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Circular 09/2009/tt-Bkhcn: Guidance On The Request, The Order And Procedures Of Conformity Assessment Organization

Original Language Title: Thông tư 09/2009/TT-BKHCN: Hướng dẫn về yêu cầu, trình tự, thủ tục chỉ định tổ chức đánh giá sự phù hợp

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Pursuant to the law of product quality, the goods on November 21, 2007;

Pursuant to Decree No. 28/2008/ND-CP dated 14 March 2008 of the Government functions, tasks, powers and organizational structure of the Ministry of science and technology;

Pursuant to Decree No. 132/2008/ND-CP on December 31, 2008 detailing the Government's implementation of some articles of the law on product quality, the goods;

The Ministry of science and technology of the unified guidance of the request, the order and procedures of conformity assessment organization are as follows: i. GENERAL PROVISIONS 1. Scope 1.1. This circular instructions on requirements, order and procedures of conformity assessment organization made the evaluation according to the respective technical regulation serve state management requirements.

1.2. This circular does not apply to measuring media auditing activities in the category measuring means are calibrated according to the provisions of the law on metrology.

1.3. in case of international treaties, agreements, mutual acknowledgment agreement between Vietnam and other countries, regions, territories relating to admit the results of conformity assessment of conformity assessment organization are specified otherwise with this circular shall apply the provisions of international treaties , agreement, that agreement.

2. Subjects of application this circular applies to: 2.1. The competent State Agency specified in clause 1 of this circular section III, concerning the activity of testing, inspection, certification, auditing to determine the fit compared to the corresponding technical regulation;

2.2. conformity assessment organizations in domestic and foreign operations of testing, inspection, testing, certification in Vietnam;

2.3. The organizer, personal business, manufacturing of products, commodities, environment, process testing, inspection, testing, certification of conformity with the corresponding technical standards.

3. The terminology and definitions In this circular the terms accreditation, admitted the results of conformity assessment and conformity assessment organizations that is specified to be applied according to the provisions of article 3 of the law on product quality, the goods.

4. General guidelines 4.1. The Organization reviews the fit by competent State agencies implement based on considering the capacity perform conformity assessment activities meet the requirements of the respective technical regulation and other relevant requirements prescribed by the law.

4.2. conformity assessment results of conformity assessment organization according to the specified area will be the competent State agencies use in-process testing, product quality inspection, commodity.

II. REQUIRE, Order And PROCEDURES Of CONFORMITY ASSESSMENT ORGANIZATION 1. Requirements for conformity assessment organization are assign 1.1. The certification organization for certification organizations must meet the following requirements: 1.1.1. Signed certificate of field operations at the Ministry of science and technology in accordance with circular No. 08/2009/TT-BKHCN on 08 April 2009 by the Minister of science and technology guidance on request, order, registration field operations reviews the fit;

1.1.2. minimum of 3 expert reviews in the official payroll (employees or contract workers have the time limit from 12 months or labor contract does not specify the time limit) of the Organization, qualified university graduates or above and consistent with operational expertise about product certification goods, the process, the respective environment and have experience from 3 years or more;

1.1.3. Have enough technical documentation, standards and certification processes in accordance with the corresponding technical standards.

1.2. With respect to the testing organization, organization assessment, auditing institutions 1.2.1. General requirements: test organization, organization assessment, auditing organizations meet the following specific requirements: 1.2.1.1. Registered scope of testing, inspection, inspection at the Ministry of industry, management field as specified in circular No. 08/2009/TT-BKHCN on 08 April 2009 by the Minister of science and technology guidance on request, order, registration field operations reviews the fit;

1.2.1.2. In each field of specialization, there are at least 2 technical staff have the appropriate qualification test activities, assessment, testing of products, commodities and have experience from 3 years or more;

1.2.1.3. Have enough technical documents, the necessary standards and test procedures, inspections, testing consistent with the respective technical regulation.

1.2.2. Other requirements: The conformity assessment organizations, in addition to satisfying the General requirements, must meet the other requirements of specialized peculiarity due to industry managers, the field, the people's Committee of the city, centrally regulated.

1.3. The conformity assessment organizations have recognized certification organization recognized Vietnam's legal or legally recognized organization is foreign participants signed an agreement of mutual acknowledgment of the International Association and the respective regional levels, will be a priority consideration , specify.

2. The order and procedures of conformity assessment organization 2.1. Conformity assessment organizations when there is active participation needs testing, inspection, certification, accreditation serves to manage the State in specific areas must establish registration documents and sent to the respective bodies as follows: 2.1.1. Focal agency responsible for managing the operation of conformity assessment in the specialized sector of the Ministry of industry, management of areas under the provisions of paragraph 1 of section III of this circular.

2.1.2. focal agency responsible for operations management reviews the suitability of people's committees of provinces and cities under central as specified in paragraph 1 of section III of this circular.

2.2. Registration documents include: 2.2.1. The specified registration certificate of conformity assessment according to the form prescribed in annex I of this circular;

2.2.2. A copy of the certificate of registration of the active field testing, inspection, certification, accreditation;

2.2.3. List of testing, assessment, accreditation, evaluation experts meet the requirements prescribed in clause 1.2.1.2 items, according to the form prescribed in annex II of this circular;

2.2.4. list of technical documentation, testing procedures and standards, inspection, testing, certification of corresponding products, commodities, environment, process of registration specified in the form prescribed in Appendix III of this circular;

2.2.5. the test results Form, inspection certificate, inspection certificate, certificate;

2.2.6. The documents that meet the requirements specified in point 1.2.2 clause 1 item (if any);

2.2.7. A certificate recognizing the capacity testing, inspection, testing, certification by the recognized organization level specified in point 1.3 paragraph 1 item (if any);

2.2.8. The results of test operation, inspection, testing, certification has been made in the field of registration of one year (if any).

2.3. Within a period of not more than thirty days from the receipt of a valid, full profile, focal agency conducted the review of records, perform capacity assessment practice at the base (if needed) and the decision to assign the Organization reviews the fit according to the form prescribed in annex IV of this circular. The time limit for the validity of the decision to appoint not more than 3 years.

In the case refused to specify, the clues are notified rejection reason in writing for conformity assessment organization.

2.4. Three months before deciding to designate conformity assessment organization expired, if there is demand, the Organization reviews the suitability to perform the procedure of registration as specified in point 2.2 clause 2 of this Section.

2.5. The Organization reviews the fit specified Active implementation testing, forensic auditing, when in need of change, add the scope, the field is specified to perform the procedure of registration of changes and supplements (new registration) as defined in point 2.2 clause 2 of this Section.

III. RESPONSIBILITIES Of The GOVERNING BODY And The ORGANIZATION REVIEWS The FIT SPECIFIED 1. Responsibility of management 1.1. The responsibility of the Ministry of industry managers, the field and the provincial people's Committee, the central cities in the range field is assigned, decentralized responsibility: 1.1.1. Direction, manage the conformity assessment activities under the provisions of this circular;

1.1.2. Designate focal agency responsible for managing the activities specified conformity assessment organization; Notice the list of specified focal agency for the institutions and individuals concerned and the Ministry of science and technology (Directorate for standards and quality) to coordinate.

1.2. The Ministry of science and technology indicated the following is the clue: 1.2.1. General Directorate for standards and quality is the focal agency for receiving, processing and registration records a decision specifying the Organization reviews the suitability for products, merchandise, process, environmental regulations in the technical regulation by the Ministry of science and technology issued (except for products related to the safety of nuclear radiation).

1.2.2. The Bureau of radiation and nuclear safety authority is receiving clues, handle registration profile specified and the specified decision for products related to nuclear radiation safety regulations in the national technical regulation by the Ministry of science and technology.

1.3. The responsibilities of the Agency specified 1.3.1 clue. Reception, registration processing and decision to designate conformity assessment Organization for the field of products, commodities, environment, process stipulated in the respective technical regulation by the Ministry of industry, management areas, provincial people's Committee, the city of centrally issued.

1.3.2. reporting on mass media the list of conformity assessment organization are assign to organizations, individuals know, the notice of the Ministry of science and technology (Directorate for standards and quality) to coordinate the management.


1.3.3. The management and check of conformity assessment activities of the Organization reviews the fit was specified. Apply the measures warning, temporary suspension of the validity of the decision to appoint, remove decided when conformity assessment organization violates the provisions of this circular or the provisions of article 20 of the law on product quality, the goods. Notice on mass media organization name reviews the fit specified has been temporarily suspended, cancelled the decision to designate, as notices of the Ministry of science and technology (Directorate for standards and quality) to coordinate the management.

1.3.4. the general situation in conformity assessment activities are specified and quarterly or irregularly when required, management reports, industry sectors, provincial people's Committee, the central cities concerned and the Ministry of science and technology (Directorate for standards and quality).

2. The liability of the Organization reviews the fit specified 2.1. Implementation of rights and obligations under the provisions of article 19 and article 20 of the law on product quality, the goods. Violations of the provisions of this circular or the provisions of article 20 of the law on product quality, the goods depending on the nature and the level will be warning, temporary suspension of the validity of the decision to appoint or remove the specified decision.

Particularly for the specified test organization, during the validity of the decision, must participate in proficiency testing program, compared the Union once.

2.2. six-month periodic, irregular when required, report the results of conformity assessment activities were specified according to the form prescribed in annex V of this circular for the specified focal agency held reviews of conformity to General.

2.3. Informs the decision-making authority specify on all changes have affected the operational capability of testing, inspection, testing, certification of conformity has to register within fifteen days from the date of the change.

IV. IMPLEMENTATION 1. The Ministry of science and technology delivered to the Directorate for standards and quality organizations implementing this circular. Periodically, the Directorate for standards and quality report the Ministry of science and technology on the work and activities of the Organization reviews the fit was specified.

2. The logical sectors, sectors, provincial people's Committee, the city of centrally responsible for specific guide the implementation of this circular in the field are assigned to management.

3. With regard to the auditing organization by the Ministry of industry, management of areas established to perform quality control of products, commodities in the range is assigned, the management is done according to the regulations of the Ministry of industry management, the respective fields.

4. the State Agency has the authority to conduct the inspection, the inspection of conformity assessment activities under this circular and the relevant regulations. If the violation, depending on the nature and extent of the violation will be handled in accordance with the law.

5. This circular takes effect 45 days after enforcement, since issued and replaced the provisions on the registration certificate of conformity of article 12 and article 13 of the regulations on the certification of conformity, certificate of conformity and published standards, appropriate disclosure rules attached to decision No 24/2007/QD-BKHCN on 28/9/2007 by the Minister of science and technology.

6. With regard to the auditing organization have been specified before this circular effect, was maintained until the expiry of validity stated in the decision.

7. in the implementation process, if there are problems, the agencies, institutions need timely reflection on the Ministry of science and technology (Directorate for standards and quality) to consider and resolve.