Decree No. 107/2016/ND-CP on conditions for operating conformity assessment services

DECREE

Regulations on Conditions for Operating Certification Services

                        

Pursuant to the Law on Government Organization dated June 19, 2015;

Pursuant to the Law on Technical Standards and Conformity Assessment Procedures dated June 29, 2006;

Pursuant to the Law on Product Quality and Goods Quality dated July 21,121, 2007;

Pursuant to the Investment Law dated June 26, 112014;

Pursuant to the proposal of the Minister of Science and Technology;

The Government issues this Decree stipulating conditions for operating certification services.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Decree stipulates conditions for operating certification services in Vietnam, including organizations conducting conformity assessment of products, goods, production processes, service provision, and environmental suitability with published standards and corresponding technical regulations, and organizations recognizing conformity assessment bodies.

Article 2. Applicability

This Decree applies to:

1. Organizations and enterprises engaged in operating certification services within the territory of Vietnam regarding:

a) Testing;

b) Inspection;

c) Examination;

d) Certification;

đ) Recognition of conformity assessment bodies.

2. State management agencies and related organizations and individuals.

Article 3. Explanation of Terms

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

1. A conformity assessment body is an organization that conducts testing, inspection, examination, and certification activities to assess the conformity of products, goods, production processes, service provision, and environmental suitability with published standards and corresponding technical regulations.

2. An accreditation body is an organization that evaluates and confirms the competence of conformity assessment bodies in accordance with the requirements specified in the relevant standards.

Article 4. Principles of Registration for Activities

1. A conformity assessment body wishing to register its conformity assessment activities for products, goods, production processes, service provision, processes, and environment (hereinafter referred to as the conformity assessment object) under the responsibility and sectoral management of a ministry assigned specific functions, tasks, and authorities shall register its activities with that ministry.

2. A conformity assessment body wishing to register its conformity assessment activities for multi-sectoral conformity assessment objects under the management responsibility of two or more ministries shall register its activities with the Ministry of Science and Technology.

3. A conformity assessment body wishing to register its conformity assessment activities for two or more specialized conformity assessment objects under the management responsibility of two or more ministries shall register its activities with each respective ministry managing those objects.

Chapter II

CONDITIONS FOR OPERATING TESTING SERVICES

Article 5. Conditions for Operating Testing Services for Product and Good Quality

1. It must be an organization established in accordance with the provisions of the law.

2. It must have a management system and operational capacity meeting the requirements set forth in the national standard TCVN ISO/IEC 17025:2007 or the international standard ISO/IEC 17025:2005 or the national or international standard for specialized testing.

3. It must have at least four full-time testing staff members (civil servants or employees under a fixed-term contract of twelve months or longer, or employees under an indefinite-term contract), trained in the national standard TCVN ISO/IEC 17025:2007 or the international standard ISO/IEC 17025:2005 or the national or international standard for specialized testing.

In cases where additional testing fields are added, there must be at least two full-time testing staff members (civil servants or employees under a fixed-term contract of twelve months or longer, or employees under an indefinite-term contract) corresponding to the registered additional testing field, trained in the national standard TCVN ISO/IEC 17025:2007 or the international standard ISO/IEC 17025:2005 or the national or international standard for specialized testing.

Article 6. Documents for Application to Issue a Quality Testing Product and Goods Registration Certificate

1. Receiving Authority:

The registration application receiving authority shall operate according to the principle stipulated in Article 4 of this Decree.

2. In case of new issuance, the documents include:

a) A quality testing activity registration form according to Form No. 01 attached to this Decree;

b) A copy of the Decision on Establishment or Business Registration Certificate or Investment Registration Certificate;

c) A list of quality testers according to Form No. 02 attached to this Decree and related certificates and documents for each tester including: A copy of the Recruitment Decision or Labor Contract; a copy of the corresponding training certificate as prescribed in Clause 3, Article 5 of this Decree;

In case the testing organization has been recognized by the organization specified in Article 21 of this Decree or foreign recognition organizations specified in Article 25 of this Decree, the testing organization submits a copy of the Recognition Certificate along with the recognized scope.

In case the testing organization has not yet been recognized, the testing organization submits relevant documents, testing procedures, and other related documents to prove its testing capacity in accordance with the corresponding standard requirements stipulated in Clause 2, Article 5 of this Decree.

e) A sample of the Test Result Report.

3. In case of supplementary or amended issuance, the documents include:

a) A supplementary or amended quality testing activity registration form according to Form No. 05 attached to this Decree;

b) A supplementary or amended list of quality testers according to Form No. 02 attached to this Decree and related certificates and documents for each tester including: A copy of the Recruitment Decision or Labor Contract; a copy of the corresponding training certificate as prescribed in Clause 3, Article 5 of this Decree;

c) A supplementary or amended list of testing machines, equipment, and measuring tools serving the testing activities for the registered field according to Form No. 04 attached to this Decree;

In case the testing organization has been recognized by the organization specified in Article 21 of this Decree or foreign recognition organizations specified in Article 25 of this Decree, the testing organization submits a copy of the Recognition Certificate along with the recognized scope.

In case the testing organization has not yet been recognized, the testing organization submits relevant documents, testing procedures, and other related documents to prove its testing capacity in accordance with the corresponding standard requirements stipulated in Clause 2, Article 5 of this Decree.

4. In case of reissuance, the documents include:

a) An application for reissue of the Registration Certificate according to Form No. 06 attached to this Decree;

b) The original Registration Certificate that is damaged (if applicable) in the case of a damaged Registration Certificate.

5. Sixty days before the expiration date of the Registration Certificate, if there is a need to continue participating in testing activities, the testing organization must prepare one set of documents as required for new issuance under Clause 2 of this Article and submit it to the receiving authority as prescribed in Clause 1 of this Article.

Article 7. Submission Forms

The testing organization prepares one set of documents according to Article 6 of this Decree and submits them through one of the following methods:

1. In case of direct submission at the receiving authority's office, copies of certificates and documents prescribed in Article 6 of this Decree that have not been authenticated must be accompanied by originals for verification.

2. In case of submission via postal service, the testing organization must submit authenticated copies of certificates and documents prescribed in Article 6 of this Decree.

3. In case of submission through the electronic portal of the receiving authority, it shall be conducted in accordance with online public service procedures.

Article 8. Procedure for Issuing the Certificate of Testing Activities Registration

1. New issuance:

a) In case the application file is incomplete as prescribed, within five working days from the date of receipt of the file, the agency receiving the file shall notify in writing to request the testing organization to amend and supplement the file;

b) In case the application file is complete and valid, within ten working days from the date of receipt of the file, the sector management body responsible for issuing the Certificate of Testing Activities for the organization according to Model No. 10 attached to this Decree;

c) The validity period of the Certificate does not exceed five years from the date of issuance.

2. Additional or amended issuance:

a) The additional or amended Certificate applies to cases where the testing organization supplements, expands, or narrows the scope of testing activities;

b) The procedure for issuing the Certificate shall be carried out in accordance with the provisions of point a and point b of Clause 1 of this Article;

c) The validity period of the Certificate shall be recorded according to the validity period of the previously issued Certificate of Testing Activities Registration.

3. Reissuance:

a) The reissued Certificate applies to cases where the testing organization has a valid Certificate but it is lost, damaged, or there is a change in the name or address of the organization;

b) Within the validity period of the Certificate, if the testing organization requests a reissue of the Certificate, it must prepare one set of application files in accordance with Clause 4 of Article 6 of this Decree and submit them to the agency receiving the file;

c) Within five working days from the date of receipt of a complete and valid application file, the sector management body responsible for reissuing the Certificate for the testing organization. If the requirements are not met, the agency receiving the file shall notify in writing and specify the reasons;

d) The validity period of the Certificate shall be recorded according to the validity period of the previously issued Certificate of Testing Activities Registration.

Chapter III

CONDITIONS FOR OPERATING TESTING SERVICES

Article 9. Conditions for Operating Testing Services for Product Quality Inspection During Use

1. It must be an organization established in accordance with the provisions of the law.

2. Having a management system and operational capacity that meet the requirements specified in the national standard TCVN ISO 9001:2008 or other national or international standards applicable to specialized inspection.

3. Having at least four full-time inspectors of the organization (civil servants or employees under a contract of at least twelve months or indefinite-term contracts), who meet the professional requirements for the corresponding inspection field, and have been trained on the national standard TCVN ISO 9001:2008.

In case of expanding the scope of inspection activities, the organization must have at least two full-time inspectors corresponding to the expanded inspection fields, who have been trained on the national standard TCVN ISO 9001:2008.

4. Having machinery, equipment, and tools as required by the inspection process.

Article 10. Application Files for Requesting the Issuance of the Certificate of Testing Activities Registration for Product Quality Inspection During Use

1. Receiving Authority:

The agency receiving the application files for registration of inspection activities shall follow the principles stipulated in Article 4 of this Decree.

2. In case of new issuance, the documents include:

a) An application form for inspection activities according to Model No. 01 attached to this Decree;

b) A copy of the Decision on Establishment or Business Registration Certificate or Investment Registration Certificate;

c) A list of inspectors according to Model No. 02 attached to this Decree and relevant certificates and documents for each inspector including: Copies of Recruitment Decision or Labor Contract; copies of relevant diplomas and training certificates as prescribed in Clause 3 of Article 9 of this Decree;

d) A list of machinery, equipment, and tools serving inspection activities according to Model No. 04 attached to this Decree;

In case the inspection organization has been certified by a certification body with a Certificate of Conformity to the TCVN ISO 9001:2008 or ISO 9001:2008 standard or recognized by an organization specified in Article 21 of this Decree or a foreign recognition organization specified in Article 25 of this Decree for conformity to national or international standards for specialized fields, the inspection organization shall submit a copy of the Certificate of Conformity to the TCVN ISO 9001:2008 or ISO 9001:2008 standard or a copy of the Recognition Certificate along with the recognized scope.

In case the inspection organization has not been recognized or certified for conformity to the TCVN ISO 9001:2008 or ISO 9001:2008 standard, the inspection organization shall submit relevant documents, inspection procedures, and other related documents to prove its operational capacity in compliance with the corresponding standard requirements stipulated in Clause 2 of Article 9 of this Decree.

e) Sample Certificate of Inspection.

3. In case of supplementary or amended issuance, the documents include:

a) An application form for additional or amended inspection activities according to Model No. 05 attached to this Decree;

b) A list of additional or amended inspectors according to Model No. 02 attached to this Decree and relevant certificates and documents for each inspector including: Copies of Recruitment Decision or Labor Contract; copies of relevant diplomas and training certificates as prescribed in Clause 3 of Article 9 of this Decree;

c) Documents proving the additional or amended inspection capacity meeting the requirements stipulated in Clause 2 of Article 9 of this Decree, specifically as follows:

In case the inspection organization has been certified by a certification body with a Certificate of Conformity to the TCVN ISO 9001:2008 or ISO 9001:2008 standard or recognized by an organization specified in Article 21 of this Decree or a foreign recognition organization specified in Article 25 of this Decree for conformity to national or international standards for specialized fields, the inspection organization shall submit a copy of the Certificate of Conformity to the TCVN ISO 9001:2008 or ISO 9001:2008 standard or a copy of the Recognition Certificate along with the recognized scope.

In case the inspection organization has not been recognized or certified for conformity to the TCVN ISO 9001:2008 or ISO 9001:2008 standard, the inspection organization shall submit relevant documents, inspection procedures, and other related documents to prove its operational capacity in compliance with the corresponding standard requirements stipulated in Clause 2 of Article 9 of this Decree.

4. In case of reissuance, the documents include:

a) An application for reissue of the Registration Certificate according to Form No. 06 attached to this Decree;

b) The original Registration Certificate that is damaged (if applicable) in the case of a damaged Registration Certificate.

5. Sixty days before the Certificate expires, if there is a need to continue participating in inspection activities, the inspection organization must prepare one set of documents as stipulated in Clause 2 of Article 10 of this Decree and submit it to the receiving authority as prescribed in Clause 1 of Article 10 of this Decree.

Article 11. Forms of submitting applications

The inspection organization shall prepare one set of documents in accordance with Article 10 of this Decree and submit them through one of the following methods:

1. In the case of submitting documents directly at the office of the receiving authority, original copies of certificates and documents specified in Article 10 of this Decree that have not been certified must be available for verification.

2. In the case of submitting documents via postal service, the inspection organization must send certified copies of the certificates and documents specified in Article 10 of this Decree.

3. In case of submission through the electronic portal of the receiving authority, it shall be conducted in accordance with online public service procedures.

Article 12. Procedures for Issuing Inspection Activity Registration Certificates

1. New issuance:

a) If the application is incomplete according to regulations, within five days from the date of receipt of the application, the receiving authority shall notify in writing the inspection organization to amend and supplement the application.

b) If the application is complete and valid, within ten working days from the date of receipt of the application, the sector management agency responsible for issuing the Certificate shall issue the Certificate to the inspection organization according to Model No. 10 attached to this Decree.

c) The validity period of the Certificate does not exceed five years from the date of issuance.

2. Additional or amended issuance:

a) The supplementary Certificate applies to cases where the inspection organization supplements, expands, or narrows the scope of inspection activities.

b) The procedures for issuing the Certificate are carried out in accordance with the provisions of points a and b of Clause 1 of this Article.

c) The validity period of the Certificate is recorded according to the validity period of the previously issued Inspection Activity Registration Certificate.

3. In the case of reissuing the Certificate:

a) The reissued Certificate applies to cases where the inspection organization has a valid Certificate but it is lost, damaged, or the name or address of the organization has changed.

b) Within the validity period of the Certificate, if the inspection organization requests a reissue of the Certificate, it must prepare one set of documents requesting the reissue of the Certificate as stipulated in Clause 5 of Article 10 of this Decree and submit it to the receiving authority.

c) Within five working days from the date of receipt of a complete and valid application, the sector management agency responsible for reissuing the Certificate shall issue the Certificate to the inspection organization. If the requirements are not met, the receiving authority shall notify in writing and specify the reasons.

d) The validity period of the Certificate is recorded according to the validity period of the previously issued Inspection Activity Registration Certificate.

Chapter IV

CONDITIONS FOR OPERATING QUALITY INSPECTION SERVICES

Article 13. Conditions for operating quality inspection services for products and goods

1. It must be an organization established in accordance with the provisions of the law.

2. Having a management system and operational capacity meeting the requirements specified in the national standard TCVN ISO/IEC 17020:2012 or the international standard ISO/IEC 17020:2012 or the national standard or international standard for specialized inspections.

3. Having at least four full-time inspectors of the organization (civil servants or employees under a fixed-term contract of twelve months or more or indefinite-term contracts), who meet the following conditions:

a) Having a college degree or higher and relevant expertise for the inspected products or goods.

b) Being trained in the national standard TCVN ISO/IEC 17020:2012 or the international standard ISO/IEC 17020:2012 or the national standard or international standard for specialized inspections.

When expanding the scope of inspection activities, the organization must have at least two full-time inspectors corresponding to the additional inspection fields registered, who meet the conditions stipulated in this clause.

Article 14. Documents for Application to Obtain a Quality Product and Goods Appraisal Registration Certificate

1. Receiving Authority:

The agency receiving the application for quality product and goods appraisal activities shall follow the principles set forth in Article 4 of this Decree.

2. In case of new issuance, the documents include:

a) An application form for quality product and goods appraisal activities according to Model No. 01 attached to this Decree;

b) A copy of the Decision on Establishment or Business Registration Certificate or Investment Registration Certificate;

In case the appraisal organization has been recognized by the recognition organization as prescribed in Article 21 of this Decree or foreign recognition organizations as prescribed in Article 25 of this Decree, the appraisal organization shall submit a copy of the Recognition Certificate along with the scope of recognition.

In case the appraisal organization has not yet been recognized, the appraisal organization shall submit relevant documents, appraisal procedures, and other related documents to prove its capability in accordance with the corresponding standard requirements as stipulated in Clause 2, Article 13 of this Decree.

e) Sample Appraisal Certification.

3. In case of supplementary or amended issuance, the documents include:

a) An additional or amended application form for quality product and goods appraisal activities according to Model No. 05 attached to this Decree;

b) An additional or amended list of appraisers according to Model No. 02 attached to this Decree and relevant certificates and documents for each appraiser including: a copy of the Recruitment Decision or Labor Contract; copies of degrees and certificates as stipulated in Clause 3, Article 13 of this Decree; a summary of work experience and appraisal activity experience according to Model No. 03 attached to this Decree and documents proving the appraisal experience of quality products and goods of the appraiser;

In case the appraisal organization has been recognized by the recognition organization as prescribed in Article 21 of this Decree or foreign recognition organizations as prescribed in Article 25 of this Decree, the appraisal organization shall submit a copy of the Recognition Certificate along with the scope of recognition.

In case the appraisal organization has not yet been recognized, the appraisal organization shall submit relevant documents, appraisal procedures, and other related documents to prove its capability in accordance with the corresponding standard requirements as stipulated in Clause 2, Article 13 of this Decree.

4. In case of reissuance, the documents include:

a) An application for reissue of the Registration Certificate according to Form No. 06 attached to this Decree;

b) The original Registration Certificate that is damaged (if applicable) in the case of a damaged Registration Certificate.

5. Sixty days before the expiration date of the Certificate's validity period, if there is a need to continue participating in quality product and goods appraisal activities, the appraisal organization must prepare one set of documents as required for new issuance under Clause 2 of this Article and submit it to the agency receiving the application as prescribed in Clause 1 of this Article.

Article 15. Forms of submitting application files

The appraisal organization shall prepare one set of application files in accordance with Article 14 of this Decree and submit them in one of the following forms:

1. In cases where the application file is submitted directly at the office of the agency receiving the file, copies of certificates and documents specified in Article 14 of this Decree that have not been certified must be accompanied by original documents for verification.

2. In cases where the application file is sent through postal service, the appraisal organization must submit certified copies of the certificates and documents specified in Article 14 of this Decree.

3. In case of submission through the electronic portal of the receiving authority, it shall be conducted in accordance with online public service procedures.

Article 16. Procedures for Issuing the Certificate of Registration for Appraisal Activities

1. New issuance:

a) In cases where the application file is incomplete according to the regulations, within five days from the date of receipt of the registration file, the agency receiving the file shall notify in writing the appraisal organization to amend and supplement the file.

b) In cases where the application file is complete and valid, within ten working days from the date of receipt of the file, the sector management agency responsible for issuing the certificate shall issue the Certificate of Registration for Appraisal Activities to the appraisal organization in accordance with Model No. 10 attached to this Decree.

c) The validity period of the Certificate does not exceed five years from the date of issuance.

2. Additional or amended issuance:

a) The supplementary or amended certificate applies to situations where the appraisal organization supplements, expands, or narrows the scope of its appraisal activities.

b) The procedures for issuing the Certificate are carried out in accordance with the provisions of points a and b of Clause 1 of this Article.

c) The validity period of the certificate is recorded according to the validity period of the previously issued Certificate of Registration for Appraisal Activities.

3. Reissuance:

a) The reissued certificate applies to situations where the appraisal organization has a valid certificate but it is lost, damaged, or there is a change in the name or address of the organization.

b) Within the validity period of the certificate, if the appraisal organization requests a reissue of the certificate, the organization shall prepare one set of application files for reissuance in accordance with Clause 4 of Article 14 of this Decree and send it to the agency receiving the file.

c) Within five working days from the date of receipt of a complete and valid application file, the sector management agency responsible for reissuing the certificate shall issue the certificate to the appraisal organization. If the requirements are not met, the agency receiving the file shall notify in writing and specify the reasons.

d) The validity period of the certificate is recorded according to the validity period of the previously issued Certificate of Registration for Appraisal Activities.

Chapter V

CONDITIONS FOR OPERATING PRODUCT CERTIFICATION SERVICES AND MANAGEMENT SYSTEM CERTIFICATION

CERTIFICATION OF MANAGEMENT SYSTEM

Article 17. Conditions for Operating Product Certification Services and Management System Certification

1. It must be an organization established in accordance with the provisions of the law.

2. Possess a management system and operational capacity meeting the requirements stipulated in national standards, international standards, and relevant international guidelines for each corresponding type of activity as follows:

a) National standard TCVN ISO/IEC 17065:2013 or international standard ISO/IEC 17065:2012 or national or international standards for specialized certification and related guidelines of the International Accreditation Forum (IAF) or equivalent standards corresponding to the requirements of specific certification programs for product certification activities.

b) National standard TCVN ISO/IEC 17021-1:2015 or international standard ISO/IEC 17021-1:2015 and related guidelines of the International Accreditation Forum (IAF) or equivalent standards corresponding to the requirements of specific certification programs for management system certification activities.

3. Have at least four officially recognized assessors of the organization (civil servants or employees under contracts of at least twelve months or indefinite-term contracts), meeting the following conditions:

b) Be trained and awarded a completion certificate for assessment skills training courses conducted by training institutions announced or recognized by the Ministry of Science and Technology in accordance with the law. In cases where there are specific provisions, be trained and awarded a completion certificate for specialized product certification technical training courses in accordance with the relevant laws.

In cases of expanding the scope of certification activities, the organization must have at least two officially recognized assessors (civil servants or employees under contracts of at least twelve months or indefinite-term contracts) corresponding to each additional certification field registered, meeting the conditions stipulated in this clause.

Article 18. Documents for Application to Obtain a Certificate of Product Certification and Management System Certification Activities Registration

1. Receiving Authority:

a) The agency receiving applications for product certification activities registration in accordance with the principles stipulated in Article 4 of this Decree;

b) The agency receiving applications for management system certification activities registration shall be assigned responsibility by the Ministry of Science and Technology.

2. In case of new issuance, the documents include:

a) A certification activity registration application form in Form No. 01 attached to this Decree;

b) A copy of the Decision on Establishment or Business Registration Certificate or Investment Registration Certificate;

In case the certification organization has been recognized by the certification body specified in Article 21 of this Decree or the certification body specified in Article 25 of this Decree for its certification activities, the certification organization shall submit a copy of the recognition certificate along with the scope of recognition.

In case the certification organization has not yet been recognized, the certification organization shall submit relevant documents, evaluation procedures, and other related documents to prove its capability to conduct activities in compliance with the corresponding standard requirements as stipulated in Clause 2, Article 17 of this Decree.

đ) Sample of the Certificate of Certification and Certification Mark.

3. In case of supplementary or amended issuance, the documents include:

a) An additional or amended certification activity registration application form in Form No. 05 attached to this Decree;

b) An additional or amended list of assessors in Form No. 02 attached to this Decree and relevant certificates and documents for each assessor including: a copy of the employment decision or labor contract; copies of degrees and certificates as prescribed in Clause 3, Article 17 of this Decree; a summary of work experience and assessment activity experience in Form No. 03 attached to this Decree and documents proving the assessor's assessment activity experience;

In case the certification organization has been recognized by the certification body specified in Article 21 of this Decree or the certification body specified in Article 25 of this Decree for its certification activities, the certification organization shall submit a copy of the recognition certificate along with the scope of recognition.

In case the certification organization has not yet been recognized, the certification organization shall submit relevant documents, evaluation procedures, and other related documents to prove its capability to conduct activities in compliance with the corresponding standard requirements as stipulated in Clause 2, Article 17 of this Decree.

4. In case of reissuance, the documents include:

a) An application for reissue of the Registration Certificate according to Form No. 06 attached to this Decree;

b) The original Registration Certificate that is damaged (if applicable) in the case of a damaged Registration Certificate.

5. Sixty days before the expiration date of the Certificate, if there is a need to continue participating in certification activities, the certification organization must prepare one set of documents as required for new issuance under Clause 2 of this Article and submit it to the agency receiving the documents as prescribed in Clause 1 of this Article.

Article 19. Methods of Submitting Applications

The certification organization shall prepare one set of documents as prescribed in Article 18 of this Decree and submit them through one of the following methods:

1. In case of submitting the application directly at the office of the agency receiving the application, original copies of the certificates and documents prescribed in Article 18 of this Decree that have not been certified must be available for verification.

2. In case the application is sent via postal service, the certification organization must submit certified copies of the certificates and documents prescribed in Article 18 of this Decree.

3. In case of submission through the electronic portal of the receiving authority, it shall be conducted in accordance with online public service procedures.

Article 20. Procedure for Issuing the Certificate of Accreditation Registration

1. New issuance:

a) In case the application dossier is incomplete according to regulations, within five working days from the date of receiving the dossier, the agency receiving the dossier shall notify in writing the certification organization to amend and supplement the dossier.

b) In case the application dossier is complete and valid, within ten working days from the date of receiving the dossier, the sectoral management agency responsible for issuing the Certificate of Accreditation for the certification organization shall issue the Certificate of Accreditation according to Model No. 10 attached to this Decree.

c) The validity period of the Certificate does not exceed five years from the date of issuance.

2. Additional or amended issuance:

a) The supplementary or amended Certificate of Accreditation shall be issued in cases where the certification organization supplements, expands, or narrows the scope of accreditation.

b) The procedures for issuing the Certificate are carried out in accordance with the provisions of points a and b of Clause 1 of this Article.

c) The validity period of the Certificate of Accreditation shall be recorded according to the validity period of the previously issued Certificate of Accreditation Registration.

3. Reissuance:

a) The reissued Certificate of Accreditation shall be issued in cases where the certification organization has an effective Certificate of Accreditation but it is lost, damaged, or there is a change in the name or address of the organization.

b) Within the validity period of the Certificate of Accreditation, if the certification organization needs to apply for reissuance of the Certificate of Accreditation, it must prepare one set of application dossier in accordance with Clause 4, Article 18 of this Decree and submit it to the agency receiving the dossier.

c) Within five working days from the date of receiving a complete and valid dossier, the sectoral management agency responsible for reissuing the Certificate of Accreditation for the certification organization shall issue the Certificate of Accreditation. In case the requirements are not met, the agency receiving the dossier shall notify in writing and specify the reasons.

d) The validity period of the Certificate of Accreditation shall be recorded according to the validity period of the previously issued Certificate of Accreditation Registration.

Chapter VI

CONDITIONS FOR OPERATING ACCREDITATION SERVICES

CERTIFICATION BODY ASSESSMENT ORGANIZATION

Article 21. Conditions for operating accreditation services for certification body assessment organizations

1. It must be a scientific public institution established in the form of a scientific and technological organization and registered to operate in accordance with the laws on science and technology.

2. The founders, managers, and directors of the accreditation organization may not establish, manage, participate in managing, or direct a conformity assessment body.

3. It must have an organizational structure, management system, and operational capacity that meet the requirements stipulated in the national standard TCVN ISO/IEC 17011:2007 or the international standard ISO/IEC 17011:2004.

Within three years from the date of establishment, the accreditation organization must build its capacity to meet the conditions stipulated in this clause to become a signatory member participating in mutual recognition agreements on the results of conformity assessment by regional or international accreditation organizations for corresponding accreditation programs.

5. It must have at least three full-time assessors of the organization (civil servants or employees under a fixed-term contract of twelve months or more or indefinite-term contracts), including one assessor-in-charge in each accreditation program, and must meet the following conditions:

b) They must be trained and certified to complete courses and meet the requirements for accreditation assessment according to current versions of standards (ISO/IEC 17025, ISO/IEC 17020, ISO 15189, ISO/IEC 17021, ISO/IEC 17065, ISO/IEC 17024, and other equivalent standards) appropriate to the registered accreditation program;

c) They must have experience in conducting at least five accreditation assessments according to current versions of accreditation standards (ISO/IEC 17025, ISO/IEC 17020, ISO 15189, ISO/IEC 17021, ISO/IEC 17065, ISO/IEC 17024, and other equivalent standards) under the supervision of an approved assessor-in-charge;

d) Assessors of testing organizations, calibration organizations, and inspection organizations must meet additional requirements specified in the ILAC-G11:07 guidance of the International Laboratory Accreditation Cooperation (ILAC).

In case of expanding the scope of accreditation activities, there must be at least two full-time assessors of the organization (civil servants or employees under a fixed-term contract of twelve months or more or indefinite-term contracts) corresponding to each expanded accreditation activity field, meeting the conditions stipulated in this clause.

Article 22. Documents for Issuing the Certificate of Accreditation Registration

1. Receiving Authority:

The Standardization, Measurement and Quality Management Agency shall be the agency assisting the Minister of Science and Technology in receiving applications for accreditation registration from conformity assessment organizations.

2. In case of new issuance, the documents include:

a) An application for accreditation registration according to Form No. 11 attached to this Decree;

b) A certificate of registration for scientific and technological activities;

c) Documentation system (documents, evaluation procedures, and other related documents) meeting the requirements of the corresponding standards stipulated in Article 21 of this Decree;

d) Description of organizational structure and responsibilities of each position within the organizational structure;

đ) Implementation plan or results of proficiency testing and inter-laboratory comparison programs; list of proficiency testing laboratories recognized by the accreditation organization for the accreditation program;

In case the accreditation organization is a member of mutual recognition agreements on conformity assessment results among regional or international accreditation organizations, the accreditation organization must submit documents proving the signing of such mutual recognition agreements along with the accreditation program;

In case the accreditation organization is not yet a member of mutual recognition agreements on conformity assessment results among regional or international accreditation organizations, the accreditation organization must submit a commitment to build capacity to meet the requirements and conditions of regional or international accreditation organizations to become a member participating in these mutual recognition agreements within three years from its establishment;

h) Sample of the accreditation decision, accreditation certificate, and accreditation logo of the organization.

3. In case of supplementary or amended issuance, the documents include:

a) An additional or amended application for accreditation activities according to Form No. 14 attached to this Decree;

b) Original certificate that has been issued;

c) Documents proving the requirements for additional or amended activities.

4. In case of reissuance, the documents include:

a) Application for reissuing the Certificate according to Form No. 15 attached to this Decree;

b) The original Registration Certificate that is damaged (if applicable) in the case of a damaged Registration Certificate.

5. Sixty days before the expiry date of the Certificate's validity period, if there is a need to continue participating in accreditation activities, the accreditation organization shall prepare one set of documents as prescribed in Clause 2 of this Article and send it to the Standardization, Measurement and Quality Management Agency.

Article 23. Methods of Submitting Applications

The accreditation organization shall prepare one set of documents as prescribed in Article 22 of this Decree and submit them through one of the following methods:

1. In case of submitting the application directly at the Standardization, Measurement and Quality Management Agency's office, unauthenticated copies of certificates and documents specified in Article 22 of this Decree must be accompanied by original documents for verification.

2. In case the application is sent via postal service, the accreditation organization must submit authenticated copies of certificates and documents specified in Article 22 of this Decree.

3. In case the application is submitted through the Standardization, Measurement and Quality Management Agency's electronic portal, it must be done in accordance with online public service procedures.

Article 24. Procedure for Issuing the Certificate of Registration for Accreditation Activities

1. New issuance:

a) In case the application dossier is incomplete as prescribed, within five working days from the date of receipt of the dossier, the General Department of Standardization, Metrology and Quality Management shall notify in writing to request the accreditation body to amend and supplement it.

b) In case the application dossier is complete and valid, within ten working days from the date of receipt of the dossier, the Ministry of Science and Technology shall be responsible for organizing an evaluation team and issuing the Certificate of Registration for the accreditation body according to Model No. 13 attached as an appendix to this Decree.

c) The validity period of the Certificate does not exceed five years from the date of issuance.

2. Additional or amended issuance:

a) The supplementary or amended certificate applies in cases where the accreditation body supplements, expands, or narrows the scope of accreditation.

b) In case the application dossier is incomplete as prescribed, within five working days from the date of receipt of the dossier, the General Department of Standardization, Metrology and Quality Management shall notify in writing to request the accreditation body to amend and supplement it.

c) In case the application dossier is complete and valid, within ten working days from the date of receipt of the dossier, the Ministry of Science and Technology shall be responsible for issuing the Certificate of Registration for the accreditation body according to Model No. 13 attached as an appendix to this Decree.

d) The validity period of the Certificate of Registration shall be recorded according to the validity period of the Certificate of Registration for the field of accreditation activities already issued.

3. Reissuance:

a) The reissued certificate applies in cases where the accreditation body has an existing valid Certificate of Registration but it is lost, damaged, or there is a change in the name or address of the organization.

b) Within the validity period of the Certificate of Registration, if the accreditation body requests to reissue the Certificate of Registration, the accreditation body shall prepare one set of application dossier for reissuance of the Certificate of Registration in accordance with Clause 4, Article 22 of this Decree and submit it to the General Department of Standardization, Metrology and Quality Management.

c) Within five working days from the date of receipt of the complete and valid dossier, the Ministry of Science and Technology shall be responsible for reissuing the Certificate of Registration for the accreditation body. In case the requirements are not met, the General Department of Standardization, Metrology and Quality Management shall notify in writing and specify the reasons.

d) The validity period of the Certificate of Registration shall be recorded according to the validity period of the Certificate of Registration for the accreditation activities already issued.

Article 25. Accreditation Organizations Established Abroad Conducting Accreditation Activities in Vietnam

1. They are members participating in mutual recognition agreements on the results of conformity assessment by regional or international accreditation organizations.

2. Before conducting accreditation of conformity assessment organizations in Vietnam, the accreditation organization shall notify the Ministry of Science and Technology (Vietnam) at least one month in advance.

3. Within three months after completing the accreditation assessment in Vietnam, the accreditation organization shall be responsible for submitting a report on the implementation results to the Ministry of Science and Technology (Vietnam).

4. Foreign accreditation organizations conducting accreditation activities in Vietnam that fail to comply with the provisions of this Article shall be subject to handling in accordance with Vietnamese law.

Chapter VII

REVOCATION OF THE CERTIFICATE OF REGISTRATION

REGISTRATION FOR CONFORMITY ASSESSMENT ACTIVITIES

The sectoral management agency shall examine and decide to revoke the Certificate of Registration for the conformity assessment activity in case the conformity assessment organization violates any of the following provisions:

1. Repeatedly violating administrative regulations stipulated in Clause 6, Article 8, Article 20 of the Law on Product and Goods Quality and the provisions of this Decree.

2. Failing to fully perform the corresponding responsibilities stipulated in Article 29 of this Decree for two consecutive years.

3. Failing to ensure one of the corresponding conditions for the conformity assessment organization as prescribed in Articles 5, 9, 13, and 17 of this Decree.

4. Forgery or false declaration of documents in the application dossier for issuance, reissuance, or supplementary issuance of the Certificate of Registration; issuing fictitious conformity assessment results.

5. Erasing, altering, or tampering with the content on the issued Certificate of Registration.

6. Failing to implement corrective actions for violations as required by the inspection and audit agencies.

Article 27. Revocation of the Certificate of Registration for Accreditation Activities of Accreditation Organizations

1. The Ministry of Science and Technology has the authority to examine and revoke the Certificate of Registration for Accreditation Activities when accreditation organizations violate the provisions set out in Clause 2 of Article 55 of the Law on Technical Standards and Regulations, relevant laws, or in the following specific cases:

a) Repeatedly violating the provisions set out in Clause 2 of Article 55 of the Law on Technical Standards and Regulations and the provisions of this Decree;

b) Failing to meet one of the conditions stipulated in Article 21 of this Decree;

c) Forgery or false declaration of documents in the application for issuance, reissuance, supplementary issuance of the Certificate, or the accreditation organization's recognition dossier;

d) Altering, erasing, or tampering with the content on the issued Certificate of Registration.

2. Accreditation organizations whose Certificates have been revoked may only be considered for reissuance of the Certificate two years after the revocation notice is issued and all violations have been rectified.

Chapter VIII

IMPLEMENTATION

Article 28. Responsibilities of Sectoral Management Ministries and Agencies

1. Sectoral management ministries and agencies:

a) Issue new, supplementary, amended, and reissued Certificates of Registration for Testing, Inspection, Examination, and Certification activities for conformity assessment organizations according to the principles stipulated in Article 4 of this Decree;

b) Lead and coordinate with the Ministry of Science and Technology and other relevant sectoral management ministries and agencies to conduct inspections and audits of registered conformity assessment organizations according to the principles stipulated in Article 4 of this Decree;

c) Publicize on their electronic portal within fifteen days from the date of registration the list of registered conformity assessment organizations and information about the Ministry of Science and Technology for monitoring purposes.

2. Ministry of Science and Technology:

a) Issue new, supplementary, amended, and reissued Certificates of Registration for Testing, Inspection, Examination, and Certification activities for conformity assessment organizations according to the principles stipulated in Article 4 of this Decree and accredit conformity assessment organizations;

b) Guide the framework training program for product certification experts, management system certification experts, and standards for training institutions; accept declarations of capability to conduct training activities from training institutions for product certification experts and management system certification experts;

c) Conduct inspections and audits: multi-sector conformity assessment organizations, accreditation organizations registered by the Ministry of Science and Technology; training institutions for product certification experts and management system certification experts;

d) Coordinate with sectoral management ministries and agencies to conduct inspections and audits of registered specialized conformity assessment organizations;

e) Publicize on the Ministry of Science and Technology’s electronic portal (National Standardization, Metrology and Quality Control Agency) the list of registered multi-sector conformity assessment organizations and accreditation organizations; the list of training institutions for product certification experts and management system certification experts;

f) Guide the implementation of standards referenced in this Decree when they are revised, supplemented, or replaced.

Article 29. Responsibilities of conformity assessment organizations and accreditation organizations

1. Conformity assessment organization:

a) Annually on a regular basis or at any time upon request, the conformity assessment organization shall be responsible for reporting to the sectoral management agency the results of conformity assessment activities registered for each type of organization according to Form No. 07, Form No. 08, and Form No. 09 attached to this Decree;

b) Notify the sectoral management agency of any changes affecting the registered capacity within fifteen days from the date of change;

c) Training institutions for product certification experts and management system evaluation experts must submit to the Ministry of Science and Technology (National Standardization Agency) a declaration of training capacity according to Form No. 17 attached to this Decree.

2. Accreditation organization:

a) Monitor and evaluate the implementation of proficiency testing programs and laboratory intercomparison programs of recognized organizations in accordance with the national standard TCVN ISO/IEC 17043:2011 or the international standard ISO/IEC 17043:2010;

b) Annually on a regular basis or at any time upon request, the accreditation organization in Vietnam shall report to the Ministry of Science and Technology (National Standardization Agency) the results of accreditation activities according to Form No. 16 attached to this Decree;

c) Notify the Ministry of Science and Technology (National Standardization Agency) of any changes affecting the registered accreditation activities within fifteen days from the date of change.

Chapter IX

IMPLEMENTING PROVISIONS

Article 30. Effective Date

This Decree takes effect from July 1, 2016.

Article 31. Transitional Provisions

1. Conformity assessment organizations and accreditation organizations that have been issued a Registration Activity Certificate by the Ministry of Science and Technology (National Standardization Agency) must review the conditions and complete the registration activity certificate issuance procedures as prescribed in this Decree within two years from the effective date of this Decree.

2. Training institutions for product certification experts and management system evaluation experts that have received a Notification of Acceptance of Capacity Declaration Application from the Ministry of Science and Technology (National Standardization Agency) may continue to provide training until the expiration date of the Notification.

Article 32. Responsibility for Implementation

The Ministers, Heads of ministerial-level agencies, Heads of agencies under the Government, Chairpersons of provincial and municipal people's committees directly under the central government shall be responsible for enforcing this Decree./.