{"text_format":"1","workbook":"xlsx","n_sheets":10,"sheets":["0 | Cover","1 |IGeneral information","2 | Scope of accreditation","3 | Resources - Personnel","4 | Resources - Dedicated areas","5 | Resour - Equipment","6 | External activity provider","7 | Management system documenta","8 | Annexes","_config"],"not_rendered":{"charts":0,"images":1,"macros":1,"external_links":0,"defined_names":122,"comments":0,"pivot_tables":0},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900"}

{"sheet":"0 | Cover","index":0,"n_rows":22,"n_cols":14,"rows_kept":22,"cut":false,"hidden":false,"merged":[[21,1,28,11],[0,0,0,3],[2,3,2,4],[2,6,2,11],[3,3,3,4],[3,6,3,11],[4,3,4,11],[5,3,5,11],[6,3,6,11],[8,1,8,11],[10,1,17,11],[19,1,19,11]]}
["Calibration Laboratories Department"]
[]
[null,"Titolo / Title",null,"Domanda di accreditamento per Biobanche (BBK)",null,null,"in conformità alla norma UNI CEI EN ISO 20387:2024"]
[null,null,null,"Application for Accreditation of Biobanks (BBK)",null,null,"in accordance to the standard ISO 20387:2018"]
[null,"Sigla / Reference",null,"DA-12",null,null,null,null,null,null,null,null,null,{"$f":"CONCATENATE(D5,\" rev. \",D6)","v":"DA-12 rev. 01-00"}]
[null,"Revisione / Revision",null,"01-00"]
[null,"Entrata in vigore / Application date",null,"03-02-2025"]
[]
[null,"Revision notes"]
[]
[null,"The overall structure of the DA-12 application document (now in rev. 01) has not been changed; however, the following modifications have been made:\n- Addition of this section (Cover) containing information related to the current revision of DA-12;\n- Graphic revision following the entry into force of the new Accredia corporate identity;\n- Sec. 1: update of the possible application types;\n- Sec. 2: deletion of the 'Disposal' activity from the possible activities subject to accreditation;\n- Sec. 6: removal of the item 'Disposal' from the list of possible activities of the external provider;\n- Sec. 7: removal of the 'Requirement' field;\n- Sec. 8: update of the possible application cases and their related attachments\n\nAnnex 1 'Areas – Sectors (biobanking)' (issued in rev. 00) has not been updated.\n"]
[]
[]
[]
[]
[]
[]
[]
[]
[null,"Notes for completion"]
[]
[null,"Make sure to review the informational notes included in the different sections of the document."]

{"sheet":"1 |IGeneral information","index":1,"n_rows":58,"n_cols":12,"rows_kept":58,"cut":false,"hidden":false,"merged":[[0,0,0,3],[3,1,3,11],[5,1,7,1],[5,3,7,4],[5,6,5,7],[5,8,5,9],[7,6,7,11],[21,3,21,4],[21,6,21,11],[23,3,23,11],[26,1,33,1],[8,3,8,4],[8,6,8,11],[10,1,18,1],[10,3,10,4],[10,8,10,11],[12,3,12,4],[12,8,12,11],[16,3,16,4],[16,6,19,11],[18,3,18,4],[47,1,47,10],[49,1,49,10],[51,6,51,10],[53,6,53,10],[14,3,14,4],[14,8,14,11],[26,3,26,10],[27,3,27,10],[28,3,28,10],[29,3,29,10],[39,3,39,9],[40,3,40,9],[42,3,42,9],[43,3,43,9],[44,3,44,9],[46,1,46,10],[41,3,41,9],[30,3,30,10],[32,3,32,10],[33,3,33,10],[25,3,25,11],[35,1,35,11],[36,7,36,11],[37,3,37,9],[38,3,38,9]]}
["Calibration Laboratories Department"]
[{"$f":"REV_DA","v":"DA-12 rev. 01-00"}]
[]
["1","General"]
[]
[null,"Name of the CAB (as required in DA-00 §2.1.2)",null,null,null,null,"BBK",null,"Number (if available)"]
[]
[]
[null,"Website",null,"www.",null,null,"[Type 'x' in the box on the left, then enter the accreditation references on the right.]"]
[]
[null,"Indicate any additional accreditations and/or certifications of the CAB.",null,"Reference material producer (ISO 17034)"]
[]
[null,null,null,"Testing laboratory (ISO/IEC 17025)"]
[]
[null,null,null,"Medical laboratory (ISO 15189)"]
[]
[null,null,null,"Other accreditations/certifications [Please specify alongside]"]
[]
[]
[]
[]
[null,"Application for",null,"ACCREDITATION"]
[]
[null,"Where necessary, provide information useful to understand the subject/objective of the application submitted"]
[]
[null,null,null,"Indicate the address of the location where biobanking is performed (city, street, and street number)\n(For precise identification of the premises and areas used at each indicated location, refer to Section 4)\n[A unique code is automatically assigned to each location in the \"ID\" column]"]
[null,"For the performance of biobanking at:",null,"Address",null,null,null,null,null,null,null,"ID"]
[null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(D28=\"\",\"\",\"A\")","v":""}]
[null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(D29=\"\",\"\",\"B\")","v":""}]
[null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(D30=\"\",\"\",\"C\")","v":""}]
[null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(D31=\"\",\"\",\"D\")","v":""}]
[null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(D32=\"\",\"\",\"E\")","v":""}]
[null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(D33=\"\",\"\",\"F\")","v":""}]
[null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(D34=\"\",\"\",\"G\")","v":""}]
[]
[null,"List of sections included in this DA-12:"]
[null,null,null,null,null,null,null,"[Type 'x' to indicate that the section has been completed."]
[null,"Sec. 1",null,"General Information (this section)"]
[null,"Sec. 2",null,{"$f":"'2 | Scope of accreditation'!B4","v":"Accreditation scope"}]
[null,"Sec. 3",null,{"$f":"'3 | Resources - Personnel'!B4","v":"Resources | Personnel"}]
[null,"Sec. 4",null,{"$f":"'4 | Resources - Dedicated areas'!B4","v":"Resources | Facilities / dedicated areas"}]
[null,"Sec. 5",null,{"$f":"'5 | Resour - Equipment'!B4","v":"Resources | Equipment"}]
[null,"Sec. 6",null,{"$f":"'6 | External activity provider'!B4","v":"External activity providers"}]
[null,"Sec. 7",null,{"$f":"'7 | Management system documenta'!B4","v":"Management system documentation"}]
[null,"Sec. 8",null,{"$f":"'8 | Annexes'!B4","v":"Annexes to be submitted with this application"}]
[]
[null,"Provide a reason if one or more sections have not been completed:"]
[]
[]
[null,"I declare that this DA-12 application, a specific annex to the Accreditation Application DA-00, is complete in all required sections, except for the reasons previously stated."]
[]
[null,"Date of last completion"]
[]
[null,"Version of this application"]
[]
[null,"Laboratory stamp, name and signature of the Legal Representative (1)"]
[]
[null,"(1)",null,"Legal Representative or their delegate."]

{"sheet":"2 | Scope of accreditation","index":2,"n_rows":77,"n_cols":13,"rows_kept":77,"cut":false,"hidden":false,"merged":[[15,3,15,5],[5,1,5,7],[0,0,0,1],[3,1,3,10],[1,0,1,1],[9,1,9,5],[11,1,11,5],[10,1,10,5],[13,1,13,5],[12,1,12,4],[12,5,12,6],[6,1,6,4]]}
["Calibration Laboratories Department"]
[{"$f":"REV_DA","v":"DA-12 rev. 01-00"}]
[]
["2","Accreditation scope"]
[]
["Purpose:","Indicate the areas and sectors (see Annex 1 to this DA-12), the biological material, the associated data, and the activities for which the Biobank is requesting accreditation."]
[null,"When filling out this section, please strictly follow the instructions provided in the notes below."]
[]
["Notes:"]
["(1)","Indicate any changes compared to the current accreditation table (in the case of a Renewal or Extension/Reduction application). [Type 'x' to select]"]
["(2)","Leave the field blank in the case of a new sector, i.e., a sector not yet included in Annex 1 for the specific area of interest."]
["(3)","Indicate the biobanking activities performed on the specific biological material, with reference to those set out in point 3.6 of ISO 20387:2024."]
["(4)","Indicate the procedure(s) related to the specific object of accreditation, using the corresponding ID from the list of procedures (Section 7).",null,null,null,"Go to the documentation list >>>"]
["i","When filling in these fields, refer to the examples provided as comments for each individual field/column."]
[]
[null,null,null,"Composition of the biological material i"]
["Variation\n(1)","Area","Sector\n(2)","Type","Additional specification (optional)","Origin (host) / Collection","Associated data i","Activity i\n(3)","Procedure / SOP\n(4)","Location / Site i","Notes"]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"VLOOKUP(B18,_AREECOD,2,FALSE)","v":{"$error":"#N/A"}}]
[null,null,null,null,null,null,null,null,null,"",null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"VLOOKUP(B50,_AREECOD,2,FALSE)","v":{"$error":"#N/A"}}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]
[null,null,null,null,null,null,null,null,null,null,null,null,{"$error":"#N/A"}]

{"sheet":"3 | Resources - Personnel","index":3,"n_rows":31,"n_cols":6,"rows_kept":31,"cut":false,"hidden":false,"merged":[[13,1,13,5],[0,0,0,1],[3,1,3,5],[5,1,5,5],[8,1,8,5],[12,1,12,5],[9,1,9,5],[10,1,10,5],[11,1,11,5],[1,0,1,1]]}
["Calibration Laboratories Department"]
[{"$f":"REV_DA","v":"DA-12 rev. 01-00"}]
[]
["3","Resources | Personnel"]
[]
["Purpose:","Provide information regarding the Biobank personnel, in terms of assigned responsibilities (role/function) and competence."]
[]
["Notes:"]
["(1)","Indicate the assigned role and/or function, with reference to the organizational chart of the Biobank structure (see A.1 in the Annexes section) and to the various roles/functions for which the Biobank has identified and documented the necessary competence requirements."]
[null,"Please note the provisions of points 5.8 and 5.9 of ISO 20387:2024 e di RT-38."]
["(2)","Select in the case of Biobank personnel with a permanent employment contract ('permanent staff').  [Type \"x\" to select]"]
[null,"Personnel who, although working within the Biobank, have a fixed-term relationship with the Biobank—such as (non-exhaustive list) fixed-term contracts, research fellowships, or doctoral scholarships—cannot be considered \"permanent staff.\""]
["(3)","Select in the case of personnel external to the Biobank, i.e., contracted to perform the assigned functions.  [Type \"x\" to select]"]
["(4)","Indicate the specific areas of expertise within the Biobank’s activities, or specify 'Management System'."]
[]
["ID","Full name","Role / Function \n(1)","Permanent (2)","External\n(3)","Areas of expertise (4)"]
[1]
[2]
[3]
[4]
[5]
[6]
[7]
[8]
[9]
[10]
[11]
[12]
[13]
[14]
[15]

{"sheet":"4 | Resources - Dedicated areas","index":4,"n_rows":31,"n_cols":14,"rows_kept":31,"cut":false,"hidden":false,"merged":[[10,1,10,5],[5,1,5,7],[0,0,0,1],[1,0,1,1],[12,1,12,5],[3,1,3,10],[11,1,11,5],[8,1,8,5],[9,1,9,5],[19,7,19,10],[17,6,17,8],[13,6,13,8],[16,6,16,8],[13,1,13,5],[14,1,14,5],[15,1,15,5],[16,1,16,5],[17,1,17,5]]}
["Calibration Laboratories Department"]
[{"$f":"REV_DA","v":"DA-12 rev. 01-00"}]
[]
["4","Resources | Facilities / dedicated areas"]
[]
["Purpose:","Provide the complete list of dedicated facilities/areas where the Biobank carries out its biobanking activities subject to accreditation, including those that may not be owned by the Biobank itself."]
[]
["Notes:"]
["(1)","Indicate the location where biobanking is carried out, using the corresponding ID from the list in Section 1. [The possible entries are shown in the drop-down list within the cell.]. Then, in the next column, enter the identification code (where applicable, otherwise use a sequential number) of the specific room/area within the indicated location.\nIf biobanking activities take place in multiple rooms/areas, fill in multiple rows (one for each room/area). "]
["(2)","Provide all details necessary to precisely identify and locate the room/area within the specified facility."]
["(3)","Select if the room is not owned by the Biobank [Type 'x' to select]."]
["(4)","Select if the area is for the exclusive use of the Biobank, regardless of ownership. [Type 'x' to select]."]
["(5)","Indicate the biobanking activities carried out in the specific area."]
["(6)","Where applicable, indicate the procedure that regulates access to the specific area. [Use the corresponding ID from the document list (Section 7)]",null,null,null,null,"Go to the documentation list >>>"]
["(7)","Please select if the environmental conditions in the room are considered critical. [Type 'x' to select]"]
["(8)","Report the environmental parameters (e.g., temperature, humidity) subject to measurement and monitoring."]
["(9)","Indicate the instruments used for measurement and monitoring.  [Use the corresponding ID from the equipment list (sec. 5)]",null,null,null,null,"Go to the equipment list >>>"]
["(10)","Indicate the procedure(s) related to environmental conditions. [Use the corresponding ID from the document list (sec. 7)]",null,null,null,null,"Go to the documentation list >>>"]
[]
[null,null,null,null,null,null,"Access","Environmental conditions"]
["ID\n(1)","Room identification code","Location\n(Building, floor, ...)\n(2)","Not owned\n(3)","Exclusive use\n(4)","Activity performed\n(5)","Procedure\n(6)","Critical\n(7)","Parameters subject to monitoring\n(8)","Instrumentation\n(9)","Procedure/s\n(10)"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(A22=\"\",\"\",CONCATENATE(A22,\".\",B22))","v":""}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(A23=\"\",\"\",CONCATENATE(A23,\".\",B23))","v":""}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,""]
[null,null,null,null,null,null,null,null,null,null,null,null,null,""]
[null,null,null,null,null,null,null,null,null,null,null,null,null,""]
[null,null,null,null,null,null,null,null,null,null,null,null,null,""]
[null,null,null,null,null,null,null,null,null,null,null,null,null,""]
[null,null,null,null,null,null,null,null,null,null,null,null,null,""]
[null,null,null,null,null,null,null,null,null,null,null,null,null,""]
[null,null,null,null,null,null,null,null,null,null,null,null,null,""]

{"sheet":"5 | Resour - Equipment","index":5,"n_rows":59,"n_cols":14,"rows_kept":59,"cut":false,"hidden":false,"merged":[[16,11,16,13],[14,9,14,10],[10,1,10,8],[9,1,9,8],[13,1,13,8],[11,1,11,8],[12,1,12,8],[1,0,1,1],[3,1,3,13],[5,1,5,8],[8,1,8,8],[14,1,14,8]]}
["Calibration Laboratories Department"]
[{"$f":"REV_DA","v":"DA-12 rev. 01-00"}]
[]
["5","Resources | Equipment"]
[]
["Purpose:","Report the complete list of equipment (e.g., samples, instruments, reference materials, software, ...) used by the Biobank for its biobanking activities subject to accreditation, including any that may not be owned by the Biobank."]
[]
["Notes:"]
["(1)","Sequential number"]
["(2)","Please select if the equipment is considered critical, meaning it has the potential to affect the quality of the biological material and associated data."]
[null,"Refer to the classification required in point 6.5.4 of ISO 20387:2024."]
["(3)","Select if the equipment is not owned by the Biobank. [Type \"x\" to select]"]
["(4)","Select if the equipment is for the exclusive use of the Biobank, regardless of ownership.[Type \"x\" to select]."]
["(5)","Indicate the procedure(s) in which the equipment is used (Use) and those that define the management activities for the equipment (Management)."]
[null,"[Use the corresponding ID from the list of management system documents (section 7).]",null,null,null,null,null,null,null,"Go to the documentation list >>>"]
[]
[null,null,null,null,null,null,null,null,null,"Use","Management","Calibration (where applicable)"]
["ID\n(1)","Critical\n(2)","Not owned\n(3)","Exclusive use\n(4)","Description","Manufacturer / Producer","Data di costruzione\n(anno)","Model / type","Serial number","Procedure\n(5)","Procedure\n(5)","Frequency\n(months)","External provider","Number / date of the last Calibration Certificate"]
[1]
[{"$f":"IF(B20=\"\",\"\",IF(A19=\"\",\"\",(A19+1)))","v":""}]
[{"$f":"IF(B21=\"\",\"\",IF(A20=\"\",\"\",(A20+1)))","v":""}]
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{"sheet":"6 | External activity provider","index":6,"n_rows":45,"n_cols":7,"rows_kept":45,"cut":false,"hidden":false,"merged":[[13,6,20,6],[13,3,20,3],[29,0,36,0],[29,1,36,1],[29,2,36,2],[29,3,36,3],[29,6,36,6],[21,6,28,6],[10,1,10,6],[0,0,0,1],[3,1,3,3],[9,1,9,6],[5,1,5,6],[8,1,8,6],[1,0,1,1],[12,4,12,5],[21,0,28,0],[21,1,28,1],[21,2,28,2],[21,3,28,3],[13,1,20,1],[13,2,20,2],[13,0,20,0],[37,0,44,0],[37,1,44,1],[37,2,44,2],[37,3,44,3],[37,6,44,6]]}
["Calibration Laboratories Department"]
[{"$f":"REV_DA","v":"DA-12 rev. 01-00"}]
[]
["6","External activity providers"]
[]
["Purpose:","Provide information regarding any external activity providers. These are competent bodies to which the Biobank entrusts a portion of its biobanking activities."]
[]
["Notes:"]
["(1)","Report the references for any relevant accreditations of the provider (e.g., testing laboratory, reference material producer, calibration laboratory, biobank).\nLeave this blank if the provider does not have any accreditation."]
["(2)","Select the activities entrusted to the provider, with reference to those specified in point 3.6 of ISO 20387:2024. [Type \"x\" next to the activity to be selected]"]
["(3)","Include any other information you consider useful to better describe the existing relationship with the provider."]
[]
["ID","Company name","Address","Any accreditations\n(1)","Activities entrusted to the provider\n (2)",null,"Any additional information\n (3)"]
["FE1",null,null,null,"Collection"]
[null,null,null,null,"Acquisition"]
[null,null,null,null,"Preparation"]
[null,null,null,null,"Preservation"]
[null,null,null,null,"Storage"]
[null,null,null,null,"Testing"]
[null,null,null,null,"Analysis"]
[null,null,null,null,"Distribution"]
["FE2",null,null,null,"Collection"]
[null,null,null,null,"Acquisition"]
[null,null,null,null,"Preparation"]
[null,null,null,null,"Preservation"]
[null,null,null,null,"Storage"]
[null,null,null,null,"Testing"]
[null,null,null,null,"Analysis"]
[null,null,null,null,"Distribution"]
["FE3",null,null,null,"Collection"]
[null,null,null,null,"Acquisition"]
[null,null,null,null,"Preparation"]
[null,null,null,null,"Preservation"]
[null,null,null,null,"Storage"]
[null,null,null,null,"Testing"]
[null,null,null,null,"Analysis"]
[null,null,null,null,"Distribution"]
["FE4",null,null,null,"Collection"]
[null,null,null,null,"Acquisition"]
[null,null,null,null,"Preparation"]
[null,null,null,null,"Preservation"]
[null,null,null,null,"Storage"]
[null,null,null,null,"Testing"]
[null,null,null,null,"Analysis"]
[null,null,null,null,"Distribution"]

{"sheet":"7 | Management system documenta","index":7,"n_rows":15,"n_cols":6,"rows_kept":15,"cut":false,"hidden":false,"merged":[[57,2,57,3],[58,2,58,3],[59,2,59,3],[12,3,12,5],[52,2,52,3],[53,2,53,3],[54,2,54,3],[55,2,55,3],[56,2,56,3],[47,2,47,3],[48,2,48,3],[49,2,49,3],[50,2,50,3],[51,2,51,3],[42,2,42,3],[43,2,43,3],[44,2,44,3],[45,2,45,3],[46,2,46,3],[37,2,37,3],[38,2,38,3],[39,2,39,3],[40,2,40,3],[41,2,41,3],[32,2,32,3],[33,2,33,3],[34,2,34,3],[35,2,35,3],[36,2,36,3],[27,2,27,3],[28,2,28,3],[29,2,29,3],[30,2,30,3],[31,2,31,3],[22,2,22,3],[23,2,23,3],[24,2,24,3],[25,2,25,3],[26,2,26,3],[17,2,17,3],[18,2,18,3],[19,2,19,3],[20,2,20,3],[21,2,21,3],[1,0,1,1],[0,0,0,1],[14,2,14,3],[15,2,15,3],[16,2,16,3],[10,1,10,3],[12,0,12,1],[3,1,3,4],[5,1,5,4],[8,1,8,3],[8,4,8,5]]}
["Calibration Laboratories Department"]
[{"$f":"REV_DA","v":"DA-12 rev. 01-00"}]
[]
["7","Management system documentation"]
[]
["Purpose:","Identify the documentation of the management system implemented by the Biobank, specifically the current revision of documented procedures and documents, and report any changes compared to previous versions (already positively evaluated by ACCREDIA DT)."]
[]
["Notes:"]
["(1)","Progressive number, to be used in the description of the scope of accreditation (section 2).",null,null,"Go to accreditation scope >>>"]
[]
["(2)","Select this option in case of any variations from the procedures already positively evaluated by ACCREDIA DT (in the case of an application for Renewal, Extension/Reduction, or Modification of the scope of accreditation). [Type \"x\" to select]"]
[]
["Management system option",null,null,"Indicate the option (A or B) adopted for the management system, with reference to §8.1 of ISO 20387."]
[]
["ID\n(1)","Acronym / identification code","Title",null,"Revision index","Variation\n(2)"]

{"sheet":"8 | Annexes","index":8,"n_rows":20,"n_cols":19,"rows_kept":20,"cut":false,"hidden":false,"merged":[[1,17,2,19],[0,0,0,2],[1,0,1,1],[1,12,2,12],[1,13,2,15],[1,16,2,16],[9,1,9,10],[3,1,3,10],[3,11,5,11],[3,12,5,12],[3,13,5,13],[3,16,5,16],[3,17,5,17],[3,18,5,18],[5,1,5,10],[7,1,7,10],[3,14,5,14],[3,15,5,15],[19,1,19,10],[17,1,17,10],[11,1,11,10],[13,1,13,10],[15,1,15,10]]}
["Calibration Laboratories Department"]
[{"$f":"REV_DA","v":"DA-12 rev. 01-00"},null,null,null,null,null,null,null,null,null,null,null,"X","Mandatory",null,null,"O","Limited to the subject of the application"]
[]
["8","Annexes to be submitted with this application",null,null,null,null,null,null,null,null,null,"Accreditation","Renewal with/without scope modification","Extension","Modification of accreditation scope","Maintenance of the flexible scope","Regulatory adjustment","Reduction","Change of registration details / Transfer of ownership"]
[]
["Note:","Failure to submit all required annexes constitutes sufficient grounds for the rejection of the entire application. "]
[]
["A.1","Named organizational chart of the Biobank structure (including at least all the individuals listed in Section 3).",null,null,null,null,null,null,null,null,null,"X","X","O",null,null,null,"O","O"]
[]
["A.2","Dated and signed professional CVs of all personnel listed in Section 3.",null,null,null,null,null,null,null,null,null,"X","X","O",null,null,null,null,"O"]
[]
["A.3","Biobank Management System documentation, as listed in Section 7.\nEach document – in its latest revision – must be provided in PDF electronic format (under controlled distribution).",null,null,null,null,null,null,null,null,null,"X","X","O","O","X","O","O","X"]
[]
["A.4","Checklist ( (MD-09-12-S-DT) duly completed in 'self-assessment' mode for the Biobank evaluation.",null,null,null,null,null,null,null,null,null,"X","X","X","O",null,null,null,"O"]
[]
["A.5","Minutes of the latest Management Review, in accordance with the requirements of  the standard.",null,null,null,null,null,null,null,null,null,"X",null,null,null,null,null,null,"X"]
[]
["A.6","Company registration extract with current legal validity (6 months) or an equivalent document certifying the legal entity (including public bodies) assuming responsibility for the activities under accreditation and/or applying for accreditation (as required by DA-00 section 2.2.1)",null,null,null,null,null,null,null,null,null,"X","X",null,null,null,null,null,"X"]
[]
["A.7","Assessment of possible effects of the reduction on other accredited fields (see RG-22 6.2.1).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"X"]

{"sheet":"_config","index":9,"n_rows":64,"n_cols":10,"rows_kept":64,"cut":false,"hidden":true,"merged":[]}
["Areas",null,null,"Setctor",null,"Type of procedure (technical/management)",null,"Type of standard/instrument",null,"Application"]
[]
["Uncoded area","NOCOD",null,"[SBK-01] Human biological material",null,"Technical",null,"Reference measurement standard",null,"ACCREDITATION"]
["[BBK] HUMAN BIOBANKING","SBH",null,"[SBK-02] Animal biological material",null,"Management",null,"Working measurement standard",null,"RENEWAL with confirmation of the scope of accreditation"]
["[BBK] ANIMAL BIOBANKING ","SBV",null,"[SBK-03] Plant biological material",null,null,null,"Travelling measurement standard",null,"RENEWAL with request for modification of the scope of accreditation"]
["[BBK] PLANT BIOBANKING","SBG",null,"[SBK-04] Microorganisms",null,null,null,"Transfer measurement device",null,"EXTENSION"]
["[BBK] BIOBANKING OF MICROORGANISMS","SBM",null,"[SBK-05] …",null,null,null,null,null,"MODIFICATION of the scope of accreditation"]
[null,null,null,null,null,"Role",null,"Production activity",null,"REGULATORY ADJUSTMENT"]
[null,null,null,null,null,null,null,null,null,"REDUCTION"]
[null,null,null,null,null,"Laboratory Manager",null,"Material processing",null,"CHANGE OF REGISTRATION DETAILS or TRANSFER OF OWNERSHIP"]
["Sector",null,null,null,null,"Substitute Manager",null,"Handling"]
[null,null,null,null,null,"UOD Manager",null,"Homogeneity assessment"]
["[SBH-01] Genetics",null,null,null,null,"Quality Management System Manager",null,"Stability assessment"]
["[SBH-02] Pathological anatomy",null,null,null,null,"Assistant to Quality Management System Manager",null,"Characterization"]
["[SBV-01] Genetics",null,null,null,null,"Operator",null,"Storage"]
["[SBV-02] Pathological anatomy",null,null,null,null,null,null,"Distribution"]
["[SBG-01] Wild species"]
["[SBG-02] Cultivated species",null,null,"Category",null,"Management"]
["[SBM-01] Bacteria",null,null,"Organism",null,"Technical Management"]
["[SBM-02] Filamentous fungi",null,null,"Organ",null,"UOD/UOT/UOM Manager"]
["[SBM-03] Yeasts",null,null,"Organoid",null,"Quality Management System Manager"]
["[SBM-04] Viruses",null,null,"Tissue",null,"Operator"]
[null,null,null,"Whole blood and/or its derivatives"]
[null,null,null,"Extracts of biological material"]
[null,null,null,"cells"]
[null,null,null,"Biological fluids"]
[null,null,null,"Secretions / excretions"]
[null,null,null,"Modified and/or processed biological material"]
[null,null,null,"Part"]
[null,null,null,"Other"]
[]
[]
[]
[]
[]
[null,null,null,"Specification"]
[null,null,null,"Whole"]
[null,null,null,"Partial"]
[null,null,null,"Cells"]
[null,null,null,"Extracts"]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
["Activity",null,null,"Data"]
["Collection",null,null,"Anthropometric"]
["Acquisition",null,null,"Personal data"]
["Preparation",null,null,"Clinical"]
["Preservation",null,null,"Biochemical"]
["Storage",null,null,"Demographic"]
["Testing",null,null,"Diagnostic"]
["Analysis",null,null,"Phenotypic"]
["Distribution",null,null,"Phylogenetic"]
[null,null,null,"Genetic"]
[null,null,null,"Procedural"]
[null,null,null,"Taxonomic"]
[null,null,null,"Other (specify)"]