Shaping the future of accreditation: DAkkS extends its flexible scopes system to all accreditation activities

The German Accreditation Body (DAkkS) has established the conditions under which accredited conformity assessment bodies (CABs) that can demonstrate the necessary competence may apply for flexible scopes of accreditation for all accreditation activities. The new system facilitates adaptation to technical developments and helps reduce administrative burden.

Objectives and benefits of flexible scopes

Flexible scopes of accreditation allow accredited CABs to make necessary changes, under their own responsibility, to the technical scope set out in the certificate annex within the accredited scope (Level 3 standard).

This enables accredited bodies to respond directly to current technical developments, innovations and the needs of the market and their clients. Following a defined internal procedure, accredited bodies may offer new conformity assessment activities and attestations within an approved flexible scope without prior assessment of these activities by DAkkS. The assessment of such new or amended activities takes place during the next surveillance assessment.

To support this approach, DAkkS has developed a harmonised system for the presentation of flexible scopes and documented it in its body of rules. In future, flexibility will be available for all conformity assessment activities accredited by DAkkS, provided no legal or sector-specific restrictions apply.

This innovative measure by DAkkS contributes significantly to the simplification of accreditation procedures and represents an important step forward in accreditation.

Fundamentals of flexible scopes

The requirements for the accreditation of flexible scopes are set out in DIN EN ISO/IEC 17011 and EA-2/15 M. DAkkS has implemented these requirements in the relevant DAkkS Rules R-17011, R-15189, R-17020, R-17021-1, R-17024, R-17025-K, R-17025-PL, R-17029, R-17034, R-17043, R-17065 and R-20387 and, where necessary, supplemented them with sector-specific provisions.

Interested CABs may now apply to DAkkS for flexible scopes. The granting of flexible scopes in certificate annexes is based on a corresponding assessment. Within these areas, accredited bodies may make use of the opportunities and benefits associated with flexible scopes for their own benefit and for the benefit of their clients.

Harmonised flexibility system with categories A, B and C

The DAkkS flexibility system is based on a hierarchical structure comprising several categories (A, B and, where applicable, C), which describe different degrees of flexibility regarding permissible changes to activities within the accredited scope.

For some conformity assessment activities, categories A, B and C have already been used for flexible scopes for some time, for example for accredited testing laboratories in accordance with DIN EN ISO/IEC 17025 and DIN EN ISO 15189.

With the harmonised introduction, the category system will now be established for all accreditation activities (for example, certification of management systems in accordance with DIN EN ISO/IEC 17021-1) or adapted accordingly (for example, calibration activities in accordance with DIN EN ISO/IEC 17025). The content of categories A, B and, where applicable, C is tailored to the specific conformity assessment activities covered by the respective accreditation standard.

A key principle of the harmonised system is the way in which flexible scopes are presented. Certificate annexes identify the defined areas together with the relevant flexibility categories. Activities performed under flexible accreditation are listed exclusively in the corresponding up-to-date list maintained and published by the CAB. This avoids duplication of information.

As a result, conformity assessment activities that already use categories A, B and C will also benefit from a new and simplified presentation system. The meaning of the established categories remains unchanged.

The list maintained by the CAB plays a central role in the context of accreditation with flexible scopes. Conformity assessment activities that a CAB includes within its accredited scope are regarded as fully equivalent to activities listed in the certificate annexes published on the DAkkS website.

Introduction and transition period

Preparations of the harmonised system for presenting flexible scopes using categories A, B and C have now been completed.

Introduction of categories A, B and C: With immediate effect, only categories A, B and C will be used for applications for initial accreditation and for applications for extension that include flexible scopes for the first time. Applications for accreditation with flexible scopes by the CAB remain voluntary for CABs. The relevant application documents are available on the DAkkS website (see links below for further information).

Transition of existing flexible scopes of accreditation: Existing accreditations with flexible scopes will be gradually adapted to the new presentation format in certificate annexes and in the corresponding up-to-date list of accredited activities at the next suitable opportunity. This may take place, for example, during surveillance assessments or when changes are made to the accreditation.

During the transition period, the previous and new presentation formats, as well as the old and new category designations, will coexist in parallel. Flexible scopes granted under the previous system will therefore remain valid throughout this period.

To ensure that DAkkS maintains an overview of activities added by CABs under flexible scopes, the current version of the list will be requested as part of every upcoming assessment. The list must be submitted with the required documents, generally as part of the completed ZIP folder. To support this process, DAkkS has developed template „Flex Lists“ for the common Level 3 standards. These may be used by CABs to record activities covered by flexible scopes. The information requested in these lists must be provided to DAkkS by all CABs.