General Information on Conformity Assessment

 

 

Conformity assessment is any activity concerned with determining directly or indirectly that relevant requirements are fulfilled. Types of conformity assessment activities include testing, inspection, assurance of conformity, accreditation and mutual recognition agreements.

Testing

Testing, which can involve measurement and calibration, is perhaps the most common form of conformity assessment. Testing is also the main technique used in product certification.

Inspection

With the growth of world trade and increasing trade liberalization – as well as the rapid development of new manufacturing and distribution technologies, hundreds of national and multinational third-party inspection bodies have come into existence.

These organizations examine a very wide range of products, materials, installations, plants, processes, work procedures and services, in the private as well as the public sector, and report on such parameters as quality, fitness for use and continuing safety in operation. The overall aim is to reduce risk to the buyer, owner, user or consumer of the item being inspected.

Assurance of conformity

This is the activity resulting in a statement giving confidence that a product, process or service fulfils specified requirements. There are two main types of assurance of conformity:

Supplier's declaration

This is the process whereby conformity assessment to a standard, specification or regulation is carried out by the supplier organization itself. In other words, it is basically a self-assessment exercise.

By making a self-declaration of conformity, a supplier organization avoids the costs incurred by third-party assessment. A supplier organization may decide to take this option if it believes that it enjoys a sufficiently high market reputation for it to dispense with independent confirmation of conformity. However, supplier's declarations may not be appropriate in all cases, particularly where the health, safety or environmental risks of the concerned product are deemed high enough to require independent assessment. Self-declaration does not exempt the supplier from the responsibility to meet relevant regulations – for example, in relation to product liability – and such declarations generally need to be accompanied by effective post-market surveillance.

Certification / registration

The best known examples are management system certification and product certification. Other types of certification include personnel certification, certification of services, certification of forests, etc.

Management system certification. Examples include the certification of quality management systems and environmental management systems as conforming, respectively, to ISO 9000 and ISO 14000 standards. More than 360,000 organizations worldwide have been certified to an ISO 9000 and/or ISO 14000 standard. It should be noted that ISO itself does not assess the conformity of quality or environmental management systems to ISO 9000 or ISO 14000 standards. ISO does not issue certificates of conformity to these standards. ISO 9000 and ISO 14000 certification is carried out independently of ISO by more than 720 "certification" or "registration" bodies active nationally or internationally.

The terms "certification" and "registration" are employed in a broader conformity assessment context than ISO 9000 and ISO 14000 alone and their standardized definitions show that they are not synonymous. However, in the ISO 9000 and ISO 14000 contexts, "certification" and "registration" are used interchangeably and they both mean the same thing. One term is preferred over the other depending on the country. Likewise, the bodies that issue ISO 9000 or ISO 14000 certificates are referred to in some countries as "certification bodies" and in others as "registration bodies" or "registrars".

Product certification. Many variants exist. For example, product certification may consist of initial testing of a product combined with assessment of its supplier's quality management system. This may be followed up by surveillance that takes into account the supplier's quality management system plus testing of samples from the factory and/or the open market. Other product certification schemes comprise initial testing and surveillance testing, while still others rely on the testing of a sample product (type testing).

Accreditation

Accreditation is the procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks. In the ISO 9000 or ISO 14000 context, it relates to the work of the accreditation bodies that have been set up in a number of countries to evaluate the competence of certification bodies. An accreditation body will accredit – approve – a conformity assessment body as competent to carry out ISO 9000 or ISO 14000 certification in specific business sectors.

Accreditation is also carried out of testing laboratories, inspection bodies and product certification bodies. In some countries, accreditation is a legal requirement for conformity assessment bodies. Even in countries where this is not the case, when there are several conformity assessment bodies in a geographical area or business sector, some may want to distinguish themselves from their competitors by having an impartial evaluation of their competence by an accreditation body based on internationally recognized criteria.

The role of certification

Certification is an asset and an advantage, both for the producer and for the purchaser, consumer or distributor. It gives an incontestable added value to the product or service bearing its mark. For the manufacturer or service provider, it valorizes the goods or service, opens up new markets and simplifies relations. For the user, it provides assurance that the product meets defined characteristics or that an organization's process meets specified requirements. Certain product certification marks may represent an assurance of safety and quality. Certification enables one to distinguish apparently identical products or services; it also offers the possibility of appeal in the event of dissatisfaction.

Mutual recognition agreements (MRAs)

The primary objective of conformity assessment is to give its users confidence that requirements applicable to products, services, systems, processes and materials have been met. One of the reasons why internationally traded goods and services are subject to repeated conformity assessment controls is a lack of confidence by users of conformity assessment in one country regarding the competence of bodies carrying out conformity assessment activities in other countries. Therefore, measures are needed to increase the confidence of both private and public sector purchasers, and of regulators, in the work of conformity assessment bodies and accreditation bodies – particularly those in other countries.

Such confidence can be engendered through cross-border co-operation among conformity assessment bodies and also among accreditation bodies. This co-operation is formalized in what are known as mutual recognition agreements (MRAs) whereby the parties involved agree to recognize the results of each other's testing, inspection, certification or accreditation. MRAs can be an important step towards reducing the multiple conformity assessment that products, services, systems, processes and materials may need to undergo, especially when they are traded across borders. Since MRAs facilitate the acceptance of goods and services everywhere on the basis of a single assessment in one country, they contribute to the efficiency of the international trading system – to the benefit of suppliers and customers alike.