Sector / Six regulated buyer groups
One ESD-controlled floor in Bayan Lepas, Penang, running six regulated sectors off the same 6 SMT lines and 3 DIP lines. The class, the laminate, and the record package change per programme. The process discipline does not.
ISO 9001:2015 - ISO 13485:2016 - IPC-A-610 Class 2 and Class 3 - ANSI/ESD S20.20 - 4,100 m2 ESD production area - founded 2008
Sector coverage
A conforming industrial board and a conforming implantable board share a footprint and almost nothing else: different laminate, different inspection class, different record retention. Pick the sector and the process plan follows.
IND-01
24/7 duty cycles with a 10-15 year field-life expectation, so 85 C / 85% RH endurance, thermal cycling, and the semiconductor obsolescence that forces mid-programme redesigns all land on the assembler. Selective soldering covers heavy through-hole power joints on the same build as 0402 SMT.
Industrial automation PCBA
IND-02
ISO 13485:2016 and FDA 21 CFR 820 put the manufacturing record inside the regulatory submission, so traceability runs to UDI level. The IEC 60601-1 barrier is where programmes slip: 2xMOPP at 250 V means 5.0 mm clearance and 8.0 mm creepage, a 4000 V AC one-minute withstand, and CTI at or above 400 V.
Medical device PCBA
IND-03
IATF 16949 gates the business and AEC-Q100, AEC-Q101, and AEC-Q200 gate the bill of materials. Under-hood logic runs Grade 0 at -40 to +150 C, IST runs 1000-2000 cycles, boards carry a laser-marked 2D serial, and records are retained 15 years. Qualification typically adds 30-100% against consumer-grade construction.
Automotive and EV PCBA
IND-04
AS9100D plus AS9102 first-article inspection on every new part number, built to IPC-A-610 Class 3 where the rejection band widens from 2-5% to 8-15% and carries a 20-40% premium. Counterfeit parts in the grey market and ITAR-aware data handling decide which suppliers are even eligible.
Aerospace and defence PCBA
IND-05
BOM cost is argued in fractions of a cent, so mixed passive packages and double-sided assembly decide the unit price. FCC Part 15 and CE EMC plus LVD run in parallel with tooling rather than after it, WEEE closes the loop, and UN38.3 applies the moment a battery ships. Returns trace back to infant-mortality solder defects.
Consumer and IoT PCBA
IND-06
Inverters, EV charging modules, and battery racks run at 1500 V DC class stack voltages where creepage and clearance set the layout. UL 1741 and UL 9540 evidence, IEC 62109, heavy copper from 2 oz, thermal via arrays, press-fit assembly, and a 10-20 year service life with components that go obsolete inside it.
Energy and power PCBACompliance matrix
The standard column is the one an auditor or a notified body reads first. The evidence column is the artifact that answers it.
| Sector | Governing standard | Other compliance in scope | Evidence delivered |
|---|---|---|---|
| Industrial automation | IPC-A-610 Class 2, Class 3 for safety modules | UL recognition, EN 61010 awareness, ANSI/ESD S20.20 | Panel-level traceability, IPC-7912 DPMO report, ionic contamination certificate |
| Medical devices | ISO 13485:2016 | FDA 21 CFR 820, EU MDR 2017/745, IEC 60601-1, UDI | Device-history-record-ready package, 510(k) and CE technical file material, cross-sections per lot |
| Automotive and EV | IATF 16949 | AEC-Q100 / Q101 / Q200, IPC-6012DA, ISO 26262 awareness | PPAP package, laser-marked 2D serial data, 15-year record retention |
| Aerospace and defence | AS9100D | AS9102, AS5553 / AS6081, ITAR-aware, NIST SP 800-171 / CMMC awareness | First-article inspection report, lot traceability dossier, counterfeit-avoidance plan |
| Consumer and IoT | FCC Part 15, CE EMC and LVD | RoHS 3, REACH SVHC, WEEE, UN38.3 for battery products, Prop 65 | Assembly cost breakdown, AOI record per board, pre-compliance test support |
| Energy and power | UL 1741 and UL 9540 awareness | IEC 62109, IEC 62477, IEC 60664-1 insulation coordination, IEC 61851 | Hipot record, X-Ray void report on power-module solder layers, thermal-cycle data |
| Telecom and data infrastructure | Telcordia GR-78 and GR-1089 | IEC 62368-1, NEBS Level 3, ISO 14001 supplier programmes | Controlled-impedance coupon report, stackup simulation data, backdrill verification |
| Robotics and industrial autonomy | ISO 10218-1 and ISO 10218-2 | ISO 13849 PL d, IEC 62061 SIL 2, CE Machinery Directive 2006/42/EC | Boundary-scan coverage map, serialized functional-test log, staking and coating record |
Requirements to capability
Same table for all six sectors. What changes between them is which row becomes the acceptance gate on the traveller.
| Requirement | Governing standard | What we do | Evidence |
|---|---|---|---|
| Minimum chip size | IPC-A-610H | Place 01005 at 0.4 x 0.2 mm and 0201 passives on the high-speed chip-shooter lines, gated by solder-paste inspection before reflow. | Placement program and SPI record per panel |
| Minimum lead pitch | IPC-7351, IPC-A-610H | 0.35 mm leadless and 0.4 mm leaded placements at plus or minus 15-25 um accuracy in ultra-fine-pitch vision mode. | First-article measurement report |
| BGA void acceptance | IPC-7095 | 2D and 3D X-Ray on every BGA and QFN to hold voids under 25% at Class 2 and under 10% at Class 3. | X-Ray images retained against the serial number |
| Printed board cleanliness | J-STD-001, IPC-TM-650 | De-ionized water cleaning with ionic contamination testing to 1.56 ug NaCl per square centimetre at Class 2 and 0.78 ug at Class 3. | ROSE or ion chromatography certificate |
| Solder alloy selection | J-STD-001, IPC-6012 | SAC305 at a 217 C liquidus for volume work; SnPb retained in a segregated cell for legacy and defence programmes. | Validated reflow profile per board design |
| Stencil geometry | IPC-7525 | 100 um foil below 0.4 mm pitch, 120 um for standard mixed technology, 150 um for large thermal pads. | Aperture drawing and paste-volume data |
| Hidden-joint inspection | IPC-A-610H | 100% AOI coverage on all SMT builds for tombstoning, bridging, polarity and placement, with X-Ray added for leadless joints AOI cannot see. | AOI and X-Ray pass record per serial |
| Electrical test access | IPC-2221, IPC-9252 | DFT review guaranteeing 1.0 mm test pads on a 2.54 mm grid, then flying probe, ICT, or functional test chosen by volume and escape risk. | Fixture qualification and test coverage report |
| Unit traceability marking | IPC-1782 | Laser-marked Data Matrix on every board, linked to panel ID, operator, and test result, which is what UDI and PPAP packages read downstream. | Traceability data file |
| Component authenticity | AS5553 / AS6081, IATF 16949 clause 8.4 | Authorized-distribution-only purchasing, incoming microscopy and XRF, and lot-level material segregation on a second sourcing desk in Shenzhen. | Material certificates and lot codes |
| Environmental compliance | RoHS 3, REACH SVHC | RoHS 3 across 10 restricted substances with REACH SVHC screening and conflict-minerals reporting on the bill of materials. | Declaration of conformity per shipment |
| Record retention | ISO 13485:2016, IATF 16949 | Device-history-record retention for medical and 15-year retention for automotive, both indexed by serial number rather than by order. | Retention register and retrieval test |
Buyer questions
Yes, provided the class is fixed in the process plan rather than the operator's judgement. We run IPC-A-610 Class 2 SMT lines at 99.4% first-pass yield and dedicated Class 3 cells with 100% inspection, separate AOI recipes, and X-Ray on every BGA and QFN. Class 3 carries a typical industry premium of 20-40% over Class 2 because the rejection band widens from 2-5% to 8-15% and no sampling is permitted.
Every regulated programme ships with material certificates and lot codes, process traceability, AOI and X-Ray results linked to the panel ID, ionic contamination data against the 1.56 ug NaCl per square centimetre Class 2 or 0.78 ug Class 3 limit, cross-sections at a minimum of 2 per lot at Class 3, and a certificate of conformance. ISO 9001:2015 and ISO 13485:2016 certificates are held in-house; UL, IATF 16949, and AS9100D evidence sits with partner facilities and is available on request.
Send Gerbers, a BOM, and an annual volume. Prototype NRE runs $150-500 per order; placement runs $0.005-0.015 per passive and $0.10-0.50 per micro-BGA. A 200-placement board runs $40-80 at 1-5 pieces and $3-7 at 1,000+ excluding the BOM. Automotive and medical qualification typically adds 30-100% and 2.5-4x to bare-board cost respectively.
Seven fields. A process engineer replies within one working day.
Seven fields. A process engineer replies within one working day.
Seven fields. A process engineer replies within one working day.