Quality & Certifications
Rollyu Fabrication
Quality is central to everything we do. Rollyu Fabrication combines documented processes, calibrated inspection equipment and customer-grade reporting to deliver repeatable, traceable parts that meet critical industry requirements.
Our Quality Approach
We apply a risk-based, data-driven quality system across engineering, production and inspection to reduce defects, shorten validation time and protect your supply chain.
Design Reviews
Design-for-manufacture reviews and documented process plans
Process Controls
In-process controls, SPC and documented corrective actions
Final Inspection
Final inspection and lot traceability before shipment
Continuous Improvement
Continuous improvement driven by data from production and customer feedback
Our Certifications
ISO 9001:2015 — Quality Management System
Certificate No.:69123Q00082R0S
Date of First Issue:April 23, 2023
Date of Issue:April 25, 2025
Certificate Expiry:April 22, 2026
Scope:Production and sales of mechanical equipment parts and hardware accessories
Issued by:Guangdong Zhongpeng Certification Co., Ltd.
ISO 13485:2016 — Medical Device QMS
Certificate No.:135049
Issue Date:May 29, 2025
Valid Until:May 29, 2028
Scope:Processing and sales of precision metal components for medical devices (dental equipment, passive external fixation devices for orthopedic surgery, medical robotics, and rehabilitation devices)
Issued by:NQA
What We Deliver to Customers
We provide per-lot documentation and inspection deliverables as required. Typical items:
Material Certificates
- • Material Test Reports (MTRs)
- • Mill certificates per lot
Inspection Reports
- • First Article Inspection (FAI) reports
- • CMM inspection reports (native or PDF)
- • CMM FAI screenshots
Process Control
- • SPC run charts
- • In-process control records
- • Process control plans
Traceability
- • Packing lists with barcoded lot labels
- • Traceability sheets
- • Operation instruction sheets
Quality Documentation
- • Acceptance criteria documentation
- • Non-conformance reports (NCR)
- • Corrective action documentation
Inspection Capability & Equipment
Precision Measurement Equipment
- Coordinate Measuring Machine (CMM):High-precision 3D measurement with 0.001mm resolution
- Optical Inspection Systems:Vision systems for small features and surface analysis
- Precision Tools:Calipers, micrometers, height gauges, surface finish testers
- Custom Gauging:In-process gauging fixtures and custom go/no-go tools
Calibration & Compliance
Routine Calibration:All gauges and CMM calibrated on a defined schedule by accredited lab (ISO/IEC 17025)
Calibration Frequency:Annual calibration for all critical measurement equipment
Traceability:All measurements traceable to national standards through certified calibration chain
Traceability & Material Control
- Lot-level traceability from raw material to finished part with labeled packs and batch records
- Incoming material verification against MTRs and specified standards
- Quarantine and disposition procedures for nonconforming material
Process Controls & Validation
- Documented process flow for each job: PFMEA, control plans and operation work instructions
- Welding procedure qualifications (WPS/PQR) and welder certifications as required
- Process validation for production runs: capability studies (Cp/Cpk) and run charts on request
Surface Finishing Controls
- Controlled finishing processes (passivation, anodizing, powder coat)
- Partner process validation and finish certificates where required
- Cleanroom-capable packaging and double-bagging for medical/clean applications
Continuous Improvement & Customer Support
Regular Audits
Regular internal audits, management reviews and preventive corrective actions (CAPA)
Customer-Specific Plans
Customer-specific inspection plans and kitting/sub-assembly checks
On-Site Support
On-request site visits, capability reviews and pilot runs to qualify processes
How to Request Quality Documentation
Include in Your RFQ
Specify which deliverables you require (FAI, MTRs, CMM reports, PPAP, traceability) in your request for quotation.
Typical request example:“Please provide FAI (AS9102) and full CMM report for first lot; material certificates and per-lot traceability for all shipments.”
Request Quality Pack and Certificate Copies
Frequently Asked Questions
Do you provide Material Test Reports (MTRs)?
Yes. We can supply mill certificates per lot with full material traceability documentation.
Can you perform FAI and provide CMM reports?
Yes. We offer CMM first-article reports and per-lot inspection data according to AS9102 standards or custom requirements.
What tolerances can you hold?
Typical tolerances are ±0.05–0.2 mm depending on geometry and material. Please confirm specific requirements per drawing.
Are you ISO certified?
Yes. We hold ISO 9001:2015 for quality management systems and ISO 13485:2016 for medical device manufacturing. Certificates are available for download above.