ISO 13485:2016
Quality management for medical device manufacturing.
- Applies to
- Medical and healthcare programs
- Registrar
- Intertek
STIM Canada / Quality and Compliance
Certified quality systems.
A documented record behind every build.
01 / OUR STANDARD
STIM is the contract electronics manufacturer OEMs choose for low-to-medium volume, high-mix assemblies where quality is paramount. Certified quality systems set the rules, controlled processes keep every build consistent, and complete records prove it.
See our certifications02 / CERTIFICATIONS AND MEMBERSHIPS
Copies of our certificates are available for your supplier qualification file. Ask and we’ll send them the same day.
Quality management for medical device manufacturing.
Quality management across every program we build.
Quality management for aviation, space and defence.
03 / QUALITY BUILT INTO THE FLOW
Quality is checked where defects start, not only at the end of the line. Every checkpoint writes to the build record, and what we find feeds back into the process.
QUALITY STUDY / 010
Parts checked in against your BOM and recorded, so each build can be traced to its materials.
The first assembly of a run checked against your drawings before the rest of the batch follows.
Placement and solder joints inspected automatically, with results fed back to the line.
Hidden joints under BGAs and bottom-terminated parts inspected where optical checks cannot see.
In-circuit, flying probe or functional test, agreed for your product and stage.
A last check to IPC-A-610 before the product is released and shipped.
04 / HOW WE CONTROL QUALITY
Executives need confidence. Quality engineers need detail. Here is both.
Every assembly can be traced back to the materials, process and people behind it, so a question about one unit has an answer.
We inspect 100% of the products we build, combining automated, X-ray and manual methods so nothing depends on a single check.
Test is planned with you before the first build. Each method answers a different question, and we balance coverage, cost and cycle time for your stage of production.
Inspection and test results are fed back to the process, and changes are controlled, so the hundredth unit is built the way the first was approved.
05 / STANDARDS BY SECTOR
Workmanship class, inspection criteria and records are agreed with you before the first build.
| Sector | Quality system | Workmanship | Records |
|---|---|---|---|
| Aerospace and Defence | AS9100D and ISO 9001 | IPC-A-610, class agreed per program | Configuration and build records |
| Medical and Healthcare | ISO 13485 and ISO 9001 | IPC-A-610, class agreed per device | Build records supporting device history |
| Industrial and Automation | ISO 9001 | IPC-A-610, coating as specified | Build and inspection records |
| Communications | ISO 9001 | IPC-A-610, X-ray for BGA joints | Build and inspection records |
| Energy and Environmental | ISO 9001 | IPC-A-610, coating as specified | Build and inspection records |
QUALIFY STIM AS A SUPPLIER
Request our certificates, send us your quality questionnaire or plan a visit to our Toronto facility. We’ll make it easy to say yes.