Regulation (EU) 2019/1383
(a) The competent authority shall establish a system of record-keeping that allows adequate storage, accessibility, and reliable traceability of:
(1) the management system’s documented policies and procedures;
(2) training, qualification, and authorisation of its personnel;
(3) the allocation of tasks, covering the elements required by point CAMO.B.205, as well as the details of tasks allocated;
(4) certification processes and continuing oversight of certified organisations, including:
(i) the application for an organisation certificate;
(ii) the competent authority’s continuing oversight programme, including all assessment, audit and inspection records;
(iii) the organisation certificate, including any changes thereto;
(iv) a copy of the oversight programme listing the dates when audits are due and when audits were carried out;
(v) copies of all formal correspondence;
(vi) details of findings, corrective actions, date of action closure, any exemption and enforcement actions;
(vii) any assessment, audit and inspection reports issued by another competent authority pursuant to point (d) of point CAMO.B.300;
(viii) copies of all organisation CAMEs or manuals and amendments thereto;
(ix) copies of any other document approved by the competent authority;
(5) the evaluation and notification to the Agency of alternative means of compliance proposed by organisations, and the assessment of alternative means of compliance used by the competent authority itself;
(6) safety information and follow-up measures in accordance with point CAMO.B.125;
(7) the use of flexibility provisions in accordance with Regulation (EU) 2018/1139 and its delegated and implementing acts.
(b) The competent authority shall maintain a list of all organisation certificates it issued.
(c) All records referred to in points (a) and (b) shall be kept for a minimum period of 5 years subject to applicable data protection law.
(d) All records referred to in points (a) and (b) shall be made available upon request to a competent authority of another Member State or the Agency.
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