Nghị định 107/2016/ND-CP

Decree No. 107/2016/ND-CP dated July 1, 2016, prescribing conditions for provision of conformity assessment services

Nội dung toàn văn Decree 107/2016/ND-CP prescribing conditions for provision of conformity assessment services


THE GOVERNMENT
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 107/2016/ND-CP

Hanoi, July 1, 2016

 

DECREE

PRESCRIBING CONDITIONS FOR PROVISION OF CONFORMITY ASSESSMENT SERVICES

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

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

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

Pursuant to the November 26, 2014 Law on Investment;

At the proposal of the Minister of Science and Technology;

The Government promulgates the Decree prescribing conditions for provision of conformity assessment services.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Decree prescribes conditions for provision of conformity assessment services in Vietnam, including conditions for organizations to assess conformity of products and goods, production or service provision processes and environment with announced applicable standards or relevant technical regulations, and conditions for organizations to accredit conformity assessment organizations.

Article 2. Subjects of application

This Decree applies to:

1. Organizations and businesses providing conformity assessment services in Vietnam’s territory regarding:

a/ Testing;

b/ Inspection;

c/ Assessment;

d/ Certification;

dd/ Accreditation of conformity assessment organizations.

2. State management agencies and related organizations and individuals.

Article 3. Interpretation of terms

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

1. Conformity assessment organization means an organization which tests, inspects, assesses or certifies the conformity of products, goods, production or service provision processes and the environment with announced applicable standards or relevant technical regulations.

2. Accreditation organization means an organization which assesses and certifies conformity assessment organizations to have capacity meeting the requirements of relevant standards.

Article 4. Principles of operation registration

1. A conformity assessment organization that wishes to register its conformity assessment of specialized products, goods, production or service provision processes and the environment (below referred to as objects of conformity assessment) under the state management of a line ministry according to its assigned functions, tasks and powers shall register its operations with the line ministry managing these objects.

2. A conformity assessment organization that wishes to register its conformity assessment of objects of conformity assessment under the management of two or more line ministries shall register its operations with the Ministry of Science and Technology.

3. A conformity assessment organization that wishes to register conformity assessment of two or more objects of conformity assessment under the management of two or more line ministries shall register its operations with each line ministry managing the respective object.

Chapter II

CONDITIONS FOR PROVISION OF TESTING SERVICES

Article 5. Conditions for provision of product and goods quality testing services

1. Being a lawfully established organization.

2. Having a control system and operation capacity meeting the requirements set out in national standard TCVN ISO/IEC 17025:2007 or international standard ISO/IEC 17025:2005 or national and international standards applicable to specialized testing.

3. Having at least four official testers (public employees or employees working under contracts with a term of 12 months or longer or with an indefinite term), who have been trained in national standard TCVN ISO/IEC 17025:2007 or international standard ISO/ IEC 17025:2005 or national and international standards applicable to specialized testing.

In case of adding an area of testing, having at least two official testers (public employees or employees working under contracts with a term of 12 months or longer or with an indefinite term) corresponding to the added area, who have been trained in national standard TCVN ISO/IEC 17025:2007 or international standard ISO/IEC 17025:2005 or national and international standards applicable to specialized testing.

4. Having testing and measurement machinery, equipment and devices as required by law and testing activities.

Article 6. Dossier of application for a certificate of registration of product and goods quality testing operations

1. Dossier-receiving agencies:

Dossier-receiving agencies shall receive dossiers of registration for testing operations according to the principles prescribed in Article 4 of this Decree.

2. For grant of a new certificate, a dossier must comprise:

a/ A written request for testing operation registration, made according to Form No. 1 provided in the Appendix to this Decree;

b/ A copy of the establishment decision or enterprise registration certificate or investment registration certificate;

c/ A list of testers, made according to Form No. 02 provided in the Appendix to this Decree, together with their relevant certificates and documents, including a copy of the recruitment decision or labor contract and copies of relevant training certificates prescribed in Clause 3, Article 5 of this Decree;

d/ A list of testing and measurement machinery, equipment and devices for the registered testing area, made according to Form No. 04 provided in the Appendix to this Decree;

dd/ Documents proving the organization’s testing capacity meeting the requirements set out in Clause 2, Article 5 of this Decree, specifically as follows:

If having had its testing operations accredited by an accreditation organization defined in Article 21 of this Decree or by a foreign accreditation organization defined in Article 25 of this Decree, the testing organization shall submit a copy of the accreditation certificate stating the scope of its accredited activities.

If its testing operations have not yet been accredited, the testing organization shall submit documents, testing processes and other relevant documents to prove that its operation capacity meets the requirements of the corresponding standard as prescribed in Clause 2, Article 5 of this Decree.

e/ A form of the testing result slip.

3. For grant of a modified certificate, a dossier must comprise:

a/ A written request for addition and modification of testing operations, made according to Form No. 05 provided in the Appendix to this Decree;

b/ A revised list of testers, made according to Form No. 02 provided in the Appendix to this Decree and their relevant certificates and documents, including a copy of the recruitment decision or labor contract and a copy of a relevant training certificate prescribed in Clause 3, Article 5 of this Decree;

c/ A revised list of testing and measurement machinery, equipment and devices for the registered testing area, made according to Form No. 04 provided in the Appendix to this Decree;

d/ Documents proving the organization’s capacity to carry out the added and modified testing operations meets the requirements set out in Clause 2, Article 5 of this Decree, specifically as follows:

If having had its testing operations accredited by an accreditation organization defined in Article 21 of this Decree or by a foreign accreditation organization defined in Article 25 of this Decree, the testing organization shall submit a copy of the accreditation certificate stating the scope of its accredited activities.

If its testing operations have not yet been accredited, the testing organization shall submit documents, testing processes and other relevant documents to prove that its operation capacity meets the requirements of the corresponding standard as prescribed in Clause 2, Article 5 of this Decree.

4. For re-grant of a certificate, a dossier must comprise:

a/ An application for re-grant of the certificate, made according to Form No. 06 provided in the Appendix to this Decree;

b/ The original certificate (if any) in case it is damaged.

5. Sixty days before its certificate expires, if wishing to continue its testing operations, a testing organization shall make a dossier as in the case of application for a certificate prescribed in Clause 2 of this Article and send it to the dossier-receiving agency defined in Clause 1 of this Article.

Article 7. Methods of dossier submission

A testing organization shall make a dossier as prescribed in Article 6 of this Decree and submit it:

1. Directly at the head office of the dossier-receiving agency. In this case, uncertified copies of the certificates and documents prescribed in Article 6 of this Decree shall be accompanied by their originals for comparison.

2. By post. In this case, certified copies of certificates and documents prescribed in Article 6 of this Decree are required.

3. Via the e-portal of the dossier-receiving agency, using the online public service.

Article 8. Order of grant of a certificate of registration of testing operations

1. For grant of a new certificate:

a/ If the dossier is incomplete as prescribed, within 5 working days after receiving it, the dossier-receiving agency shall request in writing the testing organization to modify and supplement the dossier;

b/ If the dossier is complete and valid, within 10 working days after receiving it, the line ministry shall grant a certificate to the testing organization, made according to Form No. 10 provided in the Appendix to this Decree;

c/ The validity of a certificate is 5 years at most counting from the date of its grant.

2. For grant of a modified certificate:

a/ A modified certificate may be granted to a testing organization that wishes to add, expand or narrow the scope of its testing operations;

b/ The order of grant of a modified certificate must comply with Points a and b, Clause 1 of this Article;

c/ The validity of a modified certificate is the same as that of the original one.

3. For re-grant of a certificate:

a/ A valid certificate may be re-granted if it is lost or damaged or the name or address of the testing organization is changed;

b/ Within the validity duration of its certificate, a testing organization that wishes to have this certificate re-granted shall make 1 dossier for re-grant of a certificate as prescribed in Clause 4, Article 6 of this Decree and send it to the dossier-receiving agency;

c/ Within 5 working days after receiving a complete and valid dossier, the line ministry shall re-grant a certificate to the testing organization. In case of ineligibility for re-grant, the dossier-receiving agency shall notify such in writing, clearly stating the reason;

d/ The validity of a re-granted certificate is the same as that of the original one.

Chapter III

CONDITIONS FOR PROVISION OF INSPECTION SERVICES

Article 9. Conditions for provision of quality inspection services for products and goods currently in use

1. Being a lawfully established organization.

2. Having a control system and operation capacity meeting the requirements set out in national standard TCVN ISO 9001:2008 or national and international standards applicable to specialized inspection.

3. Having at least four official inspectors (public employees or employees working under contracts with a term of 12 months or longer or with an indefinite term), who meet professional requirements for relevant inspection areas and have been trained in national standard TCVN ISO 9001:2008.

In case of adding an area of inspection, having at least two official inspectors (public employees or employees working under contracts with a term of 12 months or longer or with an indefinite term) relevant to the registered add area of inspection, who have been trained in national standard TCVN ISO 9001:2008.

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

Article 10. Dossier of application for a certificate of registration of quality inspection of products and goods currently in use

1. Dossier-receiving agencies

Dossier-receiving agencies shall receive dossiers of request for inspection operations according to the principles prescribed in Article 4 of this Decree.

2. For grant of a new certificate, a dossier must comprise:

a/ A written registration of inspection operations, made according to Form No. 01 provided in the Appendix to this Decree;

b/ A copy of the establishment decision or enterprise registration certificate or investment registration certificate;

c/ A list of inspectors, made according to Form No. 02 provided in the Appendix to this Decree, together with their relevant diplomas and certificates and documents, including a copy of the recruitment decision or labor contract and copies of diplomas and certificates as prescribed in Clause 3, Article 9 of this Decree;

d/ A list of machinery, equipment and devices serving inspection operations, made according to Form No. 04 provided in the Appendix to this Decree;

dd/ Documents proving that the organization’s inspection capacity meets the requirements set out in Clause 2, Article 9 of this Decree, specifically as follows:

If possessing a certificate of conformity with standard TCVN ISO 9001:2008 or ISO 9001:2008 granted by a certification organization or having had its inspection operations accredited by an accreditation organization defined in Article 21 of this Decree or by a foreign accreditation organization defined in Article 25 of this Decree, the inspection organization shall submit a copy of the certificate of conformity with standard TCVN ISO 9001:2008 or ISO 9001:2008 or accreditation certificate stating the scope of accredited activities.

If its inspection operations have not yet been accredited or it has no certificate of conformity with standard TCVN ISO 9001:2008 or ISO 9001:2008, the inspection organization shall submit documents, inspection processes and other relevant documents to prove that its operation capacity meets the requirements of the corresponding standard as prescribed in Clause 2, Article 9 of this Decree.

e/ A form of the inspection certificate.

3. For grant of a modified certificate, a dossier must comprise:

a/ A written request for addition and modification of inspection operations, made according to Form No. 05 provided in the Appendix to this Decree;

b/ A revised list of inspectors, made according to Form No. 02 provided in the Appendix to this Decree, together with their relevant diplomas and certificates and documents, including a copy of the recruitment decision or labor contract; copies of diplomas and certificates as prescribed in Clause 3, Article 9 of this Decree;

c/ Documents proving that the organization’s capacity to carry out inspection operations to be added and modified meets the requirements set out in Clause 2, Article 9 of this Decree, specifically as follows:

If possessing a certificate of conformity with standard TCVN ISO 9001:2008 or ISO 9001:2008 granted by a certification organization or having its inspection operations accredited by an accreditation organization defined in Article 21 of this Decree or by a foreign accreditation organization defined in Article 25 of this Decree, the inspection organization shall submit a copy of the certificate of conformity with standard TCVN ISO 9001:2008 or ISO 9001:2008 or accreditation certificate stating the scope of accredited activities.

If its inspection operations have not yet been accredited or have no certificate of conformity with standard TCVN ISO 9001:2008 or ISO 9001:2008, the inspection organization shall submit documents, inspection processes and other relevant documents to prove that its operation capacity meets the requirements of the corresponding standard as prescribed in Clause 2, Article 9 of this Decree.

d/ A revised list of machinery, equipment and devices serving inspection operations, made according to Form No. 04 provided in the Appendix to this Decree.

4. For re-grant of a certificate, a dossier must comprise:

a/ An application for re-grant of a certificate, made according to Form No. 06 provided in the Appendix to this Decree;

b/ The original certificate (if any) in case it is damaged.

5. Sixty days before its certificate expires, if wishing to continue inspection operations, an inspection organization shall make 1 dossier as in the case of application for a new certificate prescribed in Clause 2 of this Article and send it to the dossier-receiving agency defined in Clause 1 of this Article.

Article 11. Methods of dossier submission

An inspection organization shall make 1 dossier as prescribed in Article 10 of this Decree and submit it:

1. Directly at the head office of the dossier-receiving agency. In this case, uncertified copies of the certificates and documents prescribed in Article 10 of this Decree shall be accompanied by their originals for comparison.

2. By post. In this case, certified copies of certificates and documents prescribed in Article 10 of this Decree are required.

3. Via the web portal of the dossier-receiving agency, using the online public service.

Article 12. Order of grant of an inspection registration certificate

1. For grant of a new certificate:

a/ If the dossier is incomplete as prescribed, within 5 days after receiving it, the dossier-receiving agency shall request in writing the inspection organization to modify and supplement the dossier;

b/ If the dossier is complete and valid, within 10 working days after receiving it, the line ministry shall grant a certificate to the inspection organization, made according to Form No. 10 provided in the Appendix to this Decree;

c/ The validity of a certificate is 5 years at most counting from the date of its grant.

2. For grant of a modified certificate:

a/ A modified certificate may be granted to an inspection organization that wishes to add, expand or narrow the scope of its inspection operations;

b/ The order of grant of a modified certificate must comply with Points a and b, Clause 1 of this Article;

c/ The validity of a modified certificate is the same as that of the original one.

3. For re-grant of a certificate:

a/ A valid certificate may be re-granted if it is lost or damaged or the name or address of the holding organization is changed;

b/ Within the validity duration of its certificate, an inspection organization that wishes to have this certificate re-granted shall make 1 dossier for re-grant of a certificate as prescribed in Clause 5, Article 10 of this Decree and send it to the dossier-receiving agency;

c/ Within 5 working days after receiving a complete and valid dossier, the line ministry shall re-grant a certificate to the assessment organization. In case of ineligibility for re- grant, the dossier-receiving agency shall notify such in writing, clearly stating the reason;

d/ The validity of a re-granted certificate is the same as that of the original one.

Chapter IV

CONDITIONS FOR PROVISION OF ASSESSMENT SERVICES

Article 13. Conditions for an organization to provide quality assessment services for goods and services

1. Being a lawfully established organization.

2. Having a control system and operation capacity meeting the requirements set out in national standard TCVN ISO/IEC 17020:2012 or international standard ISO/IEC 17020:2012 or another national standard or international standard applicable to specialized assessment.

3. Having at least 4 official assessors (public employees or employees working under contracts with a term of at least 12 months or with an indefinite term), who must meet the following conditions:

a/ Holding a collegial or higher degree in a discipline relevant to products or goods subject to assessment;

b/ Having been trained in national standard TCVN ISO/IEC 17020:2012 or international standard ISO/IEC 17020:2012 or another national standard or international standard applicable to specialized assessment;

c/ Having at least 3 years of work experience (from the time of graduation from a college or university), including 2 years in product and goods quality assessment.

If wishing to add an area of assessment, the organization must have at least 2 official assessors (public employees or employees working under contracts with a term of at least 12 months or longer or with an indefinite term) in the added area, who must meet the conditions referred to in this Clause.

Article 14. Dossier of application for a product and goods quality assessment certificate

1. Dossier-receiving agencies:

Dossier-receiving agencies shall register assessment operations according to the principles prescribed in Article 4 of this Decree.

2. For grant of a new certificate, a dossier must comprise:

a/ A written registration of assessment operations, made according to Form No. 01 provided in the Appendix to this Decree;

b/ A copy of the establishment decision or enterprise registration certificate or investment registration certificate;

c/ A list of assessors, made according to Form No. 02 provided in the Appendix to this Decree, together with their relevant diplomas and certificates and documents, including a copy of the recruitment decision or labor contract; copies of diplomas and certificates as prescribed in Clause 3, Article 13 of this Decree; a summary of the assessor’s working period and assessment experience, made according to Form No. 03 provided in the Appendix to this Decree; and documents proving the assessor’s experience in product and goods quality assessment;

d/ Documents proving that the organization’s assessment capacity meets the requirements mentioned in Clause 2, Article 13 of this Decree, specifically as follows:

If having its assessment operations accredited by an accreditation organization defined in Article 21 of this Decree or by a foreign accreditation organization defined in Article 25 of this Decree, the assessment organization shall submit a copy of the accreditation certificate stating the scope of accredited activities.

If its assessment operations have not yet been accredited, the assessment organization shall submit documents, assessment processes and other relevant documents to prove that its operation capacity meets the requirements of the corresponding standard as prescribed in Clause 2, Article 13 of this Decree.

dd/ A form of the assessment certificate.

3. For grant of a modified certificate, a dossier must comprise:

a/ A written request for addition and modification of assessment operations, made according to Form No. 05 provided in the Appendix to this Decree;

b/ A revised list of assessors, made according to Form No. 02 provided in the Appendix to this Decree, together with their relevant diplomas and certificates and documents, including a copy of the recruitment decision or labor contract; copies of diplomas and certificates as prescribed in Clause 3, Article 13 of this Decree; a summary of the assessor’s working period and assessment experience, made according to Form No. 03 provided in the Appendix to this Decree; and documents proving the assessor’s experience in product and goods quality assessment;

c/ Documents proving that the organization’s capacity to carry out assessment operations to be added and modified meets the requirements set out in Clause 2, Article 13 of this Decree, specifically as follows:

If having had its assessment operations accredited by an accreditation organization defined in Article 21 of this Decree or by a foreign accreditation organization defined in Article 25 of this Decree, the assessment organization shall submit a copy of the accreditation certificate stating the scope of accredited activities.

If its assessment operations have not yet been accredited, the assessment organization shall submit documents, assessment processes and other relevant documents to prove that its operation capacity meets the requirements of the corresponding standard as prescribed in clause 2, Article 13 of this Decree.

4. For re-grant of a certificate, a dossier must comprise:

a/ An application for re-grant of a certificate, made according to Form No. 06 provided in the Appendix to this Decree;

b/ The original certificate (if any) in case it is damaged.

5. Sixty days before its certificate expires, if wishing to continue product and goods quality assessment operations, an assessment organization shall make 1 dossier as in the case of application for a new certificate prescribed in Clause 2 of this Article and send it to the dossier-receiving agency defined in Clause 1 of this Article.

Article 15. Methods of dossier submission

An assessment organization shall make 1 dossier as prescribed in Article 14 of this Decree and submit it:

1. Directly at the head office of the dossier-receiving agency. In this case, uncertified copies of the certificates and documents prescribed in Article 14 of this Decree shall be accompanied by their originals for comparison.

2. By post. In this case, certified copies of certificates and documents prescribed in Article 14 of this Decree are required.

3. Via the web portal of the dossier-receiving agency, using the online public service.

Article 16. Order of grant of an assessment registration certificate

1. For grant of a new certificate:

a/ If the dossier is incomplete as prescribed, within 5 days after receiving it, the dossier-receiving agency shall request in writing the assessment organization to modify and supplement the dossier;

b/ If the dossier is complete and valid, within 10 working days after receiving it, the line ministry shall grant a certificate to the assessment organization, made according to Form No. 10 provided in the Appendix to this Decree;

c/ The validity of a certificate is 5 years at most counting from the date of its grant.

2. For grant of a modified certificate:

a/ A modified certificate may be granted to an assessment organization that wishes to add, expand or narrow the scope of its assessment operations;

b/ The order of grant of a modified certificate must comply with Points a and b, Clause 1 of this Article;

c/ The validity of a modified certificate is the same as that of the original one.

3. For re-grant of a certificate:

a/ A valid certificate may be re-granted if it is lost or damaged or the name or address of the holding assessment organization is changed;

b/ Within the validity duration of its certificate, the assessment organization that wishes to have this certificate re-granted shall make 1 dossier for re-grant of a certificate as prescribed in Clause 4, Article 14 of this Decree and send it to the dossier-receiving agency;

c/ Within 5 working days after receiving a complete and valid dossier, the line ministry shall re-grant a certificate to the assessment organization. In case of ineligibility for re- grant, the dossier-receiving agency shall notify such in writing, clearly stating the reason;

d/ The validity of a re-granted certificate is the same as that of the original one.

Chapter V

CONDITIONS FOR PROVISION OF THE SERVICE OF CERTIFICATION OF PRODUCTS OR CONTROL SYSTEMS

Article 17. Conditions for an organization to provide the service of certification of products or control systems

1. Being a lawfully established organization.

2. Having a control system and operation capacity meeting the requirements set out in the national standard or international standard or international guidelines, specifically as follows:

a/ National standard TCVNISO/IEC 17065:2013 or international standard ISO/IEC 17065:2012 or another national standard or international standard applicable to specialized certification operations, and relevant guidelines of the International Accreditation Forum (IAF) or a standard corresponding to the requirements of the specific certification program, for product and goods certification operations;

b/ National standard TCVN ISO/IEC 17021-1:2015 or international standard ISO/IEC 17021 -1:2015 and relevant guidelines of the International Accreditation Forum (IAF) or a standard corresponding to the requirements of the specific certification program, for control system certification operations.

3. Having at least 4 official experts (public employees or employees working under contracts with a term of at least 12 months or with an indefinite term), who must meet the following conditions:

a/ Holding a university or higher degree in a discipline relevant to the certification program;

b/ Having been trained in and possessing a certificate of training in relevant assessment and certification skills granted by a training institution publicized or accredited under law by the Ministry of Science and Technology.

Having been training in and possessing a certificate of training in specialized product certification techniques under a specialized law as required by law;

c/ Having at least 3 years of experience (from the time of graduation from a university) and appropriate work experience as required by the relevant certification program;

d/ Having been engaged in at least 4 assessments with at least 20 working days of assessment, for the relevant certification program.

If wishing to add an area of certification, the organization must have at least 2 official experts (public employees or employees working under contracts with a term of at least 12 months or with an indefinite term) relevant to the added area, who must meet the conditions prescribed in this Clause.

Article 18. Dossier of application for a certificate of product or control system certification operations

1. Dossier-receiving agencies:

a/ Dossier-receiving agencies shall register product certification operations according to the principles prescribed in Article 4 of this Decree;

b/ Dossier-receiving agencies shall register control system certification operations as assigned by the Ministry of Science and Technology.

2. For grant of a new certificate, a dossier must comprise:

a/ A written request for registration of certification operations, made according to Form No. 01 provided in the Appendix to this Decree;

b/ A copy of the establishment decision or enterprise registration certificate or investment registration certificate;

c/ A list of assessment experts, made according to Form No. 02 provided in the Appendix to this Decree, and their relevant diplomas and certificates and documents, such as a copy of the recruitment decision or labor contract; copies of diplomas and certificates as prescribed in Clause 3, Article 17 of this Decree; a summary of the expert’s working period and assessment experience, made according to Form No. 03 provided in the Appendix to this Decree; and documents proving the expert’s assessment experience;

d/ Documents proving that the organization’s certification capacity meets the requirements mentioned in Clause 2, Article 17 of this Decree, specifically as follows:

If having had its certification operations accredited by an accreditation organization defined in Article 21 of this Decree or by a foreign accreditation organization defined in Article 25 of this Decree, the certification organization shall submit a copy of the accreditation certificate stating the scope of accredited activities.

If its certification operations have not yet been accredited, the certification organization shall submit documents, assessment processes and other relevant documents to prove that its operation capacity meets the requirements of the corresponding standard as prescribed in Clause 2, Article 17 of this Decree;

dd/ A form of the certificate and an impression of the certification seal.

3. For grant of a modified certificate, a dossier must comprise:

a/ A written request for addition and modification of certification operations, made according to Form No. 05 provided in the Appendix to this Decree;

b/ A revised list of assessment experts, made according to Form No. 02 provided in the Appendix to this Decree, together with their relevant diplomas and certificates and documents, including a copy of the recruitment decision or labor contract; copies of diplomas and certificates as prescribed in Clause 3, Article 17 of this Decree; a summary of the expert’s working period and assessment experience, made according to Form No. 03 provided in the Appendix to this Decree; and documents proving the expert’s assessment experience;

c/ Documents proving that the organization’s capacity to carry out certification operations to be added and modified meets the requirements prescribed in Clause 2, Article 17 of this Decree, specifically as follows:

If having had its certification operations accredited by an accreditation organization defined in Article 21 of this Decree or by a foreign accreditation organization defined in Article 25 of this Decree, the certification organization shall submit a copy of the accreditation certificate stating the scope of accredited activities.

If its certification operations have not yet been accredited, the certification organization shall submit documents, assessment processes and other relevant documents to prove that its operation capacity meets the requirements of the corresponding standard as prescribed in Clause 2, Article 17 of this Decree.

4. For re-grant of a certificate, a dossier must comprise:

a/ An application for re-grant of a certificate, made according to Form No. 06 provided in the Appendix to this Decree;

b/ The original of the certificate (if any) in case it is damaged.

5. Sixty days before its certificate expires, if wishing to continue certification operations, a certification organization shall make 1 dossier as in the case of application for a new certificate prescribed in Clause 2 of this Article and send it to the dossier-receiving agency defined in Clause 1 of this Article.

Article 19. Methods of dossier submission

A certification organization shall make 1 dossier prescribed in Article 18 of this Decree and submit it:

1. Directly at the head office of the dossier-receiving agency. In this case, uncertified copies of the certificates and documents referred to in Article 18 of this Decree shall be accompanied by their originals for comparison.

2. By post. In this case, certified copies of the certificates and documents referred to in Article 18 of this Decree are required.

3. Via the e-portal of the dossier-receiving agency, using the online public service.

Article 20. Order of grant of a certification activity certificate

1. For grant of a new certificate:

a/ If the dossier is incomplete as prescribed, within 5 working days after receiving it, the dossier-receiving agency shall request in writing the certification organization to modify and supplement the dossier;

b/ If the dossier is complete and valid, within 10 working days after receiving it, the related line ministry shall grant a certificate to the certification organization, made according to Form No. 10 provided in the Appendix to this Decree;

c/ The validity of a certificate is 5 years at most counting from the date of its grant.

2. For grant of a modified certificate:

a/ A modified certificate may be granted to a certification organization that wishes to add, expand or narrow the scope of its certification operation;

b/ The order of grant of a modified certificate must comply with Points a and b, Clause 1 of this Article;

c/ The validity of a modified certificate is the same as that of the original one.

3. For re-grant of a certificate:

a/ A valid certificate may be re-granted if it is lost or damaged or the name or address of the certification organization is changed;

b/ Within the validity duration of its certificate, a certification organization that wishes to have this certificated re-granted shall make 1 dossier for re-grant of a certificate as prescribed in Clause 4, Article 18 of this Decree and send it to the dossier-receiving agency;

c/ If the dossier is complete and valid, within 5 working days after receiving it, the related line ministry shall re-grant a certificate to the certification organization. In case of ineligibility for re-grant, the dossier-receiving agency shall notify such in writing, clearly stating the reason;

d/ The validity of a re-granted certificate is the same as that of the original one.

Chapter VI

CONDITIONS FOR PROVISION OF THE SERVICE OF ACCREDITATION OF CONFORMITY ASSESSMENT ORGANIZATIONS

Article 21. Conditions for an organization to provide the service of accreditation of conformity assessment organizations

1. Being a scientific non-business unit that is established as a science and technology organization and has registered its operation under the law on science and technology.

2. The person establishing, managing or administering the accreditation organization neither establishes, manages, participates in the management of, administer nor acts as an at-law representative of, the conformity assessment organization.

3. Having an organizational structure and control system and operational capacity meeting the requirements of national standard TCVN ISO/IEC 17011:2007 or international standard ISO/IEC 17011:2004.

4. Meeting the requirements and conditions of one of regional or international accreditation organizations on accreditation operations corresponding to the registered accreditation program.

Within 3 years after its establishment, an accreditation organization shall build its capacity to meet the conditions prescribed in this Clause so as to become a signatory to an agreement on mutual recognition of conformity assessment results of regional or international organizations for corresponding accreditation programs.

5. Having at least 3 official assessors (public employees or employees working under contracts with a term of 12 months or longer or with an indefinite term), including 1 chief assessor for each accreditation program, who must satisfy the following conditions:

a/ Holding a university or higher degree and having at least 4 years of work experience in a technical field, including at least 2 years in quality control and capacity assessment at a relevant conformity assessment organization, for chief assessors; or at least 1 year in quality control and capacity assessment at a relevant conformity assessment organization, for assessors;

b/ Having been trained in and possessing a certificate of training and satisfaction of accreditation assessment requirements according to current standards (ISO/IEC 17025, ISO/IEC 17020, ISO 15189, ISO/IEC 17021, ISO/IEC 17065, ISO/IEC 17024 and other equivalent standards) relevant to the registered accreditation program;

c/ Having been engaged in at least 5 accreditation assessments according to current accreditation standards (ISO/IEC 17025, 1SO/IEC 17020, ISO 15189, ISO/IEC 17021, ISO/IEC 17065, ISO/IEC 17024 and other equivalent standards) under the supervision of an approved chief assessor;

d/ Meeting other requirements set out in Guideline ILAC-G11:07 of the International Laboratory Accreditation Cooperation (ILAC), for assessors of testing, calibration and assessment organizations.

In case of adding an area of accreditation, having at least 2 official assessors (public employees or employees working under contracts with a term of 12 months or longer or with an indefinite term) corresponding to the added area of accreditation, who must satisfy the conditions prescribed in this Clause.

Article 22. Dossier for grant of an accreditation operation registration certificate

1. Dossier-receiving agency:

The Directorate for Standards, Metrology and Quality shall assist the Minister of Science and Technology in receiving registration dossiers of conformity assessment organization accreditation.

2. For grant of a new certificate, a dossier must comprise:

a/ A written request for accreditation operation registration, made according to Form No. 11 provided in the Appendix to this Decree;

b/ The registration certificate of science and technology operations;

c/ Documents (documents, assessment process and other relevant documents) meeting the requirements of the corresponding standard prescribed in Article 21 of this Decree;

d/ A description of the organizational structure and responsibilities of each post in this structure;

dd/ A plan on, or results of, implementation of proficiency testing and interlaboratory comparison programs; a list of proficiency testing organizations accredited by an accreditation organization for the registered accreditation program;

e/ Evidence of satisfaction of the requirements and conditions of a regional or an international accreditation organization, specifically as follows:

In case the accreditation organization is a signatory to an agreement on mutual recognition of conformity assessment results of regional or international accreditation organizations, it shall submit documents proving its signing of such agreement together with the accreditation program;

In case the accreditation organization is not a signatory to an agreement on mutual recognition of conformity assessment results of regional or international accreditation organizations, it shall submit a written commitment to building its capacity to meet the requirements and conditions of a regional or an international accreditation organization so as to become a signatory to an agreement on mutual recognition among these organizations within 3 years after its establishment;

g/ A list of chief assessors, assessors and technical experts, made according to Form No. 12 provided in the Appendix to this Decree, together with a copy of the recruitment decision or labor contract; copies of relevant training certificates (expertise, control system), evidence of work experience and documents proving the practical assessment experience of each person;

h/ Forms of the accreditation decision and accreditation certificate, and accreditation mark (logo) of the organization.

3. For grant of a modified certificate, a dossier must comprise:

a/ A written request for addition and modification of accreditation operations, made according to Form No. 14 provided in the Appendix to this Decree;

b/ The original certificate;

c/ Documents proving the modification requirement.

4. For re-grant of a certificate, a dossier must comprise:

a/ An application for re-grant of a certificate, made according to Form No. 15 provided in the Appendix to this Decree;

b/ The original certificate (if any), in case it is damaged.

5. Sixty days before its certificate expires, if wishing to continue its accreditation operations, an accreditation organization shall make 1 dossier as in the case of application for a new certificate prescribed in Clause 2 of this Article and submit it to the Directorate for Standards, Metrology and Quality.

Article 23. Methods of dossier submission

An accreditation organization shall make a dossier as prescribed in Article 22 of this Decree and submit it:

1. Directly at the head office of the Directorate for Standards, Metrology and Quality. In this case, uncertified copies of the certificates and documents prescribed in Article 22 of this Decree shall be accompanied by their originals for comparison.

2. By post. In this case, certified copies of the certificates and documents prescribed in Article 22 of this Decree are required. Or

3. Via the e-portal of the Directorate for Standards, Metrology and Quality, using the online public service.

Article 24. Order of grant of an accreditation operation registration certificate

1. For grant of a new certificate:

a/ If the dossier is incomplete as prescribed, within 5 working days after receiving it, the Directorate for Standards, Metrology and Quality shall request in writing the accreditation organization to modify and supplement the dossier;

b/ If the dossier is valid and complete, within 10 working days after receiving it, the Ministry of Science and Technology shall organize an assessment team and grant a certificate to the accreditation organization, made according to Form No. 13 provided in the Appendix to this Decree;

c/ The validity of a certificate is 5 years at most counting from the date of its grant.

2. For grant of a modified certificate:

a/ A modified certificate may be granted to an accreditation organization that adds, expands or narrows the scope of its accreditation operation;

b/ If the dossier is incomplete as prescribed, within 5 working days after receiving it, the Directorate for Standards, Metrology and Quality shall request in writing the accreditation organization to modify and supplement the dossier;

c/ If the dossier is valid and complete, within 10 working days after receiving it, the Ministry of Science and Technology shall grant a certificate to the accreditation organization, made according to Form No. 13 provided in the Appendix to this Decree;

d/ The validity of a modified certificate is the same as that of the original one.

3. For re-grant of a certificate:

a/ A valid certificate may be re-granted if it is lost or damaged or the name or address of the holding accreditation organization is changed;

b/ Within the validity duration of its certificate, an accreditation organization wishing to have this certificate re-granted shall make a dossier for re-grant of a certificate as prescribed in Clause 4, Article 22 of this Decree and send it to the Directorate for Standards, Metrology and Quality;

c/ If the dossier is valid and complete, within 5 working days after receiving it, the Ministry of Science and Technology shall re-grant a certificate to the accreditation organization. In case of ineligibility for re-grant, the Directorate for Standards, Metrology and Quality shall notify such in writing, clearly stating the reason;

d/ The validity of a re-granted certificate is the same as that of the original one.

Article 25. Accreditation organizations established overseas eligible to carry out accreditation operations in Vietnam

1. Being a signatory to an agreement on mutual recognition of conformity assessment results of regional or international accreditation organizations.

2. One month before performing conformity assessment in Vietnam, an accreditation organization shall notify such to Vietnam’s Ministry of Science and Technology.

3. Within 3 months after performing conformity assessment in Vietnam, an accreditation organization shall send a report on its performance to Vietnam’s Ministry of Science and Technology.

4. A foreign accreditation organization carrying out accreditation operations in Vietnam that fails to comply with this Article shall be handled in accordance with Vietnamese law.

Chapter VII

REVOCATION OF ACCREDITATION OPERATION REGISTRATION CERTIFICATES

Article 26. Revocation of operation registration certificates of conformity assessment organizations

A line ministry shall consider and decide on revocation of the operation registration certificate of a conformity assessment organization that:

1. Commits repeatedly administrative violations of Clause 6, Article 8, or Article 20 of the Law on Product and Goods Quality, or violates this Decree.

2. Fails to fulfill its respective responsibilities prescribed in Article 29 of this Decree for 2 consecutive years.

3. Fails to satisfy one of the respective conditions for conformity assessment organizations prescribed in Article 5, 9, 13 or 17 of this Decree.

4. Forges or makes false declarations in documents in the dossier of grant, re-grant or modification of a certificate; grants sham conformity assessment results.

5. Tampers with the granted registration certificate to untruthfully change its content. Or

6. Fails to redress its violations as required by inspection or examination agencies.

Article 27. Revocation of operation registration certificates of accreditation organizations

1. The Ministry of Science and Technology shall consider and revoke an accreditation operation registration certificate of an accreditation organization that violates Clause 2, Article 55 of the Law on Standards and Technical Regulations, or relevant laws, or that:

a/ Commits repeatedly administrative violations of Clause 2, Article 55 of the Law on Standards and Technical Regulations or violates this Decree;

b/ Fails to satisfy one of the conditions prescribed in Article 21 of this Decree;

c/ Forges or makes false declarations in documents in the dossier of grant, re-grant or modification of a certificate or dossier of accreditation of a conformity assessment organization; or

d/ Tampers with the granted certificate to untruthfully change its content.

2. An accreditation organization having its certificate revoked may be considered for re-grant of such certificate only 2 years after the notice of revocation of that certificate is issued and it has redressed its violations.

Chapter VIII

ORGANIZATION OF IMPLEMENTATION

Article 28. Responsibilities of line ministries

1. Line ministries:

a/ To grant, modify and re-grant registration certificates of testing, inspection, assessment and certification operations to conformity assessment organizations according to the principles prescribed in Article 4 of this Decree;

b/ To assume the prime responsibility for, and coordinate with the Ministry of Science and Technology and related line ministries in, inspecting and examining registered conformity assessment organizations according to the principles prescribed in Article 4 of this Decree;

c/ Post on their e-portals lists of registered conformity assessment organizations and, within 15 days after granting a certificate, notify such grant to the Ministry of Science and Technology for monitoring.

2. The Ministry of Science and Technology:

a/ To grant, modify and re-grant registration certificates of testing, inspection, assessment and certification operations to conformity assessment organizations according to the principles prescribed in Article 4 of this Decree, and to organizations accrediting conformity assessment organizations;

b/ To provide guidance for training institutions on the framework program on training of production certification assessors and control and standard system assessors; to receive training eligibility statements from institutions training production certification assessors and control system assessors;

c/ To inspect and examine general multi-sectoral conformity assessment organizations and accreditation organizations registered by the Ministry of Science and Technology; and institutions training production certification assessors and control system assessors;

d/ To coordinate with line ministries in inspecting and examining registered specialized conformity assessment organizations;

dd/ To post on the e-portal of the Ministry of Science and Technology (the Directorate for Standards, Metrology and Quality) the list of registered general multi-sectoral conformity assessment organizations and accreditation organizations; and the list of institutions training production certification assessors and control system assessors;

e/ To guide the implementation of the standards referred to in this Decree when they are amended, supplemented or replaced.

Article 29. Responsibilities of conformity assessment organizations and accreditation organizations

1. Conformity assessment organizations:

a/ To annually or upon request report to line ministries on results of their registered conformity assessment operations for each type of organization according to Form No. 07, 08 or 09 provided in the Appendix to this Decree;

b/ To notify line ministries of any changes which affect their registered operation capacity within 15 days after effecting such changes;

c/ Institutions training production certification assessors and control system assessors shall send to the Ministry of Science and Technology (the Directorate for Standards, Metrology and Quality) a training eligibility statement according to Form No. 17 provided in the Appendix to this Decree.

2. Accreditation organizations:

a/ To monitor and assess the implementation of proficiency testing and interlaboratory comparison programs by organizations that have been accredited for conformity with national standard TCVN ISO/IEC 17043:2011 or international standard ISO/IEC 17043:2010;

b/ To annually or upon request report to the Ministry of Science and Technology (the Directorate for Standards, Metrology and Quality) on their accreditation results according to Form No. 16 provided in the Appendix to this Decree;

c/ To notify the Ministry of Science and Technology (the Directorate for Standards, Metrology and Quality) of any changes which affect their registered accreditation operations within 15 days after effecting such changes.

Chapter IX

IMPLEMENTATION PROVISIONS

Article 30. Effect

This Decree takes effect on July 1, 2016.

Article 31. Transitional provisions

1. Conformity assessment organizations and accreditation organizations that have been granted a registration certificate of areas of operation or an operation registration certificate by the Ministry of Science and Technology (the Directorate for Standards, Metrology and Quality) shall review their conditions and complete the procedures for grant of an operation registration certificate prescribed in this Decree within 2 years after the effective date of this Decree.

2. Institutions training product certification assessors and control system assessors who have received notices of receipt of their dossiers of training capacity announcement from the Ministry of Science and Technology (the Directorate for Standards, Metrology and Quality) may continue their training activities till such notices expire.

Article 32. Implementation responsibility

Ministers, heads of ministerial-level agencies, heads of government-attached agencies and chairpersons of provincial-level People’s Committees shall implement this Decree.-

 

 

ON BEHALF OF THE GOVERNMENT
PRIME MINISTER




Nguyen Xuan Phuc

 

* The Appendix to this Decree is not translated.

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