Quality You Can Audit: ISO 9001, IATF 16949, AS9100D & ITAR
A CNC part that measures right but ships without paperwork is a rejected purchase order waiting to happen. Unity Manufacture runs one documented quality system across machining, sheet metal, molding and extrusion — with the certificates, first article reports and material traceability that regulated industries ask for.
Programs we build to
What each standard means for your purchase order
Certifications are not marketing badges — they change how the part is planned, measured and documented. Here is what actually shifts on your side of the table.
| Standard | What it governs | What you receive | Typical programs |
|---|---|---|---|
| ISO 9001:2015 | Documented process control, corrective action and continuous improvement across the whole facility | Certificate of conformity, controlled inspection records, calibrated measurement equipment traceable to national standards | All commercial orders |
| AS9100D | Aerospace additions to ISO 9001: risk management, configuration control, counterfeit-part prevention and expanded first article requirements | AS9102 first article inspection report (Forms 1, 2 and 3), ballooned drawings, full material and special-process traceability | Flight hardware, UAV, satellite |
| ITAR registration | Control of technical data and hardware listed on the United States Munitions List | Access-controlled data handling, segregated production and documented visitor control | Defense and space |
| IATF 16949 | Automotive sector quality system: APQP, PPAP, FMEA, MSA and SPC discipline | PPAP submission at the level you specify, dimensional results, PFMEA and control plan references, IMDS data | Vehicle, EV and Tier-2 supply |
| ISO 13485 | Quality management for medical device manufacture, including validation of processes and cleanliness control | Validated process records, biocompatibility material evidence, device-history style documentation | Surgical, diagnostic and lab instrumentation |
Certificates are issued per facility and per program scope. During quotation we confirm the exact registration number, issue body and expiry date for the standard your purchasing team requires, so nothing is assumed on paper and discovered later.
How a part moves through our quality system
- Contract & drawing review. We check every callout — tolerances, GD&T datum structure, surface finish symbols, special processes — and raise a DFM query before the schedule is committed.
- Incoming material control. Raw stock is verified against its mill certificate; heat and lot numbers are booked against the job and kept with it for the life of the record.
- In-process verification. First-piece approval, then dimensional checks at defined operations. Results are recorded against the operation number, so measurement has a place in the routing, not just a checkbox at the end.
- Final inspection and release. Full dimensional report or a documented sampling plan, surface finish verification, coating thickness where applicable, then a certificate of conformity before packing.
Traceability from mill certificate to shipping carton
When a customer asks for the origin of a bracket delivered eighteen months ago, the answer should take minutes, not weeks. Every job carries a record chain:
- Material identity. Mill certificates to EN 10204 3.1 for metals, resin lot and grade certificates for polymers, with heat or lot numbers recorded on the job traveller.
- Process identity. Machine, program revision, tooling offsets and operator sign-off captured at the operation where the feature was produced.
- Measurement identity. Every reported result is tied to a calibrated gauge with a valid calibration date, so numbers have a traceable source.
- Special-process identity. Anodizing, plating, passivation, heat treatment and coating batches are documented with their own certificates and appended to the pack.
- Pack and ship identity. Labels carry part number, revision, quantity and lot, so a returned carton can be matched to its inspection record without guesswork.
Retention periods can be extended to match your regulatory obligations; tell us the requirement at RFQ stage and we will set up the record plan with the job.
Documentation we ship with your parts
Standard documents
- Certificate of conformity
- Dimensional inspection report
- Material certificate (EN 10204 3.1)
- RoHS and REACH statements
- Country of origin declaration
Available on request
- First article inspection report (AS9102 Forms 1–3)
- PPAP submission — automotive programs
- Ballooned drawing with measured values
- Surface roughness and coating thickness traces
- Capability study (Cpk) on critical characteristics
- Special-process certificates for passivation and anodizing
Built into every industry we serve
The same quality system runs underneath each sector, but the deliverables differ. Pick the page for your industry to see the specific paperwork attached to it.
Aerospace & defense
AS9102 first article packs, counterfeit-part prevention and ITAR-controlled data handling.
Aerospace quality →Medical devices
ISO 13485 aligned controls, biocompatible material evidence and validated cleaning processes.
Medical quality →Automotive & EV
APQP and PPAP discipline, IMDS data and control plans built with the production cell.
Automotive quality →Frequently asked questions
How do I verify your current certificates?
Ask during quotation and we will send the current certificate with its registration number, issuing body and expiry date. We do not publish scanned copies with expiry dates that may already have rolled over.
Can you produce a first article inspection report for a one-off prototype?
Yes. FAI is a good idea for any part that will later be production-qualified, because it proves the process before volumes scale. We prepare AS9102 Forms 1–3 or a customer-supplied template.
Do you support customer source inspection?
Coordinate it with your project engineer. We can schedule witness inspection at defined operations and provide the measurement records for review before shipment.
What happens if a nonconformance is found after delivery?
The job is quarantined and a documented corrective action is raised with root cause, containment and prevention steps. Records stay linked to the lot number so we can trace the affected parts precisely.
Can you hold material certificates for long-term archiving?
Yes. Extended retention beyond our standard period can be agreed contractually, including electronic copies bundled with each shipment.
Ask for the documentation before you ask for the price
Send your drawing and the standards your quality team requires. We will confirm scope, certificates and inspection strategy before quoting.