- Corporate & Qualification Verification
Business license, medical device manufacturing license, confirm whether the manufacturing scope covers the IVD product.
ISO 13485 certificate: issuing body, validity period, certification scope; verify authenticity, whether it covers reagents / instruments.
Trademarks & intellectual property: trademark status in target sales countries, any patent infringement disputes.
Company history: records of regulatory penalties, product recalls, quality complaints, litigations, major equity changes.
- On-site Production & Hardware Inspection
Clean workshop: cleanliness class (Class 10,000 / Class 100,000), zoning (raw material, formulation, filling, packaging, QC), separation of personnel flow and material flow.
Warehouse: raw material warehouse, semi-finished goods warehouse, finished goods warehouse; temperature-controlled cold storage for reagents, moisture-proof control, temperature & humidity monitoring, inbound/outbound logs.
Production equipment: equipment list, calibration records, maintenance plan; whether backup units are available for critical equipment.
QC laboratory: testing instruments, calibrators & controls, instrument calibration certificates.
- Quality System Documentation (Core of ISO 13485)
Quality manual, procedure documents, SOPs (production, inspection, deviation, change, CAPA).
Batch records: Batch Production Record (BPR), Batch Quality Record (BQR), traceability.
Change control: evaluation process for raw material changes, process changes and packaging changes.
