Circular No. 08/2009/TT-BKHCN guiding the requirements, procedures, and processes for registering the field of conformity assessment activities.

CIRCULAR

GUIDELINES ON REQUIREMENTS, PROCEDURES, AND REGULATIONS FOR REGISTERING THE FIELD OF COMPATIBILITY ASSESSMENT ACTIVITIES

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 the requirements, procedures, and regulations for registering the field of compatibility assessment activities 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.

This Circular applies to units under the Ministry of Education and Training; departments of education and training, education and training divisions; preschool education institutions, general education institutions, regular education institutions, teacher training colleges, college of education, universities, universities, academies, other educational institutions, and related organizations and individuals (hereinafter referred to collectively as agencies and units).

1.1. This Circular guides on the requirements, procedures, and regulations for registering the field of activity of organizations providing compatibility assessment services including testing, inspection, examination, and certification.

1.2. This Circular applies to organizations providing compatibility assessment services and relevant state management agencies related to compatibility assessment activities.

1.3. This Circular does not apply to the following activities:

1.3.1. Examination of measuring instruments listed in the catalog of measuring instruments required to be examined under the law on measurement;

1.3.2. Testing for internal organizational activities that do not provide testing services externally.

2. General Principles

2.1. The Ministry of Science and Technology is responsible for unified state management over compatibility assessment activities.

2.2. Ministries managing sectors and fields are responsible for managing compatibility assessment activities within their assigned management scope.

2.3. Terminology and definitions regarding testing, inspection, examination, and certification are defined in Article 3 of the Product and Goods Quality Law.

2.4. In cases where standards prescribed in this Circular are amended, supplemented, or replaced, they shall be implemented according to the amended, supplemented, or newly issued documents.

II. REQUIREMENTS, PROCEDURES, AND REGULATIONS FOR REGISTERING THE FIELD OF COMPATIBILITY ASSESSMENT ACTIVITIES

1. For Certification Organizations

1.1. General 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. Established in accordance with the law, having functions to operate in the certification field;

1.1.2. The management system and operational capacity of the certification organization must meet the requirements stipulated in national standards, international standards, and international guidelines corresponding to each type as follows:

- National standard TCVN 7457:2004 or international standard ISO/IEC Guide 65:1996 and related guidelines of the International Accreditation Forum (IAF) for product and goods 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.

1.1.3. Having at least five full-time assessors (civil servants or employees under a contract of indefinite duration or a contract of at least twelve months) of the organization who meet the following requirements:

- Holding a bachelor's degree or higher and having expertise appropriate to the certified field;

- Possessing evaluation capabilities meeting the requirements stipulated in national standard TCVN ISO 19011:2003 or international standard ISO 19011:2002 - Guidelines for quality management systems and/or environmental management systems auditing;

- Being trained in management system certification.

1.2. Procedures and Regulations for Registering the Field of Certification Activities

1.2.1. A certification organization that meets the requirements stipulated in Point 1.1 Clause 1 Section of this Circular shall prepare and submit an application for registration of the field of certification activities to the competent authority specified in Point 1.3 Clause 1 Section III of this Circular.

1.2.2. The application for registration of the field of certification activities includes:

1.2.2.1. An application form for registration of the field of certification activities according to the model prescribed in Appendix II of this Circular;

1.2.2.2. A copy of the Decision on Establishment or Business Registration Certificate or Investment License;

1.2.2.3. A list of assessors meeting the requirements stipulated in Clause 1.1.3 Section of this Circular, according to the model prescribed in Appendix I of this Circular accompanied by copies of relevant training certificates;

1.2.2.4. Documents proving the operational capacity of certification meeting the requirements stipulated in Point 1.1 Clause 1 Section of this Circular, specifically as follows:

- For certification organizations already evaluated and granted accreditation certificates for certification activities in Vietnam by legitimate accreditation organizations in Vietnam or international accreditation organizations that are members of the International Accreditation Forum (IAF) or the Pacific Accreditation Cooperation (PAC): Submit a copy of the accreditation certificate along with the scope of accreditation.

- For certification organizations not yet accredited: Submit documents, evaluation procedures, and other related documents to prove operational capacity consistent with the requirements of the corresponding standards stipulated in Point 1.1 Clause 1 Section of this Circular.

1.2.2.5. Sample Certificates and Certification Seals;

1.2.2.6. Results of certification activities carried out in the registered field for the most recent year (if available).

1.2.3. Within seven working days from the date of receipt of a complete and valid application as stipulated in Point 1.2.2 Clause 1 Section of this Circular, the competent authority specified in Point 1.3 Clause 1 Section III of this Circular will review the application and issue a Certificate of Registration of the Field of Certification Activities according to the model prescribed in Appendix III of this Circular to the certification organization.

If the issuance of the certificate is refused, the competent authority must notify the reasons for refusal in writing to the certification organization that submitted the application.

1.3. A certification organization that has registered the field of certification activities when it needs to change or supplement the registered field of activities must follow the procedures for changing or supplementing the field of activities as stipulated in Point 1.2 Clause 1 Section of this Circular.

The application for changing or supplementing the field of activities is prescribed in Appendix IV of this Circular.

2. For Testing Organizations

2.1. General Requirements

Testing organizations must meet the following requirements:

2.1.1. Established in accordance with the law;

2.1.2. Possess testing capabilities meeting the requirements stipulated in national standard TCVN ISO/IEC 17025:2007 or international standard ISO/IEC 17025:2005;

2.1.3. Have at least one tester with expertise appropriate to the registered testing field.

In cases where there are national or international standards on quality management systems for specialized testing organizations, such specialized testing organizations must meet the requirements of those standards.

2.2. Procedures and Regulations for Registering the Field of Testing Activities

2.2.1. Organizations conducting tests must meet the requirements stipulated in Point 2.1, Clause 2, Section this, establish a registration dossier for the testing activity field, and submit it to the focal agency specified in Point 1.3, Clause I, Section III of this Circular.

2.2.2. The registration dossier for the testing activity field includes:

2.2.2.1. A registration certificate for the testing activity field according to the form prescribed in Appendix II of this Circular;

2.2.2.2. A copy of the Decision on Establishment or Business Registration Certificate or Investment License;

2.2.2.3. A list of testing personnel corresponding to the registered testing field, accompanied by copies of their training certificates;

2.2.2.4. Documents proving the capability to conduct testing activities meeting the requirements stipulated in Point 2.1, Clause 2, Section this, specifically as follows:

- For organizations conducting tests that have been legally recognized by Vietnamese certification organizations or foreign certification organizations participating in mutual recognition agreements of the International Laboratory Accreditation Cooperation (ILAC) and the Asia Pacific Laboratory Accreditation Cooperation (APLAC), submit a copy of the accreditation certificate along with the scope of accreditation.

- For organizations conducting tests that have not yet been accredited, submit relevant documents, procedures, evaluation processes, and other documents to prove the capability to conduct testing activities in compliance with the corresponding standard requirements stipulated in Point 2.1, Clause 2, Section this.

2.2.2.5. A sample of the Test Result Report;

2.2.2.6. Testing activity results conducted in the registered field within the most recent year (if available).

2.2.3. Within seven working days from the date of receipt of a complete and valid dossier as stipulated in Point 2.2.2, Clause 2, Section this, the focal agency specified in Point 1.3, Clause 1, Section III of this Circular shall examine the dossier and issue a Certificate of Registration for the Testing Activity Field according to the form prescribed in Appendix III of this Circular to the organization conducting tests.

In case of refusal to issue the certificate, the focal agency must notify the reasons for refusal in writing to the organization that submitted the registration dossier.

2.2.4. An organization conducting tests that has registered a testing activity field and wishes to change or supplement the registered fields must follow the registration change and supplementation procedures stipulated in Point 2.2, Clause 2, Section this.

The application for changing or supplementing the field of activities is prescribed in Appendix IV of this Circular.

3. For appraisal organizations and inspection organizations

3.1. General Requirements

3.1.1. For appraisal organizations

Appraisal organizations must meet the following requirements:

3.1.1.1. Established in accordance with the provisions of the law;

3.1.1.2. Possess appraisal capabilities meeting the requirements set forth in the national standard TCVN ISO/IEC 17020:2001 or the international standard ISO/IEC 17020:1998;

3.1.1.3. Have appraisers who meet the qualifications stipulated in the Law on Trade.

3.1.2. For inspection organizations

Inspection organizations must meet the following requirements:

3.1.2.1. Established in accordance with the provisions of the law;

3.1.2.2. Possess a laboratory meeting the requirements set forth in the national standard TCVN ISO/IEC 17025:2007 or the international standard ISO/IEC 17025:2005;

3.1.2.3. Have at least one inspector with appropriate professional qualifications for the registered inspection field.

3.2. Procedures and formalities for registering the appraisal and inspection activity fields

3.2.1 For appraisal organizations

3.2.1.1. The procedures and formalities for registering the appraisal activity field are carried out in accordance with the provisions of the Law on Trade and guiding documents: Decree No. 20/2006/NĐ-CP dated February 20, 2006 of the Government, Circular No. 06/2006/TT-BTM dated April 11, 2006 of the Ministry of Trade (now the Ministry of Industry and Trade).

3.2.1.2. Regarding conditions, appraisal organizations must meet the requirements stipulated in Point 3.1.1, Clause 3, Section this.

3.2.2. For inspection organizations

3.2.2.1 The procedures and formalities for registering the inspection activity field are carried out in accordance with the regulations of the sectoral management ministry for products and goods within the scope assigned to manage.

3.2.2.2. Regarding conditions, inspection organizations must meet the requirements stipulated in Point 3.1.2, Clause 3, Section this.

III. RESPONSIBILITIES OF THE MANAGEMENT AUTHORITY AND ORGANIZATIONS FOR ASSESSING COMPLIANCE

1. Responsibilities of the Sectoral Management Authority

1.1. The Ministry of Industry and Trade designates the focal agency responsible for managing appraisal activities in accordance with the laws on trade and announces it through mass media so that organizations and individuals are aware, and simultaneously informs the Ministry of Science and Technology for coordinated management.

1.2. The sectoral management authority designates the focal agency responsible for managing product quality inspection activities within the assigned management scope and announces it through mass media so that organizations and individuals are aware, and simultaneously informs the Ministry of Science and Technology for coordinated management.

1.3. The Ministry of Science and Technology designates the following agencies as focal agencies:

1.3.1. The National Standardization, Metrology and Quality Control Administration is the focal agency responsible for managing conformity assessment activities for standard conformity certification, product quality testing, and goods within its jurisdiction and conformity assessment activities for products and goods under the responsibility of the Ministry of Science and Technology (excluding nuclear radiation safety-related products).

1.3.2. The Radiation Safety and Nuclear Administration is the focal agency responsible for managing conformity assessment activities for products related to nuclear radiation safety.

2. Responsibilities of the designated focal agency

2.1. Receive, process registration dossiers, and issue certificates of registration for conformity assessment activities for conformity assessment organizations.

2.2. Manage and inspect the conformity assessment activities of organizations that have been issued a Certificate of Registration for Conformity Assessment Activities. Apply warning measures, temporary suspension of effectiveness, or revoke the Certificate of Registration for Conformity Assessment Activities when conformity assessment organizations violate the provisions of this Circular or Article 20 of the Law on Product and Goods Quality.

2.3. Compile a list of conformity assessment bodies that have been issued a Registration Certificate for their operational fields, along with the conformity assessment fields and conformity assessment bodies that have registered operational fields but have been warned, temporarily suspended, or had their Registration Certificates revoked; publicly announce on the electronic information website of the industry and sector management ministry for organizations and individuals to be aware, and report to the Ministry of Science and Technology (National Standardization Agency) for comprehensive compilation.

2.4. Regularly every six months, or at any time upon request, responsible agencies shall compile the situation and results of activities of conformity assessment bodies that have been issued a Registration Certificate for their operational fields, report to the industry and sector management ministry, and inform the Ministry of Science and Technology (National Standardization Agency) for coordinated management.

3. Responsibilities of conformity assessment bodies

3.1. Implement rights and obligations as stipulated in Article 19 and Article 20 of the Product Quality Law. In case of violation of this Circular or Article 20 of the Product Quality Law, they will be warned, temporarily suspended, or have their Registration Certificate for conformity assessment field activities revoked depending on the nature and severity of the violation.

3.2. Regularly every six months, or at any time upon request, report according to the form prescribed in Appendix V of this Circular about the results of conformity assessment activities that have been registered; specifically, certification bodies shall report according to the form prescribed in Appendix VI of this Circular about the results of certification activities; simultaneously inform the Ministry of Science and Technology (National Standardization Agency) for compiling reports to the Prime Minister.

3.3. Notify the agency specified in Clause 1, Section III of this Circular about changes affecting the conformity assessment activity capacity within fifteen days from the date of change.

IV. IMPLEMENTATION

1. The industry and sector management ministries are responsible for guiding the implementation of this Circular within their assigned management scope. Based on the guidance provided in this Circular, establish requirements and procedures for registering operational fields for inspection and testing organizations within their assigned management scope.

2. The National Standardization Agency is responsible for monitoring and urging the implementation of this Circular.

3. This Circular takes effect forty-five days from the date of issuance and replaces the provisions regarding registration of conformity assessment activities stipulated in Article 8 and Article 9 of the Regulation on Conformity Assessment, Certification, and Declaration of Conformity issued together with Decision No. 24/2007/QĐ-BKHCN dated September 28, 2007 of the Minister of Science and Technology.

4. Six months after this Circular takes effect, conformity assessment bodies that have been issued a Registration Certificate for conformity assessment activities under Decision No. 24/2007/QĐ-BKHCN dated September 28, 2007 of the Minister of Science and Technology must complete the supplementation of documents and certificates as stipulated in Item 1.2.2, Section I to convert their Registration Certificate for conformity assessment activities in accordance with this Circular.

5. Six months after this Circular takes effect, conformity assessment bodies must register their operational fields in accordance with this Circular. If violated, penalties will be imposed based on the nature and severity of the violation as stipulated by law.

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

 

 

ANNEX I

MODEL LIST OF CONFORMITY ASSESSMENT EXPERTS OF A CONFORMITY ASSESSMENT BODY
(Issued together with Circular No. 08/2009/TT-BKHCN dated April 8, 2009 of the Minister of Science and Technology)

NAME OF ORGANIZATION:...

LIST OF CONFORMITY ASSESSMENT EXPERTS OF THE REGISTERED OPERATIONAL FIELD OF THE CONFORMITY ASSESSMENT BODY

 

 

ANNEX II

MODEL APPLICATION FOR REGISTRATION OF OPERATIONAL FIELD OF CONFORMITY ASSESSMENT
(Issued together with Circular No. 08/2009/TT-BKHCN dated April 8, 2009 of the Minister of Science and Technology)

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

..., Date ..., Month ..., Year 200...

 

APPLICATION FOR REGISTRATION

OPERATIONAL FIELD OF TESTING/CERTIFICATION

To: ...(name of the competent authority designated by the Ministry of Science and Technology c))

1. Name of Organization:...

2. Contact Address: …

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

3. Establishment Decision (if applicable)/Business Registration Certificate/Investment License No..., Issuing Authority:... Issued on... At...

4. After studying the detailed regulations of the Government's Decree No. 132/2008/NĐ-CP dated December 31, 2008 on implementing certain provisions of the Product Quality Law, and Circular No. 08/2009/TT-BKHCN dated April 8, 2009 of the Minister of Science and Technology guiding the requirements, procedures, and formalities for registering operational fields of conformity assessment activities, we recognize that we meet all conditions for operating in the testing/certification field for the area of... (name of the specialized field).

5. Sample Test Result Form/Certificate of Conformity, Certification Mark attached.

We request...(name of the competent authority designated by the Ministry of Science and Technology) to consider and issue a Registration Certificate for Testing/Certification Activities in the aforementioned field.

We hereby commit to comply with all regulations on conformity assessment activities and related laws./.

 

 

Note: Register the operational field being applied for.

 

ANNEX III

MODEL CERTIFICATE OF REGISTRATION OF OPERATIONAL FIELD OF CONFORMITY ASSESSMENT
(Issued together with Circular No. 08/2009/TT-BKHCN dated April 8, 2009 of the Minister of Science and Technology)

 

CERTIFICATE OF INSURANCE OR OTHER FINANCIAL SECURITY

REGISTRATION OF OPERATIONAL FIELD OF TESTING/CERTIFICATION

Pursuant to Decision No... stipulating the functions, tasks, powers, and organizational structure of...(name of the competent authority designated by 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;

Pursuant to Circular No. 08/2009/TT-BKHCN dated April 8, 2009 of the Minister of Science and Technology guiding the requirements, procedures, and formalities for registering operational fields of conformity assessment activities;

Considering the proposal of...(name of the unit under the competent authority tasked with reviewing applications) certify:

1. …………(name of the conformity assessment body)...

Address: …

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

Has registered for testing/verification activities in the following fields:

- .........................................................  (name of the specialized field)....................................

2. Registration number: …

3. Certificate issued on the first, second …4. This certificate takes effect from the date of signature./.)

- Name of organization at item 1;

 

 

Note: MODEL FOR APPLICATION TO AMEND AND SUPPLEMENT THE FIELD OF CONFORMITY ASSESSMENT ACTIVITY

 

ANNEX IV

APPLICATION FOR AMENDMENT AND SUPPLEMENT OF TESTING/VERIFICATION ACTIVITY FIELD
(Issued together with Circular No. 08/2009/TT-BKHCN dated April 8, 2009 of the Minister of Science and Technology)

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

..., Date ..., Month ..., Year 200...

 

3. Testing/verification activity field registered according to the registration certificate number … dated …/…/200….issued by (

To: ...(name of the competent authority designated by the Ministry of Science and Technology c))

1. Name of Organization:...

2. Contact Address: …

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

).name of the competent authority designated by the Ministry of Science and Technology4. Proposed testing/verification activity field to be amended and supplemented: …

(name of primary authority designated by the Ministry of Science and Technology)

............................................................................................................................................

Request … considers and issues the application to amend and supplement the testing/verification activity field mentioned above. We hereby commit to comply with all regulations regarding conformity assessment activities in the amended and supplemented registration field./.

Supplementing the registration of which field of activity shall state the name of that field.

 

 

Note: MODEL REPORT ON THE STATUS OF CONFORMITY ASSESSMENT ACTIVITY

 

ANNEX V

(Name of conformity assessment organization)
(Issued together with Circular No. 08/2009/TT-BKHCN dated April 8, 2009 of the Minister of Science and Technology)

 

(From …/…./200….to ……/…./200….)

(name of primary authority designated by the management ministry/sector

 

 

3. Telephone: …Fax: …Email: …

3. Telephone: …;   Fax: …; Email: …

name of conformity assessment organization

4. Status of activities

…………..() reports the status of conformity assessment activities from …/…./200….to ……/…./200….as follows:- Name of specialized field

- Number and content of conformity assessment work carried out

5. Recommendations and proposals

a) Issues arising during the conformity assessment process

b) Proposals and recommendations to competent authorities to improve conformity assessment activities

......................................................................................................................................... .

.........................................................................................................................................

.........................................................................................................................................

………(name of conformity assessment organization

.........................................................................................................................................

.........................................................................................................................................

.........................................................................................................................................

) reports to …..(name of primary authority under the management ministry/sector) and National Standardization, Metrology and Quality Control Agency for their knowledge./.Reporting on which field of activity shall state the name of that field.

 

 

Note: MODEL REPORT ON THE STATUS OF CERTIFICATION ACTIVITY

 

ANNEX VI

STATUS OF CERTIFICATION ACTIVITY
(Issued together with Circular No. 08/2009/TT-BKHCN dated April 8, 2009 of the Minister of Science and Technology)

 

REPORT

National Standardization, Metrology and Quality Control Agency

(name of primary authority designated by the management ministry/sector

 

 

3. Telephone: …Fax: …Email: …

3. Telephone: …;   Fax: …; Email: …

name of conformity assessment organization

4. Status of activities

…………..() reports the status of conformity assessment activities from …/…./200….to ……/…./200….as follows:- Name of specialized field

State province/city

………(name of conformity assessment organization

5. Recommendations and proposals (if any)

) reports to National Standardization, Metrology and Quality Control Agency for their knowledge./.Certification organization