Conformity Assessment - Research Paper Example

CONFORMITY ASSESSMENT or with Number on which Assignment is Due Table of Contents Page Number 1. Introduction ………………………………………………………………… 2 2. Discussion ………………………………………………………………….. 3 2.1. Conformity Assessment is Different from Regulatory Standards …………………….. 3 2.2. Conformity Assessment …………………………………………..4 2.3. Regulatory Standards ……………………………………………. 5 2.4. Conformity Assessment: How it Works ……………………….. 6 2.4.1. The Free Trade Areas of the Americas (FTAA) ………. 6 2.4.2. Mutual Recognition Agreements (MRAs) ……………...7 2.4.3. Certification in Home State Using Host State Standards …………9 2.4.4. Self-Certification Based on Supplier’s Declaration of Conformity ….10 2.5. The Benefits of Conformity Assessment ………………………11 2.6. The Mechanisms for Performing Conformity Assessment ………………… 13 3. Conclusion …………………………………………………………………19 4. Works Cited ………………………………………………………………. 20 CONFORMITY ASSESSMENT 1. Introduction Conformity assessment is a comprehensive term defined as “measures taken by manufacturers, their customers, regulatory authorities, and independent, third parties to assess conformity to standards”1. Similarly, the joint ISO/IEC 17000, of the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) defines the term as “a demonstration that specified requirements relating to a process, system, person or body are fulfilled”2. However, ISO itself does not undertake such work. Conformity assessment and standardization differ from each other, although they are closely related. The International Organization for Standardization (ISO), though established by the United Nations, is a key non-governmental institution. It supports the progress of industrialization, as well as regulates production and consumption3. Thesis Statement: The purpose of this paper is to investigate conformity assessment, differentiate it from standardization, examine how it works, identify its benefits, and determine the mechanisms for performing conformity assessment. 2. Discussion Conformity assessment and standardization need to be mutually supportive in order to promote economic growth and sustainable development4. Conformity Assessment and the International Organization of Standardization (ISO) are considered to be at opposite ends of the technical infrastructure business5. Manufacturers frequently have their own internal testing sytems to ensure that their work meets the required standard. However, in the private economy, increasingly there is third-party certification of inspection. “In fact, many national standard setting bodies now make such third-party certification a major part of their own business”6. The national bodies provide “accreditation” certification on the qualification and eligibility of third-party inspectors to do their job. While ISO neither accredits nor certifies, ISO members “certify the certifiers”. ISO standards define what counts as accreditation and enforcement, and ISO works closely with similar international organizations providing assurance that analogous standards for accreditation are used. 2.1.Conformity Assessment is Different from Regulatory Standards There is an important distinction between substantive regulatory standards and conformity assessment systems. The applicable substantive standard is used as a benchmark for addressing the conformity of a product with the standard. Governments enforce substantive regulations, and additionally require that exporters comply with various certification, licensing and controls for manufacturing procedures, as well as financial monitoring of banks. On the other hand, conformity assessment procedures include assessment and enforcement of conformity with relevant substantive standards, by public regulatory authorities, or quasi-public or private bodies which have been delegated the authority to perform the evaluation and enforcement. Thus, in the export of goods, besides the standards applied to a product in the host state, some entity such as a public agency, public-private combination, private body, or the company itself “is responsible for assessing and possibly certifying the conformity of the product with such standards”7. Central to the Mutual Recognition Agreement (MRA) is this distinction between standards and conformity assessment. 2.2. Conformity Assessment Conformity assessment ensures that “products, services, materials, processes, systems, and personnel”8 measure up to the latest and most advanced International Standards such as those provided by ISO (International Organization of Standardization) and IEC (International Electrotechnical Commission). Conformity to the required standards contributes to the efficient functioning of economies, international trade and sustainable use of the world’s resources. Besides providing conformity assurance, the ISO/ IEC standards and guides also help in “building and maintaining national quality infrastructures and services that support economic and social progress, as well as access to world markets”9. 2.3. Regulatory Standards The International Organization for Standardization (ISO) covers public and private sectors, and is the “self-proclaimed international standard setter for business, government and society through its pursuit of voluntary standards”10. In its sixty-year history, the organization has developed more than 17,000 international standards, and is believed to produce 1,100 additional standards every year. The work of the ISO is closely related to enhancing daily life by facilitating essential technical infrastructure for the global economy, changing the methods of conducting commerce, business operating procedures, and consumers’ engagement with the markets. The ISO’s setting of standards resulted from various processes such as agreement with the government on business activities such as product development, commercial battles such as those over the best format for products such as video recorders, “the spread of imperialism such as the standardization of railway gauges, the operational language of air traffic control”11, and the international standards of quantities and units of space and time, as well as fundamental properties, known as ISO 8000 that are regulated or provided legal status by other international organizations. Further, ISO has taken up tasks which were beyond the scope of the League of Nations or the United Nations (UN)12. Moreover, ISO’s key role in contemporary economic globalization is exemplified in developing contemporary lead industries such as the development of information technology since the 1980s; and ISO’s standards for inexpensive transoceanic shipping containers with technology developed for today’s global economic chains in all fields of manufacturing. However, the pace of innovation is faster than the lengthy, voluntary, consensus process13. 2.4. Conformity Assessment: How it Works Conformity assessment is related to the evaluation of products, processes and services on the basis of clearly defined standards. It raises the confidence of buyers, users and regulators that products conform to claimed standards, thereby increasing the value of standards14. 2.4.1. The Free Trade Areas of the Americas (FTAA) The Free Trade Areas of the Americas (FTAA) eliminates market-access barriers for goods and services, along with negotiation of trade disciplines in various policy issues including standards, conformity assessment, and dispute settlement. In relation to standards and technical barriers, the FTAA Working Group increases transparency by raising the available information “on national practices with respect to standards, technical regulations, and conformity asssessment procedures”15 adopted by thirty-four participating countries. Further, the Working Group has been responsible for developing mutual recognition agreements with respect to standards and conformity assessment for facilitating world trade. 2.4.2. Mutual Recognition Agreements (MRAs) To facilitate national as well as international trade, Mutual Recognition Agreements (MRAs) between two states or countries ensure that there is reciprocal acceptance, recognition and accreditation of the standards used in the other region, as well as of their conformity assessment mechanisms and evaluations. A network of global MRAs would “enable manufacturers to test products once and obtain certification and acceptance in all national markets”16. Mutual Recognition principles apply to products and goods that are traded, as well as to their manufacturing processes. Thus, they include traditional trade issues such as technical standards, different standards of labor and environmental conditions in the production processes, and other issues emerging from the transnational provision of services. “When MRAs include developing countries, significant capacity building and technical assistance may be prerequisites for recognition of their standards and conformity-assessment decisions”17. MRAs are an increasingly important area of governmental planning and implementation for three main reasons: negotiation for mutual recognition by governments of conformity assessment systems of two different countries, to promote U.S. exports; support the streamlining of U.S. domestic conformity assessment system through the means of recognition; and the recognition by the federal government of private sector conformity assessment programs would “promote acceptance of conformity assessment among states and cities within the United States”18. In negotiating Mutual Recognition Agreements (MRAs) in the context of world trade, states are confronted with the basic initial choice of which standards to apply: those of the home or host state. An evaluation process is undertaken in the preliminary stages “to determine whether their different regulatory systems are comparable and their standards are functionally equivalent”19. If found to be so, each host state may recognize the other state or home state’s standards as equivalent20. Problems related to MRAs arise when there are differences in structure in the national standardizing activities of two different nations. An example is the great difference in approaches to product certification in the European Union (EU) and the United States (US). The former has a centralized approach which emphasizes as mandatory product certification by approved, notified bodies designated by governments. Contrastingly, the US has a decentralized approach, permitting product certification by manufacturers, or public/ private laboratories. These differences in approaches complicates agreement on how to achieve the objectives, rather than creating disagreement on the objectives themselves. Another outcome of the structural differences in national standardizing activities between two nations, produces the need for devoting a great deal of time “to exchange of information and sector-specific data in order to ascertain equivalencies of policy”21. 2.4.3. Certification in Home State Using Host State Standards On the other hand, states could agree that each regulatory system will recognize only its own standards, but that certification, monitoring and enforcement of host state standards will take place mainly in the exporting home state. “In this case, conformity assessment would be regulated by the home state, but the home state conformity assessment body would assess or certify a product’s conformity with host state standards”22. Sometimes standardization of assessment may be a prerequisite, but not adequate in itself. The only mechanism for liberalization is some type of recognition of foreign conformity assessment procedures. Hence, MRAs initially targeted conformity assessment systems, and not the underlying standards.Seen as a political economy approach, conformity assessment can prove to be costly without the recognition of either the home or the host country. 2.4.4. Self-Certification Based on Supplier’s Declaration of Conformity The use of an international standard encompassing the requirements for suppliers’ declarations of conformity is an important innovation promoting world trade. With respect to International Standards, the ISO/IEC 17050 “specifies the general crteria for a supplier’s declaration of conformity”23. ISO 17050 was developed by the Conformity Assessment Committee (CASCO) of the International Organization for Standardization (ISO). The international standard ISO 17050 governs self-certification given by manufacturers of products, declaring conformity to the required standards. It is a statement of international acceptance of supplier’s declarations, permitting suppliers increased flexibility in choosing their conformity assessment procedures. At the same time, it reduces costs related to ensuring conformance significantly, while enhancing transparency in the processes24. 2.5. The Benefits of Conformity Assessment Conformity assessment procedures help to ensure that products, services or systems manufactured or operated “have the required characteristics, and these characteristics are consistent from product to product, service to service, or system to system”25. The process is of great significance, benefiting manufacturers and providers of services, besides “users, consumers, government regulators, and international trade”26, as well as supporting sustainable development. Among those who benefit from conformity assessment are the conscientious manufacturers and service providers. When their products and services are evaluated on the basis of ISO and IEC International Standards, they are differentiated from less reputable suppliers. When public health, safety or the environmental ecology are at risk, government regulations often make conformity assessment obligatory. Without proper and adequate assessment and approval, the sale of goods may be prohibited, or suppliers disqualified from bidding for government procurement contracts. Further, “ISO/IEC International Standards and guides also provide requirements and guidance for good practice and recognition of such assessments”27. Similarly, consumers are benefited from conformity assessment because it provides them with the key elements for selecting products or services. Consumers have greater confidence in the validity and reliability of a supplier’s formal declaration, or goods bearing a stamp of certification of conformity with standards that attest quality, safety, durability, and other required characteristics. Governmental regulators also benefit from conformity assessment, since it is a channel through which they enforce “national health, safety and environmental legislation”28, besides achieving the goals of governmental public policies. Additionally, the use of ISO/IEC standards in conformity assessment procedures has far-reaching benefits especially for international trade in general. This is ascertained through integrating conformity assessment procedures around the world. The standards also facilitate trade within countries by giving confidence to the purchaser of the product or service, that it fulfills the requirements. International standards are crucial for sustainable use of the world’s resources, for the efficient functioning of economies, and for promoting international trade. Assurance is vital that “products, services, materials, process systems and personnel”29 meet state-of-the-art requirements such as those stated by the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC). The tools for providing assurance and confidence are the ISO/IEC standards and guides for conformity assessment30. On the other hand, “the United States has an extensive and increasingly complex conformity assessment system”31. The system requires reform in some aspects. Similar to the development of the standards system, it has evolved in a decentralized manner. Its uncoordinated growth has led to testing laboratories, product certifiers, manufacturers and ultimately the customers bearing large costs related to duplication, redundancy, and unrequired complexity. Moreover, the system’s complexity has created hurdles in the processes of domestic and international commerce. 2.6. The Mechanisms for Performing Conformity Assessment The various processes that constitute conformity assessment include: sampling and testing, inspection of products and processes, certification, management system evaluation and registration of those manufacturers whose quality systems are approved. When these activities are found to be competent, accreditation is given, and the program’s capability is given recognition. A particular conformity assessment process may include more than one of the above activities32. Moreover, the confidence based on reliability of an entire conformity assessment process is impacted by the inclusion or omission of any of these activities, and the level of quality in their performance. Additionally, standards underlying each of the conformity assessment activities can also have a significant effect on the results of each specific activity, as well as a cumulative effect on the end results of the whole process33. The activities constituting conformity assessment are distinctive of one another, though they are closely and mutually interrelated. Further, standards form an inherent part of all aspects of these activities, and can have extensive impact on the results of a conformity assessment process. Standards which underscore the essential characteristics required in products are related to the products themselves through the conformity assessment activities. “Together, standards and conformity assessment activities impact almost every aspect of life in the United States”34. The mechanisms for performing conformity assessment include different functions. Implementing a Management System This ascertains that products and services are manufactured or delivered by an organization, with consistency in fulfilling the promise made to customers regarding quality, and other characteristics of the product/ service35. Manufacturer’s Declaration of Conformity Manufacturer’s declaration of conformity is based on internal testing and quality assurance procedures.Through the self-declaration of conformity, a supplier organization avoids the costs of third-party assessment, while committing that they fulfill the required standards criteria, which they would be able to prove by demonstration if required. A supplier who has a high market reputation can do without an independent confirmation of conformity. At the same time, a supplier’s declaration or self-certification may not be appropriate in certain circumstances where the health, safety or environmental risks of the product concerned are high. A self-declaration also enforces the meeting of relevant regulations, and is monitored by effective post-market surveillance36. Testing The testing of products, parts and materials are conducted by independent laboratories as a service to the manufacturer. It is the most common form of conformity assessment. Testing helps to determine whether a product or service complies with or functions according to the specific requirements37. Certification This is a formal verification by an unbiased third party through testing and other means, on the product’s conforming to required standards.It is applicable to “process, personnel, organization or management system”38, to determine whether they conform to particular requirements. The terns certification and registration are equivalent, and their usage depends on the geographic location. Quality System Registration This registration is for validating the manufacturer’s quality system, after its independent audit and approval39. Inspection Inspecting the manufacturing process of a product ensures that it is produced in a safe manner in compliance with regulations. The inspection bodies study an extensive range of “produccts, materials, installations, plants, processes, work procedures and services”40 in both private and public sectors. They report their findings related to parameters such as quality, suitability for use, as well as consistent safety in functioning. The main aim is to reduce risk to the buyer, owner, or consumer of the product being inspected. Management System Certification Certification of quality management systems ISO 9000, and environmental management sytems ISO 14,000, are the commonly used modes of certifying the quality of management sytems. Significantly, ISO does not evaluate the conformity of quality or environmental management systems and quality. Thus, quality management sytems certification is undertaken “independently of ISO by the many certification or registration bodies active nationally or internationally”41. . Product Certification This procedure constitutes the initial testing of a product together with evaluation of its supplier’s quality management system. Subsequently, testing of samples from the factory or the open market is carried out. Other initiatives include initial testing and surveillance testing, while several others depend on the type testing of a sample product. The type of scheme selected for the purpose will depend on the level of risk to the consumer, along with other criteria42. Personnel Certification People are certified against specific requirements, and there is the “development and maintenance of a certification scheme for personnel”43. Accreditation The process by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks. In relation to management systems, an accreditation body assesses the competence of a certification body to perform the evaluations and certifications for accreditations. “Once accredited, this indicates to the client of the certification body that its competence to do the certifications has been independently confirmed”44. Similarly independent verification of competence in performing activities for which they are accredited, is done for testing laboratories, product certification and inspection bodies. Mutual Recognition Agreements Repeated conformity assessment contols are carried out on internationally traded goods and services. This is due to an absence among users, of confidence “regarding the competence of bodies carrying out conformity assessment activities in other countries”45. Hence various initiatives are required to increase the confidence of both public sector and private sector purchasers, of regulators, and conformity assessments groups and accreditation bodies, specifically from other countries. The purpose of these conformity assessment procedures is to provide authority over a product to related stakeholders “such as the purchaser of a product, or the regulatory agency with authority over a product, with whatever degree of confidence is needed in a particular circumstance”46. The circumstance for a purchaser could be a decision on whether to buy a product, for a regulator it may be a decision on whether to approve or forbid the use of installation of a product. When there is a lack of independent assurance of the product’s conformity to standards, the manufacturer’s word has to be accepted regarding the product’s conforming to standards. Under most circumstances, this level of assurance based on the manufacturer’s statement of conformity, is considered adequate and suitable for the stakeholder’s purpose. In particular situations, additional assurance may be required; these needs are fulfilled through the development of other features of the conformity assessment system. 3. Conclusion This paper has highlighted conformity assessment. Further, the differences between conformity assessment and standardization have been examined. How conformity assessment works, and its benefits have been discussed, and the various mechanisms which form a part of conformity assessment have been identified. It was found that it promotes confidence in the goods or services, and is beneficial for manufacturers, providers of services, consumers, government regulators, and for international trade. It also promotes the economy and supports sustainable development. The specific mechanisms for performing conformity assessment clearly indicate the significance of the process, and the importance of establishing conformity of goods and services to standards. Only by adhering to the given requirements can consistency be maintained in achieving quality, besides providing benefits to all stakeholders. Some aspects of the process need reformative actions, and the various mechanisms should be performed in a centralized manner. Coordination and simplification of the constituent processes are required, since the system is growing indiscriminately and in a complex manner. By well-planne streamlining of the process, duplication and redundancy resulting in increasing costs can be removed, and hurdles obstructing the growth of international trading can be eliminated. 4. Works Cited Breitenberg, Maureen A. The ABCs of the US Conformity Assessment System. Office of Standards Services, National Institute of Standards and Technology (NIST). (1997). Retrieved on 16th July, 2010 from: http://ts.nist.gov/Standards/Conformity/primer.cfm#abstract Bryden, Alan. Standardization and conformity assessment in support of sustainable development. Paper presented at the Regional Workshop on Conformity Assessment, Sustainable Development and Trade, Johannesburg, 9 May, 2007. Danforth, Leroy. Self-Certification: Supplier’s declarations and conformity assessment. CGMT 564 Research Paper. (July 24, 2006). Retrieved on 17th July, 2010 from: http://www.strategicstandards.com/files/SelfCertificationII.pdf ISO (International Organization for Standardization). ISO and conformity assessment. Conformity Assessment Committee (CASCO) Brochure. (2005). Retrieved on 15th July, 2010 from: http://www.iso.org/iso/casco_2005.pdf ISO/ CA. (International Organization for Standardization/ Conformity Assessment). What is conformity assessment? International Standards for Business, Government and Society. (2010). Retrieved on 16th July, 2010 from: http://www.iso.org/iso/resources/conformity_assessment/what_is_conformity_assessment.htm ISO/ Mech. (International Organization for Standardization/ Mechanisms). Mechanisms for performing Conformity Assessment. International Standards for Business, Government and Society. (2010). Retrieved on 17th July, 2010 from: http://www.iso.org/iso/resources/conformity_assessment/mechanisms_for_performing_conformity_assessment.htm Murphy, Craig & Yates, JoAnne. The International Organization for Standardization: Global governance through voluntary consensus. New York: Taylor & Francis. (2009). NRC (National Research Council, U.S.). Standards, conformity assessment, and trade into the 21st century. Washington, DC: National Academies Press. (1995). Nicolaidis, Kalypso & Shaffer, Gregory. Transnational mutual recognition regimes: Governance without global government. Law and Contemporary Problems, 68.3-4 (2005): pp.263-317. SCCG (Standards Coordination and Conformity Group). Conformity assessment information. National Insitute of Standards and Technology (NIST). (2009). Retrieved on16th July, 2010 from: http://ts.nist.gov/standards/conformity/cainfo.cfm WBP (World Bank Publications). Standards and conformity assessment as non-tariff barriers to trade. The World Bank Development Research Group. The United States of America: World Bank Publications. (1997). Read More