We hold ISO 13485 and ISO 9001 quality management system certifications. Our MES-related records can connect the released medical PCBA work order, identified materials, recorded process steps and available inspection or test results within the traceability depth agreed for the project.
You receive a defined record plan before production. It explains which revision will be built, which identifiers will be captured, what manufacturing and quality evidence will be available, how records can be retrieved and how long they will be retained.
Medical PCBA Record Map
| Your question | Our record | What it demonstrates |
|---|---|---|
| Which revision was built? | Released data and work-order link | Configuration identity |
| Which materials or parts entered production? | Agreed lot, date-code, source or UID capture | Recorded material identity |
| Which operations were completed? | MES route and station status | Covered production history |
| How was the assembly inspected? | Applicable SPI, AOI or X-ray result | Defined defect coverage |
| How was it tested? | Procedure or program revision, result and disposition | Defined electrical or functional evidence |
| Was a failure or rework controlled? | Nonconformance, repair, retest and release history | Visible quality decision |
We Begin With the Approved Product Definition
Our engineers reconcile PCB files, fabrication drawing, stack-up, BOM or AML, CPL, assembly drawing, programming files and test requirements. The approved customer part and revision are connected to the work order.
A serial number cannot prove traceability if the underlying revision is unclear. We establish configuration identity before adding material or process links.
We Define Material and Component Records Before Purchasing
The project may require PCB material grade and lot, component manufacturer and part number, source, lot code, date code, UID, moisture-sensitive handling or customer-supplied material identity.
We confirm which identifiers are captured, at which points and how they connect to the work order. This avoids promising component-level detail that was never built into receiving and production.
MES-Related Records Connect Covered Production Steps
The manufacturing route records applicable station completion and available quality information against the released order. Customer-required parameters or operator confirmations must be identified before production so their capture and report path can be confirmed.
Your team knows which process records arrive with the product and which remain available for later retrieval.
Inspection Results Stay Connected to the Build
We use applicable SPI for paste conditions, AOI for visible assembly conditions and X-ray for selected hidden joints. The approved plan defines coverage, acceptance, reaction and required output.
Images, measurements or location details are included when agreed and supported by the route. Equipment names alone are not treated as inspection evidence.
Programming and Test Records Protect Product Identity
Where programming is included, we control the approved file and identifier. Electrical or functional tests use the released procedure, fixture, firmware, limits and report requirement.
Records identify product or lot, method or program revision, result and disposition. Device-level clinical or regulatory validation remains outside manufacturing test unless explicitly assigned and defined.
Serial Numbers Support Focused Retrieval
When product serialization is included, a serial number can link to the work order and agreed history. Forward review can also start from an identified material or lot and locate related production where the required links exist.
We define serial format, marking, duplicate prevention and rework handling before production.
Nonconformance and Rework Remain Visible
We identify and contain affected product, record the issue and connect it to disposition, approved repair or rework, verification and release. Customer authorization is obtained where the quality agreement requires it.
The original failure is not hidden by a final pass. The record shows how the product reached its final status.
Why Medical Customers Use Our Record Process
We combine an ISO 13485 quality foundation with product-level traceability. Your team can see what was built, which identified inputs were used, which checks were completed and how exceptions were controlled.
This supports supplier review, repeat production, complaint investigation and focused containment.
Send Your Traceability and Record Requirements
Send product files, BOM, customer part and revision scheme, material and component identifiers, serialization rules, inspection plan, test procedure, report format, record-retention period and shipment-document needs to sales@ebestpcba.com.
We will return the proposed traceability map, available record package and any input needed before production.
