Herewith the Recreational Craft Sectoral Group, an official Coordination Group of Notified Bodies under the Recreational Craft Directive is asking a question regarding the topic of impartiality of auditors used:
- RSG Committee meeting of 10th April 2025 recorded that a number of Notified Bodies have faced accreditation challenges regarding the impartiality of personnel.
- Specifically, accreditation bodies have objected to Notified Bodies hiring personnel that have acted as a consultant within the sector on which they have acted as an assessor (i.e. inspector or auditor) for the Notified Body.
- The objections have been raised even in cases where the assessors have no connection to the manufacturer or product being assessed.
- The accreditors’ finding is assumed to be based on Decision (EU) 768/2008 article R17(4) and the analogous article 30(4) of the Recreational Craft Directive 2013/53/EU*.
- It is beyond discussion that assessors cannot be linked to the manufacturers or products being assessed.
- However, it is unclear whether the fact that a Notified Body’s contracted assessor has acted, at some point in time, as a consultant within the sector of the Notified Body, should not preclude them from assessing products with which the assessor has no connection to the manufacturer or product. It is however noted, that in the past 25 years of RCD being in force as a directive the practice has been allowed – and this issue has only arisen recently.
- It is noted that under EN ISO/IEC 17020:2012, ILAC P15 applies and there the concept of ‘items inspected’ regulates this topic differently. But under EN ISO/IEC 17065:2012, a different impartiality regime is applicable: one of reviewer and decision maker. This principle affords a mechanism for impartiality which is not prescribed in ISO 17020.
- By way of contrast, it is noted that laboratories frequently perform work within the sector that is not specifically classed as assessment for Notified Bodies. Should this preclude laboratories from testing on Notified Body certification projects?
The question is thus:
- Whether the fact that a Notified Body’s contracted assessor has acted, at some point in time, as a consultant within the sector of the Notified Body, should preclude them from assessing products with which the assessor has no connection to the manufacturer or product.
- And
- Whether article 30(4) of RCD 2013/53/EU should be interpreted as meaning that anyone involved in the conformity assessment shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products which they assess and that this is connected specifically to the specific products under assessment – but not any product as defined in the scope of accreditation in the broadest sense of the word.
*It should be noted that RCD Notified Bodies face an especially challenging position in this regard. The sector is relatively small and extremely specialized as RCD 2013/53/EU covers many engineering disciplines.” & “The only way for Notified Body personnel to have the necessary experience of these engineering disciplines is to have worked in the sector. If accreditation bodies consider this as a threat to impartiality, then there is no choice but to hire new recruits directly from universities, with no experience
March 2026
This question is complex.
It conveys a certain dose of interpretation that may not have been discussed (at least entirely) before – It is also recommended to read EA-2/20 to complement the interpretation given in this answer.
Furthermore, EA cannot discuss a finding raised by a NAB, since we have not the complete information and background of the finding – this answer is intended to be generic and providing a starting point for a discussion on specific findings.
The Directive 2013/53/EU (RCD) has a clause setting up the requirements for NoBo’s personnel, which is article 30(4), in particular the following paragraph:
“A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design or manufacture, the marketing, installation, use or maintenance of those products, or represent the parties engaged in those activities.
They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.”
A definitive interpretation for this would need to be stated by the European Court of Justice – however, a common interpretation could be:
- The first paragraph implies that any auditor or inspector contracted by the NoBo cannot have been involved in the manufacture of those products that he/she is going to assess;
- The second paragraph specifies that the prohibition applies for any consultancy that contributes to the products to be assessed.
This is in line with the golden rule that no one should assess the outcome of work for which it has contributed – while it is obvious that the NoBo cannot use a consultant that provided consultancy to the product under evaluation, it should also be recognized that having provided consultancy to other products that are parts to be incorporated in the product under evaluation also presents a conflict of interest. So, the focus shoud be placed in whether or not the evaluator has provided consultancy that ended up in the product or manufacturer being evaluated.
From the viewpoint of the harmonized standard (HS Accr) used for the accreditation of the NoBo, EA-2/17 identifies several, each according to a specific module:
- EN ISO/IEC 17020 has several clauses addressing the impartiality of its personnel (4.1, 6.1.11, 6.1.12), complemented in the case of type A inspection body by clause A1.b), which places similar requirements to those above from the RCD;
- EN ISO/IEC 17065 has also several clauses addressing the impartiality of its personnel (4.2, 6.1.3), which places similar requirements to those above from the RCD, although with more specific conditions under 4.2.10; this last clause requires an appropriate time interval between any consultancy and reviewing or deciding, and redirects any QMS auditor to comply with the applicable clauses from EN ISO/IEC 17021-1 and any inspector to comply with the applicable clauses from ISO/IEC 17020;
- EN ISO/IEC 17021-1 has several clauses addressing the impartiality of its personnel (5.2, 7.3), which places similar requirements to those above from the RCD, although with specific requirements for personnel that provided consultancy (5.2.10), where a minimum of two years of time gap is recognized as an appropriate mitigation action.
As both requirements from RCD and the relevant HS Accr apply, the most stringent text shall be used.