+Artikolu 11 2.
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Artikolu 11 2.
L-operaturi għandu jkollhom fis-seħħ politiki, kontrolli u proċeduri adegwati u proporzjonati sabiex jimmitigaw u jimmaniġġjaw effettivament ir-riskji tan-nuqqas ta’ konformità tal-prodotti rilevanti identifikati. Dawk il-politiki, il-kontrolli u l-proċeduri għandhom jinkludu:
(a)
mudelli ta’ prattiki għall-ġestjoni tar-riskju, ir-rapportar, iż-żamma tar-rekords, il-kontroll intern u l-ġestjoni tal-konformità, inkluż il-ħatra ta’ uffiċjal tal-konformità fil-livell maniġerjali għal operaturi mhux SME;
(b)
funzjoni ta’ awditjar indipendenti sabiex jiġu vverifikati l-politiki, il-kontrolli u l-proċeduri interni msemmija fil-punt (a) għall-operaturi kollha mhux SME.
1. Ħarsa ġenerali
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Regolamentazzjoni |
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1.1 Referenzi
1.2 Rekwiżiti identifikati
1.3 Standards relatati
2. Rekwiżiti identifikati
3. Standards relatati
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