Is it possible to perform initial or surveillance certification audit by a Notified Body remotely regarding the Modules based on quality assurance (such as D1 module of 2019/1009 EU Regulation)? If possible, does the decision of the detailed rules belong to the competence of the relevant notified body forum, which rules necessary to make in order to conduct remote audit?
September 2023
According to Regulation (EU) 2019/1009, the application of the conformity assessment procedure established under Module D1—Quality Assurance of the Production Process—by the NoBo shall include an assessment visit to the manufacturer’s premises as an integral part of the audit (Annex IV, Part II, Module D1, §5.3.3). For surveillance purposes, the NoBo shall be allowed to access the manufacture, inspection, testing, and storage sites of the manufacturer (Annex IV, Part II, Module D1, §6.2). Moreover, unexpected visits may be paid to the manufacturer by the NoBo (Annex IV, Part II, Module D1, §6.4).
Within the context of the Regulation, the NoBo is required to visit the manufacturer’s premises. Thus, the audits, either initial or surveillance, shall be carried out in the physical presence of the NoBo’s auditor(s).
Any deviation from these requirements should be agreed with the European Commission.
Furthermore, according to EA-2/17, Accreditation for module D1 requires the application of EN ISO/IEC 17065 + qa requirements.
qa requirements are : Ability to assess and approve manufacturer’s quality systems where required. To this end, fulfilment of clauses 7.1.1, 7.1.2, 7.2.4, 7.2.5, 7.2.8, 7.2.10 and 9.1 to 9.4 and 9.6 in EN ISO/IEC 17021-1:2015 shall be demonstrated.
9.3 and § 9.6 of EN ISO/IEC 17021-1 require on-site audits.