Thông tư 08/2009/TT-BKHCN

Circular No. 08/2009/TT-BKHCN of April 08, 2009, guidance on the requirements and order and procedures for registration of field of conformity assessment operation

Nội dung toàn văn Circular No. 08/2009/TT-BKHCN guidance on the requirements and order and procedu


THE MINISTRY OF SCIENCE AND TECHNOLOGY
---------

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

No.: 08/2009/TT-BKHCN

Hanoi, April 08, 2009

 

CIRCULAR

GUIDANCE ON THE REQUIREMENTS AND ORDER AND PROCEDURES FOR REGISTRATION OF FIELD OF CONFORMITY ASSESSMENT OPERATION

Pursuant to the Law on Quality of Products, Goods date November 21, 2007;

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

Pursuant to the Decree No.132/2008/ND-CP dated December 31, 2008 of the Government detailing the implementation of a number of Articles of the Law on Quality of Products, Goods;

Ministry of Science and Technology guides generally on the requirements and order and procedures for registration of field of conformity assessment operation as follows:

I. GENERAL PROVISIONS

1. Scope of governing and subjects of application

1.1. This Circular provides guidance on the requirements, order, and procedures for registration of the operation field of conformity assessment organizations providing for conformity assessment services including testing, expertise, calibration, and certification.

1.2. This Circular applies to organizations providing conformity assessment services and the state management agencies related to activities of conformity assessment.

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

1.3.1. Expertise of the measuring device on the list of measuring means subject to list of measuring means required to calibrate under the provisions of law on measurement;

1.3.2. Testing for internal operations of organizations; not providing the testing services to the outside.

2. General principles

2.1. Ministry of Science and Technology is responsible for the unified State management on the operation of conformity assessment.

2.2. The ministries of managing branches, sectors are responsible for managing the operation of the conformity assessment within its scope of management.

2.3. Terms and definitions of testing, expertise, calibration, and certification are prescribed in Article 3 of the Law on Quality of Products and Goods.

2.4. Where the standards prescribed in this Circular are amended, supplemented, or replaced, it shall comply with the documents which are amended, supplemented, or promulgated newly.

II. REQUIREMENTS, ORDER, AND PROCEDURES FOR REGISTRATION OF THE FIELD OF CONFORMITY ASSESSMENT OPERATION

1. For the certification organizations

1.1. General requirements

Certification organizations must meet the following requirements:

1.1.1. Established under the provisions of law, functioning in the field of certification;

1.1.2. System of management and operational capacity of the certification organizations must meet the requirements specified in national standards, international standards, and international guidelines for each following respective type:

- National standards TCVN 7457:2004 or international standards ISO/IEC Guide 65:1996 and the relevant guidelines of the International Accreditation Forum (IAF) for the certification operation of products and goods;

- National Standards TCVN ISO/IEC International Standard 17021:2008 or international standards ISO/IEC 17021:2006 and the relevant guidelines of the International Accreditation Forum (IAF) for certification operation of management system.

1.1.3. It must have at least 05 experts of assessment of the official personnel (public employees or employees signing contract with a period of 12 months or more or the labor contract of indefinite term) of the organizations and meet the following requirements:

- Having graduated from university or more and professional skill consistent with the field of certification registration;

- Having the capacity of assessment meeting the provisions in the national standards TCVN ISO 19011:2003 or international standard ISO 19011:2002 – Guideline to evaluate quality management systems and/or environmental management systems;

- Being trained on certification of management system.

1.2. The order and procedures for registration of certification operation

1.2.1. The certification organizations meeting the requirements specified in point 1.1 clause 1 of this Item, formulate the registration dossier of the field of certification operation and send to the contact-point agency stipulated in point 1.3 clause 1, Item III of this Circular.

1.2.2. Dossier for registration of the field of certification operation includes:

1.2.2.1. Registration paper of the field of certification operation in the form prescribed in Appendix II of this Circular;

1.2.2.2. A copy of the establishment decision, or the certificate of business registration, or the investment license;

1.2.2.3. List of experts of assessment meeting the requirements specified in clause 1.1.3 of this Item, in the form prescribed in Appendix I of this Circular together with the copy of respective training certificate;

1.2.2.4. The documents proving the capacity of the certification operation meeting requirements specified in point 1.1 clause 1 of this Item, specifically as follows:

- For the certification organizations that have been assessed and granted certificates for certification operation in Vietnam by the lawful accreditation organizations of Vietnam or accreditation organizations as a member of the International Accreditation Forum (IAF), The Pacific Accreditation Cooperation (PAC): Submit a copy of the certificate attached to the scope of accreditation.

- For the certification organizations that have not been accredited: Submit documents, procedures, assessment procedures and other concerned documents to demonstrate the operational capacity in accordance with the requirements of respective standards specified in point 1.1, clause 1 of this Item.

1.2.2.5. Form of certificate paper and seal of certification;

1.2.2.6. Results of certification operation carried out in the field of registration of a latest year (if any).

1.2.3. Within seven working days after receiving complete and valid dossiers under the provisions in point 1.2.2, clause 1 of this Item, the contact-point agency stipulated in point 1.3 clause 1, Item III of this Circular conducts a review of dossiers and the grant of certificate of registration of certification operation field in the form prescribed in Appendix III to this Circular for the certification organizations.

In case of refusal to grant a certificate, the contact-point agency must send written reply of the reasons therefore to the certification organization applied for registration.

1.3. When the certification organizations signed up the certification operation field have the needs of change, supplementation of operation fields which have been registered, they must perform the registration of changes and supplementation as prescribed in point 1.2, clause 1 of this Item.

Written request for change, supplementation of operation fields specified in Appendix IV of this Circular.

2. For the testing organizations

2.1. General requirements

Testing organizations must meet the following requirements:

2.1.1. Established in accordance with law regulations;

2.1.2. Having capacity of testing meeting requirements specified in national standards TCVN ISO/IEC 17025:2007 or international standards ISO/IEC 17025:2005;

2.1.3. It must have at least 01 qualified tester in accordance with the field of testing registration.

In the case of having national standards or international standards on quality management system for the specialized testing organization, the specialized testing organization must meet the requirements of such standards.

2.2. The order and procedures for registration of testing operation

2.2.1. Testing organizations meeting the requirements specified in point 2.1 clause 2 of this Item, make dossier for registration of field of testing operation and submit to the contact-point agency as specified in point 1.3, clause I Item III of this Circular.

2.2.2. Registration dossier for testing operation field includes:

2.2.2.1. Written registration for testing operation field in the form is prescribed in Appendix II of this Circular;

2.2.2.2. A copy of the establishment decision or certificate of business registration or investment license;

2.2.2.3. List of testers corresponding to the registration field for testing attached to a copy of the certificate of professional training.

2.2.2.4. The documents demonstrating the operational capacity of testing meeting the requirements specified in point 2.1 clause 2 of this Item, specifically as follows:

- For the testing organizations that have been assessed and granted accreditation certificates for testing operation in Vietnam by the lawful accreditation organizations of Vietnam or foreign accreditation organizations as a member participating in signing Agreement on mutual recognition of the Association of International Laboratory Accreditation (ILAC), Association of Laboratory Accreditation in Asia - Pacific (APLAC-Asian Pacific Laboratory Accreditation Cooperation): Submit a copy of the accreditation certificate attached to the accredited scope.

- For the testing organizations that have not been accredited: Submit documents, procedures, assessment procedures and other concerned documents to demonstrate the operational capacity in accordance with the requirements of respective standards specified in point 2.1, clause 2 of this Item.

2.2.2.5. Form of the testing results;

2.2.2.6. The testing results conducted in the field of registration of a latest year (if any).

2.2.3. Within seven working days after receiving complete and valid dossiers under the provisions in point 2.2.2, clause 2 of this Item, the contact-point agency stipulated in point 1.3 clause 1, Item III of this Circular conducts a review of dossiers and the grant of certificate of registration of testing operation field in the form prescribed in Appendix III to this Circular for the testing organizations.

In case of refusal to grant a certificate, the contact-point agency must send written reply of the reasons therefore to the testing organization applied for registration.

2.2.4. When the testing organizations signed up the testing operation field have the needs of change, supplementation of operation fields which have been registered, they must perform the registration of changes and supplementation as prescribed in point 2.2, clause 2 of this Item.

Written request for change, supplementation of operation fields is specified in Appendix IV of this Circular.

3. For expertise organizations, calibration organizations

3.1. General requirements

3.1.1. For expertise organizations

Expertise organizations must meet the following requirements:

3.1.1.1. Established in accordance with law regulations;

3.1.1.2. It must have capacity of appraisal meeting requirements specified in national standards TCVN ISO/IEC 17020: 2001 or International Standard ISO/IEC 17020:1998;

3.1.1.3. It must have qualified expertise experts under the provisions of the Commercial Law.

3.1.2. For calibration organizations

Calibration organizations must meet the following requirements:

3.1.2.1. Established in accordance with law regulations;

3.1.2.2. It must have laboratories meeting requirements specified in national standards TCVN ISO/IEC 17025:2007 or international standard ISO/IE 17025:2005;

3.1.2.3. It must have at least 01 calibration expert with professional skill in accordance with the field of calibration registration.

3.2. The order and procedures for registration of operation fields of expertise, calibration

3.2.1 For the expertise organizations

3.2.1.1. The order and procedures for registration of the expertise operation field are made under the provisions of the Commercial Law and other guiding documents: the Decree No.20/2006/ND-CP dated 20/02/2006 of the Government, Circular No.06/2006/TT-BTM dated 11/04/2006 of Ministry of Commerce (now the Ministry of Industry and Trade).

3.2.1.2. On the conditions, expertise organizations must meet the requirements specified in point 3.1.1 clause 3 of this Item.

3.2.2. For calibration organizations

3.2.2.1 The order and procedures for registration of calibration operation shall comply with the provisions of the ministries of managing branches, sectors for products and goods of its scope of management.

3.2.2.2. On the conditions, calibration organizations must meet the requirements specified in point 3.1.2 clause 3 of this Item.

III. RESPONSIBILITY OF MANAGEMENT AGENCIES AND ORGANIZATIONS OF CONFORMITY ASSESSMENT

1. The responsibilities of the ministries of managing branches, sectors

1.1. Ministry of Industry and Trade appoints the contact-point agency to take responsibility for expertise operation management in accordance with provisions of the commercial law and inform on the mass media to the organizations, individuals, and inform the Ministry of Science and Technology for coordinating the management.

1.2. The ministries of managing branches, sectors appoint the contact-point agency to take responsibility for quality expertise operation management of products and goods of the field assigned management and inform on the mass media to the organizations, individuals, and inform the Ministry of Science and Technology for coordinating the management.

1.3. Ministry of Science and Technology appoints the following agencies as the contact-point agencies:

1.3.1. Directorate for Standards, Metrology and Quality is the contact-point agency to take responsibility for management of conformity certification operation, testing of quality of products and goods in the whole country and operation of conformity assessment for products and goods on the management responsibilities of the Ministry of Science and Technology (except for products related to safety of nuclear radiation).

1.3.2. Department of Radiation Safety and Nuclear is the contact-point agency to take responsibility for management of the conformity assessment operation for products related to nuclear radiation.

2. Responsibilities of the contact-point agencies appointed

 2.1. To receive, process registration documents and grant registration certificates of fields of conformity assessment operation for organizations of conformity assessment.

2.2. Manage and inspect operations of conformity assessment of the conformity assessment organizations that have been granted certificates of registration of operation fields. Take measures of warning, temporary suspension of validity or cancellation of the certificate of registration of operation fields as organizations of conformity assessment violate the provisions of this Circular or the provisions of Article 20 of the Law on Quality of products and goods.

2.3. To sum up the list of organizations of conformity assessment that have been granted certificates of registration of operation fields together with the field of conformity assessment and organizations of conformity assessment registered operation fields but have been warned, temporarily suspended or cancelled certificates of registration; notify publicly on the website of the Ministry of managing branches, sectors to the organizations and individuals and inform the Ministry of Science and Technology (Directorate for Standards, Metrology and Quality) for general synthesis.

2.4. Every six months and irregularly when required, the contact-point agencies shall review the situation, the operation results of organizations of conformity assessment that have been granted certificates of registration of operation fields, report to Ministry of managing branches, sectors and inform the Ministry of Science and Technology (Directorate for Standards, Metrology and Quality) for coordinating the management.

3. Responsibilities of the organizations of conformity assessment

3.1. Exercise the rights and perform obligations as stipulated in Article 19 and Article 20 of the Law on Quality of Products and goods. In case of violation of the provisions of this Circular or the provisions of Article 20 of the Law on Quality of Products, Goods, depending on the nature, extent, it shall be warned or temporarily suspended its validity or cancelled certificates of registration of operation fields of conformity assessment.

3.2. Every six months and irregularly when required, report according to the prescribed form in Appendix V of this Circular on the results of the assessment operation of conformity signed up, particularly for the certification organizations, it is reported by prescribed form in Appendix VI of this Circular on the results of certification operation; and also notify the Ministry of Science and Technology (Directorate for Standards, Metrology and Quality) for synthesis and report to the Prime Minister.

3.3. Notify the contact-point agencies specified in clause 1, Item III of this Circular on the changes that affect the operational capacity of conformity assessment signed up within fifteen days from the date of the change.

IV. ORGANIZATION OF IMPLEMENTATION

1. The ministries managing fields, sectors are responsible for guiding the implementation of this Circular within its scope of management. Based on the guidance in this Circular, building requirements; order, procedures of registration for specific operation field for the calibration, expertise organizations within its scope of management.

2. Directorate for Standards, Metrology and Quality is responsible for monitoring and urging the implementation of this Circular.

3. This Circular takes effect 45 days from the date of its signing and replaces the regulations on the registration of standards conformity certification operation specified in Article 8 and Article 9 of the Regulation on standards conformity certification, rules conformity certification and publication of standards conformity, rules conformity, issued together with Decision No.24/2007/QĐ-BKHCN dated 28/09/2007 of the Minister of Science and Technology.

4. After 6 months from the effective date of this Circular, the standards conformity certification organizations that have been granted certificates of registration of standards conformity certification operation in accordance with provisions in the Decision No.24/2007/QD-BKHCN dated 28/09/2007 of the Minister of Science and Technology must complete the additional documents, diplomas and certificates prescribed in clause 1.2.2 of Item I to be converted the certificates of registration of certification operation field in accordance with provisions of this Circular.

5. After 6 months from the effective date of this Circular, the organizations of conformity assessment must register the operation fields as specified in this Circular. If it violates, depending on the nature and seriousness of the violation, it will be handled according to the law regulations.

6. During the course of implementation, if any problems arise, agencies, organizations, and individuals should promptly reflect to the Ministry of Science and Technology (Directorate for Standards, Metrology and Quality) for consideration and settlement./.

 

 

 

FOR MINISTER
DEPUTY MINISTER




Tran Quoc Thang  

 

APPENDIX I

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

ORGANIZATION’S NAME:……………

LIST OF ASSESSMENT EXPERTS OF ORGANIZATIONS OF CONFORMITY ASSESSMENT REGISTERING THE OPERATION FIELDS

No.

Full name

Professional certificate

Certificate training management system

Assessment of capability of experts

Levels of experts (assessment head /assessment/ technician…)

Assessment experience

Types of labor contract signed

Note

1

 

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

4

 

 

 

 

 

 

 

 

5

 

 

 

 

 

 

 

 

6

 

 

 

 

 

 

 

 

7

 

 

 

 

 

 

 

 

8

 

 

 

 

 

 

 

 

9

 

 

 

 

 

 

 

 

10

 

 

 

 

 

 

 

 

…….

 

 

 

 

 

 

 

 

……..

 

 

 

 

 

 

 

 

 

 

……., Date …..month…..year …….
Organization’s representative....
(Full name, Signature, seal)

 

APPENDIX II

REGISTRATION PAPER FORM OF OPERATION FIELDS OF CONFORMITY ASSESSMENT
(Issued together with Circular No.08/2009/TT-BKHCN dated April 08, 2009 by the Minister of Science and Technology)

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

……….., Date …..month…..2000…….

 

REGISTRATION PAPER

FIELD OF TESTING/ CERTIFICATION OPERATIONS

To: …..(Name of the contact-point agency appointed by the Ministry of Science and Technology)

1. Organization’s name:.....................................................................................................

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

Tel: ........................................... Fax: ............................... E-mail:......................................

3. Establishment decision (if any) / Certificate of business registration/investment license No. ... ... ...., Issued by: ... ... ... ... ... issued on ... ... .. at.......................................

4. After studying the provisions of Decree No.132/2008/ND-CP of December 31, 2008 of the Government detailing the implementation of some Articles of the Law on Quality of Products and Goods, Circular No.08/2009/TT-BKHCN April 08, 2009 by the Minister of Science and Technology guiding on the requirements, order, procedures for registration of operation field of conformity assessment, we found that we may meet the operating conditions in the testing/certification for the field (name of specialized domain).

5. Form of testing results/certificates, certification seal attached.

Request ... ... ... ....(Name of the contact-point agency appointed by the Ministry of Science and Technology) to consider and grant certificates of registration of testing/certification operation in the field as listed above.

We commit to comply with the regulations on conformity assessment operation and the relevant provisions of law./.

 

 

Organization’s representative....
(Full name, Signature, seal)

 

Note: Registration for a certain field of operation, then state name of such field.

 

APPENDIX III

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

……………………………………
(Name of the contact-point agency appointed by the Ministry of Science and Technology)
-------------
No.: …………………….

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

Hanoi, date …….month….. 200…..

 

CERTIFICATE OF

REGISTRATION OF OPERATION FIELD OF TESTING/CERTIFICATION

Pursuant to Decision No.... .....defining functions, tasks, powers and organizational structure of the ... ... ... ... (name of the contact-point agency appointed by the Ministry of Science and Technology);

Pursuant to Decree No.132/2008/ND-CP of December 31, 2008 of the Government detailing the implementation of some Articles of the Law on Quality of Products and Goods;

Pursuant to Circular No.08/2009/TT-BKHCN dated April 08, 2009 by the Minister of Science and Technology guiding the requirements, order, procedures for registration of operation of conformity assessment;

At the proposal of ... ... ... ... ... ... .. (Name of units of the contact-point agency tasked dossier calibration), it is certified that:

1. …………( Name of the conformity assessment organization).....................................

Address: ..........................................................................................................................

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

Already registered operation fields of testing/certification for the following areas:

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

2. Registration Number:………………………………………………………………………….

3. Certificate is granted for: ........ (first, second …)

4. This certificate is valid from the signing date./.

 

 

Recipients:
- Name of the organization in Item 1;
- Minitry of Science and Technology (report);
- Directorate for Standards, Metrology and Quality (for knowing);
- Archiving,…

NAME OF THE CONTACT-POINT AGENCY APPOINTED BY THE MINISTRY OF SCIENCE AND TECHNOLOGY

 

Note: Issuance for registration certificate for a certain field of operation, then state name of such field.

 

APPENDIX IV

FORM OF REGISTRATION PAPER FOR AMENDMENT, SUPPLEMENTATION OF FIELD OF CONFORMITY ASSESSMENT
(Issued together with Circular No.08/2009/TT-BKHCN dated April 08, 2009 by the Minister of Science and Technology)

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

……….., date …….month….. 200…..

 

REGISTRATION CERTIFICATE FOR AMENDMENT, SUPPLEMENTATION OF FIELD OF TESTING/CERTIFICATION

To: …..(Name of the contact-point agency appointed by the Ministry of Science and Technology)

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

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

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

3. Field of testing/certification operation which has been registered by the certificate of registration No.………..date …../…../200…. issued by (Name of the contact-point agency appointed by the Ministry of Science and Technology).

4. Field of testing/certification operation proposed for changes and supplements:............

Request ................................ (Name of the contact-point agency appointed by the Ministry of Science and Technology) to review and grant registration of changes, supplements of field of testing/certification operation mentioned above.

It is committed by us to comply with the regulations on conformity assessment in the field of registration of changes and supplements./.

 

 

Organization’s representative....
(Full name, Signature, seal)

 

Note: Additional registration for a certain field of operation, then state name of such field.

 

APPENDIX V

REPORT FORM ON OPERATION SITUATION OF CONFORMITY ASSESSMENT
(Issued together with Circular No.08/2009/TT-BKHCN dated April 08, 2009 by the Minister of Science and Technology)

(Name of the governing agency)
(Name of the organization of conformity assessment)

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

Date …….month….. 200…..

 

REPORT ON OPERATION SITUATION OF TESTING/EXPERTISE/CALIBRATION

(From...../…./200… to ……/…./200….)

To:

- …….( Name of the contact-point agency appointed by the Ministry of managing Branch)
- Directorate for Standards, Metrology and Quality (Ministry of Science and Technology)

 

1. Name of Organization of conformity assessment:.....................................................

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

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

4. Operation situation

…………..(Name of Organization of the conformity assessment) report on the operation situation of conformity assessment from...../…./200… to ……/…./200….as follows:

- Name of the specialized field

- The quantity and content of work assessed the conformity

5. Proposals and recommendations

a) The problems arising in the process of conformity assessment

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

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

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

b) Recommendations and proposals for competent state agencies to improve the conformity assessment operation

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

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

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

………( Name of Organization of the conformity assessment) report for …..(name of the contact-point agency of Ministry of managing branch, sector) and Directorate for Standards, Metrology and Quality./.

 

 

Organization of the conformity assessment
(Competent representative’s signature, seal)

 

Note: Report for a certain field of operation, then state name of such field.

 

APPENDIX VI

REPORT FORM ON OPERATION SITUATION OF CERTIFICATION
(Issued together with Circular No.08/2009/TT-BKHCN dated April 08, 2009 by the Minister of Science and Technology)

(Name of the governing agency)
(Name of the organization of conformity assessment)

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

Date …….month….. 200…..

 

REPORT

ON THE SITUATION OF CERTIFICATION OPERATION

(From...../…./200… to ……/…./200….)

To:

Directorate for Standards, Metrology and Quality (Ministry of Science and Technology)

 

1. Name of Organization of conformity assessment:......................................... .............
2. Address:
3. Phone: ....................................... Fax: ............................... E-mail :............................
4. Operation situation
... ... ... ... .. (Name of Organization of the conformity assessment) report on the activities of conformity assessment from...../ ... ./200 ... ... to... / ... ./200 ... . as follows:
a) Units that are certified in the report period

No.

Unit’s name

Address (stating place name of province/city)

Field/object

Applicable standards

Time/Validity of Certificate of certification (stating the year of expiry)

Note

 

 

 

 

 

 

 

b) Units had certificates but are revoked or expired (if any) during the report period

No.

Unit’s name

Address (stating place name of province/city)

Field/object

Applicable standards

Time/Validity of Certificate of certification (stating the year of expiry)

Note

 

 

 

 

 

 

 

5. Proposals and recommendations (if any)

... ... ... (Name of organization of conformity certification) report to Directorate for Standards, Metrology and Quality./.

 

 

Certification organization
(Signature of competent representative, seal)

 

 


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