ENAC has published a new guide to support the development of accredited conformity assessment schemes, a document aimed at organizations that design or manage these schemes and that wish them to be backed by accreditation.

The guide is especially aimed at owners or developers of schemes, including public administrations, standardisers, companies, technology centres, professional and consumer associations, manufacturers, large purchasers or distributors, and so on. This type of organization increasingly promotes certification, inspection, or assessment schemes to assess compliance with certain technical, regulatory, or market requirements.

A conformity assessment scheme is a set of documented requirements that defines what is to be assessed (product, process, service, organization, or person), what requirements it must meet, what method will be used to assess it, and which bodies will carry out that assessment.

For these schemes to achieve their objectives, it is essential to ensure that the assessment bodies operating within them have the necessary competence to carry out the tasks entrusted to them, that they work under appropriate supervision, and, in many cases, that their activities are internationally recognised. For that reason, scheme owners from around the world, and in all sectors, turn to accreditation.

Therefore, if the owners want the assessments to be carried out by accredited bodies, the scheme must meet certain technical criteria that enable the conformity assessment bodies operating within it to be accredited.

Regarding the elements that a scheme must consider in order to be used by accredited bodies, the document describes the fundamental elements that a scheme must define, among other aspects, such as:

• The scheme’s purpose and scope: clearly identifying which product, process, service, system, or person will be subject to assessment.
• The requirements that must be met: criteria or specifications against which conformity will be assessed.
• Assessment procedure: methods and activities used to determine conformity, such as tests, inspections, audits, or other assessments.
• Additional standards or requirements: conditions applicable to conformity assessment bodies (CABs) and to the scheme’s operation, such as personnel competence requirements, content of reports or certificates, assessment duration, monitoring, or management of non-conformities.
• Rules of use: conditions for using marks, certificates, or other evidence of conformity within the scheme.
• Accreditation: reference to accreditation’s role as a mechanism that assesses the OEC’s competence and supervises its activity according to applicable requirements.

Likewise, the guide addresses key issues related to the scheme’s design and management, such as the need to clearly define the assessment object and the requirements to be met, consider the risk level associated with non-compliance with these requirements when selecting assessment activities, or ensure competent persons and interested parties participate.

Another aspect analysed in the document is the scheme’s necessary alignment with the international conformity assessment standards (ISO/IEC 17000 series), which establish the requirements of technical competence, impartiality, and consistency for the bodies that carry out these activities. Designing a scheme taking these standards into account makes it easier for the bodies operating within it to obtain and maintain accreditation.

In addition to serving as a guide for designing new assessment programs, the guide can also be useful for reviewing existing schemes, enabling possible improvements to be identified that help accredited bodies use them and increase the market’s confidence and acceptance.

With this publication, ENAC reinforces its role as technical support to public and private organizations that develop assessment schemes, contributing to these programs being designed on solid foundations and being able to benefit from the added value that accreditation provides in terms of technical competence, reliability, and international recognition.

Consult the full document