ISO 9001:2015
Quality management system · 2024Scope: the quality management system covering SMT and THT assembly production services — the system that carries nonconformance, corrective action and management review.
Quality · IPC acceptance criteria & measured yield
Every board passes three gates — IQC, IPQC then OQC — and each gate is judged against a published criterion rather than an opinion: IPC-A-610 Class 2 / Class 3 for appearance, IPC J-STD-001 for through-hole fill and wetting, IPC-7095 for BGA voiding. The limits themselves are set out below, and the two internal metrics we report carry their measurement definitions next to the number, so you can copy both into a supplier audit.
Six gates
Bare boards arriving from audited partner fabs, components and moisture-sensitivity status are all checked and recorded per lot before anything is issued to a line.
Solder-paste volume, height, area and offset are measured on every print pass, so a drifting stencil or a drying paste is caught before components go down.
In-line optical inspection immediately after placement catches missing parts, offset, polarity and damaged bodies while the board can still be corrected cheaply.
After reflow, AOI looks at bridging, insufficient solder and joint appearance. Hidden joints under BGA, CSP and QFN packages get 2D X-Ray when the programme calls for it.
Bed-of-nails ICT, functional test benches, flying probe and boundary scan as the programme requires, plus temperature-controlled burn-in and Hi-Pot dielectric testing.
Final inspection against the agreed IPC class, packing verification, and release documentation issued against the production lot before the carton is sealed.
What is measured
| Stage and item | Method and equipment | Basis for acceptance |
|---|---|---|
| IncomingIQC | Bare boards from audited partner fabs, components, and MSL status recorded at bag opening. | Supplier certificate of conformance, plus dimensional and appearance checks to the drawing. |
| Solder paste3D SPI | Volume, height, area and offset measured on an in-line 3D paste inspection system. | The acceptance window for each metric is agreed per programme. |
| PlacementIn-line AOI | Missing part, offset, polarity, bridging and insufficient solder detected optically after placement and again after reflow. | IPC-A-610 Class 2 / Class 3, as specified on the order. |
| Hidden joints2D X-Ray | BGA, CSP and QFN solder joints imaged through the package where a visual check cannot reach them. | IPC-7095 voiding limits; X-Ray is configured per project. |
| Electrical test | ICT bed-of-nails with in-house fixture design, functional test benches, flying probe, JTAG boundary scan, burn-in and Hi-Pot. | Customer test specification and the approved test programme. |
| First articleFAI | SPI and AOI data captured on the first article, with the appearance criteria it was judged against. | IPC-A-610 Class 2 / Class 3 and the agreed drawing revision. |
The limits
When something fails
A failed unit does not travel quietly down the line. The lot is held, the defect is classified against the criterion it breached, and the disposition — rework, repair, scrap or concession — is recorded against that lot with the reason. Nothing is released on a verbal decision, and nothing is quietly reworked without the record showing it.
Records follow the lot: production-lot traceability, the first article inspection report with its SPI and AOI data, and the buyer's right to audit written into the quality agreement. A question raised eighteen months after shipment can be answered from the file rather than from recollection.
Measured, with definitions
First-pass yield measured at final inspection before any rework or retest, SMT + THT assembly, production lots; excludes pilot builds and post-ECN first articles.
On-time delivery measured against the confirmed ship date at order acknowledgement, counted per shipment.
Traceability is held at production-lot level, covering the process parameters and the component batches consumed by that lot.
We do not publish a DPMO figure. If your supplier audit requires an outgoing-defect number, we will agree the definition with you and report against it.
Both percentage figures are internal operating metrics, self-reported and not independently verifiable from outside; the definitions above are the measurement basis, and both can be written into a quality agreement.
Management systems
Scope: the quality management system covering SMT and THT assembly production services — the system that carries nonconformance, corrective action and management review.
Scope: the environmental management system for SMT and THT production at this site, covering flux, solvent and solder waste handling and waste-stream recording.
Scope: production of PCBA. This is a QMS certificate for the production of PCBA — not an FDA clearance and not an EU MDR certificate. Device authorisation stays with the legal manufacturer.
Scope: manufacturing of circuit board components. Permitted exclusion: product design. PPAP documentation is prepared against this system where the programme requires a submission level.
RoHS 3 to EU 2015/863 and REACH SVHC substance compliance are evidenced by declarations and test reports rather than by a certificate. Declaration and test reports available on request.
The CMRT reports smelter and refiner sources for tin, tantalum, tungsten and gold in the parts we place. It is a disclosure document, not a certification of the finished assembly. CMRT available on request.
The questions we get asked
No, and we will not write it that way. ISO 13485:2016 is a quality management system certificate for the production of PCBA — not an FDA clearance and not an EU MDR certificate. Authorisation to place a medical device on the market belongs to the legal manufacturer of that device; what we supply is the assembly, the lot traceability and the process records that support their submission.
A subassembly sold to an equipment manufacturer for further fabrication requires no authorisation, and a bare assembled board is not a CE-marked product. The OEM branding the finished device is the legal manufacturer and carries the CE and FCC conformity obligations that go with that role. What we provide is the technical file input — BOM, material declarations, process records and test data — so the declaration you sign is supported by evidence from the build.
The minimum is driven by the component packages on the board, not by a single site-wide number. Chip passives from 0603 to 2225, and SOT, SOD and MELF packages, start at 50 pcs plus 30 spares. Every other package starts at 100 pcs plus 50 spares. Prototype quantities are quoted per order rather than forced into either band, because the reel and stencil setup differs from programme to programme.
3D SPI and AOI are standard in-line configuration on the SMT process, so those two run as a matter of course. X-Ray is configured per project: it is specified where a board carries BGA, CSP or QFN joints that cannot be seen optically, and it is left out where it would add cost without adding evidence. The inspection plan for your programme is agreed before the first article, not adjusted afterwards.
Because a DPMO figure quoted without its measurement basis is not comparable between suppliers — counting method, inspection point and whether rework is netted out all change the number. We publish first-pass yield and on-time delivery with their definitions instead. If your supplier audit requires an outgoing-defect number, we will agree the definition with you and report against it.
By the product and by you, at quotation. Class 3 tightens the voiding limits under IPC-7095, the through-hole fill requirements under IPC J-STD-001 and the appearance criteria under IPC-A-610, which raises inspection time and rework cost. Most industrial and consumer programmes are designed to Class 2, while medical, automotive and high-reliability products often specify Class 3. We apply the class written on the order.
Inspection evidence
IN-LINE X-RAY · 2D transmission imaging of hidden joints
Equipment is only half of an inspection claim; the other half is what gets written down. Each station below feeds a record tied to the board serial and the process lot it came from.
Next step
Tell us the IPC class your product is designed to, the packages that need X-Ray, and the test coverage you expect. The quotation comes back with the acceptance criteria, the assembly lead time ex-components and the documentation pack stated line by line.
Reply within one business day
Quality agreements, signed NDAs and IQ/OQ/PQ documentation packages are prepared by the same team that owns the inspection plan.