Circular No. 26/2013/TT-BKHCN stipulates requirements, procedures, and formalities for designating foreign conformity assessment organizations to conduct conformity assessments of products and goods according to national technical regulations issued by the Ministry of Science and Technology.

CIRCULAR

Regulations on requirements, procedures, and formalities for designating foreign conformity assessment organizations to conduct conformity assessments of products and goods in accordance with national technical regulations

implemented by the Ministry of Science and Technology

The Minister of Science and Technology stipulates the requirements, procedures, and formalities for designating foreign conformity assessment organizations to conduct conformity assessments of products and goods in accordance with national technical regulations issued by the Ministry of Science and Technology.

________________

Pursuant to the Law on Product Quality and Commodities dated November 21, 2007;

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 Decree No. 20/2013/NĐ-CP dated February 26, 2013 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology;

At the proposal of the General Director of the Standardization, Metrology and Quality Control Department;

Article 1. This Circular stipulates the requirements, procedures, and formalities for designating foreign conformity assessment organizations to conduct conformity assessments of products and goods in accordance with national technical regulations issued by the Ministry of Science and Technology.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

Article 2. This Circular does not apply to products and goods related to nuclear radiation safety and metrological verification activities as prescribed by laws on measurement.

Article 3. In cases where international treaties to which the Socialist Republic of Vietnam is a party, or mutual recognition agreements between Vietnam and other countries or territories concerning the recognition of the results of conformity assessments by designated foreign conformity assessment organizations have different provisions from this Circular, the provisions of such treaties or agreements shall be applied.

1. Foreign conformity assessment organizations register for designation.

Article 2. Applicability

This Circular applies to:

2. Organizations and individuals producing and trading products and goods that must carry out conformity assessment activities in accordance with national technical regulations issued by the Ministry of Science and Technology.

3. The National Standardization, Metrology and Quality Control Agency and relevant state agencies.

Article 3. Terminology and Definitions

is an organization conducting conformity assessment activities of products, goods, production processes, and service supply in accordance with published standards and corresponding national technical regulations.

In this Circular, the following terms are understood as follows:

1. Organization conducting conformity assessment Foreign Conformity Assessment Organization

2. is an organization established in accordance with foreign laws, operating outside the territory of Vietnam, and providing conformity assessment results for imported products and goods into Vietnam. Designated Foreign Conformity Assessment Organization

3. is a foreign conformity assessment organization meeting the conditions stipulated by Vietnamese law and being considered and decided upon by competent state management authorities in Vietnam to be designated and announced for organizations and individuals engaged in production and trade to choose and use conformity assessment services to meet Vietnam's management requirements. is the Ministry of Science and Technology, an agency of the Government of the Socialist Republic of Vietnam.

4. Ministry of Science and Technology is a national technical regulation issued by the Ministry of Science and Technology.

5. National Technical Regulation are agencies assigned and delegated to perform state management tasks regarding product and good quality under the responsibility of the Ministry of Science and Technology.

6. Inspection authority Article 4. Basis for Designating Foreign Conformity Assessment Organizations

Article 4. General Principles

1. The designation of foreign conformity assessment organizations is proactively carried out by competent state authorities in Vietnam based on:

a) Management needs of state agencies and the actual capacity of conformity assessment organizations in Vietnam;

b) The capacity of conformity assessment organizations meeting the requirements of national technical regulations and other related requirements as prescribed by law.

2. Within the validity period of the Decision on Designation, the conformity assessment results of foreign conformity assessment organizations in the designated fields will be used by competent state authorities in Vietnam during the process of inspecting the quality of products and goods.

3. Foreign conformity assessment organizations holding certification recognized by legitimate accreditation organizations that are members of the International Accreditation Forum (IAF), the Pacific Accreditation Cooperation (PAC), the International Laboratory Accreditation Cooperation (ILAC), and the Asia Pacific Laboratory Accreditation Cooperation (APLAC) will be prioritized for consideration and designation.

4. In special cases, to serve state management requirements for product and good quality according to technical regulations, competent state authorities in Vietnam may proactively consider designating foreign conformity assessment organizations to carry out conformity assessment activities to meet Vietnam's management requirements in line with practical circumstances.

Chapter II

REQUIREMENTS, PROCEDURES, AND FORMALITIES FOR DESIGNATING FOREIGN CONFORMITY ASSESSMENT ORGANIZATIONS

Section 1

REQUIREMENTS FOR FOREIGN CONFORMITY ASSESSMENT ORGANIZATIONS REGISTERING FOR DESIGNATION

Article 5. Requirements for certification organizations

Foreign certification organizations that register for designation must meet the following requirements:

1. Be a legally established organization with functions to operate in the field of certification according to the regulations of the country or territory where the organization registers its activities.

2. Establish, apply, and maintain effectively a management system in accordance with the requirements of the latest version of the ISO/IEC 17065 standard (Conformity assessment - Requirements for product, process and service certification bodies).

3. Have a laboratory of the organization or enter into a contract with a subcontractor to conduct tests that meet the following requirements:

a) Possess the capability to test all technical indicators according to the testing methods specified in the corresponding national technical regulations;

b) Establish, apply, and maintain effectively a management system in accordance with the requirements of the latest version of the ISO/IEC 17025 standard (General requirements for the competence of testing and calibration laboratories).

4. Always have at least three experts who sign long-term employment contracts (or equivalent) with the organization and meet the following requirements:

a) Hold a bachelor's degree or higher and have expertise relevant to the corresponding product certification activities;

b) Have at least five years of experience in evaluation.

5. Have technical experts knowledgeable about the corresponding national technical regulations and related requirements to carry out certification assessments as prescribed by the Vietnamese government.

6. Be introduced by the competent state management agency responsible for quality control in the corresponding product field and by the diplomatic mission of the country or territory where the organization registers its activities.

Article 6. Requirements for testing organizations

Foreign testing organizations that register for designation must meet the following requirements:

1. Be a legally established organization with functions to operate in the field of testing according to the regulations of the country or territory where the organization registers its activities.

2. Possess the capability to test all technical indicators according to the corresponding national technical regulations' testing methods.

3. Establish, apply, and maintain effectively a management system in accordance with the requirements of the latest version of the ISO/IEC 17025 standard (General requirements for the competence of testing and calibration laboratories).

4. Have at least two technical staff members with appropriate professional qualifications to engage in testing products and goods specified in the corresponding national technical regulations; have at least three years of work experience in the testing field and sign long-term employment contracts (or equivalent) with the organization.

5. Have technical experts knowledgeable about the corresponding national technical regulations and related requirements to carry out testing as prescribed by the Vietnamese government.

6. Be introduced by the competent state management agency responsible for quality control in the corresponding product field and by the diplomatic mission of the country or territory where the organization registers its activities.

Article 7. Requirements for inspection organizations

Foreign inspection organizations that register for designation must meet the following requirements:

1. Be a legally established organization with functions to operate in the field of inspection according to the regulations of the country or territory where the organization registers its activities.

2. Establish, apply, and maintain effectively a management system in accordance with the requirements of the latest version of the ISO/IEC 17020 standard (General criteria for the operation of organizations conducting inspections).

3. Have a laboratory of the organization or enter into a contract with a subcontractor to conduct tests that meet the following requirements:

a) Possess the capability to test all technical indicators according to the testing methods specified in the corresponding national technical regulations;

b) Establish, apply, and maintain effectively a management system in accordance with the requirements of the latest version of the ISO/IEC 17025 standard (General requirements for testing and calibration laboratories).

4. Always have at least two inspectors who sign long-term employment contracts (or equivalent) with the organization and meet the following requirements:

a) Hold a bachelor's degree or higher and have expertise relevant to the corresponding product inspection activities;

b) Have at least five years of experience in inspection.

5. Have technical experts knowledgeable about the corresponding national technical regulations and related requirements to carry out inspections as prescribed by the Vietnamese government.

6. Be introduced by the competent state management agency responsible for quality control in the corresponding product field and by the diplomatic mission of the country or territory where the organization registers its activities.

Section 2

PROCEDURE AND PROCEDURAL REQUIREMENTS FOR DESIGNATING FOREIGN CONFORMITY ASSESSMENT ORGANIZATIONS

Article 8. Registration Documents for Designation

1. When foreign conformity assessment organizations wish to participate in conformity assessment activities for products and goods according to national technical regulations issued by the Ministry of Science and Technology, they shall prepare two sets of registration documents (one set in English and one set in Vietnamese) and submit them via postal service or directly at the headquarters of the Standardization, Metrology and Quality Agency under the Ministry of Science and Technology.

2. The registration dossier includes:

a) A registration application for designation of conformity assessment signed by the organization's leadership, containing the following complete information:

- Name of the registering organization;

- Address;

- Telephone number, Fax;

- Field of conformity assessment being registered for designation;

- Product and good fields (specifying product and good names and corresponding national technical regulations) being registered for designation.

b) An introduction letter from the competent state management agency responsible for quality in the relevant product and good field in the country or territory where the organization wishes to operate;

c) An introduction letter from the Embassy, Consulate, or equivalent diplomatic agency of the country or territory where the organization wishes to operate;

d) Documentation proving the establishment, implementation, and maintenance of management systems as stipulated in Articles 5, 6, and 7 of this Circular, specifically as follows:

- For organizations that have been legally recognized as members of the International Accreditation Forum (IAF), Pacific Accreditation Cooperation (PAC), International Laboratory Accreditation Cooperation (ILAC), Asia Pacific Laboratory Accreditation Cooperation (APLAC) and have received certification, submit a copy of the accreditation certificate along with the scope of recognition and relevant documents, procedures, and processes of the recognized system;

- For organizations not yet accredited, submit relevant documents, procedures, processes, and other related materials to prove the establishment, implementation, and maintenance of their management systems according to applicable standards;

e) A list of conformity assessment experts, testers, inspectors, and technical specialists meeting the requirements stipulated in Articles 5, 6, and 7 of this Circular, accompanied by copies of professional training certificates and summaries of work experience;

g) A sample Conformity Assessment Result Certificate;

h) A summary of the results of conformity assessment activities conducted in the registered field within the most recent year.

Article 9. Processing of Registration Documents for Designation

1. Within sixty (60) working days from the date of receipt of complete and valid documents, based on the principles stipulated in Article 4 of this Circular, the Standardization, Metrology and Quality Agency will review the documents and issue a decision to designate foreign conformity assessment organizations (in accordance with the form prescribed in the Appendix of this Circular). The validity period of the designation decision shall not exceed three (03) years.

2. In cases requiring additional or supplementary documents, the Standardization, Metrology and Quality Agency shall notify the foreign conformity assessment organization in writing to supplement or complete the documents within thirty (30) days from the date the notification is signed and issued.

3. In cases requiring an actual assessment, within ninety (90) working days from the date of receipt of complete documents, the Standardization, Metrology and Quality Agency will dispatch experts or establish an assessment team to conduct an actual assessment at the organization. The costs for the assessment activities of the expert or assessment team shall be borne by the foreign conformity assessment organization applying for designation.

4. After the time limit specified in Clause 1 of this Article, if the designation is refused, the Standardization, Metrology and Quality Agency shall notify the foreign conformity assessment organization in writing of the reasons for refusal.

Article 10. Registration for Reappointment, Change, and Supplement to Scope and Field of Appointment

1. Prior to the decision on the termination of the appointment becoming effective ninety (90) days later, if necessary, foreign conformity assessment organizations submit registration applications for reappointment in accordance with the provisions of points a, b, and c, and report changes in their management system and personnel as stipulated in points d and e of Clause 2, Article 8 of this Circular.

2. When there is a need to change or supplement the scope and field of appointment, foreign conformity assessment organizations that have been appointed shall submit applications for change or supplementation in accordance with the provisions of points a, d, e, and h of Clause 2, Article 8 of this Circular.

Article 11. Suspension and Revocation of Effectiveness of Appointment Decisions

1. The effectiveness of the appointment decision shall be suspended when a foreign conformity assessment organization violates any of the following cases:

a) Failure to comply with the conformity assessment procedures and processes, relevant legal regulations, and related guidance from the National Standardization Agency;

b) Failure to maintain the capability required of conformity assessment organizations as specified in Articles 5, 6, and 7, Section 1, Chapter II of this Circular;

c) Conducting assessments without ensuring independence and objectivity;

d) Providing incorrect conformity assessment results.

2. The effectiveness of the appointment decision shall be revoked when a conformity assessment organization violates any of the following cases:

a) Being dissolved, bankrupted, or seriously violating the laws of the host country;

b) Repeated violations significantly affecting compliance with the conformity assessment procedures and processes, relevant legal regulations, and requirements for conformity assessment organizations;

c) Evidence of false declarations in the appointment registration application;

d) Issuing conformity assessment results without conducting the assessment;

e) Forgery of conformity assessment application and documentation;

g) Fraud in conformity assessment activities;

h) Submission of a request not to continue the appointment decision;

i) Having its appointment decision suspended but failing to complete corrective actions within the suspension period noted in the suspension notice;

k) Failure to comply with national regulatory authority requirements regarding inspections.

3. A foreign conformity assessment organization whose appointment decision has been revoked may only be considered for reappointment one (01) year after the revocation notice and after having remedied all violations.

Chapter III

GUIDELINES FOR INSPECTION AND HANDLING OF VIOLATIONS BY APPOINTED FOREIGN CONFORMITY ASSESSMENT ORGANIZATIONS

Article 12. Guidelines for Inspection

1. Foreign conformity assessment organizations that have been appointed are subject to inspection by the competent state management agency of Vietnam concerning the implementation of the requirements stipulated in this Circular and relevant Vietnamese legal regulations.

2. In the event that the inspection agency discovers batches of products or goods that do not meet the corresponding national technical standards but have been issued conformity assessment results by an appointed foreign conformity assessment organization:

a) The inspection agency will handle the batch of products or goods according to regulations and report to the National Standardization Agency;

b) Based on the severity of the violation, the National Standardization Agency will consider issuing a decision to suspend the effectiveness of the appointment decision or conduct an unannounced inspection of the implementation and maintenance of the capabilities of the appointed foreign conformity assessment organization in accordance with the requirements stipulated in this Circular and relevant legal regulations. The costs of such inspections shall be borne by the appointed foreign conformity assessment organization.

Conformity assessment results from organizations that have been suspended will not be used by Vietnamese competent authorities in product quality inspections. After three (03) consecutive batches of products or goods with conformity assessment results from the suspended organization and conformity assessment results from domestic organizations that have been appointed and are consistent with the corresponding technical standards, the foreign conformity assessment organization shall report to the National Standardization Agency for consideration to restore the effectiveness of the appointment decision.

Article 13. Handling Violations

Appointed foreign conformity assessment organizations that violate the provisions of this Circular and relevant legal regulations will be dealt with according to the provisions of this Circular and relevant legal regulations based on the severity of the violation.

Chapter IV

RESPONSIBILITIES OF THE MANAGEMENT AUTHORITY AND APPOINTED CONFORMITY ASSESSMENT ORGANIZATIONS

Article 14. Responsibilities of the General Department of Standardization, Measurement, and Quality Control

1. Receive, process registration files for designation and issue decisions on designating foreign conformity assessment organizations in product and goods areas specified in national technical regulations issued by the Ministry of Science and Technology.

2. Announce on the General Department's electronic information website a list of designated foreign conformity assessment organizations for organizations and individuals to know and choose from.

3. Manage and conduct inspections of the activities of designated foreign conformity assessment organizations according to this Circular and relevant current regulations. Apply measures to suspend or revoke the validity of designation decisions when foreign conformity assessment organizations violate the provisions of this Circular and other related regulations. Notify relevant agencies and announce on the General Department's electronic information website the name of the suspended or revoked decision-designated foreign conformity assessment organization.

4. Report annually or upon request to the Ministry of Science and Technology on the work of designation and the operational status of designated foreign conformity assessment organizations.

Article 15. Responsibilities of designated foreign conformity assessment organizations

During the validity period of the designation decision, designated foreign conformity assessment organizations must:

1. Maintain organizational capacity as stipulated in Articles 5, 6, and 7 of this Circular;

For designated testing organizations, they must participate in proficiency testing and inter-laboratory comparison programs in the designated field at least once.

2. Announce on their organization's electronic information website the results of conformity assessments granted to organizations and individuals in the designated field.

3. Notify the General Department of Standardization, Measurement, and Quality Control of significant changes affecting the capacity for conformity assessment within the designated scope.

4. Notify the General Department of Standardization, Measurement, and Quality Control within three (03) days of cases where conformity assessment results have been withdrawn, canceled, or expired.

5. In case of recognition, designated foreign conformity assessment organizations must submit a copy of the assessment report signed by the expert of the recognizing organization after each assessment round.

6. Comply with state management agency regulations and inspection requirements.

7. Have agreements to compensate losses incurred by organizations and individuals requesting conformity assessment in cases of providing incorrect assessment results.

8. Report in writing on the conformity assessment activity status in the designated field to the General Department of Standardization, Measurement, and Quality Control annually in December or promptly upon request. The report content includes:

a) Conformity assessment activity results during the reporting period, including the following information:

- A list including the following contents: certificate number, test result, appraisal certificate issued and their validity status; name, address, product of the corresponding organization issued;

- Changes in the organization related to the capacity to perform designated conformity assessment activities;

- Proposals and recommendations of the organization.

b) Units with certificates/testings/appraisals revoked, canceled, or expired during the reporting period (if any);

c) Recommendations and proposals (if any).

Chapter V

IMPLEMENTING PROVISIONS

Article 16. Effective Date

This Circular takes effect from December 31, 2013.

Article 17. Implementation Organization

1. The General Department of Standardization, Measurement, and Quality Control shall organize guidance and implementation of this Circular.

2. Based on the provisions of this Circular, sector ministries may use or issue specific guiding documents for the designation of foreign conformity assessment organizations in their assigned management fields.

3. During implementation, if there are difficulties, agencies and organizations should promptly reflect them to the Ministry of Science and Technology (General Department of Standardization, Measurement, and Quality Control) for consideration and resolution./.