1. 15.06.2009 G. Dal Maso 1 Complaint Handling

2. 2 Technical Support Production Area Reagents Finished Product Bioreagents Technical Support Moulding

3. 3 Technical Support 1. AREA Production 2. Aim - Customer Support - Customer Support - Communication improvement - Communication improvement - Complaint handling of all the Diesse products - Complaint handling of all the Diesse products - Corrective Action development and management - Corrective Action development and management

4. 4 Complaint : definition A "complaint" is any indication of the failure of a device to meet customer or user expectations for quality or to meet performance specifications. Thus, any written, oral, or returned goods expression of dissatisfaction relative to the identity, quality, durability, reliability, safety, effectiveness, or performance of any device manufactured by this manufacturer would be considered a complaint A "complaint" is any indication of the failure of a device to meet customer or user expectations for quality or to meet performance specifications. Thus, any written, oral, or returned goods expression of dissatisfaction relative to the identity, quality, durability, reliability, safety, effectiveness, or performance of any device manufactured by this manufacturer would be considered a complaint (UNI EN ISO 13485:2004) (UNI EN ISO 13485:2004)

5. 5 Complaint : the process

6. 6 Complaint handling : Involved Departments Production Production R&D R&DQC Technical Assistance Sales Quality and Regulatory Affair

7. 7 Production(investigation,Corrective Action,implementation, verification) Production(investigation,Corrective Action,implementation, verification) R&D (investigation,Corrective Action,implementation, verification) R&D (investigation,Corrective Action,implementation, verification) QC (investigation,Corrective Action,implementation, verification) QC (investigation,Corrective Action,implementation, verification) Technical Assistance (Investigation,Corrective Action,implementation, verification) Technical Assistance (Investigation,Corrective Action,implementation, verification) Sales (information,replacement) Sales (information,replacement) Quality and Regulatory Affair (ISO compliance and incident report) Quality and Regulatory Affair (ISO compliance and incident report) Complaint handling : Involved Departments and Actions

8. 8 Complaint Handling : The Software

9. 9 Complaint handling timelines 1 day – (customer contact) 0-3 months – (clear cases) 3- 6 months –(complex cases) > 6 months– (complex cases - monitoring, efficacy of undertaken actions)

10. 10 Complaint Handling The review Every 3 months a complaint review Is perfomed. Is perfomed. The final report is discussed with: The final report is discussed with: production department production department R&D R&D The final report is distributed to all the involved area The final report is distributed to all the involved area

11. 11 Technical Support: what has been changed? Responsibilities: marketing –sales areaproduction area marketing –sales areaproduction area Handling process Handling process

12. 12 Technical Support: what has been changed Staff Staff 1 person 3 persons Environment Environment Office Laboratory Actions Actions Registration Case resolution