Quality
ISO 13485 certified since 2012
Our quality management system for medical contract manufacturing is certified to ISO 13485:2016 by BSI. Below is the certificate, exactly what it covers, and a link to check it with BSI yourself.
| Standard | ISO 13485:2016 — quality management systems for medical devices |
|---|---|
| Certification body | BSIAccredited certification (RvA C 122 mark on the certificate) |
| Certificate number | FM 579695 |
| Certified organization | LasX Industries, Inc, 4444 Centerville Road, Suite 170, White Bear Lake, Minnesota 55127, USAThe certificate names the site as White Bear Lake; our mailing address uses St. Paul, the postal name for the same 55127 location. |
| Scope, as certified | “The provider of contract manufacturing services for high precision digital converting of non-metallic materials for the medical industry.” |
| First registered | November 27, 2012 |
| Current certificate | Effective November 27, 2024 · expires November 26, 2027Latest revision September 16, 2024 |
Open the PDFScope
What the certificate covers
A supplier-quality team reads the scope line, not the logo. Here is what that line means for your part.
Contract manufacturing of parts for the medical industry from non-metallic materials (films, laminates, and adhesive constructions, for example), laser converted on LasX equipment at the certified site.
The laser equipment LasX designs, builds, and sells, and contract work outside the scope, such as metal parts or parts that are not for the medical industry. Metal medical parts are built under the same ISO 13485 quality system; they are outside the certificate’s current scope. Not sure where your part falls? Ask when you request a quote.
Facility
Where medical parts are made
| Certified site | 4444 Centerville Road, Suite 170, White Bear Lake, Minnesota 55127As named on certificate FM 579695. |
|---|---|
| Cleanrooms | Class 10,000 (ISO 14644-1 Class 7)Particulate from the laser process is measured per material during qualification. |
Adding LasX to your approved supplier list?
Download the certificate above or check it directly with BSI. For a supplier questionnaire or anything else your supplier file needs, ask, and tell us about the part.