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ASIANOPS
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Supplier audit services

Comprehensive on-site verification of supplier quality systems, by cross-functional teams in China and Southeast Asia.

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Two auditors with clipboards reviewing an automated production cell
AsianOPS On-site expertise / Asia
Standards
ISO 13485, QMSR, IATF 16949, GMP
Pre-audit planning
1–2 weeks
On-site audit
2–3 days
Report preparation
1 week

What we audit

Suppliers following their own quality systems

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 and change management
  • Process controls and validation
  • Equipment maintenance and calibration
  • Material controls and traceability
  • Warehouse and inventory management
  • Nonconforming product controls
  • Corrective and 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 and receiving, and lot traceability systems.

Validation & risk management

Process validation protocols, equipment qualification (IQ/OQ/PQ), cleaning validation, and risk management systems.

How it works

Our audit process

  1. Step 1

    Planning

    Define scope, review supplier documentation, and prepare the audit plan.

  2. Step 2

    On-site audit

    A cross-functional team conducts comprehensive quality system and operational verification.

  3. Step 3

    Reporting

    Detailed findings, risk assessment, and improvement recommendations.

  4. Step 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: a high-level overview for management.
  • Risk assessment: prioritized findings with risk levels.
  • Photo documentation: visual evidence of observations.
  • Corrective action plan template: a framework for the supplier's 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 and 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.

Industries & regulatory focus

Industries we serve

  • Medical devices

    Supplier audits against ISO 13485:2016 and applicable QMSR requirements for medical device manufacturers. Class I, II, and III device suppliers.

    Experience IRRAS (Class III), Tria Beauty (Class II handheld laser)

  • Pharmaceutical & biotech

    Supplier audits against applicable GMP requirements for pharmaceutical and biotechnology components and packaging. FDA and EU regulatory experience. Pharmaceutical-class goods export compliance.

  • Consumer electronics & IoT

    PCBA assembly, WiFi-enabled devices, set-top boxes, power supplies.

    Experience Trend Micro (cybersecurity devices), Flight Display Systems (complex PCBA), Daily Mail (AC/DC power supplies)

  • Building products & industrial

    Electromechanical systems, BLDC motors, fluid management systems, plumbing components.

    Experience Fluidmaster (2-year joint development, electromechanical toilet systems)

  • Aerospace & defense

    Complex PCBA with end-of-life components, precision CNC machining, flight display systems. Expertise in strategic sourcing for specialized aerospace components.

  • Regulated consumer products

    FDA-regulated vaping and e-cigarette products. Battery safety, PCBA quality, and regulatory compliance.

    Experience American Vapor, Vape World, Firefly (high-end vaporizers)

Request an audit quote

Contact us to discuss your supplier audit requirements.

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