Circular No. 21/2010/TT-BKHCN stipulates the management of accreditation activities in Vietnam

CIRCULAR

Regulations on the management of accreditation activities in Vietnam

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006;

Based on Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing implementation of certain provisions

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

The Minister of Science and Technology stipulates the management of accreditation activities in Vietnam as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. These Circulars regulate the management of accreditation activities in Vietnam, including conditions for accreditation organizations; procedures and formalities for registering accreditation activities; supervision of accreditation activities and the responsibilities of related parties.

2. These Circulars apply to organizations providing accreditation services (hereinafter referred to as accreditation organizations), conformity assessment bodies recognized by accreditation, and relevant state management agencies concerning accreditation activities.

Article 2. Interpretation of Terms

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

1. Accreditation assessor is a person with competence designated by the accreditation organization to assess conformity assessment bodies. An accreditation assessor may conduct an assessment alone or be a member of an assessment team.

2. Lead accreditation assessor is an accreditation assessor with competence assigned by the accreditation organization to direct the implementation of specified assessment activities.

3. Technical expert is a person with competence designated by the accreditation organization to ensure the provision of specific knowledge and skills regarding the scope of accreditation to be assessed. A technical expert is a member of the assessment team, providing technical support to the team but is not an accreditation assessor.

4. Registration confirmation for accreditation activities is the act of the competent state authority examining and assessing the competence of the accreditation organization according to the conditions for accreditation activities to issue a Registration Confirmation Certificate for Accreditation Activities.

Article 3. General Principles

1. Accreditation organizations must ensure their operational capacity meets the requirements set forth in national standards, international standards, and the provisions of the International Accreditation Forum (IAF), the International Laboratory Accreditation Cooperation (ILAC), the Asia Pacific Laboratory Accreditation Cooperation (APLAC), and the Asia-Pacific Accreditation Cooperation (PAC).

2. The experts of the accreditation organizations must be trained and knowledgeable about the standards, procedures, formalities, and corresponding evaluation principles for the accreditation programs; they must meet the competency requirements as prescribed by the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC).

Article 4. Conditions for Accreditation Activities

Scientific and technological public institutions primarily providing accreditation services established by ministries managing sectors and fields, which have been issued a Registration Certificate for Scientific and Technological Activities in accordance with the Law on Standards and Technical Regulations, must satisfy the conditions stipulated in Clause 2 of Article 54 of the Law on Standards and Technical Regulations, specifically as follows:

1. The management system and operational capacity of the accreditation organization must meet the requirements set forth in the national standard TCVN ISO/IEC 17011:2007 or the international standard ISO/IEC 17011:2004.

2. It must have an organizational structure that meets the requirements stipulated in Decision No. 26/2007/QD-BKHCN dated October 31, 2007 of the Minister of Science and Technology on the organization and operation of accreditation organizations.

3. Organize, link up organizations, or serve as the focal point for proficiency testing and inter-laboratory comparison programs in accordance with the international standard ISO/IEC 17043:2009 for laboratory accreditation programs.

4. Meet the requirements and conditions of one of the regional or international accreditation organizations that prescribe the conditions for accreditation activities corresponding to the registered accreditation programs, specifically as follows:

a) Accreditation organizations conducting accreditation activities for certification bodies of management systems and product certification bodies must meet the requirements stipulated by the Asia Pacific Accreditation Cooperation (PAC) and the International Accreditation Forum (IAF);

b) Accreditation organizations conducting accreditation activities for laboratories, calibration facilities, and inspection bodies must meet the requirements stipulated by the Asia Pacific Laboratory Accreditation Cooperation (APLAC), the International Accreditation Forum (IAF), and the International Laboratory Accreditation Cooperation (ILAC).

Within two years from the date of establishment, the accreditation organization must build its capacity to meet the conditions stipulated herein to become a member of a regional or international accreditation organization for the corresponding accreditation programs.

5. There must be at least two assessors, including one lead assessor, in each accreditation program. These assessors must be permanent staff members of the organization (civil servants or indefinite-term contract workers). The assessors must meet the following requirements:

a) General requirements:

- Hold a bachelor's degree or higher.

- Have at least four years of work experience in the technical field, including:

+ For lead assessors: at least two years of experience related to quality management, evaluating quality management systems of conformity assessment bodies.

+ For assessors: at least one year of experience related to quality management, evaluating quality management systems of conformity assessment bodies.

- Be trained and awarded a certificate of completion of a course and meet the requirements for accreditation assessment according to the relevant standards (ISO/IEC 17025, ISO/IEC 17020, ISO 15189, ISO/IEC 17021, ISO/IEC Guide 65, ISO/IEC 17024...) corresponding to the registered accreditation program.

- Regarding assessment experience:

+ For assessors: have conducted at least two accreditation assessments according to the relevant accreditation standards (ISO/IEC 17025, ISO/IEC 17020, ISO 15189, ISO/IEC 17021, ISO/IEC Guide 65, ISO/IEC 17024...) under the supervision of an approved lead assessor.

+ For lead assessors: meet the assessment experience requirements for assessors and have managed and directed at least two accreditation assessments according to the relevant accreditation standards (ISO/IEC 17025, ISO/IEC 17020, ISO 15189, ISO/IEC 17021, ISO/IEC Guide 65, ISO/IEC 17024...) under the supervision of an approved lead assessor.

b) Specific requirements: The expert must recognize testing organizations, calibration organizations, and appraisal organizations, in addition to meeting the general requirements set forth in point a, Clause 5 of this Article, must also meet other requirements specified in the ILAC-G11:07/2006 guidance document of the International Laboratory Accreditation Cooperation (ILAC).

6. Technical experts must meet the following requirements:

- Hold a bachelor's degree or higher.

- Having at least four years of work experience, including two years of technical experience related to the accreditation program.

The accreditation organization may enter into a contract with technical experts to support the assessment team in conducting evaluations.

7. Issued a Registration Confirmation Certificate for accreditation activities by the General Department of Standardization, Metrology, and Quality Control.

Chapter II

PROCEDURES FOR REGISTRATION AND SUPERVISION OF ACCREDITATION ACTIVITIES

Article 5. Application Documents

An accreditation organization that meets the conditions stipulated in Article 4 of this Circular shall prepare one set of application documents for accreditation activities and submit them to the General Department of Standardization, Metrology, and Quality Control. The application documents include:

1. An accreditation activity registration form according to the model prescribed in Appendix I of this Circular;

2. A copy of the Decision on Establishment;

3. A copy of the Scientific and Technological Activities Registration Certificate;

4. Documentation system (documents, procedures, evaluation processes, and other relevant documents) to demonstrate the capability to meet the requirements of the corresponding standards as stipulated in Clause 1 and Clause 2 of Article 4 of this Circular;

5. A description of the organizational structure and responsibilities of each position within the organizational structure;

6. A plan for implementation or results (if any) of the proficiency testing and inter-laboratory comparison programs for the registered accreditation program;

7. Evidence demonstrating compliance with the requirements and conditions of regional or international accreditation organizations, specifically as follows:

a) For accreditation organizations that are members of mutual recognition agreements for the recognition of conformity assessment results among regional or international accreditation organizations: Submit supporting documents along with the accreditation program and scope involved in the mutual recognition agreement;

b) For accreditation organizations that are not members of mutual recognition agreements for the recognition of conformity assessment results among regional or international accreditation organizations: Submit a commitment to build capabilities to meet the requirements and conditions of regional or international accreditation organizations to become members within two years from the date of establishment;

8. A list of lead assessors, assessors, and technical experts who meet the requirements stipulated in Clause 5 and Clause 6 of Article 4 of this Circular, accompanied by copies of training certificates (specialty, management system), work experience, and practical assessment experience according to the model prescribed in Appendix II of this Circular;

9. Samples of accreditation decision, accreditation certificate, and accreditation logo of the organization;

10. Results of recent accreditation activities performed (if any);

Article 6. Procedures for Issuing the Registration Confirmation Certificate for Accreditation Activities

1. For accreditation organizations as specified in point a, Clause 7 of Article 5 of this Circular

Within seven working days from the date of receipt of complete and valid application documents as stipulated in Article 5 of this Circular, the General Department of Standardization, Metrology, and Quality Control will review the application documents and issue the Registration Confirmation Certificate (hereinafter referred to as the Confirmation Certificate) according to the model prescribed in Appendix III of this Circular to the accreditation organization.

2. For accreditation organizations as specified in point b, Clause 7 of Article 5 of this Circular

The General Department of Standardization, Metrology, and Quality Control will establish an inspection team to conduct on-site inspections at the accreditation organization. The on-site inspection must be notified in writing to the accreditation organization that has submitted the application documents. The time limit for reviewing the application documents, conducting on-site inspections, and issuing the Registration Confirmation Certificate for accreditation organizations as stipulated in this clause is thirty working days from the date of receipt of complete and valid application documents. The Confirmation Certificate issued in this case is valid for two years from the date of issuance.

In the event of refusal to issue the Confirmation Certificate, the General Department of Standardization, Metrology, and Quality Control must notify the reasons in writing to the accreditation organization that has submitted the application documents.

3. Accreditation organizations that have registered accreditation activities and wish to change or supplement their registered activities must submit a change or supplementary registration and provide necessary evidence as stipulated in Clauses 2, 4, 5, 6, 7, 8, 9, and 10 of Article 5 of this Circular.

A request for changes or supplements to the activities according to the model prescribed in Appendix IV of this Circular.

Article 7. Supervision of Accreditation Activities

1. Accreditation organizations, after being issued the Registration Confirmation Certificate, must maintain their operations and compliance capabilities in accordance with the conditions stipulated in this Circular.

2. The General Department of Standardization, Metrology and Quality Control shall organize the supervision of accreditation activities. Such supervision shall be carried out through reviewing the documents and files of the accreditation organization; re-evaluating the files related to the expertise capacity; the certification accreditation process; interviewing relevant staff and experts; and re-checking the activities of conformity assessment bodies that have been accredited.

3. Measures requiring corrective actions, warnings, temporary suspension of effectiveness, and revocation of the Registration Confirmation Certificate for accreditation activities shall be applied when the accreditation organization violates the provisions of this Circular, Article 55 of the Law on Standards and Technical Regulations, and other relevant laws, specifically as follows:

a) Applying measures requiring corrective actions: when there is evidence of minor violations by the accreditation organization;

b) Applying warning measures: when there is evidence of the following violations by the accreditation organization:

- Repeated violations by the accreditation organization;

- Failure to take appropriate action after receiving notification from the competent authority regarding the violation of relevant laws by the conformity assessment body that has been accredited.

c) Applying measures to temporarily suspend the effectiveness of the issued Registration Confirmation Certificate when there is evidence of the following violations by the accreditation organization:

- Repeated violations affecting compliance with the conditions and requirements for accreditation organizations; or

- Lack of supervision over the activities of recognized conformity assessment bodies leading to serious violations of the requirements and conditions for such bodies; or

- Intentionally issuing or maintaining certification for conformity assessment bodies that seriously violate the requirements and conditions set forth in relevant regulatory documents.

d) Applying measures to revoke the issued Registration Confirmation Certificate when there is evidence of the following violations by the accreditation organization:

- Within sixty days from the date of the decision to temporarily suspend the effectiveness of the Registration Confirmation Certificate, the accreditation organization does not implement corrective measures; or

- Repeated violations significantly impacting compliance with the conditions and requirements for accreditation organizations; or

- Evidence of false declarations in the accreditation evaluation files; or

- Failure to meet the conditions stipulated in Clause 4, Article 4 of this Circular.

An accreditation organization whose Registration Confirmation Certificate has been revoked may only be considered for reissuance of the Registration Confirmation Certificate two years after the notice of revocation and after remedying the violations.

In cases where an accreditation organization that has been granted a time-limited Registration Confirmation Certificate has been established for two years, the General Department of Standardization, Metrology and Quality Control will conduct supervision of the accreditation organization's activities. If the accreditation organization fails to meet the conditions stipulated in Clause 4, Article 4 of this Circular, the General Department of Standardization, Metrology and Quality Control will decide to revoke the issued Registration Confirmation Certificate and simultaneously notify the principal management ministry to take adjustment and organizational measures.

Chapter III

RESPONSIBILITIES OF THE MANAGEMENT AUTHORITY, ACCREDITATION ORGANIZATIONS AND

RECOGNIZED CONFORMITY ASSESSMENT BODIES

Article 8. Responsibilities of the General Department of Standardization, Measurement and Quality

1. Implementing this Circular.

2. Receive and review applications for accreditation activities; issue and revoke the Certificate of Registration for Accreditation Activities for accreditation organizations in accordance with this Circular.

3. Supervise and manage the accreditation activities of accreditation organizations.

4. Publicly announce on the electronic information website of the General Department of Standardization, Measurement and Quality the accreditation organizations that have registered their accreditation activities.

5. Report annually and at any time when required on the issuance of Certificates of Registration for Accreditation Activities and the status of accreditation activities to the Ministry of Science and Technology.

Article 9. Responsibilities of accreditation organizations

1. Comply with the provisions of this Circular and related legal regulations.

2. Ensure that conformity assessment bodies recognized comply with the conditions and requirements stipulated in the corresponding accreditation standards and relevant legal regulations.

3. Be responsible for the results of accreditation conducted by themselves.

4. Conduct accreditation activities openly, transparently, and without discrimination.

5. Announce procedures, processes for assessment and accreditation, and other related requirements.

6. Collect and disburse accreditation fees according to agreements between the accreditation organization and the conformity assessment body, and publicly disclose these financial transactions.

7. Report annually and at any time when required on the results of accreditation activities according to the model specified in Appendix V of this Circular to the General Department of Standardization, Measurement and Quality.

8. Notify the General Department of Standardization, Measurement and Quality of any changes affecting the registered accreditation activities within fifteen days from the date of change.

Article 10. Responsibilities of recognized conformity assessment bodies

1. Maintain operations and management systems in compliance with the conditions and requirements set by the accreditation organization and the corresponding accreditation standards.

2. Adhere to supervision requirements imposed by competent state authorities regarding accreditation activities and conformity assessment activities.

3. Ensure compliance with the provisions of the Law on Standards and Technical Regulations, the Law on Product and Goods Quality, and related legal regulations.

Chapter IV

IMPLEMENTATION

Article 11. Effective Date

This Circular takes effect forty-five days from the date of issuance.

Article 12. Implementation Organization

1. The General Department of Standardization, Measurement and Quality shall organize the implementation of guidance and management over the activities of accreditation organizations in Vietnam in accordance with this Circular and other relevant regulations.

2. Accreditation organizations violating the provisions of this Circular will be subject to legal sanctions depending on the nature and severity of the violation.

3. In cases where national standards, international standards, or legal regulations mentioned in this Circular are amended, supplemented, or replaced, the revised, supplemented, or newly published standards and regulations shall be applied.

4. During the implementation of this Circular, if there are any difficulties, agencies, organizations, and individuals shall promptly reflect them to the Ministry of Science and Technology for consideration and resolution./.