11-Nov--2026ISO 13485:2016 is a quality management system standard for medical device manufacturers, not a product certificate. Since February 2, 2026, the FDA's QMSR (21 CFR Part 820) incorporates it by reference, so one audited system now serves both U.S. and international markets.
The standard controls design, validated processes, supplier approval, batch traceability and closed-loop corrective action. Each leaves a document behind — which is what separates a working system from a framed certificate.
Verify a supplier with three checks:
1. Certificate scope names "manufacture of disposable medical devices," not "general textiles" or "trade."
2. Batch records and CoA per lot show lot number, tested parameters, limits and actual results.
3. Current test reports come from ISO/IEC 17025 accredited labs and match your product type.
About Qingdao Bestex Plastic Products Co., Ltd.
| Certification | Detail |
| ISO 13485:2016 | NQA certificate no. 36437, valid to 2 November 2027, UKAS-accredited |
| Scope | Production and sales of disposable medical products (nonwoven face mask, face mask with shield/visor, protective face shield, protective eye visor, nonwoven disposable protective apparel, dental/patient bibs) — non-sterile, export only |
| FDA Establishment | Reg. no. 9616862, FEI 3003208290, status active |
| Multi-site | Qingdao Best Health Care Products Co., Ltd., certificate 36437/1, same address and scope |
Explore: Face Shields · Isolation Gowns · Masks · Certificates
Note: QMSR alignment is regulatory framework, not a product-specific FDA clearance.
