- Home
- Medical Extrusion Operations
- ISO 13485 Quality Systems
ISO 13485 Quality Systems
ISO 13485:2016 certified quality, with laser gauging and vision inspection before, during and after every run.
Quality is everyone’s job here
ISO 13485 medical tubing extrusion depends on more than a certificate on the wall. Everyone at MicroSpec is responsible for the quality of the custom medical tubing we extrude. Because the whole extrusion cycle stays in-house, from tooling to final inspection, we keep tight control over the outcome. We are certified to ISO 13485:2016 by Intertek, certificate number 0052503-03.
When we inspect
- On the production floor, with in-line laser gauging
- In our quality control room
- At the start of, during and after each run
- Before shipment
How we inspect
We use the latest inspection techniques, including laser gauges, automated vision systems, highly precise electronic microscopes and ultrasonic technologies. Automated inspection routines improve measurement repeatability and reproducibility. Among other measurements, we check outside and inside diameters, number of lumens, wall thickness and profile against your specifications, and we perform burst and tensile testing on finished product. All incoming raw materials are inspected.
Our quality team works proactively with your quality team to align inspection methods, so we measure the part the same way you do. Defining inspection methods early and minimizing measurement error are key parts of a successful validation.
Our quality commitments
- Continuous improvement through innovation, automation and data-driven process optimization
- Effective use of production and post-production feedback
- Growing production capacity and optimizing efficiency to meet market demand
- A culture of employee engagement, development and morale
- An effective, compliant quality management system under ISO 13485:2016
- Reducing our carbon footprint with environmentally friendly processes and equipment
Training and experience
Quality begins with training. Each quality inspector is trained in our standards and procedures for custom medical tubing, and our quality staff brings decades of combined experience in the medical device and extrusion industries. We welcome customer audits.
On this page
Quality facts
| Certification | ISO 13485:2016 |
| Registrar | Intertek |
| Certificate | 0052503-03 |
| Validation | JumpStart, OQ, PQ, PPAP |
| Audits | Customer audits welcome |
What we measure
Dimensions and properties we check.
| Characteristic | How it is measured | When |
|---|---|---|
| Outside diameter | In-line laser micrometers | Continuously during the run |
| Inside diameter and wall | Vision systems and electronic microscopes | Start, during and end of each run |
| Lumen count, size and position | Vision systems | Start, during and end of each run |
| Profile and cross-section | Optical measurement against your print | Start, during and end of each run |
| Burst and tensile strength | Mechanical testing | Finished product |
| Resin consistency | Melt flow testing of incoming lots | Before material is released to the line |
Certification history
Certified since 1997.
1997
ISO 9002:1994
2003
ISO 9001:2000
2009
ISO 9001:2008
2016
ISO 13485:2003
2019
ISO 13485:2016, Intertek
Inspection equipment
The tools behind every measurement.
Validation
JumpStart Validation Program.
Validation planned from the first prototype, not bolted on at the end.
01
Identify intent early
We confirm your plan to validate as soon as possible so prototype data can support it.
02
Reduce risk up front
Inspection methods, measurement error, process variation and multiple resin lots are addressed early.
03
Align specs and capability
Print tolerances are discussed openly so CTQ and CTF features are both functional and capable.
04
OQ and PQ
Defined phases take the process through OQ and PQ to a robust production state.
Read more about how JumpStart works.
Questions
Quality, answered.
Have a question about our quality system? Ask our team.
Is MicroSpec ISO 13485 certified?
Yes. We are certified to ISO 13485:2016 by Intertek, certificate number 0052503-03.
How do you inspect tubing?
With in-line laser gauges, automated vision systems, electronic microscopes and ultrasonic technologies, at the start of, during and after each run and before shipment, plus burst and tensile testing.
Do you support process validation?
Yes. Our JumpStart Validation Program supports your master validation plan, DV builds and submission, with OQ, PQ and PPAP as needed.
Can we audit your facility?
Yes. We welcome customer audits.
Planning a quality audit?
Send us your specs, drawing or just describe the problem. A member of our team will follow up personally to walk through tolerances, materials and schedule.
Start a project
Tell us about your part and our team will follow up personally.
Have full drawings and tolerances? Use our detailed request form.