Bs. As., 23/8/94
VISTO file No. 601.424/94 of the Register of MINISTERY OF ECONOMY AND ARTWS AND PUBLIC SERVICES, and Decree No. 331 of 13 March 1989, Decree No. 2181 of 19 September 1978, as amended by Decree No. 2082 of 24 September 1980 and Decree No. 843 of 14 April 1983, and
That the progressive development of quality is an indispensable condition for industrial modernization in line with current technological and management patterns.
That the promotion of the quality of goods and services is part of the process of social transformation as a guarantee of greater excellence of the social organization, generating in turn a highly qualified productive environment.
That the country has public and private institutions, with proven technical capabilities to assume the tasks associated with quality development, such as the National Institute of Industrial Technology and universities.
That the Argentine economy is inserted into a highly competitive international market in which the transactions of goods and services present, in particular and increasingly, the modality of demanding quality certifications.
There are international agencies responsible for issuing standards of quality of voluntary compliance, which employ under strict models of organization and application facilitate the acceptance of goods and services under them certified in most external markets.
It is necessary to implement a system that allows companies to access certifications that facilitate the placement of goods and services in competitive conditions in the domestic and external market.
That the State should ensure quality assurance in the organization of both the standardization and accreditation bodies for which it must conclude agreements establishing the obligations of the entities that assume such roles.
That in order to obtain the wide acceptance of the certifications generated by the System, in addition to having an efficient accreditation and certification system, it is appropriate to promote mutual recognition agreements with similar international agencies.
That the State should guide its purchasing capacity in order to ensure the quality of the goods and services provided to the community by demanding compliance with quality standards in its contracts.
This Decree is issued in use of the powers conferred upon it by Article 86(1) of the National Constitution.
THE PRESIDENT OF THE ARGENTINA NATION
Article 1 . Créase the National Quality System to provide reliable tools at the local and international levels for companies willing to certify their quality systems, products, services and processes through a mechanism that has the standardization, accreditation and certification agencies, integrated in accordance with existing international standards. The rules deriving from the established system shall be voluntary. (Denomination of the National System of Standards, Quality and Certification Is replaced by the name of the National System of Quality Issued by Art. 1 Decree No. 1066/2018 B.O. 23/11/2018. Watch: from the day after the date of publication in the Official Gazette)
Art. 2o . The application of the standards of the National Quality System does not exempt from the observance of the technical and marketing regulations of compulsory compliance in the national territory, which are in force at the date of this decree and those that are dictated in the future by the competent bodies.
Art. 3o El The National Quality System will be organized as detailed in the Annex (IF-2018-58250507-APN-MPYT) which is an integral part of this Decree and will be composed of:
a. Level 1:
The National Quality Council, as a senior coordinating body in quality policies and in the field of standardization and certification; and the Advisory Committee to act as the consultative body of the Council;
(b) Level 2:
I) The NATIONAL INSTITUTE OF INDUSTRIAL TECHNOLOGY (INTI), a decentralized body within the scope of the MINISTERY OF PRODUCTION AND WORK, in exercise of the functions assigned by article 3 of Decree No. 960 of 24 November 2017, as an institution responsible for the realization, maintenance and dissemination of national patterns of measure and their international recognition.
II) The Standardization Agency as a national entity responsible for issuing and updating standards.
III) The Technical Regulatory Commission (CRT), as an inter-ministerial commission responsible for the coordination between regulatory bodies and for ensuring compliance with good regulatory practices.
IV) The Accreditation Agency, as an entity at the national level responsible for the accreditation of the certification bodies of quality, products, services and processes systems, and for the accreditation of the conformity assessment agencies.
(c) Level 3:
The Certification Agencies of quality systems, products, services and processes, and the laboratories that will operate in the field of testing and calibration.
They shall be constituted under the forms provided for in the relevant rules and are accredited at the national level by the Accreditation Agency provided for in subparagraph (b), paragraph IV of this article.
Also, at this level, the Quality Systems Auditors, qualified and duly certified persons by the Quality Accreditation Agency shall be incorporated in accordance with the relevant standards, which shall perform audit tasks of quality systems for certification agencies.
(Article replaced by art. 2° Decree No. 1066/2018 B.O. 23/11/2018. Watch: from the day after the date of publication in the Official Gazette)
OF THE NATIONAL COUNCIL
Art. 4o . Trust the National Quality Council in the orbit of the SECRETARIAN OF INDUSTRIA of the MINISTERY OF ECONOMY AND PUBLIC SERVICES. (Denomination of the National Council of Standards, Quality and Certification is replaced by the name of the National Council of Quality, by art. 3rd of the Decree No. 1066/2018 B.O. 23/11/2018. Watch: from the day after the date of publication in the Official Gazette)
Art. 5o : The functions of the Council:
(a) To propose to the NATIONAL EXECUTIVE PODER the necessary measures to ensure the efficient functioning and credibility of the created system, updating it permanently in accordance with the internationally prevailing guidelines;
(b) To cooperate in the planning, implementation and evaluation of public policies aimed at improving the quality of goods and services;
(c) To promote the dissemination of the System created by this Decree, implementing the necessary measures to ensure that the private sector is incorporated into it;
(d) To represent the Argentine State, where appropriate, in all matters inherent at the national and international levels;
(e) Indicate the rules applicable temporarily to the System until the corresponding rules are issued;
(f) To request the standardization agency to develop, modify or derogate from rules where they do not exist or the existing ones do not conform to the internationally accepted criteria, verifying their dictation;
(g) To recommend to the Standardization Agency on the incorporation of observations made during the pre-emission public discussion stage, where it deems them relevant;
(h) control compliance with established standards for the organization and operation of the system ' s standardization and accreditation agencies. To that end, it may engage the services of accredited and recognized auditors who are free from economic pressure, financial or commitments of any kind that question their impartiality, in accordance with the guidelines established by regulation.
You may also request all members of the System, documentation and information when necessary for the performance of this function;
(i) To propose to the competent authorities in the field of education the inclusion of the topic of quality and specific content in the programmes of instruction at different levels in order to promote a culture of standardization and quality in the community.
(j) To propose the adequacy of compulsory compliance rules in the national territory with those of the National Quality System.
Art. 6th El The National Quality Council shall be composed of the highest authority of each of the following agencies, or who they designate for the performance of their functions, with rank not inferior to the Assistant Secretary or their equivalent: MINISTERIES OF PRODUCTION AND WORK, FOREIGN AND CULTOBER RELATIONS, OF HACIENDA, OF HEALTH AND SOCIAL DEVELOPMENT, OF TRANSPORTATION, DETECTION, OF THE NATION, Normalization Agency or its delegate, Accreditation Agency or its delegate, NATIONAL INSTITUTE OF INDUSTRIAL TECHNOLOGY (INTI), and Technical Ruler Commission.
The National Quality Council will be chaired by the representative of the MINISTERY OF PRODUCTION AND WORK, and its members will exercise their responsibilities as a “liad honorem.”
Where it deems appropriate, the National Quality Council may extend the invitation to other public or private entities, according to the topics under consideration.
(Article replaced by art. 4° Decree No. 1066/2018 B.O. 23/11/2018. Watch: from the day after the date of publication in the Official Gazette)
Art. 7o . The National Quality Council will have an Advisory Committee, composed of representatives from the various productive sectors, consumer associations, workers ' associations and universities who will act on a single-honorem basis and will collaborate with the National Quality Council on the analysis and study of issues related to the functioning of the System and other topics specific to its competence.
Where the nature of the topics under study so requires, the National Quality Council may convene other sectors for participation in the Advisory Committee.
(Article replaced by art. 5° Decree No. 1066/2018 B.O. 23/11/2018. Watch: from the day after the date of publication in the Official Gazette)
Art. 8o La The Authority of Implementation, at the end of CIENTO VEINTE (120) days from the date of the publication of this Decree, will elevate to the NATIONAL EXECUTIVE PODER the draft organization and rules of operation of the Council.
OF THE ORGANIZATIONALIZATION
Art. 9th de They are functions of the Standardization Agency:
(a) The development and issuance of standards;
(b) To keep a permanent update of the standards;
(c) The dissemination of standards;
(d) The implementation of a mechanism that promotes the full participation of all interests and sectors involved in the development of standards in international and regional standardization agencies;
(e) The conclusion of agreements with international, regional or other peer bodies, of recognized prestige, in respect of their strict competence.
Art. 10. , In the process of developing and issuing standards the Standardization Agency must:
(a) Ensure representation of all sectors of the community with interests in normalization. It will be understood that the interests involved in the normalization process are those of the productive sector, consumption and institutions of general interest represented among others by technology, scientists, professionals and education. It should also ensure, through the balance of interests of its members, that decisions taken are free from commercial and financial pressures that question their impartiality and have such an organization and decision-making procedures to ensure full independence between standardization and certification activities.
(b) To adopt, where available, criteria set out in rules issued by internationally and regionally recognized standardizing bodies, in cases which may be duly justified, to deviate from such criteria upon authorization by the Council. The Standardization Agency should adopt for its organization and operation a Quality System in accordance with the standard that is established in the future in a specific manner for the standardization agencies, which will be verified by the National Standards, Quality and Certification Council.
Art. 11. . Prior to its issue the rules must be subject to public discussion. To that end, a consultation should be carried out through the means to ensure the wide dissemination of the proposed rules so that the sectors involved can comment.
The Standardization Agency should reconsider the proposed rule based on properly substantiated observations. In this instance, the observation and at the request of a party shall be subject to an arbitral settlement of the Council whose procedure shall be established by regulation. The resolution adopted at this stage will be binding on the Agency for Standardization.
The standards issued by the Standardization Agency shall be regarded as the standards of the National Quality System, provided that the procedure described above has been completed.
Art. 12. . The Implementing Authority, within the VEINTE SCIENTY (120) days from the date of publication of this Decree, shall designate the entity that shall assume the functions of the Normalization Agency with which it shall hold an agreement in order to implement the system implemented by Articles 9, 10 and 11 of this Decree.
OF THE ORGANIZATION OF ACREDITATION
Art. 13. de They are functions of the Accreditation Agency:
(a) To certify the certification bodies of the quality, products, services and processes systems and the testing and calibration laboratories in accordance with the existing regulations in the matter and to replace or modify it in the future. Such accreditation shall specify its scope and duration;
(b) certify auditors in accordance with the relevant regulations;
(c) To audit certification bodies and accredited laboratories to ensure compliance with the relevant standards during the period of accreditation;
(d) revoke or suspend all or partly the accreditation in the event of non-observance of the relevant rules, or when the inability to perform the functions for which they are accredited is ascertained;
(e) To participate in the integration of international or regional bodies with common accreditation interests;
(f) To keep a permanently updated record of accredited agencies and certified auditors within the System.
Art. 14. El The Accreditation Agency must be a non-profit entity and be integrated and operated in accordance with the standards of the System. Its overall direction and administration will be in charge of a Council, within which all those sectors whose presence is necessary for the effective performance of accreditation functions will be widely and homogeneously represented.
This Council will be chaired by a representative of the SECRETARIAT of INDUSTRIA, TRADE and MINERIA of the MINISTERY OF PRODUCTION, and will be composed among others by the productive sector, consumption, university, technological and scientific. All its members will perform their duties "ad honorem".
This Agency shall:
(a) Have permanent staff. Staff will be free of influence from those parties that have a commercial interest in the results of the accreditation process.
(b) Include a Quality System in its organizational structure that allows it to give confidence in its ability to successfully apply a certification system of certification bodies and quality auditor certification laboratories.
(c) Having a policy and procedures for decision-making based on information provided by interested parties;
(d) To conclude mutual recognition agreements with peer agencies of foreign states in order to promote recognition of certificates issued by the national system in such countries.
(Article replaced by Article 1 of the Decree No. 73/2003 B.O. 14/01/2003)
Art. 15. El The Accreditation Agency shall have CUATRO (4) committees to which it shall entrust the management of all tasks required for the accreditation and audit of certification bodies, test laboratories, calibration laboratories and for the certification and audit of quality auditors. To that end, the recruitment of staff may be made available when the specialization necessary to carry out its duties so as to require.
Recruitment requirements and conditions shall be established by regulation.
Art. 16. . Commend the Authority for the Application of this Decree to convene within the TREINTA (30) days from the date of its publication, all sectors involved in the process of quality certification for the constitution of an entity with the characteristics specified in Articles 13 and 14, with which it will hold an agreement to enable it as a Accreditation Agency.
Art. 17. . The rules established by the INSTITUTE ARGENTINO DE RACIONALIZATION OF MATERIALS in force at the date of the adoption of the convention referred to in Article 12 shall be considered the rules adopted by this system. They may be revised at the request of the interested party. This request shall proceed in accordance with the procedure established for the observations described in Article 11.
Art. 18. . The Central Administration, Special Accounts, Decentralized Agencies and State Enterprises, including all business organizations where the State has majority participation in the capital or in the formation of corporate decisions, should clearly establish the quality specifications required for the products and services subject to their contracts.
Art. 19. de Facultase the Implementation Authority to regulate in due course the obligation to require that the quality of the products and services subject to their contracting, whether national or foreign, be certified by an accredited certification agency indistinctly by:
(a) the system accreditation body established by this Decree,
(b) accreditation agencies that have signed mutual recognition agreements with the agency mentioned in the preceding paragraph,
(c) Internationally recognized accreditation bodies that integrate the list to that end by the Authority for the Implementation of this Decree.
Art. 20. . Until the implementation of the system created by this Decree and for the purposes set out in Article 19, the certifications issued by the INSTITUTO ARGENTINO DE RACIONALIZATION DE MATERIALES or by national or foreign certification bodies that comply with the IRAM standards of the 350 or ISO/IEC series in their organization and for the issuance of certifications.
Art. 21. . Exclude the MINISTERY OF DEFENSA and the COMANDS IN JEFE OF ARMED FORCES and dependent agencies and companies, whatever their legal nature, from the application of this regime.
Art. 22. . Designate as Authority of Application of this Decree to the MINISTERY OF PRODUCTION AND WORK.
(Article replaced by art. 6° Decree No. 1066/2018 B.O. 23/11/2018. Watch: from the day after the date of publication in the Official Gazette)
Art. 23. La The Authority for the Implementation of this Decree must develop and propose to the MINISTERY OF ECONOMY AND ARTWORKS AND SERVICES PUBLICS financial assistance mechanisms aimed at promoting the implementation of the National Quality System.
Art. 24. . Default of Decree No. 2181/78 as amended by Decree No. 2082/80 and 843/83 and Decree No. 331/89.
Art. 25. el Replace Article 1 of Decree 254/89 with the following text:
"ARTICULO 1o : : Believe in the jurisdiction of the NATION PRESIDENCE, on an honorary basis, the Commission for the Quality of Products and Services, with the mission to develop policies and coordinate actions related to the management, promotion and dissemination of quality, except those corresponding to the National Quality System".
Art. 26. . Communicate, publish, give to the National Directorate of the Official Register and archvese. . MENEM. . Domingo F. Cavallo.Annex I
(Annex replaced for Decree No. 1066/2018 B.O. 23/11/2018. Watch: from the day after the date of publication in the Official Gazette)