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Mechanisms for performing conformity assessment

Testing

This is the most common form of conformity assessment. Testing also provides the basis for other types of conformity assessment like inspection and product certification. Here a product is tested against a specified set of criteria. It can be used to make decisions on the performance of the product.  Depending on the risk associated with the product, the testing laboratory may choose to be accredited.

The general requirements for laboratories or other organizations to be considered competent to carry out testing calibration and sampling are specified in the joint International Standard ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories.

Inspection bodies

These organizations examine a huge 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.

The general requirements for the operation of various types of inspection body are given in the joint International Standard ISO/IEC 17020:1998 General criteria for the operation of various types of bodies performing inspection.

Certification/registration

Certification/registration is when a third party gives written assurance that a product (including services), process, personnel, organization or management system conforms to specific requirements.

The terms certification and registration are interchangeable and the use of one over the other is largely dependant on the geographical region.

Management system certification

The most well-known examples are the certification of quality management systems and environmental management systems as conforming, respectively, to ISO 9000 and ISO 14000 standards. More than 800 000 organizations worldwide have been certified to ISO 9001 and/or ISO 14001. 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 9001 and ISO 14001 certification is carried out independently of ISO by the many certification or registration bodies active nationally or internationally.

Although ISO does not control the certification bodies, it contributes to best practice and consistency in their activities through the development of standards and guides. ISO/IEC 17021, which gives general requirements for bodies providing audit and certification of management systems, is applicable for all types of management systems generally. ISO has developed some sector specific management standards which all have their basis in ISO/IEC 17021 and only differ in those areas which are deemed absolutely necessary and relate specifically to the discipline covered. For example, food safety and ISO/TS 22003, developed for the certification of management systems related to food safety.

The list of accreditation bodies with their contact information and links to their Web sites can be found on the Internet site of the International Accreditation Forum (www.iaf.nu), under "Members" > "Accreditation members". In general, accreditation bodies' Web sites contain an up-to-date list of certification bodies that they have accredited which can be used for selecting a certification body.

Product certification

ISO/IEC Guide 65:1996 General requirements for bodies operating product certification systems can be used in combination with a number of related product standards and guides to demonstrate that a product complies with specified criteria. There are other standards within this family of standards that give guidance of the various types of product certification schemes which can be used.

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 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  - this is known as type testing.

The type of product certification scheme chosen will depend on the level of risk to the consumer as well as other factors.  For a very low risk product you may have a once-off type test and for a high risk product you may have a scheme which has type testing, requires an ISO 9001 management system in place with regular product testing from the factory and also products taken from the outlets for testing.

Personnel certification

ISO/IEC 17024:2003 specifies requirements for a body certifying persons against specific requirements, including the development and maintenance of a certification scheme for personnel.

A listing of all CASCO documents (referred to collectively as the CASCO toolbox) is available under the section Publications and Resources.

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 relation to management systems, an accreditation body will evaluate the competence of a certification body to perform the certifications for which  it wishes to be accredited. Once accredited, this indicates to the client of the certification body that its competence to do the certifications has been independently confirmed.

Accreditation of testing laboratories, product certification and inspection bodies is also carried out. This again is independent verification that they are competent to perform the activities for which they are accredited.

Some conformity assessment bodies may wish to distinguish themselves from their competitors by having an impartial evaluation of their competence by an accreditation body based on internationally-recognized criteria. These criteria are contained in ISO/IEC 17011 Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies. These conformity assessment bodies are then said to be accredited.

Mutual Recognition Agreements (MRA's)

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 achieved through cross-border cooperation among conformity assessment bodies and also among accreditation bodies. This cooperation is formalized in what are known as Mutual Recognition Agreements/Arrangements (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.

ISO/IEC Guide 68:2002 provides an introduction to the development, issuance and operation of arrangements for the recognition and acceptance of results produced by bodies undertaking similar conformity assessment and related activities.

Supplier's declaration of conformity (SDoC)

By making a self-declaration of conformity, a supplier organization avoids the costs of third-party assessment but commits that they do in fact meet the criteria and should be able to demonstrate this should they be so requested. A supplier 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, a supplier's declaration may not be appropriate in all cases, particularly where the health, safety or environmental risks of the product concerned are high. A self-declaration does not exempt the supplier from its 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.

ISO/IEC 17050 specifies the general criteria for a supplier's declaration of conformity in relation to International Standards.