 ORGANIZATION:...

LIST OF DOCUMENTS
SUPPORTING TESTING/INSPECTION/EXAMINATION/CERTIFICATION

No.	Name of document	Code Number	Effective from	Issuing Authority	Remarks
1
2
3
4
5
6
7
8
9
10
....
....

..., date..., month..., year... Representative of the Organization... (Name, Signature, Stamp)

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)

(Name of the competent state authority) -------- (Name of the competent agency designated by the competent state authority)	SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom - Happiness ---------------
....( Decision No.)...	..., date..., month..., year...

Pursuant to …;

On the designation of conformity assessment organization

....(Position of the decision maker)

....(Name of the competent agency designated by the competent state authority)

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

Pursuant to Decree/Decision No...providing 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;

Pursuant to 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);

Based on the proposal of...( name of the unit under the competent agency tasked with examining the application for designation),

DECISION:

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

Article 2The validity period of this Decision is three years, from the date of signature.

Article 3. This shall record the responsibility of the conformity assessment body designated. (for example: The organization...is 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./.

Place of Receipt: - As above; - Name of the competent state authority designating the lead agency (for filing); - General Department of Standardization, Metrology and Quality Assurance (for information); - Name of related organization (for information); - To be filed VT,...

Position and name of the decision signer (Signature and stamp)

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)

(Name of the supervising agency) (Name of the conformity assessment body) ---------	SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom - Happiness ---------------
	..., day...... month ......... year 20...

REPORT

STATUS OF CONFORMITY ASSESSMENT ACTIVITIES

(From date.../.../ 20.. to date.../.../20...)

Respectfully submitted to:

- .........( name of the competent agency designated by the competent state authority) - General Department of Standardization, Metrology and Quality Assurance

1. Name of the conformity assessment body:…

2. Address:…

3. Telephone:…Fax:…Email:…

4. Status of activities

………..(name of the conformity assessment organization) report on the status of designated conformity assessment activities from date... /…/ 200... to date…/…/ 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

No.	Unit Name	Currency Exchange Agent No. 3 (indicate province/city name)	Field/Object	Name of technical regulation	Validity period of testing/surveying/calibration/certification certificate (indicate expiration year)	Remarks

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 Standardization, Metrology and Quality Assurance for information. /.

Organization conducting conformity assessment (Authorized representative's signature and seal)