ED Decision 2022/011/R
OVERSIGHT PLANNING CYCLE — AUDIT
(a) For each organisation certified by the competent authority, all applicable requirements including relevant processes should be audited at periods that do not exceed the applicable oversight planning cycle. The beginning of the first oversight planning cycle is normally determined by the date of issue of the first certificate. If the competent authority wishes to align the oversight planning cycle with the calendar year, it should shorten the first oversight planning cycle accordingly.
(b) Audits should include at least one on-site audit within each oversight planning cycle. For organisations that carry out their regular activities at more than one site, the determination of the sites and the requirements at these sites to be audited should consider the results of past oversight activities and the volume of activities at each site, as well as the main risk areas identified.
(c) For organisations that hold more than one certificate under Regulation (EU) 2018/1139, the competent authority may define an integrated oversight schedule that includes all the applicable audit items. In order to avoid any duplication of audits, credit may be granted for specific audit items that have already been completed during the current oversight planning cycle, provided that:
(1) the specific audit item is the same for all the certificates under consideration;
(2) there is satisfactory evidence on record that those specific audit items were carried out, and that all the related corrective actions have been implemented to the satisfaction of the competent authority;
(3) the competent authority is satisfied that there is no evidence that standards have deteriorated regarding those specific audit items for which credit is granted.
AMC2 145.B.305(c) details oversight planning cycles, audit frequency, multi-site considerations, and conditions for granting audit credit for organisations with multiple certificates.
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