Quality and certifications: one integrated management system for regulated manufacturing
ISO 13485, ISO 9001 and IATF 16949 certified, run as one Integrated Management System at our FDA-registered U.S. facility, with industry-specific requirements built into every process.
UTP Solutions runs a single Integrated Management System that covers all of its certifications: ISO 13485, ISO 9001, IATF 16949 and CMMC Level 1. UTP's U.S. facility is FDA registered, its system is aligned with FDA's Quality Management System Regulation (QMSR, 21 CFR Part 820), and it is working toward AS9100D certification, targeted for 2027. Over a rolling 24 months, UTP has delivered more than 99% on time and in full with fewer than 100 PPM defects. When a problem does occur, the first five disciplines of our 8D response reach the customer within 24 hours.
Performance, rolling 24 months
99%+ OTIF
On-time, in-full delivery across programs over a rolling 24 months.
<100 PPM
Defects per million parts shipped over the same rolling 24 months.
24-hour 8D response
Disciplines D1 through D5 of the 8D, from team and problem definition through containment, root cause and chosen corrective action, delivered to the customer within 24 hours.
Certifications and registrations
| ISO 13485 | Certified · quality management system for medical device manufacturing |
|---|---|
| ISO 9001 | Certified · quality management system |
| IATF 16949 | Certified · automotive quality management system |
| CMMC Level 1 | Certified and renewed annually · Cybersecurity Maturity Model Certification for defense programs |
| FDA | Registered U.S. facility · Integrated Management System aligned with the QMSR (21 CFR Part 820) |
| ITAR | Compliant, with controls scaled to each part's classification |
| AS9100D | In progress · certification targeted for 2027 |
One system, not one per industry
We don't run separate quality systems by business unit or market. Our Integrated Management System covers every certification we hold, and industry-specific requirements are built into the processes themselves. Each program team applies the requirements that fit the program, whether that is ISO 13485 and QMSR for a medical device, IATF 16949 for automotive, or CMMC and ITAR controls for defense.
The result is one way of working on the floor, with the discipline of the strictest standard available to every customer.
Standards we work to
Beyond our certifications, programs at UTP are built and documented to these standards and specifications:
- FDA Quality Management System Regulation (QMSR, 21 CFR Part 820), which incorporates ISO 13485:2016 by reference
- ISO 14971 risk management, with DFMEA and PFMEA
- ISO 14644-1 cleanroom classification (ISO Class 8 cleanroom)
- ASTM F67, F136 and F138 implant material specifications
- ASTM A967 and ASTM F86 for passivation and surface preparation
- MIL-SPEC and MIL-STD requirements for defense programs, for both machined and molded components
Change control and corrective action
No surprise changes
Once a part is validated, we don't change its material, process, equipment, site or sub-supplier without notifying you in writing and getting your approval first. Your validation stays valid, and your design history file stays accurate.
8D corrective action, fast
Supplier corrective action requests run through a staged 8D process. The first five disciplines, covering team, problem definition, containment, root cause and the chosen corrective action, reach you within 24 hours. Effectiveness is verified before the 8D is closed.
Metrology
Our onsite QC laboratory's equipment includes:
Two CMMs
Coordinate measuring machines that measure features to 0.0001" for first article and production inspection.
Keyence vision system
Fast optical measurement of small features, profiles and edges without touching the part.
Profilometer
In-house surface finish measurement for implant, instrument and sealing surfaces.
Gauges and fixtures
Gauges and checking fixtures designed in-house for fast, repeatable inspection at the machine.
How quality is built into a program
- Risk first. DFMEA and PFMEA identify critical-to-quality features before tooling and programs are released.
- Trusted measurement. MSA, including Gage R&R, confirms the inspection method is capable before it's used to accept parts.
- Capable processes. Capability studies on critical features, then SPC in production to catch drift early.
- First article inspection on the production process, with full dimensional reports.
- Traceability. Material certifications, lot records and inspection data traced through to shipment.
- Supplier controls for heat treat, polishing, anodizing and sterilization providers.
Qualification and validation, matched to the process
Injection molding
Scientific, decoupled process development with DOE, then IQ/OQ/PQ, because molding conditions can change material properties that aren't fully measurable on the finished part.
Precision machining
Equipment, CNC program and setup qualification, tool-wear and tool-life studies, surface finish and material verification, then first article and ongoing inspection.
Special processes
Cleaning, citric or nitric passivation to ASTM A967 and ASTM F86, and UDI laser marking are performed and validated in-house.
Supplier onboarding
Every customer qualifies suppliers differently. We support your supplier onboarding requirements, including quality questionnaires, certificates, quality agreements and on-site or virtual audits, at whatever point your process calls for them.
Quality and certification questions
Is UTP ISO 13485 certified?
Yes. UTP Solutions is ISO 13485 certified for medical device manufacturing, and also holds ISO 9001, IATF 16949 and CMMC Level 1 certification, all under one Integrated Management System.
Is UTP FDA approved?
FDA doesn't approve contract manufacturers. Manufacturers register their establishments with FDA, and FDA clears or approves devices, not suppliers. UTP's U.S. facility is FDA registered, and its Integrated Management System is aligned with FDA's Quality Management System Regulation (QMSR, 21 CFR Part 820).
What is UTP's on-time delivery and quality performance?
Over a rolling 24 months, UTP has delivered more than 99% on time and in full, with fewer than 100 PPM defects.
How quickly do you respond to a corrective action request?
Corrective action requests run through a staged 8D process. The first five disciplines, through root cause and the chosen corrective action, reach the customer within 24 hours, and effectiveness is verified before closure.
Is UTP AS9100 certified?
Not yet. UTP is working toward AS9100D certification, targeted for 2027. Aerospace requirements are already being integrated into our management system.
Is UTP ITAR compliant?
Yes. UTP is ITAR compliant, with controls scaled to each part's classification, and CMMC Level 1 certified for defense programs.
How do you validate manufacturing processes?
We match the method to the process. Molding gets IQ/OQ/PQ. Machining is qualified through equipment, program and setup qualification, tool-life studies and inspection, because machined dimensions can be fully measured. Cleaning, passivation and laser marking are validated special processes.
Can you support our supplier onboarding and audits?
Yes. We support each customer's supplier onboarding requirements, including questionnaires, certificates, quality agreements and on-site or virtual audits.
Talk to an engineer, not a call center.
Ask for certificates or send your supplier onboarding requirements. A UTP engineer replies within two business days.