Thông tư 21/2010/TT-BKHCN

CIRCULAR

REGULATING MANAGEMENT ON ACCREDITATION ACTIVITIES IN VIETNAM

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006;
Pursuant to Decree No. 127/2007/ND-CP dated August 1, 2007 of the Government detailing the implementation of some articles of the Law on Standards and Technical Regulations;
Pursuant to Decree No. 28/2008/ND-CP dated March 14, 2008 of the Government regulating functions, tasks, powers and organizational structure of the Ministry of Science and Technology;
the Minister of Science and Technology release regulations on the management of accreditation activities in Vietnam are as follows:

Chapter 1.

GENERAL PROVISIONS

Article 1. Regulation scope and subjects of application

1. This circular regulate the management of accreditation activities in Vietnam, including the conditions for accreditation organizations; the order and procedures for registration of accreditation activities; supervision of accreditation activities and the responsibility of the relevant parties.

2. This Circular applies to organizations that provide accreditation services (hereinafter referred to as accreditation organizations), conformity assessment institutions and the state management agencies related to accreditation activities.

Article 2. Interpretation of terms

In this Circular, the terms below are construed as follows:

1. Evaluation specialist is a qualified person whom is designated by an accreditation organization to evaluate the conformity assessment bodies. Evaluation specialists can perform an assessment independently or act as a member of the assessment team.

2. Chief evaluation specialist is a qualified person to whom an accreditation organization assigned to direct the implementation of specified evaluation activities.

3. Technical specialist is a qualified person whom is designated by an accreditation organization to ensure the provision of specific knowledge and skills about the scope of recognition to be assessed. A technical expert is a member of assessment team, supporting technically the assessment team, but is not an evaluation specialist.

4. Certification of registration of accreditation activities is consideration and evaluation of the capacity of an accreditation organization by a competent state agency in accordance with conditions for accreditation activities to grant a certificate of registration of accreditation activities.

Article 3. General principles

1. Accreditation organizations shall ensure their operational capacity meet the requirements specified in national standards, international standards and regulations of the International Accreditation Forum (IAF), International Laboratory Accreditation Cooperation (ILAC), Asian Pacific Laboratory Accreditation Cooperation (APLAC), and Pacific Accreditation Cooperation (PAC).

2. Experts of the accreditation organization must be trained and understand the standards, procedures, orders and principles for assessment corresponding to the accreditation program; meet capacity requirements in accordance recognized by the International Accreditation Forum (IAF), International Laboratory Accreditation Cooperation (ILAC).

Article 4. Conditions for accreditation

Being a scientific professional units functioning primarily to provide accreditation services founded by the ministries that manage branches or fields; being granted a certificate of registration for science and technology activities in accordance with the law on science and technology; satisfying the conditions specified in Clause 2 of Article 54 of the Law on Standards and Technical Regulations, in particularly as follows:

1. Management systems and operational capacity of an accreditation organization must meet the requirements specified in national standard TCVN ISO / IEC 17011: 2007 or International Standard ISO / IEC 17011:2004.

2. To have organization and structure that meet the requirements specified in Decision No. 26/2007/QD-BKHCN on 31/10/2007 by Minister of Science and Technology that regulate organizational mode and operation of accreditation organizations.

3. To organize, jointly organize or act as centre for proficiency testing programs, inter-laboratory comparison accordance with international standard ISO / IEC 17043:2009 for laboratories accreditation program.

4. To meet the requirements and conditions of one of the regional or international accreditation organizations regulating accreditation activities corresponding to the registration accreditation program, as follows:

a) Accreditation organizations conducting accreditation activities of accreditation organizations, management systems, product certification organization must meet the requirements prescribed by The Pacific Accreditation Cooperation (PAC) and the International Accreditation Forum (IAF);

b) Accreditation organizations conducting accreditation activities of testing laboratories, calibration laboratories and inspection organization must meet the provisions of Asian Pacific Laboratory Accreditation Cooperation (APLAC), International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC).

Within 02 years from the date of establishment, accreditation organizations must generate their capacity to meet the conditions specified in this clause so as to become members of international or regional accreditation organization accreditation organization for corresponding accreditation programs.

5. To have at least 02 evaluation specialists, including 01 chief evaluation specialist in each accreditation program. These experts are official staff of the organization (or officials of employee with a contract of indefinite term). The evaluation specialists must meet the following requirements:

a) General requirements:

- Having a university degree or higher.

- At least 04 years of experience working in technical areas, including:

+ For the chief evaluation specialist: at least 02 years of experience related to quality management and evaluation of the quality management system of conformity assessment institutions.

+ For the evaluation specialist: at least 01 years of experience related to quality management and evaluation of the quality management system of conformity assessment institutions.

- Being trained and granted a certificate of the course and meet the requirements for accreditation evaluation under the standards (ISO / IEC 17025, ISO / IEC 17020, ISO 15189, ISO / IEC 17021, ISO / IEC Guide 65, ISO / IEC 17024 ...) corresponding to the registration accreditation program.

- The experience of assessment:

+ For evaluation specialists: having conducted at least 02 evaluations of accreditation in accordance with accreditation standards (ISO / IEC 17025, ISO / IEC 17020, ISO 15189, ISO / IEC 17021, ISO / IEC Guide 65, ISO / IEC 17024 ...) under the supervision of approved the chief evaluation specialist.

+ For the chief evaluation specialists: meeting the requirements for experience of evaluation for evaluation specialist and have managed and directed at least 02 evaluations of accreditation in accordance with accreditation standards (ISO / IEC 17025 , ISO / IEC 17020, ISO 15189, ISO / IEC 17021, ISO / IEC Guide 65, ISO / IEC 17024 ...) under the approved supervision of the chief evaluation specialists.

b) Specific requirements: The evaluation specialist accredit testing organizations, standardization organizations, expertise organization, in addition to meeting the requirements mentioned in point a clause 5 of this Article, must meet other requirements specified in the instruction ILAC-G11: 07/2006 by International Laboratory Accreditation Cooperation (ILAC).

6. Technical experts must meet the following requirements:

- Having a university degree or higher.

- At least 04 years of working experience, including 02 years of technical experience related to the registration accreditation program.

Accreditation organizations may sign a contract with technical experts to support the assessment team to carry out the assessment.

7. Obtaining a certificate of registration of accreditation activities from the General Department of Standards and Quality Measurement.

Chapter 2.

ORDER AND PROCEDURES FOR REGISTRATION AND SUPERVISION OF ACCREDITATION ACTIVITIES

Article 5. Registration dossier

Accreditation organizations that meet the conditions specified in Article 4 of this Circular, shall 01 set of dossier for registration of accreditation activities and submit it to the General Department for Standards and Quality Measurement.

A registration dossier includes:

1. Registration certificate for accreditation activities in the form prescribed in Annex I to this Circular;

2. A copy of establishment decision;

3. A copy of certificate of registration of science and technology;

4. A system of documents (documents, processes, procedures for assessment and other relevant documents) to prove that the operational capacity is suitable to the requirements of corresponding standards prescribed in Clause 1 and Clause 2 of Article 4 of this Circular.

5. An explanation of organization and structure and responsibilities for each position in the organization and structure.

6. An implementation plan or implementation results (if any) proficiency testing program, inter-laboratory comparison for the registration accreditation program.

7. Evidences to demonstrate the satisfaction with the requirements and conditions of the regional and international accreditation organizations, as follows:

a) For the accreditation organizations acting as a member that has signed or participated an agreement of mutual accreditation with respect to results of conformity assessment of international or regional accreditation organization: Submit proving documentation together with the program and field of accreditation to be participated with respect to the mutual accreditation agreement;

b) For accreditation organizations that are not members signing or participating an agreement of mutual accreditation of results of conformity assessment of international or regional accreditation organization: Submit written commitments stating that they will build their capacity to meet requirements and conditions of regional or international accreditation organizations so as to become members of these organizations within 02 years since their establishment.

8. List of chief evaluation specialists, evaluation specialists, and technical experts meeting the requirements specified in Clauses 5 and 6 of Article 4 in the form prescribed in Annex II of this Circular, together with corresponding copies of training certificates (professional knowledge, management system), working experience, and practical assessment experience.

9. A template of accreditation decision, a certificate of accreditation and seal (logo) of accreditation of the organization.

10. Most recent results of accreditation activities (if any).

Article 6. Order and procedures for certificate registration accreditation

1. For accreditation organizations stipulated in clause 7 of Article 5 of this Circular.

Within 07 working days after receipt of a complete and valid dossier as specified in Article 5 of this Circular, the General Department for Standards and Quality Measurement conduct the appraisal of the dossier, grant a certificate of registration of accreditation activities (hereinafter referred to as the certificate) in the form prescribed in Annex III to this Circular to accreditation organizations.

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

General Department for Standards and Quality Measurement establish a practical evaluation team in the accreditation organization. The practical evaluation in the accreditation organization must be notified in writing by the General Department for Standards and Quality Measurement to the accreditation organization that has submitted the dossier for registration. Time limit to evaluate the dossier, evaluate the practical matters of the accreditation organization, and issue a certificate of registration for accreditation activities for accreditation organizations specified in this clause is 30 working days after receipt of a complete and valid dossier. Certificate issued in this case is valid for 02 years from the date of grant.

In case of refusal to grant a certification, the General Department for Standards and Quality Measurement must notify in writing, stating the reasons to the accreditation organization that have filed the dossier of registration.

3. Accreditation organizations which have registered accreditation activities when having a need for change or supplement to accreditation activities shall perform procedure for registration of change or supplement and provide evidence necessary under the provisions of Clause 2, 4, 5, 6, 7, 8, 9, 10, Article 5 of this Circular.

A written in the form prescribed in the Appendix IV of this Circular that request for changes, supplementation of activities.

Article 7. Supervision of accreditation activities

1. After getting a Certificate, accreditation organizations must maintain their operation and capacity in accordance with the conditions stipulated in this Circular.

2. General Department for Standards and Quality Measurement organize the supervision of the activities of accreditation organizations. The supervision of accreditation activities are conducted through the review of documents, records of the accreditation organizations; re-examination of records relating to competence of experts; the process of granting accreditation certificate; interviews of relevant officials and experts; re-examination the operation of conformity assessment institutions that has been recognized.

3. Applying the measures to require corrective action, warning, temporary suspension of validity or cancellation of registration certificate of accreditation activities when accreditation organization violate the provisions of this Circular or the provisions in Article 55 of Law on Standards and Technical Regulations and the provisions of relevant laws, as follows:

a) Applying measures to require corrective action: when there is evidence of a mild violation of accreditation organizations;

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

- The repetitive violations of accreditation organizations;

- No appropriate action for treatment has been done after getting the notice of competent state agencies on the fact that the recognized conformity assessment organization has already violated the regulations of the relevant laws.

c) Applying measures to temporarily suspend the validity of the granted certificate when there is an evidence of following violation of the accreditation organizations:

- The violations are repeatability and affect compliance with the conditions and requirements for accreditation organizations, or

- Lack of supervision of the activities by the conformity assessment organization, leading to the serious violations of the requirements and conditions for conformity assessment organization; or

- Intentionally granting and/or maintaining an accreditation certificate to the conformity assessment organizations that have caused serious violations to the requirements and conditions for conformity assessment organizations stipulated in the related legal documents.

d) Applying measures to cancel the granted Certificate when there is evidence of following violations of the accreditation organizations:

- Within 60 days after getting the decision to temporarily suspend the validity of Certificate, accreditation organizations do not implement remedial measures, or

- The violations are repetitive and seriously affect the compliance of the conditions and requirements for accreditation organizations, or

- There is evidence of dishonesty in the declaration of the dossier for accreditation evaluation, or

- Not meeting the conditions specified in clause 4 of Article 4 of this Circular.

Accreditation organizations of which the certificate was revoked may only be considered for re-certifications after 02 years, since they get the notice of cancellation of validity and violations is made good.

Where accreditation organizations have been granted certificate with a fixed period of time, the General Department for Standards and Quality Measurement shall conduct supervision of activities of the accreditation organizations after 02 years of establishment. Where accreditation organizations did not meet the conditions specified in Clause 4, Article of this Circular, the General Department for Standards and Quality Measurement decide to cancel the granted certificate, and also notify the Ministry in charge of managing to take measures to adjust and rearrange the accreditation organizations accordingly.

Chapter 3.

RESPONSIBILITIES OF MANAGEMENT ORGANIZATION ACCREDITATION ORGANIZATION AND RECOGNIZED CONFORMITY ASSESSMENT ORGANIZATION

Article 8. Responsibility of the General Department for Standards and Quality Measurement

1. Organizing the implementation of this Circular

2. Receiving and evaluating dossiers for registration of accreditation activities; granting and revoking certificates of registration for accreditation activities to accreditation organization under the provisions of this Circular.

3. Supervising and managing accreditation activities of the accreditation organization.

4. Publicizing the accreditation organizations that have registered for accreditation activities on the website of the General Department for Standards and Quality Measurement.

5. Reporting annually or irregularly upon requirement concerning situation of granting Certificate of registration for accreditation activities and situation of accreditation activities to the Ministry of Science and Technology.

Article 9. Responsibilities of Accreditation Organizations

1. Complying with the provisions of this Circular and other relevant legal documents.

2. Ensuring recognized conformity assessment organization is in compliance with the conditions and requirements specified in the corresponding accreditation standards and the provisions of relevant laws.

3. Being responsible for the results of accreditation done by themselves.

4. Being public and transparent and without discrimination in carrying accreditation activities.

5. Publishing procedures, formalities for evaluation, accreditation and other relevant requirements.

6. Receiving and spending expenses from accreditation under the agreement between the accreditation organization and the conformity assessment organization and make public the cost of accreditation.

7. Reporting annually or irregularly upon requirement for results of accreditation activities in the form prescribed in Annex V of this Circular to the General Department for Standards and Quality Measurement.

8. Notifying the General Department for Standards and Quality Measurement of any changes that affect the registered accreditation activities within fifteen days from the date of any change.

Article 10. Responsibility of the recognized conformity assessment accreditation

1. Maintaining the operation and management system in accordance with the conditions and requirements for accreditation organizations and the requirements of corresponding accreditation standards.

2. Complying with supervision requirements of the competent state management agency over accreditation activities and conformity assessment activities.

3. Ensuring compliance with the provisions of the Law on Standards and Technical Regulation, Law on Quality Control of Products and other relevant legal documents.

Chapter 4.

ORGANIZATION OF IMPLEMENTATION

Article 11. Effect of implementation

This Circular takes effect after 45 days from the date of signing.

Article 12. Organization of implementation

1. General Department for Standards and Quality Measurement shall organize the guidance and management of the operation of accreditation organizations in Vietnam as stipulated in this Circular and other relevant regulations.

2. Accreditation organizations that violate the provisions of this Circular, depending on the nature and seriousness of violations, will be dealt with according to law.

3. In the case where national standards, international standards, legal documents mentioned in this Circular have been revised, supplemented or replaced; the revised or new ones are applied.

4. In the course of implementation of the Circular, if any problems arise, agencies, organizations and individuals promptly inform the Ministry of Science and Technology for consideration and settlement. /.