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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
A. Certification Organizations and Programs

Antigua & Barbuda

Argentina

Bahamas
Certification
The only certification program conducted in the Bahamas is for meats and it requires that all meat animals, i.e., cows, pigs, sheep and goats be slaughtered at the Government Abattoir and be subject to inspections to certify compliance and conformance to standards. The Government conducts certification. Any future system to ensure competence of certification programs will be embodied in a National Bureau of Standards. In general, they will be conducted in accordance with international standards. There is no experience in the area of acceptance in other economies of certifications of products and quality systems undertaken.

Quality Systems
The Bahamas Quality Council is a private organization offering consultant services and sensitizing companies and organizations to the quality concept. The Government has no control over this organization. Testing and inspection by approved bodies are the normal requirements, but self-certification by manufacturers are also used.

Barbados
The Barbados National Standards Institution administers the Barbados National Standards Institution (Certification Marks) Act which empowers BNSI to operate a Certification Marking Scheme. The Act is strengthened by regulations.

The scheme is a third party scheme - type testing and assessment of factory quality control and its acceptance followed by surveillance that takes into account the audit of factory quality control and testing of samples from the factory and open market.The scope of the certification operated by BNSI extends to products and processes. Certification Marks are issued based on national standards. At the moment, BNSI facilitates the implementation of ISO 9000 Quality Management systems for certification and registration.

Belize
A certification or quality registration programme has not been implemented.

Bolivia
IBNORCA has the capacity to certify quality in accordance with the following points: certification by type; certification by lot; certification of conformity to a standard by use of a conformity seal or mark; certification of personnel. At present new legislation is pending that will create the Bolivian System for Standardization, Metrology, Accreditation, and Certification. This system will make possible certification by duly accredited entities and/or laboratories. It is expected that certifying entities will be accredited by specialty and area of application, such as: entities that certify firms (registry of quality systems) and entities that certify products by specialty in characteristic or specialized categories. Bolivia has already adopted the ISO 9000 series of standards. At present IBNORCA has the capacity to certify quality control systems.

Brazil
The National System of Metrology, Standardization and Industrial Quality (SINMETRO) set up in 1973, has as one of its objectives to provide the country with an infrastructure of technological services for quality and productivity, consisting of basically, a system of generating standards and technical regulations, of networks of calibration and testing laboratories and also a system of certification of conformity.

Working groups in the Brazilian Program of Quality and Productivity (PBQP) were set up to carry out the need to reformulate the SINMETRO organization. In 1992, the CONMETRO approved a change in the organization of SINMETRO. INMETRO was given the objective of managing the entire system and of organizing all the institutions that are a part of SINMETRO.

INMETRO has separate and distinct accreditation programs for certification of products, certification of quality systems, certification of persons, test and calibration laboratories and inspection bodies.INMETRO assesses third party certification organizations in Brazil and abroad in accord with public criteria. Those that meet the criteria are granted accreditation and are audited annually to ensure continuing compliance with the terms of their accreditation.

Canada
The Standards Council of Canada (SCC) was established by an Act of Parliament in 1970 and given a mandate to, among other things, accredit organizations that are involved in standardization activities. The SCC has separate and distinct accreditation programs for certification of products (certification organizations) and for registration of quality systems (registration organizations). SCC assesses third party certification organizations in accordance with published criteria. Those that meet the criteria are granted accreditation and are audited annually to ensure continuing compliance with the terms of their accreditation. SCC has accredited ten certification organizations, seven Canadian organizations and three U.S. organizations. Most of the subject areas for which organizations have been accredited involve products that fall in areas regulated by the provincial government regulatory authorities, with whom SCC has a close working relationship. SCC criteria is in harmony with the ISO/IEC Guides produced by ISO/CASCO, the ISO Council Committee on Conformity Assessment.

The extent of acceptance in other countries of product certification carried out by SCC accredited certification organizations, depends upon the degree to which those organizations, individually, have been able to satisfy the appropriate regulatory authorities in those other countries of their capability to respond to the requirements of those authorities. Provincial government authorities generally accept products certified by SCC accredited certifications to standards referenced in provincial/territorial legislation, with no distinction as to whether the products are certified in Canada or abroad by those organizations.

At the present time SCC does not have any affiliation with other national or regional bodies that accredit certification organizations. However, several SCC accredited certification organizations have affiliations of various types with certification bodies in other countries.

Chile
The certification process, in the voluntary area, includes the participation of various certifying entities, both national (universities and private) and transnational (Bureau Veritas, Société Général de Surveillance, Lloyd Register, etc.). A bill now before the legislature would establish a National System (voluntary) for Quality Certification of Products for Export. In addition, the INN is laying the bases for consolidating, at the national level, the accreditation system for entities that certify products and testing laboratories, and for the certification of quality systems, as per the standards of ISO 900.

Colombia
Certification is a fundamental tool for the development of activities such as: control of national and imported products for which there is a mandatory technical standard or technical regulation; quality verification of inputs, materials and products that are acquired by state entities; creation of confidence and assurance of quality under the voluntary framework of the contractual client-supplier relation.

Certifications may be issued under the following modalities:
- certification of conformity of products: test of type, test of lots, test of 100%;
- certification of conformity of quality systems;
- certification of personnel.

Provisions for the evaluation of conformity are established in Decree 2269 of 1993 which creates the National System for Standardization, Certification, and Metrology; the Resolution 140 of 1994 of the Superintendency of Industry and Commerce; Decree 300 of 1995; and Resolution 343 of 1995.

Decree 2269 determines that when a mandatory technical standard or a technical regulation exists. It must be shown that its specifications are observed through a certificate of conformity issued by an accredited body, regulated by Decree 300 of 1995 and/or Resolution 343 of 1995 of the Superintendency of Industry and Commerce.

In the case of goods and services that are not subject to mandatory technical standards or technical regulations, certification may be required by the purchasers of the goods and services, which should be issued by an accredited body.

The following types of certificate of conformity may be issued:

a- Certificates issued in Colombia by a duly accredited entity;
b- Certificates issued by a recognized certification entity, i.e. one accredited in another country and that has been recognized by Colombia by agreement or convention;
c- Certificates issued in countries with which mutual recognition agreements are not in place. In these cases the exporter must obtain the certificate of conformity at one of the entities recognized or accredited in the country of origin or purchase of the merchandise, and must meet the requirements of the Colombian technical standard. This document may be validated in Colombia by an accredited agency.

The following participate in the certification process:

- the Superintendency of Industry and Commerce;
- the Advisor for Accreditation;
- the duly accredited certification and inspection entities;
- the duly accredited testing and metrology laboratories;
- other governmental authorities as provided for in the law on accreditation and certification functions.

At the present the following are part of the National Certification System:

** The Colombian Technical Standards Institute (ICONTEC), which is accredited to certify industrial products and quality systems through Resolution 2330 of 1/November/1994.

The modalities of certification issued by ICONTEC are: certification of lots; certification of samples; ICONTEC's seal of conformity with the Colombian Technical Standard (seal of quality); certification of declared quality given to products which are elaborated in conformity with international technical standards; ICONTEC certificate of quality assurance based on the standards of the ISO 9000 series. In Colombia, ICONTEC is the center of inspection of the Underwrites Laboratories Inc., acting as its agent through a program called ICAM.

As a private entity, ICONTEC has signed Memoranda of Understanding with entities such as SQS of Switzerland, QMI of Canada, AFAQ Inc. of France and DQS of Germany. It was accredited as well by TGA to certify quality systems. ** The Corporación Colombia Internacional, which is accredited to certify organic fruits, vegetables, and agricultural food products through Resolution 0561 of 23/March/1994.

**The telecommunications research center (CINTEL), accredited through resolution 1693 of 14/November/1995, certifies conformity as to products for the telecommunications sector, by lot and type.

In the case of imported fuel, the certifications of product quality issued by inspection agencies that verify the specifications both at the port of shipment and upon unloading at port in Colombia are accepted.

The main regulations related to agricultural food products have to do with fertilizer, pesticides, and seeds. The Colombian Agricultural Institute (ICA) directly checks the conformity of these products through analysis in its laboratories.

In terms of pharmaceutical and food products, national regulations refer to specifications as to composition, banned substances, and consumer information. The national standards are similar to the international ones (Codex Alimentarius).

These products can be certified through the health register. In the case of imported goods, the certification may be issued in the country of origin of the products and then validated by the Ministry of Health.

Costa Rica
The ONNUM (National Office of Standards and Units of Measure) is entrusted with extending official accreditation to entities performing conformity assessments and certifications, which are carried out pursuant to the legal provisions detailed in Executive Decrees Nos. 22269 and 22969.

The certification activity is subject to technical regulation, which may be effectuated by public or private entities, which are accredited to provide certification services in specific areas of conformity with standards and technical regulations. To this end, the following requirements for the certification of each type of test must be met, and this should be reflected in the accreditation document. By technical regulation, the certifying entities must have a quality system documented in the respective manual, and it should include: 1) a statement of general policy; 2) description of legal status; 3) membership in international certifying organizations; 4) description of its organization, including details on its composition, missions, and by-laws of its Board of Directors; 5) the decision-making organs in the technical and administrative areas, including the names, responsibilities, and qualifications of the various posts; 6) an organizational chart showing its administrative and operational hierarchical structure; and 7) the operational procedures for issuing certificates. There are also a series of general disciplines on conduct that should be respected by the certifying entities, many of which are aimed at avoiding the creation of unnecessary burdens on international trade.

In addition, local companies can freely carry out internal quality review programs. Some local companies have been accredited for their application of ISO 9000 by foreign certifying entities. Many other companies are working to achieve this accreditation. INTECO provides advisory services in these areas to the companies that so request.

By order of Law No. 7575, the "Sistema de Sellos Verdes o Certificaciones Forestales" was established, and is administered through a Commission which proposes the granting of licences for environmental protection to the Bureau of Forest Protection ( "Administración Forestal del Estado").

Dominica

Dominican Republic

Ecuador
Certifying Organizations
- INEN (Ecuadorian Standardization Institute) is the entity entrusted with granting Certificates of Conformity with Quality Seal.
- National Fisheries Institute.

Programs
- Certification of Quality in Conformity with the Standard for isolated lots of production. This program is based on the System for Third Party Certification, module 7 of the ISO.
- Certification of Conformity with Quality Seal. This program is based on the System for Third Party Certification, module 5 of the ISO.

El Salvador
The CONACYT is responsible for official accreditation of conformity assessment and certification entities, but the standard to accredit certification entities has yet to be drafted.

Grenada

Guatemala
Guatemala has a legal basis for developing a National System for Accreditation of Calibration and Testing Laboratories. On March 14, 1994, through government order (no. 109-94) the National System for Accreditation of Calibration and Testing Laboratories (SINAL) was created. The regulations of SINAL are now under study.

The government order by which the National System for Accreditation of Calibration and Testing Laboratories does not include the accreditation of product and quality system certifying entities, as called for in the respective ISO standards. To date there is no accreditation agency in operation or with accredited laboratories for testing and analysis. However, there are pre-certification laboratories. These are private entities, and are approved by government order by the Ministry of Agriculture, Livestock, and Food, and recognized by the USDA and FDA.

Guyana

Haiti
Quality control certificates are emitted by the Direction du Controle de la Qualite et de la Protection du Consommateur (DCQPC), a body of the Ministry of Trade and Industry, on the basis of inspections of sample merchandiese by interested firms. This is, for example, the case of rum.

Honduras

Jamaica
Certification Systems by Governmental Organizations
The Bureau of Standards of Jamaica operates a National Mark Programme. The Ministry of Agriculture provides pre-clearance certification for fresh agricultural produce for the U.S. market. The Jamaica Bauxite Institute and the Regional Drug Testing Agency are also active in provinding certification in their respective fields.

Certification Systems by Private Organizations
Certification by the private sector include: the Coffee Industry Board, the Coconut Industry Board, the Banana Board and the Pool Association. This is not an exhaustive list.

Quality Systems by Governmental Organizations
At present there are no local certification organization, however, the JBS offers services to industries in the area of quality systems implementation and certification. The service covers training and consultancy and includes two overseas based companies. The JBS is preparing to become an accredited Registar. The government currently has no jurisdiction over the private companies engaging in quality systems assessments. In the future, the JBS hopes to establish, through the government, a programme requiring all consultants and certification bodies wishing to operate locally to be registered with them.

Quality Systems by Private Organizations
There are aproximately five private organizations who along with the JBS offer services to industry in the area of quality systems implementation and certification.

Mexico
The Department of Commerce and Industrial Development (SECOFI) through the General Bureau of Standards (DGN) is the body in charge of the Certification and Quality Systems. The DGN is a governmental body and also accredits the other certification bodies within its scope of activity. In addition, in order to be accredited, these certification bodies must obtain the approval of the competent office.

Panama
The Department of Quality Certification of the General Bureau of Standards and Industrial Technology, Ministry of Commerce and Industry, is the product certification agency; product certification is done by lot and by prototype. Certification of quality systems is done in the private sphere.

Paraguay

Peru
Peru has entities that certify products and systems. The product certification agencies provide services in different product areas, to which end they must contract or subcontract laboratories accredited for those areas of products. The certifying entities are accredited voluntarily, conferring on them the status of official certification entity.

Saint Lucia

Trinidad & Tobago
Trinidad and Tobago Bureau of Standards is engaged in product certification and quality system registration.

Product Certification
The criteria for product certification are type testing of the product, evidence of a quality system bearing similarity to the ISO 9000 series of standards and testing of the products purchased on the open market from time to time. The procedures comply with ISO Guide 48 and EN 45011.

Quality System Registration
Registration of quality systems depends on conformity with the applicable standard from the ISO 9000 series. The Procedures comply with the EN 45012 and ISO 10011 standards.

United States
Product certification
In the United States, there is widespread reliance upon a supplier's declaration of conformity to standards and technical regulations. Third party certification bodies may also be utilized to build confidence regarding products' compliance with requirements. Such third-party certification programs are operated by a variety of organizations, including: professional or technical societies; trade associations; independent testing/inspection organizations; and/or organizations composed of producers, testing laboratories and others. There are also certification programs administered by the Federal Government, including programs to certify products which directly affect the health or safety of the user or the general public, or programs designed to provide a uniform basis for trade by assessing the quality and condition of products offered for sale. State governments also administer certification programs. In some cases, states inspect or test products under authority delegated by the Federal Government (e.g., meat and meat products are certified to USDA standards). States also regulate products under their own authority, for health and safety reasons, or they may impose requirements in addition to those required by the Federal Government.

Quality systems
There are approximately fifty private U.S.-based organizations offering consulting services, assessment and/or quality system registration to ISO/9000 and/or its U.S. equivalent (ANSI/ASQC Q90 series), and the number of such organizations is growing rapidly. The U.S. Government has no oversight over private businesses that engage in quality assessment, although it does have oversight over some industries that utilize quality system assessments. The process of registration is market-driven, not regulation-driven.

In July 1993 DOC/NIST proposed the establishment of a National Voluntary Conformity Assessment System Evaluation Program (NVCASE). The purpose of this program would be to "enable U.S. industry to satisfy mandated foreign technical requirements using the results of U.S.-based conformity assessment programs" and is intended to meet a perceived need for government recognition for purposes of satisfying foreign government regulatory requirements. The generic requirements of the program would be based on ISO/IEC guides for the acceptance of conformity assessment activities. It would not operate in areas that are not regulated by foreign governments.

Uruguay
For the last 25 years UNIT has been giving courses on quality control based on five different levels, and has helped carry out similar courses at the Universidad de la República and other educational centers.
Like most standardization institutes worldwide, UNIT has implemented an Independent Quality Certification System, under which use of the "Mark of Conformity with the UNIT Standard" is granted to those products for which UNIT standards were previously established and whose manufacturers constantly attain the quality level demanded. Granting the mark implies that UNIT has first:
- evaluated conformity of the product design to the requirements of the UNIT standards;
- ascertained that the manufacturer's quality control system can produce in compliance with the specifications set in the UNIT standard;
- approved the prototypes;
- audited, on an ongoing basis, the manufacturer's quality control (including staggered and unannounced inspections of the plant, controls of components and raw materials, and control of the finished product at the point of sale), and where appropriate, carried out inspection and approval of the different product lots prior to their being placed on the market.

The School of Engineering is to provide extensive assistance in this activity through its Materials Testing Institute; this support is regulated by the agreement signed by UNIT and the Universidad de la República.

More than 60 enterprises rely on products that have obtained the UNIT seal of conformity with UNIT standards, which is based on ISO's model _ 5. UNIT has also developed a scheme of certification of quality systems according to ISO 9000 standards (in Uruguay UNIT-ISO 9000). As of the end of 1996, UNIT has granted ten certificates, seven with AENOR (Spanish Association for Standardization and Certification), one of which also with IRAM (Argentine Institute of Standardization); and three with DQS of Germany and Foundation VANZOLINI of Brazil.

UNIT has concuded a series of agreements for the certification of quality systems, as well as for the certification of products, among which the following are highlighted:
- Germany: with DQS;   - Spain: with AENOR;
- Argentina: with IRAM;   - Italy: with UNI and IMQ;
- Brazil: with ABNT, IBQN, VANZOLINI and UCIEE;    - Switzerland: with SQS.
- Colombia: with ICONTEC;    

The LATU (Technological Laboratory of Uruguay) develops its activities in:
1- Training through courses organized in conjunction with the Deutsche Gesselschaft fur Qualite (DGQ) for the formation of quality engineers and auditors, and through participation in the quality programs of the OAS for more than ten years.
2- Certification of Quality Systems (ISO 9000) through agreement with OQS (quality control entity of Austria) and agreement on joint electrical-electronic certification with UCIEE of Brazil;
3- Certification of Products for companies in different product lines through the quality mark, or quality seal, against established standards.
4- Certification of Export Products based on the inspection and approval of finished lots and/or controlof the production, or quality systems of private enterprises.

For the development of these activities LATU counts on the support of approximately twenty laboratories and specialized areas of work, in conjunction with duly qualified technical personnel.

Venezuela
Official certification in Venezuela is by FONDONORMA and is based on national, regional, and international standards. The Venezuelan Standards of COVENIN are used as the national standards. FONDONORMA is an organization authorized by the Ministry of Development to undertake certification activities pursuant to standards through Resolution 1450 of June14, 1993 published in the Official Gazette of the Republic of Venezuela No. 35237 of June21, 1993. FONDONORMA undertakes quality certification activities in:

Certification of products: There are systems for certifying the quality of products, consistent with the ISO classification of certification systems. The "Marca Norven" official quality seal has been developed, pursuant to Model 5, and 256 certifications have been granted; and for the certification of lots, the "Certiven" system, as per Model 7 of the ISO.

Certification of quality systems: There is a scheme for certification of quality systems based on the ISO 9000 series, and 79 certifications have been issued. Both certifications are voluntary; nonetheless, the Ministry of Health and Social Assistance grants three types of product certifications:
a) Certification of free sale and consumption.
b) Certification of sanitary guarantee.
c) Certification of the analysis.
The above-mentioned certifications are compulsory and are based on the Organic Law of the National Health System and the General Regulation on Foods.

 
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