Aesthetic Device Factory Audits: From the Gate to Final Inspection

One-Day Audit Route

Opening (30 min): history, organization, capacity, customer mix — gauge compliance sensitivity.
Documents (1 h): ISO 13485 certificate, design-history samples, CAPA records, supplier evaluations.
Production line (2 h): pick one unit’s serial and walk the full chain — incoming inspection → assembly instructions → process validation → final calibration.
Key processes (1 h): laser/RF assembly (cleanliness, ESD), burn-in room records.
Final inspection (1 h): energy-meter station (metrology certificates), electrical safety, packaging drop standards.
Warehouse (30 min): temperature logs, spare-parts stock (proof of service promises).
Closing (30 min): findings and corrective deadlines.

Ten High-Frequency Questions

Show the incoming-inspection record for this serial.
Show the energy meter’s calibration certificate.
Last internal audit and management review findings.
Top 3 return/repair causes in the past year.
Second-source strategy for key components.
How software versions and fault logs flow back for analysis?
Contractual spare-part supply years.
Evidence of target-market registration progress.
Worker training and certification records.
Last customer’s audit findings and closure.

Red Flags

Showroom only, no production line.
Complete certificates but failed live traceability.
“We never had repairs” (a lie, or no data).
Refusing target-market compliance evidence.

LEIJEX welcomes audits — book the standard route via the factory page.

FAQ

Is a remote audit viable?

Viable at a discount: live video traceability covers 60-70% of onsite value; for first large orders, at least one onsite visit.

Are small factories acceptable?

Yes, with heavier verification: their strengths are flexibility and direct owner accountability; the risk is system volatility — offset with tighter acceptance tests and spare-part clauses.