Audit Sections
Quick Facts
- Est. Date: 2010
- Employees: 120+
- Site Size: 15,000 m²
- Sterile? NO (Non-sterile)
1. General Facility Information
Basic entity data for "Supplier Information" section of your questionnaire.
Question 1.1
Supplier Legal Name & Address
Valid Industrial Systems Ltd.
Unit 1005, 10/F, Prosper Commercial Building, 9 Yin Chong Street, Mongkok, Kowloon, Hong Kong.
Unit 1005, 10/F, Prosper Commercial Building, 9 Yin Chong Street, Mongkok, Kowloon, Hong Kong.
Question 1.2
Manufacturing Site Address (If different)
SinoTitanium Metals Co., Ltd (Wholly owned subsidiary)
No. 18, Jingwei 10th Road, Economic & Technological Development Zone, Xi'an, Shaanxi, China.
No. 18, Jingwei 10th Road, Economic & Technological Development Zone, Xi'an, Shaanxi, China.
2. Quality Management System
ISO 13485 and MDSAP compliance details.
Question 2.1
Is the QMS certified to ISO 13485?
Yes. ValidTi's QMS is certified to ISO 13485:2016 by NQA (Notified Body). The certificate scope covers "Manufacture and Sales of Titanium and Titanium Alloy Materials for Medical Devices". Current certificate is valid until 2026.
3. Traceability
From sponge to finished disc.
Question 3.1
How is batch traceability maintained?
Traceability is maintained via a unique Lot Numbering System (Format: VT-YYMM-XXX). This Lot ID links the finished product back to the specific titanium ingot heat number, forging logs, and raw material test certificates (MTC 3.1). Records are retained for 15 years.
4. Production Control
Process validation and contamination control.
Question 4.2
Is there a risk of cross-contamination?
Risk is minimized. The facility processes ONLY Titanium and Titanium Alloys. No non-ferrous metals (Cobalt Chrome, Nickel) or ceramics are processed on the same machinery, eliminating the risk of cross-contamination from other materials.