Revised template documents published
Deutsche Akkreditierungsstelle (DAkkS) has published the “Lists of documents to be submitted” and the “Annual statements” relevant for accredited bodies in revised form on its website. The documents were revised with due regard to the feedback provided by the relevant accredited bodies and interest groups. The documents are now available for download and use.
With the lists and annual statements, DAkkS requests essential documents and information from accredited bodies for the planning and preparation of its assessments. The newly revised versions have been simplified in some places. The provision of the “normative documents in scope” is still required.
What are the main changes?
The uniformity of the lists is maintained. As a rule, adjustments made relate to all lists of documents to be submitted or annual statements. The main changes are:
Request for information about the employees of the body
No lists with personal information about the qualifications of employees are requested. The information required includes details of the number of employees, broken down by role, details of qualification requirements for each role and the type of connection to the accredited body (internal/external). Samples of evidence documents for individual employees are inspected on a random basis during the assessment.
Request for samples instead of copies of originals
As a rule, copies of originals are not required for contracts and reports of results, but rather samples of the relevant documents. Samples of originals are inspected on a random basis during the assessment.
Protection against liability risks: proof of insurance sufficient
In the lists of documents to be submitted, the wording of “Risk analysis and liability calculation” has been made more specific, indicating that appropriate proof of insurance with information on the scope of insurance cover is sufficient. The accredited body must set out how it deals with liability risks only if it has no insurance cover.
No submission of documents freely available to the public
Documents listed in the certificate annex that describe the scope and are available to the public free of charge do not have to be submitted. However, documents that are commercially available for purchase, such as standards, must be provided by the accredited body.
Note: For testing laboratories, the so-called DEV and ASU methods are exempt from the obligation to submit. This is noted in the list of documents to be submitted for testing laboratories.
Annual statement no longer included in the documents to be submitted
The annual statement is no longer included in the documents to be submitted. The annual statement now only has to be submitted once a year to the relevant DAkkS case managers by 31 March for the previous year.
Other changes to the annual statements
The terminology used in the annual statement has been edited and standardised. In some cases, conformity assessment bodies can provide their information on the scope of their activities in the accredited area in different ways. In the case of laboratories, for example, this information can be based on reports of results or findings, samples examined or tests or examinations carried out – depending on availability. Furthermore, in the absence of precisely determined data, valid estimates of the activities in the accredited area are sufficient.
For certification bodies, the annual statement now includes an additional section, which requests information on conformity assessment activities and other activities of the body that are not set out in the certificate annex but are offered and carried out by the certification body. This information is required in particular to assess the impartiality of these bodies.
Is there a transitional arrangement for use of the revised documents?
If the documents submitted are already available for specific processes, they do not have to be submitted again, even if the assessment has already been scheduled. The revised templates should then be used for future assessments.
Deadline for annual statement ends on 31 March 2022
Accredited bodies must submit the annual statement for the year 2021 to the relevant DAkkS case managers by the end of the first quarter on 31 March 2022. Here again, the previous template can still be used this year.