ISO 20387 ASSESSMENT WORKSHEET Self-assessment 4 GENERAL REQUIREMENTS

(outcome of discussions with staff observations; procedures & documentation reviewed) 6.2.1.5 Biobank shall ensure heath and safety requirements are meet level of safety training shall be determined from a risk assessment of the biological and chemical material, processes and equipment 6.2.2 Competence and Competence assessment 6.2.2.1 Biobank Shall define and document required competence fo. [...] (outcome of discussions with staff observations; procedures & documentation reviewed) 7.4.1 Biobank shall establish, document and implement procedures for shipping and receiving biological material Including conditions for the maintenance of biological material integrity 7.4.2 Biobank shall maintain chain of custody for all biological material from point of dispatch to point of receipt When shippi. [...] (outcome of discussions with staff observations; procedures & documentation reviewed) - Including for inquiries regarding biological material distribution and complaints 7.5.3 Biobank shall establish, document and implement a procedure for the disposal and transfer of biological material and / or data due to a planned event or as a results of an emergency 7.6 Preparation and preservation of biol. [...] (outcome of discussions with staff observations; procedures & documentation reviewed) 8.1.1 General 8.1.1 Management system supports and demonstrates the consistent achievement of the requirements of the Standard assures the quality of the biobank results allows the requirements of clauses 4 to 7 to be met is in accordance with either Option A or Option B AP5-0-5-1 / Issue 1 / December 202. [...] (outcome of discussions with staff observations; procedures & documentation reviewed) 8.9.3 Records of outputs include all decisions and actions relating to a) effectiveness of the management system b) improvement of activities relating to satisfying the requirements of the Standard c) provision of required biological material and associated data d) any need for change(s) AP5-0-5-1 / Issue 1 / D.