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Inventory of National Practices on Standards, Technical Regulations
and Conformity Assessment in the Western Hemisphere


VII. Certification of Products and Quality Systems
C. Relevance to International Practices

Antigua & Barbuda

Argentina
ISO/IEC Guides 28, 39, and 40 are used to certify products and processes. ISO/IEC Guides 48 and 62 (formerly CASCO 227) are used to certify quality systems. ISO/IEC Guide 58 is used for certifying accreditation of laboratories, and ISO/IEC 61 (former CASCO 226) for accrediting certification entities.

Bahamas
International Standards are being used to draft appropriate legislation and regulations. Standards used by other economies are accepted.

Barbados

Belize

Bolivia
Bolivia is supporting the development of regional accreditation and certification activities in the Andean Group as a signatory to the Cartagena Agreement. Under this Agreement, Bolivia is responsible for organizing and developing the Andean Network of Testing Laboratories.

IBNORCA and the Secretariat for Industry and Commerce have adopted the current criteria for accreditation and certification. The structures of the standardization and certification system in Bolivia are being modernized. To this end, reference has been sought from ISO/IEC and ISO/CASCO Guides for accreditation and certification. Also used as a references were EN 45000 and the ISO 9000 series of standards.

Brazil
The procedures and criteria defined by INMETRO to accredit Certification Bodies are in accordance with ISO/IEC Guides and meet the requirements of EN 45011, 12 and 13, as well as ISO 10011 series of standards.

The certification bodies accredited by INMETRO to operate product certification adopt the eight models for certification suggested by ISO in its book "Conformity Assessment and Related Activities" and the ISO/IEC Guides relevant to implement such activities. Concerning the Quality System Certification, the procedures adopted by the Certification Bodies are based on the ISO/IEC Guides 48 and 62, as well as on ISO 9000 standards.

Canada
The Standards Council of Canada (SCC) criteria for accreditation is in harmony with the ISO/IEC Guides produced by ISO/CASCO (the ISO Council Committee on Conformity Assessment), and calls up the requirements of EN 45012 and the ISO 10011 series of standards. All of the accredited registration organizations register suppliers to the ISO 9000 series of quality standards and some of them have registered suppliers to other quality standards, such as the CAN-3 Z299 series.

Chile
The accreditation system is based on international criteria recommended by the ISO and the IEC, and on the model established by the European Union through the EN 45000 standards.

Colombia
The Colombian regulations, which create and develos the National System for Standardization, Certification, and Metrology are based on internationally accepted standards.

The technical requirements for the accreditation of certification bodies are listed in Annex 1 of Resolution 140 of 1994. They follow ISO/IEC Guide 28, ISO/IEC Guide 40, ISO/IEC Guide 42, Standards EN 45011/12/13, and ISO/IEC Guide 2.

The technical requirements for the accreditation of inspection bodies constitute Annex 2 of Resolution 140 of 1994, and they follow ISO/IEC Guides 2, 39 and 57.

The technical requirements for the accreditation of testing laboratories are contained in Annex 3 of Resolution 140 and refer to ISO/IEC Guides 2, 25, 38, 43 and 45; to the Colombian technical standards series 3000, the European Standards EN45001 and 45002; and to ISO Standard 10012-1.

The technical requirements for the accreditation of metrology laboratories constitute Annex 4 of Resolution 140 of 1994 and refer to ISO/IEC guides 2,25,38 and 45; Colombian technical standards of the series 3000; European standards EN 45001; ISO 10012-1; the BIPM-IEC-ISO-OIML international vocabulary of basic and general terms in metrology; OIML R-5, R-6, R-10, R-14, R-16; OIML planning of metrology and testing laboratories; and WECC document 19 guide on the expression of measurement uncertainty in calibrations.

Costa Rica
The National Accreditation Entity (ENA) is regulated by a legal framework whose technical aspects are adopted with the international standards on accreditation. The technical regulations related to accreditation establish identical procedures to those of EN 45000 and the ISO Guides.

Dominica

Dominican Republic

Ecuador
The following ISO standards and guides will be taken into account for accreditation activities:
- Certification Entities
GPE INEN ISO/IEC 40. General requirements for acceptance of certification entities.
- Inspection Entities
GPE INEN ISO/IEC 39. General requirements for accreditation of inspection entities.
- Testing and Calibration Laboratories
GPE INEN ISO/IEC 25. General requirements for the competence of calibration and testing laboratories.
- Accreditation of personnel
NTE INEN ISO/IEC 10011-2. Guidelines for the Audit of Quality Systems. Part 2. Criteria for Qualifying Auditors.

El Salvador
El Salvador uses the international criteria recommended by the ISO/IEC and standard EN 45000 as a basis of the accreditation subsystem.

Grenada

Guatemala
Guatemala is supporting the development of activities for accreditation and certification, based on the international criteria set forth in the standards of the respective ISO/IEC series.

Guyana

Haiti

Honduras

Jamaica
JBS operates along ISO guidelines and uses standards from ISO member countries.

Mexico
The Mexican system of accreditation uses the correspondents ISO/IEC Guides as well as the Mexican Standards series NMX-CC which are the technical equivalent of the ISO 9000 guides.

Panama
Certification is evaluated by reference to a standard, the procedure is established and samples taken, and sent to the state or private laboratory; the results are made known, and then the report of results is analyzed and a technical report is submitted in conformity with the specifications.

Paraguay

Peru
The accreditation of certification entities is based on international standards such as ISO Guide 16 (G.P. 066: 1992) and ISO Guide 40 (G.P.) 008: 1995). The certification entities should meet the requirements established internationally for their accreditation.

Saint Lucia

Trinidad & Tobago
TTBS uses ISO guides and Codes of Practices in implementing its certification programs.

United States
Product certification
ANSI is working cooperatively with the national accreditation systems in the United Kingdom, the Netherlands and Canada to establish the commonality of the accreditation processes with the ultimate goal of achieving mutual recognition agreements. ANSI has represented U.S. interests in the International Accreditation Forum (along with Australia, New Zealand, Brazil, Canada, Germany, Japan, Korea, Mexico, the Netherlands, and the U.K.) in an effort to facilitate the global acceptance of accredited certifications and registrations. ANSI manages U.S. participation in the ISO Committee on Conformity Assessment (CASCO). With respect to occupational safety and health, while the OSHA NRTL program is open to foreign-based organizations, in general, OSHA does not accredit certification bodies that have open-ended recognition agreements with other laboratories. The accredited certification body has to retain responsibility for the evaluation and certification. OSHA expects that the laboratory will accept and evaluate the data on a test-by-test basis. OSHA has recognized certification organizations in other countries under its NRTL program. For some other mandatory regulations, there is acceptance by the U.S. Government of foreign-based standards when there is a recognition agreement in place.

Quality systems
The ANSI-RAB program provides U.S. industry with a nationally and internationally recognized program for accrediting registrars of quality systems. The program uses internationally accepted guides and procedures as the basis for the national accreditation of the registrars in order that the industrial clients of accredited registrars will have confidence in the competence of the registrars and the quality system registrations will be accepted in the U.S. as well as abroad. There is a strong effort of cooperation with accreditation activities in other countries.

Uruguay
The guides ISO-IEC referring to Accreditation, Certification and Inspection have been adopted as UNIT-ISO-IEC Guides.

Venezuela
The procedures and criteria defined by SENORCA to accredit certification bodies are in accordance with ISO/IEC Guides 62 and 65. ISO/IEC Guide 39 is used for the accreditation of inspection entities and ISO/IEC guide 25 for labs accreditation.

 
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