Ever enter the recognition regime established by Resolution No. 123/99 calibration laboratories and inspection bodies whose work is intended to fulfill the mandatory certification schemes. Requirements.
Bs. As., 06/28/99
File No. 064004853/99 SEEN Registry of the MINISTRY OF ECONOMY AND PUBLIC WORKS AND SERVICES, and WHEREAS:
Article 12, subsection b) of Law No. 22,802 delegates to the of Industry, Trade and Mining Secretariat establish safety requirements to be met by products or services that are not governed by other laws.
To that effect they have been issued the necessary resolutions establishing security requirements for products and services.
That the establishment of such security requirements requires, for its effective implementation, determining the modalities, procedures and institutions for the control and verification of compliance with the issued regulations.
That Resolution S.I.C. and M. No. 1233/97 was delegated to the National Board of Trade INTERIOR implementation of Law No. 22,802 and its regulatory resolutions.
Also, that this Secretariat Resolution No. 123, of March 3, 1999, establishes the requirement for intervention by certification bodies and laboratories mandatory certification schemes, counting with the respective recognition by this body.
The reliability of security schemes that aims to make it necessary to extend the requirements referred to calibration laboratories and inspection bodies.
It is necessary to explain the conditions of eligibility and background that are deemed necessary to fulfill the functions of certification, testing, calibration and inspection.
It is common practice internationally through the respective assessment accreditation body, compliance by certification bodies, laboratories and inspection bodies of the guidelines set by the respective guides and ISO Standards.
That is appropriate to recognize and foster the implementation of agreements of mutual recognition of all the functions inherent in certification, between domestic and foreign entities.
That, also, it is appropriate to recognize the validity of certifications that, even in the voluntary sphere, they trust the behavior of the products for their safety.
Which, as noted however, it is necessary to verify the behavior of the respective products in terms of basic security features.
That both the type tests required for certification relevant, as the aforementioned basic tests, should be performed in laboratories that offer greater reliability, impartiality and transparency about their performance.
That Resolution S.I.C. and M. No. 123/99 provides for the extension of the respective recog foundation through the National Directorate of Domestic Trade under the Secretariat of Domestic Trade of the Secretariat.
For that reason that it is the appropriate body to monitor and implement any sanctions that apply to recognized organizations.
It is convenient to set a limit for the insistence of the entities that have not agreed to the recognition, in order to ensure the results of their adaptation to the requirements of the enforcement authority.
Which it is necessary to monitor the development of the recognized organizations, providing measures for the effective recognition to the detection of irregularities in their actions.
That it is essential for their willingness to provide as much information and cooperation with the work of the enforcement authority.
It is convenient to characterize the anomaly liable to be punished in the development of the activities of mandatory certification.
The abnormalities detected in both cast doubt on the safety of products on the market, should encourage the immediate actions of the authorities and dissemination enough to alert consumers.
That, similarly, there should be a defense mechanism that allows entities to ensure even-handed and objective procedures.
That Resolution S.I.C. and M. No. 123/99 provides for the involvement of an Evaluation Committee in the process of recognition.
The analysis of applications for recognition by an Evaluation Committee, must be made with the best guarantees of competence and impartiality, in order to ensure the transparency of the system.
It is necessary to promote the free movement of products covered by mandatory certification schemes, including the States of MERCOSUR.
That the General Directorate of Legal Affairs of the Ministry of Economy and Public Works and Services has taken action within its jurisdiction.
That this is issued in exercise of the powers conferred by Articles 11 and 12 paragraph b) of Law No. 22,802, articles 41 and 43, paragraph a) of Law No. 24,240 and Decree No. 1183 of 12 November 1997.
Thus,
The Minister of Industry, Trade and Mining RESOLVED:
Article 1 – Join the recognition regime established by Resolution SIC and M. No. 123/99 calibration laboratories and inspection bodies whose work is intended to fulfill the mandatory certification schemes established by the Secretariat.
Art. 2 – The certification bodies referred to in Article 1 of Resolution SIC M. No. 123/99 and must, in addition to those mentioned in the same, the following requirements:
a) have been accredited by the accreditation body belonging to the national system of standards, quality and certification, created by Decree No. 1474 of August 23, 1994.
b) have legal status in the country;
c) have a campus-based staff in the country attesting background with an antique and not less than five (5) years in product certification mark of conformity and three (3) years in the sector of activity for which It aspires to be recognized;
d) have a Certification Committee decision-making based in the country;
e) take civil, commercial, administrative and emerging criminal responsibility of the certification tasks, and commitment to also hire a liability insurance with coverage of the risk of the activity not less than FIVE HUNDRED THOUSAND PESOS ($ 500,000 ), to the satisfaction of the Secretariat. Such insurance must be approved by the National Directorate of Domestic Trade as a precondition for obtaining recognition.
Art. 3 – The testing laboratories referred to Article 1 of Resolution SIC and M. No. 123/99, calibration and Article 1 of this resolution refers, must meet the following requirements:
a) operate and have legal status in the country;
b) it has been certified by the accreditation body belonging to the national system of standards, quality and certification, created by Decree No. 1474 of August 23, 1994.
c) comply with the guidelines established by the ISO / IEC Guide No. 25;
d) assume civil, commercial, administrative and criminal liability of emerging functions ocalibración trial. Except in cases where the risk is explicitly covered by the national or provincial governments, the laboratory must undertake to also take out liability insurance with coverage of the risk of the activity not less than one hundred fifty thousand pesos ($ 150,000) to the satisfaction of the Secretariat. Such insurance must be approved by the National Directorate of Domestic Trade as a precondition for obtaining recognition.
Art. 4 – The inspection bodies referred to in Article 1 of this resolution, to carry out their functions in the country, must meet the following requirements:
a) have been accredited by the accreditation body belonging to the national system of standards, quality and certification, created by Decree No. 1474 of August 23, 1994.
b) have legal status in the country;
c) comply with the guidelines established by the ISO / IEC Guide No. 39;
d) assume civil, commercial, administrative and emerging criminal responsibility of inspection functions, and commitment to also hire a liability insurance with coverage of the risk of the activity not less than ONE HUNDRED THOUSAND PESOS ($ 100,000 ), to the satisfaction of the Secretariat. Such insurance must be approved by the National Directorate of Domestic Trade as a prerequisite for obtaining recognition.
Art. 5 – The National Directorate of Domestic Trade can not recognize certification bodies, laboratories and inspection bodies being representations, branches, subsidiaries, licensees or are linked in a relationship of dependency or control, certification bodies, laboratories and inspection agencies residing abroad, whether in the countries of filing of such certification bodies, laboratories and inspection bodies, governing rules of any kind which require the recognition of accreditation bodies, laboratories and inspection bodies to act in the mandatory field, in addition to those required by this resolution requirements.
Art. 6 – The National Board of Trade dependent INTERIOR SECRETARY OF COMMERCE within this Secretariat has the following functions and powers:
a) grant, suspend and cancel the recognition of certification bodies, test and calibration laboratories and inspection bodies referred to by SIC Resolution and M. No. 123/99 and Article 1 of this, explicitly defining the certification scheme and the extent to which they are issued;
b) organize the evaluation committee and, where appropriate, the Subcommittees, to which refers art. 8 of this and appoint and remove members;
c) convene the committee or the relevant Sub when matters within its competence arise;
d) establish procedures to be met by the product certification mark of conformity, which are made pursuant to the schemes referred SIC Resolution and M. No. 123/99;
e) determine the basic security features for each system of compulsory certification.
. Article 7 – Certification bodies, laboratories and inspection bodies shall:
a) issue documents on the basis of reliable records of the results of conformity assessment based on verifiable information or data in its veracity;
b) comply with all the provisions of this resolution;
c) strictly comply with the procedures established for the development of its activities;
d) maintaining the resources or ability to issue documents of conformity assessment, assessed in respect of the recognition granted opportunity;
Art. 8 – In case of failure to incur the standards set here, their behavior will be assessed by the National Directorate of Domestic Trade. To that end, it made the finding of facts allegedly committed, within five (5) days will be granted to the entities involved to present his defense and relevant evidence in writing. After this deadline without submit discharged or filled out and submitted the release test deemed conducive by Arrangement founded the National Board of Trade INTERIOR, if verified investigated the facts, you can:
a) if it were the first fact, warn the entity evaluated;
b) if it were done in the second year, suspend the validity of the recognition by a period of sixty (60) to one hundred eighty (180) days;
c) if it were the third fact, cancel the recognition. In all cases, the finding of an anomaly in the procedures for the granting of certification will lead also to the cancellation of the same. The suspensions and cancellations of survey and certification will be disseminated through media nationwide. When the gravity of the act was such that it could lead to their prosecution in light of the provisions of Law No. 22,802, Ley recognition is automatically canceled.
Art. 9 – The Evaluation Committee of certification bodies, testing and calibration laboratories and inspection bodies will have an advisory role developing recommendations regarding applications for recognition and performance of the aforementioned entities. It will be established for materials, sectors and specific rules and shall consist of qualified experience in conformity assessment specialists, and representatives of academia and research, and technical and senior officials of the enforcement authority, who shall serve in an honorary basis. It will integrate with the number of members determined the National Directorate of Domestic Trade. Settle least six (6) members: one (1) official of the National Directorate of Domestic Trade who shall preside, three (3) technical experts in the field, one (1) representative from the academic sector and research and ONE (1) technical representative DIRECCIoON NATIONAL DOMESTIC TRADE.
In the opinion of the National Board of Trade INTERIOR, when the needs of service so require and the number of members permits, the Committee will be divided into specialized by subject, sector and / or specific rules Subcommittees. Subcommittees, to be integrated with the least number of members provided in the preceding paragraph shall comply with the functions assigned to the Committee within their specific area. The Sub-Committee or, where appropriate, may meet with the presence of two-thirds (2/3) of its total members.
Art 10. -. In all matters subject to consideration of the Evaluation Committee will seek to reach consensus on the decisions taken. In cases where such consensus is not obtained, we will proceed to a vote decisions were made that have reached half plus one of the total members of the Committee. In case of a tie, the vote casting the president will decide.
Art 11. -. All members of the Evaluation Committee must explicitly contracting with the Secretariat a confidentiality on all activities and information submitted for consideration thereof.
Art 12. -. Left inhibited from participating in the respective discussions, one member of the evaluation committee have a relationship that involves a conflict of interest with an entity involved in a matter under consideration by it.
Art 13. -. In case of rejection of an application for recognition submitted by a certification body or a testing laboratory calibration or inspection body, the applicant may not file a new application for approval before the expiry of one hundred eighty ( 180) days of notification of rejection.
Art 14. -. The heads of those products or product families, to the date of entry into force of the respective regime of mandatory certification, have a national certificate, in effect at the volunteer level, enforcement of safety standards by brand of conformity issued by a certification body recognized by the Secretariat, may request, before it, the validation certificate referred to issue the certificate of type or brand in accordance with the application of the security seal of the Secretariat, as appropriate. The validation may be granted on condition substantiate by tests within one hundred eighty (180) days is granted, that the product or product family meets the basic safety features, and also within eighteen (18) months of the same date, submit a complete type test.
Art 15. -. The recognition agreements of any kind between certification bodies based in the country and recognized by the Secretariat and agencies located abroad certification must be explicitly validated by the National Directorate of Domestic Trade effects of this Resolution. In cases where recognition agreements between foreign certification and national certification body recognized by the Secretariat to achieve all the functions inherent in the certification, except for the issuance of reports of laboratory tests, the recognized national certification body will validate the foreign certificate after verifying its authenticity and scope, issuing the type certificate or mark of conformity with the implementation of the security seal of the Secretariat, as appropriate. The validation may be granted on condition substantiate by tests, within ninety (90) days is granted, that the product or family of products concerned satisfies basic safety features, and also submit a complete type test within twelve (12) months of issuance of the validation.
Art 16. -. In cases where mutual recognition agreements between a foreign body decertification and national certification body recognized by the Secretariat to achieve all the functions inherent in certification, including issuing test reports laboratories, the agency recognized national certification may validate the foreign certificate, provided previously verify its authenticity and scope.
Art. 17. – is instructed to INTERIOR SECRETARY OF COMMERCE, under this Ministry to speed, as it depends on the mechanisms of harmonization of procedures for the mutual recognition of product certification, granted to statutory schemes, in elámbito MERCOSUR.
Art 18. -. The type tests required for certification referred SIC Resolution and M. No. 123/99, as well as validation tests to be established to comply with this shall be performed in laboratories recognized by the Secretariat.
Art 19. -. The certification bodies, laboratories and inspection bodies recognized must provide the National Directorate of Domestic Trade, in a timely and complete fashion, the information requested by them about the development of their tasks. They shall allow the free development of control tasks on their performance, do the same.
Otherwise the National mentioned, you can proceed to suspend respectivoreconocimiento until compliance is given as required.
Art 20. -. The person responsible for the manufacture, import, distribution or marketing of a product achieved by a system of compulsory certification you can not make, offer, display, or publish mentioning features not included in the technical standards based on the which certification was made, leading the user to believe that these features are supported by certification.
Art 21. -. The certifications awarded to products covered by the schemes introduced by the Secretariat, does not relieve those responsible for marketing compliance with the essential safety requirements by a respective regulation. In cases where those responsible for the products, after the introduction of these on the market, become aware of the danger, should immediately report that fact to the enforcement authority and consumers by sufficient advertising.
Art 22. -. Violations of this resolution shall be punished according to the provisions of Law No. 22,802 and, if appropriate, by Law No. 24,240.
Art. 23. – On a transitional basis, until 31 August 1999 the National Directorate of Internal Trade will recognize certification bodies, testing laboratories, calibration and inspection bodies that do not meet the formal requirements of accreditation or certification established in this resolution and provided them commit to accede, within one (1) year from the date of recognition, their accreditation by the accreditation body belonging to the national system of standards, quality and CERTIFICATION created by Decree No. 1474 of August 23, 1994.
24. Art. – This Resolution shall take effect from the date of its publication in the Official Gazette.
25. Art. – Communicate, published, submitted to the National Official Registry and filed. -Alieto A. Guadagni.
Disposition D.N.C.I. Nº 431/99
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