Conformity Assessment Systems


Conformity assessment is the process of evaluating whether a product, service, or system meets specific standards or requirements. This process is essential to ensure the quality and safety of products and services, as well as to protect consumers and the environment.

In the standards point of view, there are three ways of verifying that a standard is met.

Self-assessment: This method involves the manufacturer or service provider evaluating their own product or service to ensure that it meets the required standards. However, self-assessment can be subject to bias and may not provide the same level of assurance as third-party assessment.

This method is also called first-party verification. For example, in the early days of the organic farming industry, producer groups checked themselves that all group members complied with the standard chosen by the group.

In the second case, a firm may demand that its suppliers meet the standard and control itself that they do so. This is second-party verification. Second party verification is widespread among food processors and retailers.

Third-party assessment: This method involves an independent organization evaluating the product or service to verify that it meets the required standards. This independent organization is not involved in the business relationship to control the compliance of the suppliers. This is alco called a third-party verification, or certification.

 

CERTIFICATION, ACCREDITATION AND MUTUAL AGREEMENTS

The International Organization for Standardization defines certification as “a procedure by which a third party gives written assurance that a product, process or service is in conformity with certain standards” (ISO Guide 2, 1996). Certification can be seen as a form of communication along the supply chain. The certificate demonstrates to the buyer that the supplier complies with certain standards, which can be more convincing than if the supplier itself provided the assurance. The rise of certification is to a large extent the result of trade globalization and progress in information technology.

It is important to underscore that certification is by definition done by a third party (named certification body or certifier) which does not have a direct interest in the economic relationship between the supplier and buyer. Ideally, the organization that has set and owns the standard should not carry out the certification operations itself. Rather, it should authorize competent independent certification bodies to do this work after checking their capabilities.

To ensure that the certification bodies have the capacity to carry out certification programmes, they are evaluated and accredited by an authoritative institution. Certification bodies may have to be accredited by a governmental or para-statal institute, which evaluates compliance with guidelines for the operation of such bodies set by, for example, ISO, the European Union or some other entity. In addition, standard setting bodies may accredit certification bodies for the scope of their particular standard.

Accreditation is the process of evaluating and certifying the quality and credibility of a product, service, or process. It is a way for organizations or countries to ensure that certain standards are met and that the product, service, or process is safe and effective. Accreditation is often required for products and services in industries such as healthcare, education, and manufacturing.

Mutual recognition of accreditation refers to the acceptance of accreditation by one organization or country as valid and equivalent to accreditation in another organization or country. It allows organizations or countries to rely on the quality and credibility of products, services, or processes from other locations. Without mutual recognition, organizations or countries may have to undergo their own separate accreditation process, which can be time-consuming and costly. Mutual recognition also allows for easier trade and exchange between organizations or countries, as it reduces the need for additional evaluations and certifications.

There are several organizations that facilitate mutual recognition of accreditation. The International Laboratory Accreditation Cooperation (ILAC) is an organization that promotes mutual recognition of accreditation for laboratories around the world. The International Accreditation Forum (IAF) promotes mutual recognition of accreditation for conformity assessment bodies, which are organizations that evaluate and certify the quality and credibility of products, services, or processes.

There are also bilateral and multilateral agreements that allow for mutual recognition of accreditation between specific organizations or countries. For example, the European Union has mutual recognition agreements with several countries, including the United States, Canada, and Australia. These agreements allow for mutual recognition of accreditation for products and services in specific industries, such as medical devices and pharmaceuticals.

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