According to EA-2/17 (ANNEX B), the notified bodies should take into account the relevant IAF MD documents while assessing quality management system-based modules e.g. Modules D, E and their derivatives as long as there are no other specific requirements of the corresponding notified body coordination group in this regard. For module H and its derivatives, Notified Bodies shall comply with the relevant IAF MD documents.
In case of there is an issued notified body coordination group document, the notified body shall apply them (EA-2/17, 3.5; Article R17 paragraph 11 of Decision (EC) 768/2008).
Q1 : In case of there is an issued notified body coordination group document, could such a document differ completely the relevant IAF documents?
The question is focusing on IAF MD 1:2023 (IAF Mandatory Document for the Audit and Certification of a Management System Operated by a Multi-Site Organization).
Q2 : Would it be acceptable, that a notified body coordination group document set the audit the production sites within the scope of module D or E sequentially with the frequency of maximum 4 years? (In certain cases it could lead to an audit cycle of 80 years when the manufacturer has 20 production sites within its scope of module D-E.)
March 2025
Q1 : YES, provided that the IAF document has been considered (for modules D and E as stipulated in EA2/17) and judged not appropriate in regard to the requirements of the regulation which prevail.
Q2 : NO
In the case of Regulation (EU) 2019/1009 (FPR : Fertilizing Products Regulation), the only quality management system-based module pursuant EA-2/17, Annex B, which can be applied, is Module D1 – Quality Assurance of the Production Process.For such a module, EA-2/17 foresees that the notified bodies should consider the relevant IAF MD documents as long as there are no other specific requirements of the corresponding notified body coordination group in this regard.
To this end, FPR (or similarly regulated) notified bodies and their corresponding notified body coordination group should consider the relevance, consistency and applicability of those IAF Mandatory Documents’ requirements to ensure the conduct of a technically sound evaluation against the requirements of the Regulation, by NBs. Especially, with respect to IAF MD1, it is unlikely that the application of multi-site sampling would be appropriate and consistent with the requirements of the Regulation, which explicitly stipulates that “the conformity assessment procedure established under Module D1 shall include an assessment visit to the manufacturer’s premises” [i.e. sites] “as an integral part of the audit (Annex IV, Part II, Module D1, §5.3.3) for initial and surveillance audits”.