Flexible Scopes
Accreditation of flexible scopes Harmonised system helps to reduce administrative burdens and bureaucracy
DAkkS has established the conditions to enable accredited conformity assessment bodies to apply for flexible scopes of accreditation for all accreditation activities, provided they meet the relevant criteria. On this page, you will find an overview containing the key information on the accreditation of flexible scopes.
Objectives of flexible scopes
The flexible scope of accreditation allows accredited conformity assessment bodys (CABs) to make necessary changes to the technical scope set out in the annex to the certificate, on their own responsibility, within the scope of accreditation (Level 3 standard).
In accordance with a defined internal procedure, accredited bodies may offer new conformity assessment services and certifications under the scope of the flexibility granted within their accreditation, without DAkkS having to assess the new activities beforehand. The assessment of these new or amended services, offered under the flexibility scheme, will only take place as part of the next surveillance audit.
Accordingly, DAkkS has developed a harmonised system for defining flexible scopes of accreditation and documented this in its set of rules. With immediate effect, greater flexibility is available for all conformity assessment activities that are accredited by DAkkS, provided there are no legal or sector-specific reductions.
This innovative measure represents a major step forward in the field of accreditation. By extending flexible scopes to all accreditation standards, DAkkS is taking on a pioneering role at international level.
Overview of the latest publications
Important information regarding the transition period
Existing accreditations with a flexible scope of accreditation will be gradually converted to the new format. The conversion will take place at the next available opportunity, for example as part of a requested amendment to the accreditation. If an attachment to a certificate is converted as part of a request for amendment, all attachments to the relevant case will be converted.
As a matter of principle, an unprompted adjustment of existing certificate attachments is not currently envisaged. Furthermore, DAkkS has not set a deadline by which the flexible scopes of validity must be fully converted to the new system.
Flex Lists: Guidelines on identification and use of the accreditation symbol
At the heart of the new, harmonised system is the clear distinction in the presentation between the annex to the certificate and the list of flexible scopes of application maintained by the CAB, known as the ‘Flex List’. The annexes to the certificates set out the specified areas of activity together with the categories of flexibility, which must be included in the Flex List. This means that the activities actually carried out under flexible accreditation are managed and published exclusively by the CAB in this associated, up-to-date Flex List, under its own responsibility.
The following additional guidelines apply to the maintenance of the Flex List:
- In all cases, the Flex list must be identified with at least a reference to the relevant document attachment (e.g. D-PL-12345-01-0X).
- The use of the graphical accreditation symbol on the Flex list is permitted (exclusively) in conjunction with the digital accreditation symbol. The digital accreditation symbol must be applied for separately from the CAB.
To ensure that DAkkS retains an overview at all times of the activities included under the flexibility scheme, the current Flex List will be requested for every assessment in future. This should generally be submitted in the form of a ZIP folder, together with the other documents.
DAkkS provides templates for flex lists for the standard Level 3 standards. These can be found in the ZIP folders containing the required documents.
Documents
FAQ
Do you have any further questions? Below you will find answers to questions of high frequency about the flexible scopes of application.
For which accreditation activities can applications be made for flexible scopes of accreditation?
Provided they are suitably qualified, accredited conformity assessment bodies may apply to DAkkS for flexible scopes of accreditation for all accreditation activities.
Where are the requirements for the accreditation of flexible scopes set out?
The requirements for the accreditation of flexible scopes of accreditation 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, further specified through sector-specific provisions.
How is the harmonised system for increasing flexibility structured?
The DAkkS system, which is designed to increase flexibility, is based on a hierarchical structure comprising several categories (A, B and, where applicable, C). These categories describe varying degrees of freedom with regard to permissible changes to activities within the accredited scope.
The content of categories A, B and, where applicable, C is tailored to specific conformity assessment activities set out in the relevant reference standard.
The new category designations replace the previous categories 'III, I and II'. They make it clearer than before that the categories build upon one another. This is intended to prevent misinterpretations.
What requirements need to be taken into account in the individual technical units?
Additional templates adapted by individual technical units will soon be made available. These templates will take specific requirements into account in order to minimise the workload involved in processing the procedures.
Who can I contact if I have any questions about the flexible scopes of application?
If you have any questions, the relevant contact persons for your ongoing case are always available to assist you.
Your contact
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