Basics of accreditation Step 1 of the accreditation process
Are you interested in the topic of accreditation or would you like to be accredited for the first time? Are you wondering about the requirements that will need to be fulfilled? Here you will find answers to the basic questions about the accreditation procedure, as well as information about how to get in touch.
Where does DAkkS accredit?
DAkkS provides both statutory and non-statutory accreditation activities.
Statutory accreditation activities
DAkkS is responsible for the accreditation of conformity assessment bodies that have their registered office in Germany. DAkkS performs these statutory activities within the framework of the German Act on the Accreditation Body (AkkStelleG) or of European Regulation (EC) No 765/2008.
In exceptional cases, DAkkS also acts a statutory body in the member states of the European Union or the European Economic Area (EEA). In these cases, DAkkS has been mandated by the state or national accreditation body in question or has received an exemption on a case-by case basis. This is done in compliance with the applicable provisions of Regulation (EC) No 765/2008 and the corresponding rules of the European accreditation organisation EA.
Accreditation in the statutory area also includes all locations of a conformity assessment body outside Germany, regardless of whether they are in the EU, the EEA or in third countries.
Non-statutory accreditation activities
Non-statutory is the term used to refer to all cases of accreditation by DAkkS in which the registered office of the conformity assessment body is not within the scope of the Act on the Accreditation Body (AkkStelleG) or of Regulation (EC) No 765/2008. In these third-country cases, the head office of the conformity assessment body is therefore not located in Germany and is also outside the member states of the EU and the EEA.
The accreditation of these conformity assessment bodies makes allowance for the applicable rules in each case of the European accreditation organisation EA and the international accreditation networks ILAC and IAF.
Who can be accredited?
DAkkS accredits organisations that offer and perform conformity assessment activities. These include the following types of conformity assessment bodies (accreditation activities).
What is the scope of an accreditation?
As a rule, an accreditation does not apply to an organisation as a whole, but only to specific activities. This “scope” varies from case to case. It is precisely defined as part of the application for accreditation and is reviewed and evaluated during the assessment phase.
If the outcome of a case is positive, an accreditation confirms that an organisation fulfils the requirements within the defined scope and can competently perform specific conformity assessment tasks.
What are the requirements to be fulfilled?
DAkkS grants accreditation if the conformity assessment body fulfils the requirements in place for it. The essential requirements are set out in the relevant harmonised standards (e.g. DIN EN ISO/IEC 17025). There may however also be additional requirements, for example from
- The standard DIN EN ISO/IEC 17011
- Level 5 standards, which define the requirements for the object of conformity assessment or for the specific conformity assessment activity
- The agreements or requirements of owners of conformity assessment schemes, or
- The rules and regulations of the accreditation system
The exact technical requirements to be met for the granting of accreditation are very individual and depend on the scope of accreditation being sought.
How long does a case of accreditation take?
An accreditation is a very complex procedure and takes several months depending on the level of technical complexity. The duration of the procedure varies and depends on a number of factors. These include for example:
- The extent of the scope being sought
- The number of locations
- The experience and involvement of the conformity assessment body
- The maturity of the quality management system and its processes
- The availability of staff resources
For how long are accreditations valid?
As a rule, accreditations in the statutory area are granted for an unlimited period. They remain valid until they are withdrawn, suspended, reduced or amended by DAkkS or until the body gives up its accreditation. Reasons for the reduction of accreditations by DAkkS may for example be the discontinuation of essential accreditation requirements or a lack of cooperation on the part of the body in surveillance of the accreditation. Feedback from the market or market surveillance may also lead to the reduction of accreditation.
Accreditations are granted for a limited period in the following cases in particular:
- in the statutory area, if the time limits for the accreditation are prescribed by law
- In the non-statutory area (“third country cases” outside Germany, the EU and the EEA)
Limited accreditations lose their validity on the expiry date specified in the accreditation decision and certificate and must undergo a reaccreditation procedure in good time.
What does an accreditation cost?
There is no general answer to this question, because the costs of an accreditation procedure depend on various different criteria. Before we can estimate the effort required for an accreditation procedure, and hence its cost, we will need to know the type of accreditation you are seeking, the scope of the activities to be accredited, the number of locations to be assessed and the overall complexity of the case as a whole.
In addition to the initial accreditation, the maintenance of a granted accreditation will also incur costs. These expenses are incurred in particular for regular surveillance or reassessments and case processing.
Basis of cost calculation
The basis for calculating the costs of our accreditation service depends on whether the activity in question is statutory or non-statutory.
In the statutory area (Germany, EU and European Economic Area), the costs for an accreditation are based on the time required for the case. The accreditation costs are not calculated using general fees and flat rates. They are instead calculated precisely using a time-based fee and stated in a fee notice.
The legal basis for the calculation of these fees is AkkStelleGebV, the German ordinance on fees for accreditation bodies enacted by the Federal Ministry for Economic Affairs and Energy. In addition, the calculation of expenses incurred in the case is based on BGebG, the act on fees and expenses for federal services.
All fee rates are calculated to cover all personnel and material costs associated with “individually attributable public services” provided by DAkkS.
DAkkS also works in the non-statutory area (countries outside the European Economic Area). DAkkS calculates the costs for these accreditation services on the basis of a separate list of fees for activities abroad. You can find it by following this link:
Who do I contact if I am interested in an initial accreditation?
Are you interested in an initial accreditation by DAkkS? As a new customer, please feel free to arrange an initial meeting at one of our offices. The discussion will take up to two hours and is free of charge.
Possible subject matter of an initial meeting:
- Information about the content, process and budget for the accreditation procedure
- Clarification of the scope of the accreditation being sought
- Information about specific accreditation criteria for the accreditation being sought
- Rights and obligations of the client and DAkkS after the granting of accreditation