Thông tư 09/2009/TT-BKHCN hướng dẫn về yêu cầu, trình tự, thủ tục chỉ định tổ chức đánh giá sự phù hợp do Bộ Khoa học và Công nghệ ban hành

CIRCULAR

PROVIDING GUIDANCE ON THE REQUIREMENTS AND PROCEDURE FOR DESIGNATION OF CONFORMITY ASSESSMENT BODIES

Pursuant to the Law on Product and goods quality dated November 21, 2007;

Pursuant to the Government's Decree No. 28/2008/NĐ-CP dated March 14, 2008 defining the functions, tasks, powers and organizational structure of the Ministry of Science and Technology;

Pursuant to the Government's Decree No. 132/2008/NĐ-CP dated December 31, 2008, detailing the implementation of the Law on Product and goods quality;

The Ministry of Science and Technology provides guidance on the requirements and procedure for designation of conformity assessment bodies:

I. GENERAL PROVISIONS

1. Scope of regulation  

1.1. This Circular provides guidance on the requirements and procedure for designation of conformity assessment bodies to carry out assessments according to corresponding technical regulations in order to serve state management.

1.2. This Circular is not applicable to the inspection of measurement instruments in the list of measurement instruments that need inspecting according to the laws on measurement.

1.3. Where international agreements on mutual recognition between Vietnam and other countries or territories related to the recognition of conformity assessment results of designated conformity assessment bodies are at odds with this Circular, such international agreements shall apply.

2. Subjects of application  

This Circular is applicable to:

2.1. The competent authorities specified in Clause 1 Section III of this Circular that are related to the testing, verification, inspection, and certification serving the assessment of conformity to corresponding technical regulations;

2.2. The Vietnamese and foreign conformity assessment bodies engaged in testing, verification, inspection, and certification in Vietnam;

2.3. The organizations and individuals that have products, goods, professes, and environments that need testing, verifying, inspecting, and certifying the conformity with corresponding technical regulations.

3. Terms and definitions

The definition of the terms in this Circular about verification and recognition of conformity assessment results and designated conformity assessment bodies are similar to Article 3 of the Law on Product and goods quality.

4. General principles

4.1. Conformity assessment bodies are designated by competent authorities based on the performance of conformity assessment and the fulfillment of the requirements of corresponding technical regulations and other relevant requirements stipulated by law.

4.2. The conformity assessment results presented by conformity assessment bodies shall be used by competent authorities during the inspections of product quality.

II. REQUIREMENTS AND PROCEDURE FOR DESIGNATION OF CONFORMITY ASSESSMENT BODIES  

1. Demands on a designated conformity assessment body

1.1. Certification body

Every certification body must satisfy the requirements below:

1.1.1. The certification operation is registered at the Ministry of Science and Technology according to the Circular No. 08/2009/TT-BKHCN dated April 08, 2009 of the Minister of Science and Technology, providing guidance on the requirements and procedure for registration of conformity assessment;

1.1.2. At least 03 experts are on the official payroll (officials or employees that sign contracts for at least 1 months, or indefinite contracts) that hold bachelor's degrees (or above), proficient in the assessment of corresponding products, goods, process, or environments, and have at least 03 years’ experience;

1.1.3. Technical documents, standards, and processes of assessment of conformity to corresponding technical regulations are adequate.

1.2. Testing bodies, inspecting bodies, and verifying bodies

1.2.1. General requirements:

Testing bodies, inspecting bodies, and verifying bodies must satisfy the requirements below:

1.2.1.1. The testing, verification, and inspection operation are registered at managing Ministries according to the Circular No. 08/2009/TT-BKHCN dated April 08, 2009 of the Minister of Science and Technology, providing guidance on the requirements and procedure for registration of conformity assessment;

1.2.1.2. At least 02 technicians that are proficient in the testing, verification, or inspection of corresponding products, and have at least 03 years’ experience;

1.2.1.3. Technical documents, standards, and processes of testing, verification, and inspection of conformity with corresponding technical regulations are adequate.

1.2.2. Other requirements:

Apart from the general requirements, the conformity assessment bodies must satisfy specialized requirements of managing Ministries or provincial People’s Committees.

1.3. The conformity assessment bodies that have certificates issued by Vietnam or foreign accreditation bodies, which are signatories to agreements on mutual recognitions of international and regional accreditation cooperations, shall be prioritized.

2. Procedure for designation of conformity assessment bodies  

2.1. When a conformity assessment body wishes to participate in the testing, verification, inspection, and certification serving state management of a particular field, it shall make an application and send to:

2.1.1. The designating authority in charge of conformity assessment specialized in a field under the management of a Ministry, according to Clause 1 Section III of this Circular.

2.1.2. The designating authority in charge of conformity assessment which is affiliated to a provincial People’s Committees according to Clause 1 Section III of this Circular.

2.2. The application includes:

2.2.1. The application sheet for the designation, in accordance with the form in Appendix I to this Circular;

2.2.2. A copy of the Certificate of Registration of testing, verification, inspection, or certification;

2.2.3.  The list of testers, verifiers, inspectors, and assessors that meet the requirements in Clause 1.2.1.2 of this Section, in accordance with the form in Appendix II to this Circular.

2.2.4. The list of technical documents, standards, and processes of testing, verification, and inspection, and certification, which correspond to the products, goods, processes, and environments that are registered, in accordance with the form in Appendix III of this Circular;

2.2.5. The form of test result sheet, certificate of inspection, certificate of verification, certificate;

2.2.6. Documents proving the fulfillment of the requirements in Point 1.2.2 Clause 1 of this Section (if any);

2.2.7. The Certificate of eligibility for testing, verification, inspection, or certification issued by an accreditation organization according to Point 1.3 Clause 1 of this Section (if any);

2.2.8. The results of the testing, verification, inspection, or certification in the registered field that were carried out in the latest year (if any);

2.3. Within 30 working days from the day on which the adequate and valid application is received, the designating authority shall examine the application, assess the capacity of the body at its premises (where necessary) and issue a decision to designate the conformity assessment body in accordance with the form in Appendix IV to this Circular. The period of validity of the decision on designation shall not exceed 03 years.

If the designation is rejected, the designating authority shall provide the explanation in writing for the conformity assessment body.

2.4. Three months before the expiration of the decision to designate the conformity assessment body, the conformity assessment body shall follow the procedure for renewal specified in Point 2.2. Clause 2 of this Section if it wishes to continue operating.

2.5. The designated conformity assessment body shall follow the procedure for adjustment or new registration specified in Point 2.2 Clause 2 of this Section when it wishes to change or expand its operation.

III. RESPONSIBILITY OF MANAGING AUTHORITIES AND DESIGNATED CONFORMITY ASSESSMENT BODIES

1. Responsibility of managing authorities

1.1. The managing Ministries and provincial People’s Committees, within the area of their competence, are responsible for:

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

1.1.2. Appointing designating authorities in charge of the designation of conformity assessment bodies; providing the list of designating authorities for the organizations and individuals concerned and the Ministry of Science and Technology (the Directorate for Standards, Metrology, and Quality).

1.2. The Ministry of Science and Technology shall appoint the agencies below as designating authorities:

1.2.1. The Directorate for Standards, Metrology, and Quality shall receive, process applications and issue decisions to designate conformity assessment bodies in charge of the products, goods, processes, and environments in the technical regulations promulgated by the Ministry of Science and Technology (except for the products related to nuclear and radiation safety)

1.2.2. The Vietnam Agency for Radiation and Nuclear Safety shall receive, process applications and issue decisions to designate conformity assessment bodies in charge of the products related to nuclear and radiation safety in the National Technical Regulations promulgated by the Ministry of Science and Technology.

1.3. Responsibility of designating authorities:

1.3.1. Receiving, processing applications, and issuing decisions to designate conformity assessment bodies in charge of the products, goods, processes, and environments in corresponding technical regulations promulgated by the managing Ministries or provincial People’s Committees.

1.3.2. Announcing the list of designated conformity assessment bodies on the media and send it to the Ministry of Science and Technology (the Directorate for Standards, Metrology, and Quality) for managing in cooperation.

1.3.3. Managing and inspecting the conformity assessments carried out by the designated conformity assessment body. Issue warnings, suspend or annul the decision on designation when the conformity assessment bodies that violate this Circular or  Article 20 of the Law on Product and goods quality. The names of designated conformity assessment bodies that have the decision on designation suspended or annulled shall be announced on the media and sent to the Ministry of Science and Technology (the Directorate for Standards, Metrology, and Quality) for managing in cooperation.

1.3.4. Summarize the conformity assessment and send reports to the managing Ministries, provincial People’s Committees concerned, and the Ministry of Science and Technology (the Directorate for Standards, Metrology, and Quality) every quarter or on request.

2. Responsibility of designated conformity assessment bodies

2.1. Exercising the rights and fulfilling the obligations in Article 19 and Article 20 of the Law on Product and goods quality. The conformity assessment bodies that violate this Circular or Article 20 of the Law on Product and goods quality shall receive warnings or have the decision on designation suspended or annulled, depending on the nature and severity of the violations.

Designated testing bodies must participate in the proficiency testing program once during the period of validity of the decision on designation.

2.2. Sending reports on the conformity assessment to the designating authority every six months or on request, in accordance with the form in Appendix V to this Circular.

2.3. Notifying the designating authority of the changes that affect the capacity for testing, inspection, verification, and conformity certification within 15 days from the day on which the changes occur.

IV. IMPLEMENTATION  

1. The Ministry of Science and Technology shall assign the Directorate for Standards, Metrology, and Quality to organize the implementation of this Circular. The Directorate for Standards, Metrology, and Quality shall send periodic reports to the Ministry of Science and Technology on the designation and operation of designated conformity assessment bodies.

2. Managing Ministries and provincial People’s Committees shall provide guidance on the implementation of this Circular.

3. The verifying bodies established by managing Ministries shall inspect the quality of products and goods in accordance with the regulations of the corresponding managing Ministries.

4. Competent authorities shall inspect the conformity assessment in accordance with this Circular and relevant regulations. Actions against the violations shall be taken depending on the nature and severity of the violations.

5. This Circular takes effect after 45 days from the day on which it is signed, and supersedes the regulations on registration of conformity certification in Article 12 and Article 13 of the Regulation on certification of conformity and declaration of conformity issued together with the Decision No. 24/2007/QĐ-BKHCN dated September 28, 2007 of the Minister of Science and Technology.

6. The verifying bodies that were designated before this Circular takes effect shall continue operating until the expiration date written in the decisions on designation.

7. Difficulties that arise during the implementation should be reported to the Ministry of Science and Technology (the Directorate for Standards, Metrology, and Quality) for consideration and settlement./.

APPENDIX I

FORM OF APPLICATION FOR DESIGNATION OF CONFORMITY ASSESSMENT  
(to the Circular No. 09/2009/TT-BKHCN dated April 08, 2009 of the Minister of Science and Technology)

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

(Location and date)

APPLICATION FOR DESIGNATION OF CONFORMITY ASSESSMENT  

To: …………… [name of the designating authority appointed by a competent authority]

1. Name of organization:.......................................................................................

2. Address: ...........................................................................................................

Phone number: ........................................... Fax: ...................... E-mail:..............

3. Number of Establishment Decision/Certificate of business registration/Investment license: .......................... Issuing authority: …………… Date of issue: ……..  Location: .........................................................................................................................

4. Enclosed documents:

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

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

5. After considering the conditions for conformity assessment in the Government's Decree No. 132/2008/NĐ-CP dated December 31, 2008, detailing the implementation of the Law on Product and goods quality; the Circular No. 09/2009/TT-BKHCN dated April 08, 2009 of the Minister of Science and Technology, providing guidance on the requirements and procedure for designation of conformity assessment bodies; guiding documents of ……….. [name of the managing Ministry] on the conditions for testing/inspection/verification/certification and capacity in technical regulations, we find that we meet all conditions for being assigned to carry out testing/inspection/verification/certification (specify the products, goods, processes, environments, and corresponding technical regulations.)

We hereby request [name of the designating authority] to consider designating [name of the organization] to engage in testing/inspection/verification/certification.

We commit to comply with all regulations of the State on conformity assessment and take responsibility for the information provided above./.

APPENDIX II

FORM OF LIST OF OFFICIALS, EMPLOYEES/EXPERTS OF CONFORMITY ASSESSMENT BODY
(to the Circular No. 09/2009/TT-BKHCN dated April 08, 2009 of the Minister of Science and Technology)

Name of organization:........................................................

LIST OF OFFICIALS, EMPLOYEES/EXPERTS OF CONFORMITY ASSESSMENT BODY THAT APPLY FOR ASSIGNMENT OF TESTING/INSPECTION/VERIFICATION/CERTIFICATION

Notes: Enumerate all fields are registered.

APPENDIX III

FORM OF LIST OF DOCUMENTS FOR CONFORMITY ASSESSMENT
(to the Circular No. 09/2009/TT-BKHCN dated April 08, 2009 of the Minister of Science and Technology)

Name of organization:........................................................

LIST OF DOCUMENTS SERVING  TESTING/INSPECTION/VERIFICATION/CERTIFICATION

Notes: Enumerate all fields are registered.

APPENDIX IV

FORM OF DECISION ON DESIGNATION OF CONFORMITY ASSESSMENT BODY  
(to the Circular No. 09/2009/TT-BKHCN dated April 08, 2009 of the Minister of Science and Technology)

DECISION

On designation of conformity assessment body

Name and position of the decision signer: ..........................
.......[Name of the designating authority appointed by the competent authority]

Pursuant to the Law on Product and goods quality dated November 21, 2007;

Pursuant to the Decree/Decision No. ............... defining the functions, tasks, entitlements and organizational structure of .............. [name of the designating authority appointed by the competent authority)

Pursuant to the Government's Decree No. 132/2008/NĐ-CP dated December 31 2008, detailing the implementation of the Law on Product and goods quality;

Pursuant to the Circular No. 09/2009/TT-BKHCN dated April 08, 2009 of the Minister of Science and Technology, providing guidance on the requirements and procedure for designation of conformity assessment bodies:

Pursuant to the Decision No. ………… dated ………………… of ………… [name of the managing Ministry] providing guidance on the conditions for testing/inspection/verification/certification, and the capacity in technical regulations (if any);

At the request of …………… [name of the unit assigned to verify the application by the designating authority],

DECIDES:

Article 1. Designate ………….. [name of the conformity assessment body] affiliated to …………… [name of the managing authority, If any] located at ………….. to carry out testing/inspection/verification/certification of …………………..  [name of the products, goods, processes, environments] in accordance with ……………….. [name and number of the technical regulation]

Article 2. This period of validity of this Decision is 3 years from the day on which it is signed.

Article 3. This Article shall specify the responsibility of the designated conformity assessment body (e.g. the designated conformity assessment body is responsible for carrying out conformity assessment on request to serve state management, comply with regulations and guidance of competent authorities).

The body in Article 1 and relevant organizations are responsible for the implementation of this Decision./.

APPENDIX V

FORM OF REPORT ON CONFORMITY ASSESSMENT  
(to the Circular No. 09/2009/TT-BKHCN dated April 08, 2009 of the Minister of Science and Technology)

[Location and date]

REPORT

ON CONFORMITY ASSESSMENT  

(From...../…./200… to ……/…./200….)

1. Name of the conformity assessment body: .......................................................

2. Address: ...........................................................................................................

3. Phone number: ........................................... Fax: .................. E-mail:...............

4. Operation:

…………..[name of the conformity assessment body] reports the assigned conformity assessments from ...../…./200… to ……/…./200…. as follows:

a) The tests/inspections/verifications/certifications carried out in the period:

- Name of the field

- Amount and contents of works that have undergone conformity

- ….

b) The units that have expired or annulled license for testing/inspection/verification/certification (if any) in the period:

5. Suggestions (if any):

……… [Name of the designating authority appointed by the competent authority] makes this report for ……. [name of the designating authority] and the Directorate for Standards, Metrology, and Quality./.