DAkkS body of rules
What role does the DAkkS body of rules play, how is it structured and what principles does it follow? Here we explain the most important facts about the new DAkkS body of rules, the document types, conversion of the existing set of rules and the consultation procedure for new or revised DAkkS Rules.
Standards and body of rules
DAkkS accredits conformity assessment bodies (CABs) on a legal basis and on the basis of the so-called “harmonised standards”, such as DIN EN ISO/IEC 17020 for inspection bodies, DIN EN ISO/IEC 17025 for testing laboratories or calibration laboratories or DIN EN ISO/IEC 17065 for product certification bodies.
In conjunction with DIN EN ISO/IEC 17011, which sets out the requirements for the accreditation body and the procedure, these standards define the criteria that a CAB must fulfil for accreditation.
The purpose and content of the DAkkS body of rules is – where necessary – to specify the general requirements of these standards in greater detail, to interpret indeterminate terms or to explain content.
Document types in the DAkkS body of rules
DAkkS has started with the gradual conversion of its body of rules to a new approach.
The new approach to rules essentially provides for two types of documents: rules (R) and information sheets (M). While rules, as administrative provisions, constitute binding detailed definitions of normative requirements, information sheets provide explanations and information on understanding the normative requirements or on the course of the accreditation procedure.
These document types are supplemented as required by resolutions (B) and official communications (AM). In addition to these DAkkS document types, internationally mandatory rules are provided as translations (Ü).
DAkkS rules are administrative provisions laying down general or sectoral rules for the interpretation, specification or addition of laws, technical regulations or standards. DAkkS rules set out both binding specifications for the accreditation activities of DAkkS and binding interpretations of legal or normative requirements for conformity assessment bodies.
In addition, DAkkS rules may also contain general or sectoral critical limits or risk assessments for accreditation or conformity assessment (anticipated expert reports). A DAkkS rule can also document DAkkS guidelines on discretion and instructions on simplification to ensure that the behaviour of all employees is as uniform as possible. The objective in all cases is to ensure uniform administrative action by DAkkS. Administrative provisions may not establish new requirements beyond statutory or normative terms and definitions and are limited in their effect to the internal workings of the authority.
DAkkS rules are sent to the Accreditation Advisory Board (AKB) for determination pursuant to Section 5 (2) numbers 1 and 2 AkkStelleG (Accreditation Body Act).
DAkkS information sheet
A DAkkS information sheet contains essential information on the administrative procedure. In particular, it may be used to publish information on necessary evidence, documents to be submitted, the course of the procedure or application requirements. This also includes instructions on transition.
Information sheets may also contain general abstract technical elaborations as an aid for the conformity assessment body or to present best practice, and may discuss questions and answers concerning specific technical or sectoral issues.
Information sheets help applicants in the accreditation procedure to carry through their case simply, properly and quickly. They contain no new arrangements for conformity assessment bodies that have not already been defined by other provisions, though they may repeat such arrangements in the context of guidance or explanation.
A DAkkS resolution is the same as a rule in terms of content, but is dealt with by DAkkS in an abbreviated procedure, including its forwarding to the Accreditation Advisory Board (AKB), because the arrangements in question are a matter of urgency.
Official communications from DAkkS contain information (warnings) about identified risks, statutory violations, any prohibitions in place, inadmissible actions or market-relevant deviations, and serve solely to provide information on government action. They do not contain arrangements for conformity assessment bodies, but instead provide general information for market participants.
A DAkkS translation is the translation of ILAC, IAF and EA documents into the German language version.
Level structure of the body of rules
The structure of the DAkkS body of rules is based on the so-called “level structure” of the international mutual recognition agreements (MLA/MRA) of EA, ILAC and IAF. This structure is described in the documents EA 1/06 A-AB and IAF PR 4, which are valid internationally.
The approach at present provides for a horizontal rule (R 17011) for application of the level 1 standard DIN EN ISO/IEC 17011. For application of the various level 3 standards (activities of conformity assessment bodies), one horizontal rule is published in each case – for example rule R 17020 for application of the standard DIN EN ISO/IEC 17020 for the accreditation of inspection bodies.
In addition, DAkkS also issues sectoral annexes to these rules if a level 3 standard needs to be specified in greater detail in a technical sector. For the accreditation of testing laboratories in the area of “consumer health protection”, for example, an annex to rule R 17025 to this effect may be created.
DAkkS makes every effort to ensure that the body of rules remains clear and straightforward, and to issue rules only when necessary for application in the accreditation procedure. The relevant DAkkS sector committees in each case contribute to the preparation of sectoral rules.
The structure of the content of a DAkkS rule corresponds strictly to the structure of the respective standard being fleshed out. This approach enables a clear correlation to the content of standards.
Principles for the DAkkS body of rules
- Accreditation against harmonised standards, not against DAkkS rules
The scope of DAkkS rules is limited to what is actually necessary. Accreditation is based on the harmonised level 3 standards and the specific scope of accreditation being sought.
- DAkkS rules do not specify the best available technology or codes of practice
DAkkS rules do not define requirements for the object of conformity assessment or requirements for the specific conformity assessment activity for which DAkkS confirms competence.
- DAkkS assessors have a margin of discretion with regard to the interpretation of standards
As part of any specific assessment, DAkkS assessors assess whether or not the general requirements of the standard are met. DAkkS does not pursue the objective of minimising these powers of discretion by defining firmer rules.
- DAkkS rules do not establish new requirements
DAkkS rules set out existing requirements in greater detail. No requirements are generated that are not laid out in legal or normative requirements.
- The mandatory international rules of EA, ILAC and IAF apply
DAkkS applies mandatory international rules published by EA, ILAC or IAF for the purpose of the harmonisation and comparability of accreditation activities in Europe and around the world. For easier application, DAkkS makes these rules available in translation into German.
- DAkkS applies legal, regulatory or scheme-specific requirements, but is not the owner of these requirements
DAkkS applies applicable legal, regulatory or scheme-specific requirements to conformity assessment bodies or their activities in the accreditation procedure. However, DAkkS is not the owner of these requirements and does not include such requirements in its body of rules. DAkkS refers to existing requirements and links to the relevant documents where applicable.
Valid old body of rules and conversion to the new approach to rules
The conversion of the existing body of rules to the new structure of rules and information sheets is a major challenge for DAkkS. This process will not take place “in one go”, but will instead happen gradually over a longer period of time. The existing rules are being analysed, withdrawn where necessary, transferred in whole or in part to the new structure of the body of rules, or rewritten.
During the transition period, DAkkS will apply the old and new rules concurrently. In the event of contradictory requirements as a result of the application of old and new rules, DAkkS undertakes to clarify the matter as appropriate.