Chương VI Nghị định 107/2016/NĐ-CP quy định về điều kiện kinh doanh dịch vụ đánh giá sự phù hợp: Điều kiện kinh doanh dịch vụ công nhận tổ chức đánh giá sự phù hợp

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.