Chương 4: Trách nhiệm của cơ quan quan lý và tổ chức đánh giá sự phù hợp được chỉ định

CIRCULAR

REGULATIONS ON REQUIREMENTS, AND PROCEDURES FOR DESIGNATION OF FOREIGN CONFORMITY ASSESSMENT BODIES TO ASSESS CONFORMITY OF PRODUCTS AND GOODS IN ACCORDANCE WITH NATIONAL TECHNICAL REGULATION ISSUED BY MINISTRY OF SCIENCE AND TECHNOLOGY

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

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

Pursuant to the Decree No. 20/2013/ND-CP of the Government dated February 26, 2013 defining the functions, tasks, entitlements and organizational structure of the Ministry of Science and Technology;

At the request of the Director of the Directorate for Standards, Metrology, and Quality;

The Minister of Science and Technology issues regulations on the requirements and procedures for the designation of the foreign conformity assessment bodies to assess the conformity of the products and goods in accordance with the National technical regulation issued by the Ministry of Science and Technology.

Chapter 1

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Circular gives the regulations on the requirements and procedures for the designation of the foreign conformity assessment bodies to assess the conformity of the products and goods in accordance with the National technical regulation issued by the Ministry of Science and Technology.

2. This Circular is not applied to the products and goods related to the nuclear radiation safety and the inspection of the measurement instruments under the regulations of the law on measurement.

3. In case of any regulation of the International Agreement that the Socialist Republic of Vietnam is a State Party to; the Agreement between Vietnam and other relevant countries and territories on the mutual recognition of the conformity assessment results of the designated foreign conformity assessment bodies different from this Circular, such regulation shall apply.

Article 2. Regulated objects

This Circular is applied to:

1. The foreign conformity assessment bodies that apply for the designation.

2. Organizations and individuals that produce or trade the products and goods whose conformity must be assessed in accordance with the National technical regulation issued by the Ministry of Science and Technology.

3. The Directorate for Standards, Metrology, and Quality and relevant competent authorities.

Article 3. Terms and definitions

In this Circular, these terms shall be construed as follows:

1. Conformity assessment body is a body that conducts the assessment of the conformity of the products, goods, manufacturing process, provision of services suitable to the corresponding applied standards and National technical regulation.

2. Foreign conformity assessment body is a body that is established under the laws of a foreign country and operated outside Vietnam’s territory to provide the conformity assessment results of the products and goods that are imported into Vietnam.

3. The designated foreign conformity assessment body is a foreign conformity assessment body that satisfies all conditions under the laws of Vietnam. It is considered, designated and announced by the competent authorities of Vietnam in order to provide the conformity assessment service to the clients and suit the management requirements of Vietnam.

4. The Ministry of Science and Technology is the Ministry of Science and Technology, an authority of the Government of the Socialist Republic of Vietnam.

5. National technical regulation is the National technical regulation issued by the Ministry of Science and Technology.

6. An inspecting authority is an authority in charge of quality control of the products and goods under the management of the Ministry of Science and Technology.

Article 4. General principles

1. A foreign conformity assessment body is designated by the competent authorities based on:

a) the management requirements of the competent authorities and competence of the conformity assessment body in Vietnam;

b) the competence of the conformity assessment body that satisfies the National technical regulation and other relevant requirements under the regulations of the laws.

2. Within the effective period of the Designation, the conformity assessment results of the foreign conformity assessment bodies shall be used by the competent authorities of Vietnam during the inspection of product and goods quality according to their designated fields.

3. The foreign conformity assessment bodies evaluated and issued with the Certificates by any legal accreditation organization that is a member of either the International Accreditation Forum (IAF), Pacific Accreditation Cooperation (PAC), International Laboratory Accreditation Cooperation (ILAC), Asia Pacific Laboratory Accreditation Cooperation (APLAC) shall be preferably considered and designated.

4. The competent authorities in Vietnam can consider and designate a foreign conformity assessment body to conduct the conformity assessment in order to control the quality of products and goods in accordance with the technical regulations in special cases, which is conformable with the reality.

Chapter 2

REQUIREMENTS AND PROCEDURES FOR DESIGNATION OF FOREIGN CONFORMITY ASSESSMENT BODIES

Section 1: REQUIREMENTS FOR CONFORMITY ASSESSMENT BODIES APPLYING FOR DESIGNATION

Article 5: Requirements for certification bodies

Any foreign certification body that applies for the designation must:

1. Be a legal body and operated in the certification field under the regulations of the country or territory where such certification body registers its operation.

2. Create, apply and maintain the management system effectively conformable with the latest version of the ISO/IEC 17065 (conformity assessment – requirements for the certification body in charge of products, process and services).

3. Have a laboratory or sign a contract to employ an outside contractor to conduct experimental assessments who:

a) has competence in conducting testing of the technical regulations based on the test method prescribed in the corresponding National technical regulation.

b) creates, applies and maintains the effective management system conformable with the latest version of the ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories).

4. Employ at least 03 assessing experts on long-term labor contracts (or equivalent) who:

a) have at least Bachelor's Degrees in the fields conformable with the corresponding certification of products and goods;

b) have at lease 05 years’ experience of assessment.

5. Employ technical experts having thorough knowledge of the corresponding National technical regulation and relevant requirements to provide the certification under the regulations of Vietnam.

6. Be recommended by a competent authority in chare of quality control of the corresponding types of products and goods and diplomatic authorities of the country or territory where such foreign conformity assessment body registers its operation.

Article 6: Requirements for testing bodies

Any foreign testing body that applies for the designation must:

1. Be a legal body and operated in the testing field under the regulations of the country or territory where such testing body registers its operation.

2. a) have competence in conduct testing of the technical regulations based on the corresponding test method prescribed in the corresponding National technical regulation.

3. b) Create, apply and maintain the management system effectively conformable with the latest version of the ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories).

4. Employ at least 02 competent technicians who are eligible for the testing of the products and goods prescribed in the corresponding National technical regulation; have at least 03-year-experience of testing and sign long-term contracts (or equivalent) with the testing body.

5. Employ technical experts having thorough knowledge of the corresponding National technical regulation and relevant requirements to carry out testing under the regulations of Vietnam.

6. Be recommended by a competent authority in chare of quality control of the corresponding types of products and goods and diplomatic authorities of the country or territory where such testing body registers its operation.

Article 7: Requirements for inspection bodies

Any foreign inspection body that applies for the designation must:

1. Be a legal body and operated in the inspection field under the regulations of the country or territory where such inspection body registers its operation.

2. b) Create, apply and maintain the management system effectively conformable with the latest version of the ISO/IEC 17020 (standard of every operations of the inspection bodies).

3. Have a laboratory or sign a contract to employ an outside contractor to conduct experimental assessments who:

a) have competence in conducting experimental assessment of the technical regulations based on the test method prescribed in the corresponding National technical regulation.

b) Create, apply and maintain the management system effectively conformable with the latest version of the ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories).

4. Employ at least 02 inspectors on long-tern labor contracts (or equivalent) who:

a) have at least Bachelor's Degrees in the fields conformable with the inspection of corresponding products and goods;

b) have at lease 05 years’ experience of inspection.

5. Employ technical experts having thorough knowledge of the corresponding National technical regulation and relevant requirements to carry out the inspection under the regulations of Vietnam.

6. Be recommended by a competent authority in charge of quality control of the corresponding types of products and goods and diplomatic authorities of the country or territory where such inspection body registers its operation.

Section 2: PROCEDURES FOR DESIGNATING FOREIGN CONFORMITY ASSESSMENT BODIES

Article 8. Applications for designation

1. Any foreign conformity assessment body that wishes to conduct the conformity assessment of the products and goods in accordance with the National technical regulation issued by the Ministry of Science and Technology shall file 02 applications (01 in English and 01 in Vietnamese) and send them to the head office of the Directorate for Standards, Metrology, and Quality – the Ministry of Science and Technology directly or by post.

2. An application includes:

a) An application form for designation as a conformity assessment body that is signed by the Director of such conformity assessment body, containing the information below:

- Name of the foreign conformity assessment body;

- Address;

- Phone number, fax number;

- Email, Website;

- The field of the conformity assessment;

- Types of products and goods (specifying the names of the products and goods, corresponding National technical regulation);

b) A letter of recommendation of a competent authority in charge of quality control with regard to the corresponding types of products and goods in the country or territory where the foreign conformity assessment body registers its operation;

b) A diplomatic note of recommendation of the Embassy, Consulate or a diplomatic authority in the country or territory where the foreign conformity assessment body registers its operation;

d) Documents proving the establishment, application and maintenance of the management systems in accordance with the regulations in Articles 5, 6 and 7 of this Circular, in particular:

- A photocopy of the Certificate of Accreditation enclosed with the scope of accreditation and accredited documents and procedures of the system (if the foreign conformity assessment body is evaluated and issued with a Certificate by any legal accreditation organization that is a member of either the International Accreditation Forum (IAF), Pacific Accreditation Cooperation (PAC), International Laboratory Accreditation Cooperation (ILAC), Asia Pacific Laboratory Accreditation Cooperation (APLAC))

- d) Other relevant documents and procedures proving the establishment, application and maintenance of the management systems in accordance with the corresponding standards (if the foreign conformity assessment body has not been accredited);

e) A list of assessing experts, testers, assessor, technical experts that satisfy the regulations in Articles 5, 6 and 7 of this Circular enclosed with their professional certificates and a summary of their working experience;

g) The form for the conformity assessment result;

h) A summary of the result of the conformity assessment conducted in the registered field in a latest year.

Article 9. Processing applications for designation

1. The Directorate for Standards, Metrology, and Quality shall review the application and make a decision on the designation of the foreign conformity assessment body within sixty (60) working days from the receipt of any satisfactory application in accordance with the regulations in Article 4 of this Circular (using form in the Appendix of this Circular). The period of validity of the designation is at most three (03) years.

2. If any application is incomplete, the Directorate for Standards, Metrology, and Quality shall send a written notification to the foreign conformity assessment body. The foreign conformity assessment body shall complete its application within thirty (30) days from the written notification is signed to be issued.

3. In case of site inspection, the Directorate for Standards, Metrology, and Quality shall assign experts or an Inspectorate to conduct the site inspection at the foreign conformity assessment body within ninety (90) working days from the receipt of its complete application. The expenditure on the inspection conducted by the experts or inspectorate shall be provided by the foreign conformity assessment body that applies for the designation.

4. In case of disapproval, the Directorate for Standards, Metrology, and Quality shall provide the foreign conformity assessment body with a written explanation after the deadline prescribed in Clause 1 this Article,

Article 10. Registration of re-designation, change in designated scope and fields

1. Any foreign conformity assessment body in need of re-designation shall submit an application for the re-designation in accordance with the regulations in points d, e Clause 2 Article 8 of this Circular and send a report on the changes in its management system or personnel prescribed in points d and e Clause 2 Article 8 of this Circular within 90 days prior to the expiration of the designation.

2. Any designated foreign conformity assessment body in need of change in the designated scope and field shall submit an application for the registration of the change in accordance with the regulations in points a, d, e, h Clause 2 Article 8 of this Circular .

Article 11. Suspension and withdrawal of designation

1. The designation of a foreign conformity assessment body shall be suspended if it:

a) does not follow the prescribed procedures for the conformity assessment, relevant legislative documents and instructions of the Directorate for Standards, Metrology, and Quality.

b) does not maintain the fulfillment of requirements prescribed in Articles 5, 6 and 7 Section 1 Chapter II of this Circular.

c) does not conduct the assessments independently and impartially;

g) provides inaccurate conformity assessment results.

2. The designation of a conformity assessment body shall be withdrawn in one of the cases below:

a) It is dissolved, goes bankrupt or commits serious violations of the laws of the home country;

b) Violations are recommitted, which seriously affects the adherence to the prescribed procedures for the conformity assessment, relevant regulative documents and requirements for the conformity assessment body;

c) There is evidence of incorrect information in the application for designation

g) Conformity assessment results are given without actual assessments.

e) Forges documents are used;

g) Fraud is committed during conformity assessment;

h) A written request for the withdrawal of designation is submitted;

i) Violations are not rectified by the deadline written in the notification of suspension.

k) Regulations on the inspection by the competent authorities are not complied with;

3. The re-designation of a conformity assessment body whose designation is withdrawn shall be considered if it remedies its violations after one (01) year from the withdrawal.

Chapter 3

INSTRUCTIONS ON INSPECTION AND IMPOSITION OF PENALTIES FOR DESIGNATED FOREIGN CONFORMITY ASSESSMENT BODIES

Article 12. Instructions on inspection

1. The competent authorities in Vietnam shall inspect the compliance with the regulations of this Circular and other legislative documents of Vietnam of the designated foreign conformity assessment bodies.

2. If an inspecting authority detects any substandard consignment of products or goods unconformable with the corresponding National technical regulation that has been issued with the conformity assessment result by a designated foreign conformity assessment body:

a) Such authority shall dealt with such consignment under the regulations and report that to the Directorate for Standards, Metrology, and Quality;

b) The Directorate for Standards, Metrology, and Quality shall consider and decide to suspend the designation or conduct surprise inspection of the operation and competence maintenance of such designated foreign conformity assessment body in accordance with the regulations of this Circular and relevant legislative documents according to the degree of violation. The expenditure on the inspection shall be provided by the designated foreign conformity assessment body.

The conformity assessment results of the suspended conformity assessment body shall not be used by the competent authorities of Vietnam during the inspection of the quality of the products and goods. If the conformity assessment results of the next three (03) consignments of products and goods provided by the suspended conformity assessment body and designated Vietnamese conformity assessment body is conformable with the corresponding technical regulations, the foreign conformity assessment body shall request the Directorate for Standards, Metrology, and Quality to consider and restore the validity of its designation.

Article 13. Penalty imposition

Any designated foreign conformity assessment body that breaches any regulation of this Circular and relevant legislative documents shall be penalized under the regulations of this Circular and relevant legislative documents according to the degree of violation.

Chapter 4

RESPONSIBILITIES OF REGULATORY AUTHORITIES AND DESIGNATED CONFORMITY ASSESSMENT BODIES

Article 14. Responsibilities of Directorate for Standards, Metrology, and Quality

1. Receive and deal with the application for designation and designate the foreign conformity assessment bodies with regard to the products and goods prescribed in the corresponding National technical regulation issued by the Ministry of Science and Technology.

2. Publish the list of the designated conformity assessment bodies on the website of the General Department to be selected by the clients.

3. Manage and examine the conformity assessments of the designated foreigner conformity assessment bodies in accordance with the regulations of this Circular and relevant current regulations. Suspend or withdraw the designation of the foreign conformity assessment bodies that breach the regulations of this Circular and other relevant regulations. Notify the names of the foreign conformity assessment bodies whose designation is suspended or withdrawn to the relevant agencies and publish them on the website of the General Department.

4. Report the designation and the operation of the designated foreign conformity assessment bodies to the Ministry of Science and Technology annually or when required.

Article 15. Responsibilities of designated foreign conformity assessment bodies

Within the effective period of the designation, each foreign designated conformity assessment body must:

1. Maintain its competence in accordance with the regulations in Articles 5, 6, 7 of this Circular;

With regard to the designated testing bodies, each one must take part in the proficiency Testing programs or Inter-laboratory comparisons in the designated field at least once.

2. Publish the conformity assessment results issued to the clients in its designated field on its website.

3. Notify the significant changes that produce effects on its competence in conducting the conformity assessment within the designated scope to the Directorate for Standards, Metrology, and Quality.

4. Notify the conformity assessment results that are revoked, cancelled or expired to the Directorate for Standards, Metrology, and Quality within three (03) days.

5. Send a photocopy of the assessment report that bears the sign of its expert after each assessment in case of recognition;

6. Comply with the regulations, requirements for the inspection of the competent authorities;

7. Reach agreement on the compensation for the damage to the clients provided with inaccurate conformity assessment results.

8. Send an annual report in December or irregular report when required on the operation of the conformity assessment in its designated field to the Directorate for Standards, Metrology, and Quality. Such report must be written in both Vietnamese and English, including:

a) The conformity assessment operation within the reporting period, including:

- A list including: the number of certificates, test results, assessment documents that have been issued and the validity; names, addresses and products of the corresponding clients.

- Its changes related to the competence in conducting the designated conformity assessment;

- Its requests and suggestions.

b)The units whose certificates, test results, assessment documents are revoked, canceled or expired within reporting period (if any);

c) Requests and suggestions (if any).

Chapter 5

IMPLEMENTATION

Article 16. Effect

This Circular takes effect from December 31, 2013.

Article 17. Implementation

1. The Directorate for Standards, Metrology, and Quality shall give instructions and implement this Circular.

2. Pursuant to the regulations of this Circular, the Ministries shall use or issue the guiding documents on the designation of the foreign conformity assessment bodies in the fields that they are in charge of.

3. Any difficulty or obstacle that arises during the implementation of this Circular should be reported to the Ministry of Science and Technology (the Directorate for Standards, Metrology, and Quality) for consideration./.

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