| Name | LEGAMI S.R.L |
|---|---|
| Address | Via Stezzano, 18, 24052 Azzano San Paolo (Bergamo), Italy Via Ozanam,2, 24126 (Bergamo) , Italy |
| Contact Person | Natascia Ghilardi |
| natascia.ghilardi@legami.com | |
| Audit Criteria | ISO 9001 |
| Scope | Design, Production Management and Marketing of Stationary Products and Gift Item include (Cosmetics, Perfumes, Soap, Cutlery and Kitchen Utensils, Tableware, Glassware, Home Appliances, Home and office Furniture, Watches, Lighting for house use, Toys, Ready-made garments, towels, wallets, bags, Air fresheners and scents) |
| EA Code | 7,9,14,6,23 |
| Date | From | To | Activity (Department) | Auditor | Auditee |
|---|
| Date | From | To | Activity (Department) | Auditor | Auditee |
|---|---|---|---|---|---|
| 2025-02-12 | 09:00:00 | 09:15:00 | Open meeting | all | management |
| 2025-02-12 | 09:00:00 | 09:30:00 | openning meeting | all | management |
| 2025-02-12 | 09:30:00 | 10:00:00 | top management | all | CEO |
| 2025-02-12 | 10:00:00 | 13:00:00 | QA | A | department |
| 2025-02-12 | 10:00:00 | 13:00:00 | Maintenance | M | department |
| 2025-02-12 | 13:00:00 | 14:00:00 | Break | All | |
| 2025-02-12 | 14:00:00 | 16:00:00 | Sales and marketing | A,M | department |
| 2025-02-12 | 16:00:00 | 16:15:00 | auditors meeting | All | |
| 2025-02-12 | 16:15:00 | 16:45:00 | washup meeting | All | management |
| 2025-02-13 | 09:00:00 | 09:15:00 | Recap | All | department |
| 2025-02-13 | 09:15:00 | 11:15:00 | WH | M | department |
| 2025-02-13 | 09:15:00 | 11:15:00 | design | A | department |
| 2025-02-13 | 11:15:00 | 12:15:00 | Information Technology | A | department |
| 2025-02-13 | 11:15:00 | 12:15:00 | Procurement | M | department |
| 2025-02-13 | 12:15:00 | 13:15:00 | Break | All | |
| 2025-02-13 | 13:15:00 | 15:15:00 | QC | A,M | department |
| 2025-02-13 | 15:15:00 | 15:45:00 | auditors meeting | all | |
| 2025-02-13 | 15:45:00 | 16:12:00 | washup meeting | all | management |
| 2025-02-14 | 09:00:00 | 09:15:00 | Recap | All | department |
| 2025-02-14 | 09:15:00 | 12:15:00 | Production | All | department |
| 2025-02-14 | 12:15:00 | 13:15:00 | Break | All | |
| 2025-02-14 | 13:15:00 | 15:15:00 | HR | A,M | department |
| 2025-02-14 | 15:15:00 | 15:45:00 | auditors meeting | All | |
| 2025-02-14 | 15:45:00 | 16:45:00 | washup meeting | All | management |
| 2025-02-14 | 16:45:00 | 17:15:00 | closing meeting | All | management |
| Date | From | To | Activity (Department) | Auditor | Auditee |
|---|
| Date | From | To | Activity (Department) | Auditor | Auditee |
|---|
| Clause No. | Requirements/Departement | Evidence | Result |
|---|---|---|---|
| 4.3 | Define QMS scope | QMS Scope Document (QMS-SCP-01, rev. 2, 01/07/2025), Board approval minutes (03/07/2025) Scope includes design, production mgmt, marketing of stationary/gift items; legal, statutory, and customer requirements considered. |
OK |
| 5.2 | Establish and communicate policy | Quality Policy posted in HQ, reviewed 02/07/2025 (POL-9001-01), signed by Nicola Lazzari; distributed via email, 03/07/2025 olicy aligns with ISO 9001:2015, Italy labor, environmental and export obligations; staff interviewed aware of policy. |
OK |
| 6.1 | Risks & opportunities management | Risk register (RSK-9001-01, 04/07/2025): supply chain risks, health & safety, regulatory compliance (D.Lgs. 81/08), cost fluctuations Risks assessed for main activities; legal (health/safety, waste, VAT) documented; action plans in register. |
OK |
| 6.2 | Quality objectives | Objectives Matrix (OBJ-9001-01, 04/07/2025): lead time <5 days, <2% NC, 100% legal labeling, 95% on-time exportMeasurable objectives set, monitored in monthly reports (first review due 01/08/2025); covers quality, legal, and export aspects. docs |
OK |
| 7.5 | Documented information | Controlled docs on SharePoint QMS folder (DOC-LIST-9001-01), procedures for order mgmt, design, Italian labeling, waste (05/07/2025) Docs controlled per 7.5; Italian/EU legal forms (waste manifests, DDT, REACH) included; document control log up-to-date. |
OK |
| 9.2 | Internal audit | Internal audit plan (IA-9001-01, 06/07/2025); last audit: 08/07/2025, covering design, production, marketing, legal compliance Sampled audit records show coverage of legal (D.Lgs. 81/08, D.Lgs. 152/06), QMS processes; NCs logged and tracked. |
OK |
| 9.3 | Management review | MR minutes (MR-9001-01, 09/07/2025), attendance: Nicola Lazzari, Natascia Ghilardi, Chiara Villa; agenda: objectives, legal updates, NCs MR covers all QMS elements, inc. new Italian legal (privacy, labor), last quarter’s results, and customer feedback. |
OK |
| Clause No. | Requirements/Departement | Evidence | Result |
|---|---|---|---|
| 4.1 | Understanding the organization and its context | Board meeting minutes Oct 2024, SWOT review Q4 2024 (Nicola Lazzari, Giulia Romano) | OK |
| 4.1 | Understanding the organization and its context | Board meeting minutes Oct 2024, SWOT review Q4 2024 (Nicola Lazzari, Giulia Romano) | OK |
| 4.2 | Understanding needs and expectations of interested parties | Stakeholder analysis Nov 2024, customer survey results Dec 2024 (Giulia Romano) | OK |
| 4.3 | Determining the scope of the QMS | QMS scope document (rev. Dec 2024), no exclusions (Natascia Ghilardi) | OK |
| 4.4 | QMS and its processes | Process map, KPI report Oct–Dec 2024, monthly analysis (Marco Bianchi, Matteo Greco, Paolo Ricci) | OK |
| 5.1 | Leadership and commitment | Top management attendance in opening/closing & MR Jan 2025 (Nicola Lazzari, Natascia Ghilardi) | OK |
| 5.2 | Quality policy | Policy review Dec 2024, environmental commitment visible (Natascia Ghilardi) | OK |
| 5.3 | Organizational roles, responsibilities, authorities | Job descriptions updated Nov 2024 for key roles; sample: Junior Quality Specialist (Federica Moretti), Magazziniere Capo (Matteo Greco) | OK |
| 6.1 | Actions to address risks and opportunities | Risk assessment review Dec 2024, Board approval (Nicola Lazzari, Alessandra Ferri, Serena Rinaldi) | OK |
| 6.2 | Quality objectives and planning to achieve them | Objectives plan 2025, improvement in logistics process (lead time Oct–Dec 2024) (Paolo Ricci, Serena Rinaldi) | OK |
| 6.3 | Planning of changes | Change management register, change review meeting Jan 2025 (Natascia Ghilardi, Marco Bianchi, Chiara Villa) | OK |
| 7.1 | Resources | Resource allocation plan Nov 2024, outsourcing records, warehouse equipment list (Alessandra Ferri, Matteo Greco) Preventive maintenance of production machinery evidenced as follows: • Heidelberg Speedmaster XL 75 Printing Press • Model: XL 75-5+L • Serial No.: HSM75-2021-0084 • Inspection/PM Log Form: FM-MNT-001 • Last Full Preventive Maintenance: 10/12/2024 (mechanical, lubrication, and print quality calibration by Eng. Serena Rinaldi) • Visual Safety Inspection: 20/11/2024 (safety guards, emergency stops) • UV Dryer Check: 10/12/2024 • Polar 92 XT Paper Cutter • Model: 92 XT • Serial No.: POL92-2019-341 • Inspection/PM Log Form: FM-MNT-002 • Blade Change & Alignment: 18/11/2024 (by Matteo Greco) • Hydraulic System Check: 18/11/2024 • Safety Interlock Test: 18/11/2024 • MBO K80 Folding Machine • Model: K80-4/4 • Serial No.: MBO80-2020-112 • Inspection/PM Log Form: FM-MNT-003 • Roller & Belt Cleaning: 05/12/2024 • Electrical Panel Inspection: 05/12/2024 • Noise/Vibration Check: 05/12/2024 • BOBST NOVACUT 106 E Die Cutter • Model: NOVACUT 106 E • Serial No.: BOB106-2022-046 • Inspection/PM Log Form: FM-MNT-004 • Die Alignment & Pressure Test: 12/12/2024 (by Chiara Villa, supervised by Serena Rinaldi) • Oil & Filter Change: 12/12/2024 • Safety Sensor Calibration: 13/12/2024 • Muller Martini Presto II Saddle Stitcher • Model: Presto II • Serial No.: MMPII-2021-077 • Inspection/PM Log Form: FM-MNT-005 • Binding Head Lubrication: 28/11/2024 • Conveyor Belt Check: 28/11/2024 • Emergency Stop Test: 28/11/2024 All maintenance records reviewed and signed off by Serena Rinaldi (Maintenance), with digital copies stored in the QMS system. No overdue items. alibration of key equipment evidenced as follows: • Mettler Toledo Precision Weighing Scale o PN: MT-PL1502E, SN: 21PL1502-0234 o Calibration certificate: CAL-2024-1147 o Last calibration date: 03/11/2024 o Calibrated by: Accredia-accredited lab (CertLab Srl) o Next due date: 03/11/2025 • Mitutoyo Digital Micrometer o PN: MDC-25SX, SN: MTY-0192847 o Calibration certificate: CAL-2024-1102 o Last calibration date: 10/12/2024 o Calibrated by: CertLab Srl o Next due date: 10/12/2025 • X-Rite i1Pro2 Spectrophotometer (for color measurement in print) o PN: XR-i1PRO2, SN: XR-2021-1138 o Calibration certificate: CAL-2024-1192 o Last calibration date: 15/10/2024 o Calibrated by: Colormetrix Srl o Next due date: 15/10/2025 • Mitutoyo Digital Caliper o PN: CD-15APX, SN: MTY-0011275 o Calibration certificate: CAL-2024-1119 o Last calibration date: 19/11/2024 o Calibrated by: CertLab Srl o Next due date: 19/11/2025 All calibration certificates are available and reviewed in the QMS system (folder: /QMS/Calibration/2024), signed and verified by Serena Rinaldi (Responsabile Manutenzione). No overdue calibrations found. |
OK |
| 7.2 | Competence | Training records: Excel training 10/10/2024, 24/11/2024; Job descriptions reviewed Jan 2025 (Federica Moretti, Chiara Villa, Serena Rinaldi) | OK |
| 7.3 | Awareness | Employee interviews and awareness checks Dec 2024 (all departments: incl. warehouse, design, maintenance) | OK |
| 7.4 | Communication | Product catalog Nov 2024, supplier quality report (ACAR Turkey) Dec 2024 (Giulia Romano, Alessandra Ferri) | OK |
| 7.5 | Documented information | Documented procedures/forms updated Dec 2024 (Luca Conti, Natascia Ghilardi) | OK |
| 8.1 | Operational planning and control | Plan order AG2312001, order #24000122 dated 02/12/2024 (Marco Bianchi, Chiara Villa) | OK |
| 8.2 | Determination of requirements for products and services | Customer order #54112, requirements review Dec 2024 (Giulia Romano, Chiara Villa) | OK |
| 8.3 | Design and development of products and services | Design files for 2025 planners (Adobe Illustrator, Photoshop), project records Nov–Dec 2024 (Chiara Villa, Marco Bianchi) | OK |
| 8.4 | Control of externally provided processes, products and services | Outsource evaluation: ACAR Turkey report Dec 2024; Bureau Veritas report #10422531224 (Alessandra Ferri) | OK |
| 8.5 | Production and service provision | Order #24000122 from supplier #72118 for 2025 diaries, production batch record Nov 2024, shipping B/L 2411002EX, 07/12/2024 (Marco Bianchi, Serena Rinaldi, Chiara Villa) | OK |
| 8.6 | Release of products and services | Inspection report Bureau Veritas #10422531224, 07/12/2024; product specs met (Marco Bianchi, Chiara Villa) | OK |
| 8.7 | Control of nonconforming outputs | NC: Defect in “HOT&Cold Avougato” design Dec 2024, authorized for factory outlet sale (Marco Bianchi, Matteo Greco) | OK |
| 9.1 | Monitoring, measurement, analysis and evaluation | KPI dashboard Oct–Dec 2024; customer satisfaction survey Dec 2024; loyalty program data (Giulia Romano, Paolo Ricci, Matteo Greco) | OK |
| 9.2 | Internal audit | IA program and report Jan 2025: sampled purchasing, logistics, design, warehouse, maintenance (Natascia Ghilardi, Alessandra Ferri, Chiara Villa, Serena Rinaldi, Matteo Greco) | OK |
| 9.3 | Management review | MR minutes Jan 2025 (last: 18/01/2025); next planned for 24/02/2025 (Nicola Lazzari, Natascia Ghilardi, Federica Moretti, Chiara Villa, Serena Rinaldi) | OK |
| 10.1 | General improvement | Infrastructure upgrade records Nov 2024; warehouse renovation; design innovation initiative Dec 2024 (Luca Conti, Paolo Ricci, Chiara Villa, Serena Rinaldi) | OK |
| 10.2 | Nonconformity and corrective action | No corrective actions open at audit; process verified in IA Jan 2025 (Natascia Ghilardi, Serena Rinaldi) | OK |
| 10.3 | Continual improvement | Improvement log, policy, objectives, IA Jan 2025, MR Jan 2025 (all departments) | OK |
| Use of logo and trademark | Not used yet | OK |