SUPPLIER AUDIT SERVICES
Comprehensive on-site verification of supplier quality systems
WHAT WE AUDIT
We verify that your suppliers follow their own quality management systems and meet regulatory requirements for medical device and pharmaceutical production.
Our audit process covers:
- Quality Management Systems (QMS)
- Document and Record Controls
- Design Controls & Change Management
- Process Controls & Validation
- Equipment Maintenance & Calibration
- Material Controls & Traceability
- Warehouse & Inventory Management
- Nonconforming Product Controls
- Corrective & Preventive Actions (CAPA)
- Internal Audit Programs
CROSS-FUNCTIONAL QUALITY EXPERTS
Comprehensive coverage across all critical functional areas
ENGINEERING & TECHNICAL
Reviews technical processes, equipment, tooling, design controls, validation protocols, and product quality.
QUALITY SYSTEMS & REGULATORY
QMS assessment, document controls, CAPA systems, training records, and regulatory compliance verification.
MATERIAL CONTROLS & TRACEABILITY
Inventory controls, material handling, storage conditions, shipping/receiving, and lot traceability systems.
VALIDATION & RISK MANAGEMENT
Process validation protocols, equipment qualification (IQ/OQ/PQ), cleaning validation, and risk management systems.
INDUSTRIES & REGULATORY FOCUS
Medical Devices
- ISO 13485:2016 compliance verification
- FDA 21 CFR Part 820 (Quality System Regulation)
- Class I, II, and III device suppliers
- Molding, tooling, assembly operations
- Component and sub-assembly suppliers
Pharmaceutical & Biotech
- GMP (Good Manufacturing Practice) compliance
- FDA and EU regulatory standards
- Component and packaging suppliers
- API (Active Pharmaceutical Ingredient) manufacturers
- Biotech equipment and consumables
OUR AUDIT PROCESS
1
PLANNING
Define scope, review supplier documentation, prepare audit plan
2
ON-SITE AUDIT
Cross-functional team conducts comprehensive quality system and operational verification
3
REPORTING
Detailed findings, risk assessment, and improvement recommendations
4
FOLLOW-UP
Corrective action verification and ongoing monitoring support
AUDIT DELIVERABLES
Each audit includes:
- Comprehensive Audit Report - Detailed findings organized by functional area
- Executive Summary - High-level overview for management
- Risk Assessment - Prioritized findings with risk levels
- Photo Documentation - Visual evidence of observations
- Corrective Action Plan Template - Framework for supplier response
- Follow-up Recommendations - Ongoing monitoring suggestions
TYPICAL TIMELINE
| Pre-audit Planning | 1-2 weeks |
| On-site Audit | 2-3 days |
| Report Preparation | 1 week |
| Report Delivery | Final audit report with photos and recommendations |
SUPPLIER TYPES WE AUDIT
Comprehensive audit coverage across your Asia supply chain
MOLDING & TOOLING
Injection molding, compression molding, blow molding, tooling shops, and precision machining centers
ELECTRONICS & PCBA
PCB assembly, cable/wire harness manufacturers, sensors, displays, and embedded electronics for smart medical devices
STERILIZATION SERVICES
Contract sterilizers (ETO, gamma, e-beam) requiring ISO 11135 compliance and validation protocols
ASSEMBLY & INTEGRATION
Sub-assembly operations, final device assembly, cleanroom assembly, integration and functional testing facilities
METAL FABRICATION
CNC machining, stamping, die casting, investment casting, wire forming, and surface treatments (anodizing, plating, passivation)
PACKAGING & MATERIALS
Sterile packaging converters (Tyvek/foil), medical-grade pouches, trays, labels, glass vials, and pharmaceutical containers
SILICONE & RUBBER
Medical-grade silicone molding, extrusion (tubing, catheters), O-rings, seals, gaskets, and elastomeric components
TESTING & CALIBRATION
Third-party testing laboratories, calibration services, biocompatibility testing, and validation support facilities
REQUEST AN AUDIT QUOTE
Contact us to discuss your supplier audit requirements