欧洲质量04001.pdf

Pacific Regulatory Support Document No.: 04-001 Revision No.: 1 Page: 1 of 8 Standard Operating Procedure Customer Complaints Approved by: Effective Date: mm/dd/yy 1. PURPOSE 1.1 This procedure describes the system to be used for the reporting, receiving and investigation of customer complaints. 2. SCOPE 2.1 This procedure applies to all manufactured products distributed by the company that receive a complaint. 3. POLICY 3.1 All complaints must be investigated and reported promptly and in accordance with regulatory requirements. 4. REFERENCES 4.1 21 CFR 211.198, 820.198 4.2 Pacific Regulatory Support Document No. 04-003, “Material Review Board” 4.3 Pacific Regulatory Support Document No. 04-007, “Medical Device Reporting” 4.4 Pacific Regulatory Support Document No. 04-008, “Adverse Event Reporting” 4.5 Pacific Regulatory Support Document No., 05-009, “Returned Goods” 5. DOCUMENTATION REQUIREMENTS 5.1 Customer Complaint Report - Attachment 1 5.2 Customer Complaint Report Log - Attachment 2 6. MATERIALS AND EQUIPMENT 6.1 None 7. HEALTH AND SAFETY CONSIDERATIONS 7.1 Use safety considerations described in part specific documentation when handling returned product. 8. RESPONSIBILITIES 8.1 The Quality Assurance Manager, or designee, is responsible for maintaining the customer complaint reporting system. 8.2 Customer Service Representatives are responsible for interfacing with customers and submitting