Nghị định 105/2016/NĐ-CP hoạt động của tổ chức kiểm định, hiệu chuẩn đo lường

THE GOVERNMENT

DecreeNo. 105/2016/ND-CPdatedJuly 01, 2016 of the Governmenton requirements for organizations in charge of inspecting/calibrating/testing measuring instruments, measurement standards

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

Pursuant to the Law on measurement dated November 11, 2011;

Pursuant to the Law on investment dated November 26, 2014;

At the request of the Minister of Science and Technology;

The Government hereby promulgates the Decree on requirements for organizations in charge of inspecting/calibrating/testing measuring instruments, measurement standards.

Chapter I

GENERAL PROVISIONS

Article 1.Scope of regulation

1.This Decree provides for requirements for organizations in charge of inspecting/calibrating/testing measuring instruments, measurement standards, rights and obligations of organizations and individuals in the inspection/calibration/testing of measuring instruments and measurement standards.

2.Requirements for organizations in charge of inspecting/calibrating/testing measuring instrument and measurement standards directly serving the peculiar measurement activities in field of national defense and security and of organizations in charge of inspecting and calibrating radiation measurement equipment which is not governed by this Decree.

Article 2.Subjects of application

1.Organizations providing services of inspecting/calibrating/testing measuring instruments, measurement standards (hereinafter referred to as inspection/calibration/testing service providers).

2.Organizations in charge of inspecting/calibrating/testing measuring instruments and measurement standards which are appointed (hereinafter referred to as appointed inspection/calibration/testing organizations).

3.Other regulatory agencies, organizations and individuals relevant to the inspection/calibration/testing of measuring instruments, measurement standards.

Chapter II

REQUIREMENTS FOR INSPECTION/CALIBRATION/TESTING ORGANIZATIONS

Article 3. Requirements for inspection/calibration/testing service providers

Any inspection/calibration/testing service provider shall:

1.Have legal status according to Vietnam’s laws.

2.Have sufficient facilities which satisfy the following requirements:

a) Have working site, environmental conditions and other conditions conformable to the requirements in the inspection/calibration/testing procedures specified in clause 3 of this Article;

b)Have sufficient measurement standards and instrument for the inspection/calibration/testing suitable for the corresponding inspection/calibration/testing. Such measurement standards and instruments must be periodically inspected, calibrated and tested at the inspection/calibration/testing service provider with suitable domains and shall be maintained, preserved and used as prescribed by heads of the organization; the certificate of inspection/calibration/testing must be unexpired.

3.Have sufficient procedures for inspection/calibration/testing suitable for the registered domains.

Procedures for inspection/calibration/testing shall be formulated and issued by the inspection/calibration/testing service provider in accordance with the guidelines of the Ministry of Science and Technology or the international advices of the International Organization of Legal Metrology, the standards of the International Electrotechnical Commission, the standards of International Organization for Standardization and documents of relevant manufacturers.

4.Assign at least 02 technicians for each domain. Such technicians must:

a) Be civil servants or employees under contracts with terms of 12 months or more;

b) Have graduated from a vocational school or higher level in field of technique;

c) Have completed a course of training in inspection/calibration/testing depending on the domain and in accordance with the guidelines of the Minister of Science and Technology.

5.Fulfill requirements on the independence and objectiveness as follows:

a) Publish the procedures for inspection/calibration/testing which have been declared and applied;

b) Heads of the inspection/calibration/testing service provider must comply with the management system, the procedures for inspection/calibration/testing which have been declared and applied and shall take responsibility for the accuracy of the inspection/calibration/testing results;

c) Persons in charge of conducting the inspection/calibration/testing must comply with the procedures for inspection/calibration/testing which have been declared and applied and take responsibility for the accuracy of the inspection/calibration/testing results.

6.Establish and maintain the management system in conformity with the National regulation TCVN ISO/IEC 17025 for the inspection/calibration/testing of measuring instruments and measurement standards. Have documents issued by the heads of the organization providing for the management of stamps, seals, certificates of inspection/calibration/testing; professional techniques (affixure of seals) which must be conducted during the inspection/calibration/testing process to prevent and aviod cahnegs in main technical features of the measuring instruments, measurement standards during the use thereof.

7.Have the certificate of registration for the provision of services of inspection/calibration/testing of measuring instruments, measurement standards (hereinafter referred to as the registration certificate) according to regulations in this Decree.

Article 4. Requirements for appointed inspection/calibration/testing service providers

1.Fulfill the requirements specified in clauses 1, 2, 4, 5, 6 and 7 Article 3 of this Decree.

2.Have working standards and reference materials directly used for inspecting group 2 measuring instruments of the assigned domain which are calibrated, tested or compared at the organization conducting the inspection/calibration/testing and are certified according to regulations in Article 14 and Article 15 of the Law on measurement.

3.Have sufficient procedures for inspection/calibration/testing suitable for the appointed domains.

4.Have at least 02 inspectors having the certificate and the metrological inspector for specific fields of inspection of group 2 measuring instruments which are appointed.

5.Ensure the independence and objectiveness. Any establishment trading goods or providing services for customers by using group measuring instruments shall not be entitled to make appointment of the inspection of such measuring instruments. Any establishments manufacturing group 2 measuring instruments shall not be entitled to make appointment of the periodic inspection and post-repair inspection for such group 2 measuring instruments.

6.Have been appointed according to regulations in Article 25 of the Law on measurement.

Article 5. Application for certificate of registration of the provision of inspection/calibration/testing services

An application for the certificate of registration for the provision of inspection/calibration/testing services (hereinafer referred to as application) shall comprise:

1.The Form No. 01 in the Annex enclosed with this Decree.

2.A certified true copy or a duplicate enclosed with the original for comparison of the establishment decision or the certificate of registration of science and technology activities or the certificate of business registration issued by competent agencies.

3.A report on technical facilities and human resources (using the Form No. 02 in the Annex enclosed with this Decree).

4.A list of documents of the management system which has been established and maintained for the inspection/calibration/testing activities registered.

5.A document providing for the management of certificates of inspection/calibration/testing containing the following main contents: contents and form of the certificates; the formulation, management and use of the certificates; size and location of the number of registration (the phrase “DK...”) on the certificates to ensure being noticed easily by naked eyes; documents regulating the maintenance, storage and use of the measurement standards, measuring instruments for inspecting/calibrating/testing activities; documents providing for professional techniques (by affixing seals) to be applied when carrying out the inspection/calibration/tests.

Article 6. Issuance of registration certificate

1.Application receiving agencies

The Directorate for Standards, Metrology, and Quality shall be the agency assisting the Minister of Science and Technology to receive applications for the registration certificate within the management of the Ministry of Science and Technology.

2.Any organization applying for the certificate of registration for the provision of inspection/calibration/testing services (hereinafter referred to as the applicant organization) shall send 01 set of application directly to the Directorate for Standards, Metrology, and Quality or viaweb portalof the Directorate for Standards, Metrology, and Quality.

3.If the application is sufficient and satisfactory, within 07 working days from the day on which the application is received, the Ministry of Science and Technology shall issue the certificate of registration for the provision of services of inspection/calibration/testing of measuring instruments, measurement standards (using the Form No. 03 in the Annex enclosed with this Decree).

4.If the application is unsatisfactory or insufficient, within 05 working days from the day on which the application is received, the Directorate for Standards, Metrology, and Quality shall send the applicant organization a notification of the explanation for the refusal or of request for amendment and supplement to the application.

5.In case there is information or comments or the inspection result reflects that one or a number of conditions of the applicant organization is unconformable toregulations or at the request of acompetent agency, within 30 days from the day on which such information, comment, result or request is received,the Directorate for Standards, Metrology, and Qualityshall conduct an on-site assessment to formthe basis forissuing the registration certificate as prescribed in clause 3 of this Article. If the result of the assessment is unconformable to the regulations, the applicant organization shall pay the cost of the on-site assessment.

Article 7. Reissuance of registration certificate

The reissuance of a registration certificate shall be considered in any of the following cases:

1. The reissuance of the registration certificate which is lost or damaged shall be carried out as follows:

a)The service provider shall send 01 application for reissuance of the certificatedirectly tothe Directorate for Standards, Metrology, and Qualityor via the web portal ofthe Directorate for Standards, Metrology, and Quality.

The application shall comprise:an official application formof the service provider containing explanation for the application for reissuance; the issued registration certificate (applicable to cases where the certificate is damaged);

b) The reissuance of the certificate shall comply with provisions of clause 3 Article 6 of this Decree.

2. Regarding the application for modification of the registration certificate whichhas beenissued:

a) The service provider shall send 01 application for reissuance of the certificate directly to the Directorate for Standards, Metrology, and Quality or via the web portal of the Directorate for Standards, Metrology, and Quality.

The application shall comprise the application form for the certificate of registration for  services of inspection/calibration/testing of measuring instruments, measurement standards (using the Form No. 01 in the Annex enclosed with this Decree); documents relevant to the contents to be modified;

b) The reissuance of the certificate shall comply with provisions of clause 3, clause 4 and clause 5 Article 6 of this Decree.

3.For certificates of registration that are invalidated according to regulations in clause 1 Article 8 of this Decree and the service provider have taken remedial measures, the certificate shall be reissued according to the following procedures:

a) The service provider shall send 01 application for reissuance of the certificate directly to the Directorate for Standards, Metrology, and Quality or via the web portal of the Directorate for Standards, Metrology, and Quality.

The application shall comprise: an official application form for reissuance of the registration certificate; the issued registration certificate; documents proving the completion of remedial measures;

b) The reissuance of the certificate shall comply with provisions of clause 3, clause 4 and clause 5 Article 6 of this Decree.

Article 8. Invalidation of registration certificate

A registration certificate shall be ineffective if it is invalidated. Procedures for invalidation of the effect of a registration certificate:

1.If the inspection/calibration/testing service provider fails to comply with any of the requirements specified in Article 3 or fails to fulfill the responsibilities specified in clause 1 Article 11; the employee in charge of conducting the inspection, calibration or testing fails to fulfill the responsibilities specified in clause 2 Article 11 of this Decree, the Minister of Science and Technology shall issue a decision to invalidate the effect of the issued registration certificate (hereinafter referred to as decide to invalidate registration certificate).

2.If the inspection/calibration/testing services provider commits a violation against laws that results in the revocation of the registration certificate or the suspension of operation according to a decision of a competent agency, the Minister of Science and Technology shall decide to terminate the effect of the registration certificate.

3.If the inspection/calibration/testing service provider is bankrupt or is dissolved, the Minister of Science and Technology shall decide to terminate the effect of the registration certificate.

4.If the inspection/calibration/testing service provider applies to terminate all activities in the registration certificate, the effect of the certificate shall be invalidated according to the following procedures:

a) The service provider shall sendtheapplicationform enclosed with the issued registration certificate directly or via web portal to the Directorate for Standards, Metrology, and Quality;

b) Within 05 working days from the day on which the application is received, the Minister of Science and Technology shall decide to invalidate the registration certificate.

Chapter III

ORGANIZATION OF IMPLEMENTATION

Article 9. Responsibilities of Ministries and ministerial-level agencies

1.The Minister of Science and Technology shall provide guidance and manage the inspection/calibration/testing activities, conduct inspection of the implementation of responsibilities of relevant agencies, organizations and individuals specified in this Decree.

2.Ministries, ministerial-level agencies and Governmental agencies shall, within their tasks and power, cooperate with the Ministry of Science and Technology in providing inspection/calibration/testing services according to regulations in this Decree in accordance with their competence.

Article 10. Responsibilities of People’s Committees of provinces and central-affiliated cities

1.Disseminate and conduct the implementation of regulations in Decree within local areas.

2.Conduct and organize the implementation of this Decree; conduct regular inspection, according to the schedule or susprise inspection at the request of competent agencies, of the provision of inspection/calibration/testing services in local areas according to regulations in this Decree and other relevant law provisions pertaining to measurement.

Article 11. Responsibilities of inspection/calibration/testing service providers

1.Responsibilities of organizations providing inspection/calibration/testing service:

a) Conduct the inspection/calibration/testing in the field specified on the registration certificate; comply with regulations, retain and store documents related to the conduct and implementation of requirements specified in this Decree;

b) Issue and implement regulations on the management of inspection/calibration/testing carried out by the employees in charge; retain, preserve and use the measurement standards and instruments to conduct the inspection/calibration/testing; print, produce, manage and use certificates of inspection/calibration/testing; measures for preventing and fighting against the changes of main meatrological features of the measuring instruments or measurement standards during the use thereof;

c) Publish the service prices; comply with regulations in prices of inspection/calibration/testing service and the state inspection of measurement by competent agencies;

d) Before the 31st of March of every year or at the request of competent agencies, formulate and send reports on inspection/calibration/testing activities (using the Form No. 04 in the Annex enclosed with this Decree).

2.Responsibilities of persons conducting the inspection/calibration/testing:

a) Conduct inspection/calibration/testing registered on the registration certificate according to the appointment of the heads of the organizations providing inspection/calibration/testing and in accordance with their profession;

b) Comply with the procedures specified in the inspection/calibration/testing procedures and take responsibility for the inspection/calibration/testing results;

c) Take measures to prevent and avoid technical changes of the measuring instruments, measurement standards in the use thereof;

d) Any violation against laws on measurement must be immediately reported to the heads of the organizations for cooperation with competent agencies in solution according to laws.

Chapter IV

IMPLEMENTARY CLAUSE

Article 12. Effect

This Decreetakes effect onJuly 01, 2016.

Article 13. Transitional clause

Any organization providing services of inspection/calibration/testing of measuring instrument, measurement standards which has obtained the registration certificate and has been appointed according to current regulations on inspection/calibration/testing of measuring instruments, measurement standards, shall continue performing the inspection/calibration/testing in the certified/appointed acitivities according to regulations in this Decree.

Article 14. Responsibilities

Ministers, Heads of ministerial-level agencies, Heads of Governmental agencies, Presidents of People’s Committees of provinces and central-affiliated cities and relevant organizations and individuals shall be responsible for implementing this Decree./.

On Behalf Of The Government

The Prime Minister

Nguyen Xuan Phuc